Humalog

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  • Humalog
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Staðsetning

  • Fáanlegt í:
  • Humalog
    Evrópusambandið
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  • enska

Meðferðarupplýsingar

  • Meðferðarhópur:
  • Drugs used in diabetes,
  • Lækningarsvæði:
  • Diabetes Mellitus
  • Ábendingar:
  • For the treatment of adults and children with diabetes mellitus who require insulin for the maintenance of normal glucose homeostasis. Humalog is also indicated for the initial stabilisation of diabetes mellitus.
  • Vörulýsing:
  • Revision: 29

Staða

  • Heimild:
  • EMA - European Medicines Agency
  • Leyfisstaða:
  • Authorised
  • Leyfisnúmer:
  • EMEA/H/C/000088
  • Leyfisdagur:
  • 29-04-1996
  • EMEA númer:
  • EMEA/H/C/000088
  • Síðasta uppfærsla:
  • 27-03-2019

Opinber matsskýrsla

EMA/477399/2014

EMEA/H/C/000088

EPAR summary for the public

Humalog

insulin lispro

This is a summary of the European public assessment report (EPAR) for Humalog. It explains how the

Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in

favour of granting a marketing authorisation and its recommendations on the conditions of use for

Humalog.

What is Humalog?

Humalog is a range of solutions and suspensions for injection that contain the active substance insulin

lispro and are supplied in vials, cartridges and prefilled pens (Humalog KwikPen). The Humalog range

comprises fast-acting insulin solutions (Humalog), longer-acting insulin suspensions (Humalog Basal),

and combinations of both in various proportions (Humalog Mix):

Humalog: insulin lispro solution, available in a standard or a higher strength (100 or 200 units/ml);

Humalog Basal: insulin lispro protamine suspension;

Humalog Mix25: 25% insulin lispro solution and 75% insulin lispro protamine suspension;

Humalog Mix50: 50% insulin lispro solution and 50% insulin lispro protamine suspension.

What is Humalog used for?

Humalog is used to treat patients who have diabetes and need insulin to keep their blood glucose

(sugar) level controlled, including patients whose diabetes has just been diagnosed.

The medicine can only be obtained with a prescription.

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© European Medicines Agency, 2014. Reproduction is authorised provided the source is acknowledged.

How is Humalog used?

Humalog, Humalog Basal and Humalog Mix may be given by injection under the skin of the upper arm,

thigh, buttock or abdomen (tummy). Humalog 100 units/ml may also be given by continuous infusion

using an insulin pump or into a vein. Humalog 200 units/ml must only be injected under the skin, using

the KwikPen device in which it is supplied.

Humalog and Humalog Mix are normally given shortly before a meal, but they can be given just after a

meal if necessary. Humalog can be used with a longer-acting insulin or with sulphonylureas (a group of

diabetes medicines that are taken by mouth).

Patients can inject themselves with this medicine if they have been trained appropriately.

For further information, see the package leaflet.

How does Humalog work?

Diabetes is a disease in which the body does not produce enough insulin to control the level of glucose

in the blood or when the body is unable to use insulin effectively. Humalog is a replacement insulin

which is very similar to the insulin made by the body.

The active substance in Humalog, insulin lispro, is produced by a method known as ‘recombinant DNA

technology’: it is made by bacteria into which a gene (DNA) has been introduced, which makes them

able to produce insulin lispro.

Insulin lispro is very slightly different from human insulin. The difference means that insulin lispro is

absorbed faster by the body than human regular insulin, and can therefore act faster. Insulin lispro is

available as Humalog in the soluble form, which acts more or less immediately after injection, and as

Humalog Basal in the ‘protamine suspension’ form, which is absorbed much more slowly so that it

works for longer. Humalog Mix is a mixture of these two formulations.

The replacement insulin acts in same way as naturally produced insulin and helps glucose enter cells

from the blood. By controlling the level of blood glucose, the symptoms and complications of diabetes

are reduced.

How has Humalog been studied?

Humalog was originally studied in eight clinical trials including 2951 patients with type 1 diabetes

(when the body cannot produce insulin) or type 2 diabetes (when the body is unable to use insulin

effectively). The effectiveness of Humalog was compared with that of Humulin R (a soluble

recombinant DNA human insulin), when added to long-acting insulins given once or twice a day. The

studies measured the level of a substance in the blood called glycosylated haemoglobin (HbA1c), which

gives an indication of how well the blood glucose is controlled, and ‘fasting’ blood glucose levels

(measured when the patient had not eaten for at least eight hours). Studies also looked at the use of

Humalog in 542 patients aged between two and 19 years, and the use of Humalog in combination with

sulphonylureas.

What benefit has Humalog shown during the studies?

Humalog and Humulin R had a similar effect on the control of diabetes, as measured by HbA1c and

fasting glucose levels.

Humalog

EMA/477399/2014

Page 2/3

What is the risk associated with Humalog?

Humalog may cause hypoglycaemia (low blood glucose levels) and must not be given to patients

whose blood glucose is already low. Humalog doses might need to be adjusted when given with other

medicines that may have an effect on blood glucose levels.

Humalog Mix, Humalog Basal and Humalog 200 units/ml should never be given into a vein.

For the full list of all side effects and restrictions with Humalog, see the package leaflet.

Why has Humalog been approved?

The Committee for Medicinal products for Human Use (CHMP) decided that Humalog’s benefits are

greater than its risks for the treatment of patients with diabetes mellitus who require insulin for the

maintenance of normal glucose homeostasis, and for the initial stabilisation of diabetes mellitus. The

Committee recommended that Humalog be given marketing authorisation.

What measures are being taken to ensure the safe and effective use of

Humalog?

A risk management plan has been developed to ensure that Humalog is used as safely as possible.

Based on this plan, safety information has been included in the summary of product characteristics and

the package leaflet for Humalog, including the appropriate precautions to be followed by healthcare

professionals and patients.

In addition, the company that makes Humalog has provided information to patients and healthcare

professionals to remind them that there are two strengths of Humalog and to advise them on how to

use them safely to avoid medication errors.

Other information about Humalog

The European Commission granted a marketing authorisation valid throughout the European Union for

Humalog on 30 April 1996.

The full EPAR for Humalog can be found on the Agency’s website:

ema.europa.eu/Find

medicine/Human medicines/European public assessment reports. For more information about

treatment with Humalog, read the package leaflet (also part of the EPAR) or contact your doctor or

pharmacist.

This summary was last updated in 08-2014.

Humalog

EMA/477399/2014

Page 3/3

Upplýsingar um fylgiseðil sjúklinga: samsetning, vísbendingar, aukaverkanir, skammtar, milliverkanir, aukaverkanir, meðgöngu, brjóstagjöf

B. PACKAGE LEAFLET

PACKAGE LEAFLET: INFORMATION FOR THE USER

Humalog 100 units/ml, solution for injection in vial

insulin lispro

Read all of this leaflet carefully before you start using this medicine because it contains

important information for you.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,

even if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side

effects not listed in this leaflet. See section 4.

What is in this leaflet

What Humalog is and what it is used for

What you need to know before you use Humalog

How to use Humalog

Possible side effects

How to store Humalog

Contents of the pack and other information

1.

What Humalog is and what it is used for

Humalog is used to treat diabetes. Humalog works more quickly than normal human insulin because

the insulin molecule has been changed slightly.

You get diabetes if your pancreas does not make enough insulin to control the level of glucose in your

blood. Humalog is a substitute for your own insulin and is used to control glucose in the long term. It

works very quickly and lasts a shorter time than soluble insulin (2 to 5 hours). You should normally

use Humalog within 15 minutes of a meal.

Your doctor may tell you to use Humalog as well as a longer-acting insulin. Each kind of insulin

comes with another patient information leaflet to tell you about it. Do not change your insulin unless

your doctor tells you to. Be very careful if you do change insulin.

Humalog is suitable for use in adults and children.

2.

What you need to know before you use Humalog

Do NOT use Humalog

if you think

hypoglycaemia

(low blood sugar) is starting. Further in this leaflet it tells you how

to deal with mild hypoglycaemia (see Section 3: If you take more Humalog than you need).

if you are

allergic

to insulin lispro or any of the other ingredients of this medicine (listed in

section 6).

Warnings and precautions

If your blood sugar levels are well controlled by your current insulin therapy, you may not feel

the warning symptoms when your blood sugar is falling too low. Warning signs are listed later

in this leaflet. You must think carefully about when to have your meals, how often to exercise

and how much to do. You must also keep a close watch on your blood sugar levels by testing

your blood glucose often.

A few people who have had hypoglycaemia after switching from animal insulin to human

insulin have reported that the early warning symptoms were less obvious or different. If you

often have hypoglycaemia or have difficulty recognising it, please discuss this with your doctor.

If you answer YES to any of the following questions, tell your doctor, pharmacist or diabetes

nurse

Have you recently become ill?

Do you have trouble with your kidneys or liver?

Are you exercising more than usual?

The amount of insulin you need may also change if you drink alcohol.

You should also tell your doctor, pharmacist or diabetes nurse if you are planning to go abroad.

The time difference between countries may mean that you have to have your injections and

meals at different times from when you are at home.

Some patients with long-standing type 2 diabetes mellitus and heart disease or previous stroke

who were treated with pioglitazone and insulin experienced the development of heart failure.

Inform your doctor as soon as possible, if you experience signs of heart failure such as unusual

shortness of breath or rapid increase in weight or localised swelling (oedema).

Other medicines and Humalog

Your insulin needs may change if you are taking

the contraceptive pill,

steroids,

thyroid hormone replacement therapy,

oral hypoglycaemics,

acetyl salicylic acid,

sulpha antibiotics,

octreotide,

“beta

stimulants” (for example ritodrine, salbutamol or terbutaline),

beta-blockers, or

some antidepressants (monoamine oxidase inhibitors or selective serotonin reuptake inhibitors),

danazol,

some angiotensin converting enzyme (ACE) inhibitors (for example captopril, enalapril), and

angiotensin II receptor blockers.

Please tell your doctor, if you are taking or have recently taken any other medicines, including

medicines obtained without a prescription (see section “Warnings and precautions”).

Pregnancy and breast-feeding

Are you pregnant or thinking about becoming pregnant, or are you breast-feeding? The amount of

insulin you need usually falls during the first three months of pregnancy and increases for the

remaining six months. If you are breast-feeding, you may need to alter your insulin intake or diet.

Ask your doctor for advice.

Driving and using machines

Your ability to concentrate and react may be reduced if you have hypoglycaemia. Please keep this

possible problem in mind in all situations where you might put yourself and others at risk (e.g. driving

a car or operating machinery). You should contact your doctor about the advisability of driving if you

have:

frequent episodes of hypoglycaemia

reduced or absent warning signs of hypoglycaemia

Important information about some of the ingredients of Humalog

This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-

free’.

3.

How to use Humalog

Always check the pack and the vial label for the name and type of the insulin when you get it

from your pharmacy. Make sure you get the Humalog that your doctor has told you to use.

Always use Humalog exactly as your doctor has told you. You should check with your doctor if you

are not sure.

Dosage

You should normally inject Humalog within 15 minutes of a meal. If you need to, you can inject

soon after a meal. But your doctor will have told you exactly how much to use, when to use it,

and how often. These instructions are only for you. Follow them exactly and visit your diabetes

clinic regularly.

If you change the type of insulin you use (for example from a human or animal insulin to a

Humalog product), you may have to take more or less than before. This might just be for the

first injection or it may be a gradual change over several weeks or months.

Inject Humalog under the skin. You should only inject it into a muscle if your doctor has told

you to.

Preparing Humalog

Humalog is already dissolved in water, so you do not need to mix it. But you must use it

only

it looks like water. It must be clear, have no colour and no solid pieces in it. Check each time

you inject yourself.

Injecting Humalog

First wash your hands.

Before you make an injection, clean your skin as you have been instructed. Clean the rubber

stopper on the vial, but do not remove the stopper.

Use a clean, sterile syringe and needle to pierce the rubber stopper and draw in the amount of

Humalog you want. Your doctor or clinic will tell you how to do this.

Do not share your

needles and syringes.

Inject under the skin, as you were taught. Do not inject directly into a vein. After your injection,

leave the needle in the skin for five seconds to make sure you have taken the whole dose. Do

not rub the area you have just injected. Make sure you inject at least half an inch (1 cm) from

the last injection and that you ‘rotate’ the places you inject, as you have been taught. It doesn’t

matter which injection site you use, either upper arm, thigh, buttock or abdomen, your Humalog

injection will still work quicker than soluble human insulin.

Your doctor will tell you if you have to mix Humalog with one of the human insulins. For

example if you do need to inject a mixture, draw the Humalog into the syringe before the long

acting insulin. Inject the liquid as soon as you have mixed it. Do the same thing every time. You

should not normally mix Humalog with one of the mixtures of human insulins. You should

never mix Humalog with insulins produced by other manufacturers or animal insulins.

You must not administer Humalog by the intravenous route. Inject Humalog as your physician

or nurse has taught you. Only your physician can administer Humalog by the intravenous route.

He will only do this under special circumstances such as surgery or if you are ill and your

glucose levels are too high.

Using Humalog in an infusion pump

Only certain CE-marked insulin infusion pumps may be used to infuse insulin lispro. Before

infusing insulin lispro, the manufacturers instructions should be studied to ascertain the

suitability or otherwise for the particular pump. Read and follow the instructions in the product

literature supplied with the infusion pump.

Be sure to use the correct reservoir and catheter for your pump.

Changing of the infusion set (tubing and needle) must be done according to the instructions in

the product information supplied with the infusion set.

In the event of a hypoglycaemic episode, the infusion should be stopped until the episode is

resolved. If repeated or severe low blood glucose levels occur, notify your doctor or clinic and

consider the need to reduce or stop your insulin infusion.

A pump malfunction or obstruction of the infusion set can result in a rapid rise in glucose levels.

If an interruption to insulin flow is suspected, follow the instructions in the product literature

and if appropriate, notify your doctor or clinic.

When used with an insulin infusion pump, Humalog should not be mixed with any other insulin.

If you take more Humalog than you need

If you take more Humalog than you need, a low blood sugar may occur. Check your blood sugar.

If your blood sugar is low

(mild hypoglycaemia)

, eat glucose tablets, sugar or drink a sugary drink.

Then eat fruit, biscuits, or a sandwich, as your doctor has advised you and have some rest. This will

often get you over mild hypoglycaemia or a minor insulin overdose. If you get worse and your

breathing is shallow and your skin gets pale, tell your doctor at once. A glucagon injection can treat

quite severe hypoglycaemia. Eat glucose or sugar after the glucagon injection. If you do not respond to

glucagon, you will have to go to hospital. Ask your doctor to tell you about glucagon.

If you forget to use Humalog

If you take less Humalog than you need, a high blood sugar may occur. Check your blood sugar.

If hypoglycaemia (low blood sugar) or hyperglycaemia (high blood sugar) is not treated they can be

very serious and cause headaches, nausea, vomiting, dehydration, unconsciousness, coma or even

death (see A and B in section 4 “Possible Side Effects”).

Three simple steps

to avoid hypoglycaemia or hyperglycaemia are:

Always keep spare syringes and a spare vial of Humalog.

Always carry something to show you are diabetic.

Always carry sugar with you.

If you stop using Humalog.

If you take less Humalog than you need, a high blood sugar may occur. Do not change your insulin

unless your doctor tells you to.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Systemic allergy is rare (

1/10,000 to <1/1,000). The symptoms are as follows:

rash over the whole body

blood pressure dropping

difficulty in breathing

heart beating fast

wheezing

sweating.

If you think you are having this sort of insulin allergy with Humalog, tell your doctor at once.

Local allergy is common (

1/100 to <1/10). Some people get redness, swelling or itching around the

area of the insulin injection. This usually clears up in anything from a few days to a few weeks. If this

happens to you, tell your doctor.

Lipodystrophy (thickening or pitting of the skin) is uncommon (

1/1,000 to <1/100). If you notice

your skin thickening or pitting at the injection site, tell your doctor.

Oedema (e.g. swelling in arms, ankles; fluid retention) has been reported, particularly at the start of

insulin therapy or during a change in therapy to improve control of your blood glucose.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects

not listed in this leaflet.

You can also report side effects directly via the national reporting system

listed in Appendix V. By reporting side effects you can help provide more information on the safety of

this medicine.

Common problems of diabetes

A.

Hypoglycaemia

Hypoglycaemia (low blood sugar) means there is not enough sugar in the blood. This can be caused if:

you take too much Humalog or other insulin;

you miss or delay meals or change your diet;

you exercise or work too hard just before or after a meal;

you have an infection or illness (especially diarrhoea or vomiting);

there is a change in your need for insulin; or

you have trouble with your kidneys or liver which gets worse.

Alcohol and some medicines can affect your blood sugar levels.

The first symptoms of low blood sugar usually come on quickly and include the following:

tiredness

rapid heartbeat

nervousness or shakiness

feeling sick

headache

cold sweat.

While you are not confident about recognising your warning symptoms, avoid situations, e.g. driving a

car, in which you or others would be put at risk by hypoglycaemia.

B.

Hyperglycaemia and diabetic ketoacidosis

Hyperglycaemia (too much sugar in the blood) means that your body does not have enough insulin.

Hyperglycaemia can be brought about by:

not taking your Humalog or other insulin;

taking less insulin than your doctor tells you to;

eating a lot more than your diet allows; or

fever, infection or emotional stress.

Hyperglycaemia can lead to diabetic ketoacidosis. The first symptoms come on slowly over many

hours or days. The symptoms include the following:

feeling sleepy

no appetite

flushed face

fruity smell on the breath

thirst

feeling or being sick

Severe symptoms are heavy breathing and a rapid pulse.

Get medical help immediately.

C.

Illness

If you are ill, especially if you feel sick or are sick, the amount of insulin you need may change.

Even

when you are not eating normally, you still need insulin.

Test your urine or blood, follow your

‘sick rules’, and tell your doctor.

5.

How to store Humalog

Before the first use store your Humalog in a refrigerator (2

C – 8

C). Do not freeze. Keep your vial in

use in a refrigerator (2°C – 8°C) or at room temperature up to 30°C and discard after 28 days. Do not

put it near heat or in the sun.

Keep out of the reach and sight of children.

Do not use this medicine after the expiry date which is stated on the label and the carton. The expiry

date refers to the last day of that month.

Do not use this medicine if you notice it is coloured or it has solid pieces in it. You must use it

only

it looks like water. Check this each time you inject yourself.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to

dispose of medicines no longer required. These measures will help to protect the environment.

6.

Contents of the pack and other information

What Humalog 100 units/ml solution for injection in vial contains

The active substance is insulin lispro. Insulin lispro is made in the laboratory by a ‘recombinant

DNA technology’ process. It is a changed form of human insulin and so is different from other

human and animal insulins. Insulin lispro is closely related to human insulin which is a natural

hormone made by the pancreas.

The other ingredients are m-cresol, glycerol, dibasic sodium phosphate 7 H

O, zinc oxide and

water for injection. Sodium hydroxide or hydrochloric acid may have been used to adjust the

acidity.

What Humalog looks like and contents of the pack

Humalog 100 units/ml, solution for injection is a sterile, clear, colourless, aqueous solution and

contains 100 units of insulin lispro in each millilitre (100 units/ml) solution for injection. Each vial

contains 1000 units (10 millilitres). Humalog 100 units/ml, solution for injection in vial comes in a

pack of 1 vial, 2 vials or a multipack of 5 x 1 vial. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Humalog 100 units/ml, solution for injection in vial is made by:

Lilly S.A., Avda. de la Industria 30, 28108 Alcobendas, Madrid, Spain.

The product licence is held by: Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The

Netherlands.

For any information about this medicinal product, please contact the local representative of the

Marketing Authorisation Holder:

Belgique/België/Belgien

Eli Lilly Benelux S.A./N.V.

Tél/Tel: + 32-(0)2 548 84 84

Lietuva

Eli Lilly Holdings Limited atstovybė

Tel. +370 (5) 2649600

България

ТП "Ели Лили Недерланд" Б.В. - България

тел. + 359 2 491 41 40

Luxembourg/Luxemburg

Eli Lilly Benelux S.A./N.V.

Tél/Tel: + 32-(0)2 548 84 84

Česká republika

ELI LILLY ČR, s.r.o.

Tel: + 420 234 664 111

Magyarország

Lilly Hungária Kft.

Tel: + 36 1 328 5100

Danmark

Eli Lilly Danmark A/S

Tlf: +45 45 26 6000

Malta

Charles de Giorgio Ltd.

Tel: + 356 25600 500

Deutschland

Lilly Deutschland GmbH

Tel. + 49-(0) 6172 273 2222

Nederland

Eli Lilly Nederland B.V.

Tel: + 31-(0) 30 60 25 800

Eesti

Eli Lilly Holdings Limited Eesti filiaal

Tel:

+

372 6817 280

Norge

Eli Lilly Norge A.S.

Tlf: + 47 22 88 18 00

Ελλάδα

ΦΑΡΜΑΣΕΡΒ-ΛΙΛΛΥ Α.Ε.Β.Ε.

Τηλ: +30 210 629 4600

Österreich

Eli Lilly Ges. m.b.H.

Tel: + 43-(0) 1 711 780

España

Lilly S.A.

Tel: + 34-91 663 50 00

Polska

Eli Lilly Polska Sp. z o.o.

Tel: +48 22 440 33 00

France

Lilly France S.A.S.

Tél: +33-(0) 1 55 49 34 34

Portugal

Lilly Portugal - Produtos Farmacêuticos, Lda

Tel: + 351-21-4126600

Hrvatska

Eli Lilly Hrvatska d.o.o.

Tel: +385 1 2350 999

România

Eli Lilly România S.R.L.

Tel: + 40 21 4023000

Ireland

Eli Lilly and Company (Ireland) Limited

Tel: + 353-(0) 1 661 4377

Slovenija

Eli Lilly farmacevtska družba, d.o.o.

Tel: +386 (0) 1 580 00 10

Ísland

Icepharma hf.

Sími + 354 540 8000

Slovenská republika

Eli Lilly Slovakia, s.r.o.

Tel: + 421 220 663 111

Italia

Eli Lilly Italia S.p.A.

Tel: + 39- 055 42571

Suomi/Finland

Oy Eli Lilly Finland Ab

Puh/Tel: + 358-(0) 9 85 45 250

Κύπρος

Phadisco Ltd

Τηλ: +357 22 715000

Sverige

Eli Lilly Sweden AB

Tel: + 46-(0) 8 7378800

Latvija

Eli Lilly Holdings Limited pārstāvniecība Latvijā

Tel:

+

371 67364000

United Kingdom

Eli Lilly and Company Limited

Tel: + 44-(0) 1256 315000

This leaflet was last revised in

{MM/YYYY}.

Detailed information on this medicine is available on the European Medicines Agency web site:

http://www.ema.europa.eu/.

PACKAGE LEAFLET: INFORMATION FOR THE USER

Humalog 100 units/ml, solution for injection in cartridge

insulin lispro

Read all of this leaflet carefully before you start using this medicine because it contains

important information for you.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,

even if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side

effects not listed in this leaflet. See section 4.

What is in this leaflet

What Humalog is and what it is used for

What you need to know before you use Humalog

How to use Humalog

Possible side effects

How to store Humalog

Contents of the pack and other information

1.

What Humalog is and what it is used for

Humalog is used to treat diabetes. Humalog works more quickly than normal human insulin because

the insulin molecule has been changed slightly.

You get diabetes if your pancreas does not make enough insulin to control the level of glucose in your

blood. Humalog is a substitute for your own insulin and is used to control glucose in the long term. It

works very quickly and lasts a shorter time than soluble insulin (2 to 5 hours). You should normally

use Humalog within 15 minutes of a meal.

Your doctor may tell you to use Humalog as well as a longer-acting insulin. Each kind of insulin

comes with another patient information leaflet to tell you about it. Do not change your insulin unless

your doctor tells you to. Be very careful if you do change insulin.

Humalog is suitable for use in adults and children.

2.

What you need to know before you use Humalog

Do NOT use Humalog

if you think

hypoglycaemia

(low blood sugar) is starting. Further in this leaflet it tells you how to

deal with mild hypoglycaemia (see Section 3: If you take more Humalog than you need).

if you are

allergic

to insulin lispro or any of the other ingredients of this medicine (listed in

section 6).

Warnings and precautions

If your blood sugar levels are well controlled by your current insulin therapy, you may not feel the

warning symptoms when your blood sugar is falling too low. Warning signs are listed later in this

leaflet. You must think carefully about when to have your meals, how often to exercise and how

much to do. You must also keep a close watch on your blood sugar levels by testing your blood

glucose often.

A few people who have had hypoglycaemia after switching from animal insulin to human insulin

have reported that the early warning symptoms were less obvious or different. If you often have

hypoglycaemia or have difficulty recognising it, please discuss this with your doctor.

If you answer YES to any of the following questions, tell your doctor, pharmacist or diabetes nurse

Have you recently become ill?

Do you have trouble with your kidneys or liver?

Are you exercising more than usual?

The amount of insulin you need may also change if you drink alcohol.

You should also tell your doctor, pharmacist or diabetes nurse if you are planning to go abroad.

The time difference between countries may mean that you have to have your injections and meals

at different times from when you are at home.

Some patients with long-standing type 2 diabetes mellitus and heart disease or previous stroke who

were treated with pioglitazone and insulin experienced the development of heart failure. Inform

your doctor as soon as possible, if you experience signs of heart failure such as unusual shortness

of breath or rapid increase in weight or localised swelling (oedema).

Other medicines and Humalog

Your insulin needs may change if you are taking

the contraceptive pill,

steroids,

thyroid hormone replacement therapy,

oral hypoglycaemics,

acetyl salicylic acid,

sulpha antibiotics,

octreotide,

“beta

stimulants” (for example ritodrine, salbutamol or terbutaline),

beta-blockers, or

some antidepressants (monoamine oxidase inhibitors or selective serotonin reuptake inhibitors),

danazol,

some angiotensin converting enzyme (ACE) inhibitors (for example captopril, enalapril), and

angiotensin II receptor blockers.

Please tell your doctor, if you are taking or have recently taken any other medicines, including

medicines obtained without a prescription (see section “Warnings and precautions”).

Pregnancy and breast-feeding

Are you pregnant or thinking about becoming pregnant, or are you breast-feeding? The amount of

insulin you need usually falls during the first three months of pregnancy and increases for the

remaining six months. If you are breast-feeding, you may need to alter your insulin intake or diet.

Ask your doctor for advice.

Driving and using machines

Your ability to concentrate and react may be reduced if you have hypoglycaemia. Please keep this

possible problem in mind in all situations where you might put yourself and others at risk (e.g. driving

a car or operating machinery). You should contact your doctor about the advisability of driving if you

have:

frequent episodes of hypoglycaemia

reduced or absent warning signs of hypoglycaemia

Important information about some of the ingredients of Humalog

This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-

free’.

3.

How to use Humalog

The 3 ml cartridge is only for use in Lilly 3 ml pens. It is not for use in 1.5 ml pens.

Always check the pack and the cartridge label for the name and type of the insulin when you get

it from your pharmacy. Make sure you get the Humalog that your doctor has told you to use.

Always use Humalog exactly as your doctor has told you. You should check with your doctor if you

are not sure. To prevent the possible transmission of disease, each cartridge must be used by you only,

even if the needle on the delivery device is changed.

Dosage

You should normally inject Humalog within 15 minutes of a meal. If you need to, you can inject

soon after a meal. But your doctor will have told you exactly how much to use, when to use it,

and how often. These instructions are only for you. Follow them exactly and visit your diabetes

clinic regularly.

If you change the type of insulin you use (for example from a human or animal insulin to a

Humalog product), you may have to take more or less than before. This might just be for the

first injection or it may be a gradual change over several weeks or months.

Inject Humalog under the skin. You should only inject it into a muscle if your doctor has told

you to.

Preparing Humalog

Humalog is already dissolved in water, so you do not need to mix it. But you must use it

only

it looks like water. It must be clear, have no colour and no solid pieces in it. Check each time

you inject yourself.

Getting the pen ready to use

First wash your hands. Disinfect the rubber membrane of the cartridge.

You must only use Humalog cartridges in Lilly insulin pens. Please make sure that

Humalog or Lilly cartridges are mentioned in the leaflet accompanying your pen. The

3 ml cartridge only fits the 3 ml pen.

Follow the instructions that come with the pen. Put the cartridge into the pen.

You will set the dose to 1 or 2 units. Then hold the pen with the needle pointing up and tap the

side of the pen so that any bubbles float to the top. With the pen still pointing up, press the

injection mechanism. Do this until a drop of Humalog comes out of the needle. There may still

be some small air bubbles left in the pen. These are harmless, but if the air bubble is too big, it

may make the dose of your injection less accurate.

Injecting Humalog

Before you make an injection, clean your skin as you have been instructed. Inject under the

skin, as you were taught. Do not inject directly into a vein. After your injection, leave the needle

in the skin for five seconds to make sure you have taken the whole dose. Do not rub the area

you have just injected. Make sure you inject at least half an inch (1 cm) from the last injection

and that you ‘rotate’ the places you inject, as you have been taught. It doesn’t matter which

injection site you use, either upper arm, thigh, buttock or abdomen, your Humalog injection will

still work quicker than soluble human insulin.

You must not administer Humalog by the intravenous route. Inject Humalog as your physician

or nurse has taught you. Only your physician can administer Humalog by the intravenous route.

He will only do this under special circumstances such as surgery or if you are ill and your

glucose levels are too high.

After injecting

As soon as you have done the injection, take the needle off the pen using the outer needle cap.

This will keep the Humalog sterile and prevent leaking. It will also stop air going back into the

pen and the needle clogging up.

Do not share your needles.

Do not share your pen. Replace the

cap on your pen. Leave the cartridge in the pen.

Further injections

Before every injection, dial 1 or 2 units and press the injection mechanism with the pen pointing

up until a drop of Humalog comes out of the needle. You can see how much Humalog is left by

looking at the gauge on the side of the cartridge. The distance between each mark on the gauge

is about 20 units. If there is not enough for your dose, change the cartridge.

Do not mix any other insulin in a Humalog cartridge. Once the cartridge is empty, do not use it

again.

Using Humalog in an infusion pump

Only certain CE-marked insulin infusion pumps may be used to infuse insulin lispro. Before

infusing insulin lispro, the manufacturers instructions should be studied to ascertain the

suitability or otherwise for the particular pump. Read and follow the instructions in the product

literature supplied with the infusion pump.

Be sure to use the correct reservoir and catheter for your pump.

Changing of the infusion set (tubing and needle) must be done according to the instructions in

the product information supplied with the infusion set.

In the event of a hypoglycaemic episode, the infusion should be stopped until the episode is

resolved. If repeated or severe low blood glucose levels occur, notify your doctor or clinic and

consider the need to reduce or stop your insulin infusion.

A pump malfunction or obstruction of the infusion set can result in a rapid rise in glucose levels.

If an interruption to insulin flow is suspected, follow the instructions in the product literature

and if appropriate, notify your doctor or clinic.

When used with an insulin infusion pump, Humalog should not be mixed with any other insulin.

If you take more Humalog than you need

If you take more Humalog than you need, a low blood sugar may occur. Check your blood sugar.

If your blood sugar is low

(mild hypoglycaemia)

, eat glucose tablets, sugar or drink a sugary drink.

Then eat fruit, biscuits, or a sandwich, as your doctor has advised you and have some rest. This will

often get you over mild hypoglycaemia or a minor insulin overdose. If you get worse and your

breathing is shallow and your skin gets pale, tell your doctor at once. A glucagon injection can treat

quite severe hypoglycaemia. Eat glucose or sugar after the glucagon injection. If you do not respond to

glucagon, you will have to go to hospital. Ask your doctor to tell you about glucagon.

If you forget to use Humalog

If you take less Humalog than you need, a high blood sugar may occur. Check your blood sugar

If hypoglycaemia (low blood sugar) or hyperglycaemia (high blood sugar) is not treated they can be

very serious and cause headaches, nausea, vomiting, dehydration, unconsciousness, coma or even

death (see A and B in section 4 “Possible Side Effects”).

Three simple steps

to avoid hypoglycaemia or hyperglycaemia are:

Always keep spare syringes and a spare vial of Humalog, or a spare pen and cartridges, in case

you lose your pen or cartridges or they get damaged.

Always carry something to show you are diabetic.

Always carry sugar with you.

If you stop using Humalog.

If you take less Humalog than you need, a high blood sugar may occur. Do not change your insulin

unless your doctor tells you to.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Systemic allergy is rare (

1/10,000 to <1/1,000). The symptoms are as follows:

rash over the whole body

blood pressure dropping

difficulty in breathing

heart beating fast

wheezing

sweating

If you think you are having this sort of insulin allergy with Humalog, tell your doctor at once.

Local allergy is common (

1/100 to <1/10). Some people get redness, swelling or itching around the

area of the insulin injection. This usually clears up in anything from a few days to a few weeks. If this

happens to you, tell your doctor.

Lipodystrophy (thickening or pitting of the skin) is uncommon (

1/1,000 to <1/100). If you notice

your skin thickening or pitting at the injection site, tell your doctor.

Oedema (e.g. swelling in arms, ankles; fluid retention) has been reported, particularly at the start of

insulin therapy or during a change in therapy to improve control of your blood glucose.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects

not listed in this leaflet.

You can also report side effects directly via the national reporting system

listed in Appendix V. By reporting side effects you can help provide more information on the safety of

this medicine.

Common problems of diabetes

A.

Hypoglycaemia

Hypoglycaemia (low blood sugar) means there is not enough sugar in the blood. This can be caused if:

you take too much Humalog or other insulin;

you miss or delay meals or change your diet;

you exercise or work too hard just before or after a meal;

you have an infection or illness (especially diarrhoea or vomiting);

there is a change in your need for insulin; or

you have trouble with your kidneys or liver which gets worse.

Alcohol and some medicines can affect your blood sugar levels.

The first symptoms of low blood sugar usually come on quickly and include the following:

tiredness

rapid heartbeat

nervousness or shakiness

feeling sick

headache

cold sweat.

While you are not confident about recognising your warning symptoms, avoid situations, e.g. driving a

car, in which you or others would be put at risk by hypoglycaemia.

B.

Hyperglycaemia and diabetic ketoacidosis

Hyperglycaemia (too much sugar in the blood) means that your body does not have enough insulin.

Hyperglycaemia can be brought about by:

not taking your Humalog or other insulin;

taking less insulin than your doctor tells you to;

eating a lot more than your diet allows; or

fever, infection or emotional stress.

Hyperglycaemia can lead to diabetic ketoacidosis. The first symptoms come on slowly over many

hours or days. The symptoms include the following:

feeling sleepy

no appetite

flushed face

fruity smell on the breath

thirst

feeling or being sick.

Severe symptoms are heavy breathing and a rapid pulse.

Get medical help immediately.

C.

Illness

If you are ill, especially if you feel sick or are sick, the amount of insulin you need may change.

Even

when you are not eating normally, you still need insulin.

Test your urine or blood, follow your

‘sick rules’, and tell your doctor.

5.

How to store Humalog

Before the first use store your Humalog in a refrigerator (2

C – 8

C). Do not freeze.

Keep your cartridge in use at room temperature (15° - 30°C) and discard after 28 days. Do not put it

near heat or in the sun. Do not keep your pen or the cartridges you are using in the fridge. The pen

with the inserted cartridge should not be stored with the needle attached.

Keep out of the reach and sight of children.

Do not use this medicine after the expiry date which is stated on the label and the carton. The expiry

date refers to the last day of that month.

Do not use this medicine if you notice it is coloured or it has solid pieces in it. You must use it

only

it looks like water. Check this each time you inject yourself.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to

dispose of medicines no longer required. These measures will help to protect the environment.

6.

Contents of the pack and other information

What Humalog 100 units/ml solution for injection in cartridge contains

The active substance is insulin lispro. Insulin lispro is made in the laboratory by a ‘recombinant

DNA technology’ process. It is a changed form of human insulin and so is different from other

human and animal insulins. Insulin lispro is closely related to human insulin which is a natural

hormone made by the pancreas.

The other ingredients are m-cresol, glycerol, dibasic sodium phosphate 7 H

O, zinc oxide and

water for injection. Sodium hydroxide or hydrochloric acid may have been used to adjust the

acidity.

What Humalog looks like and contents of the pack

Humalog 100 units/ml, solution for injection is a sterile, clear, colourless, aqueous solution and

contains 100 units of insulin lispro in each millilitre (100 units/ml) solution for injection. Each

cartridge contains 300 units (3 millilitres). The cartridges come in packs of 5 or10 cartridges. Not all

pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Humalog 100 units/ml, solution for injection in cartridge

is made by:

Lilly France S.A.S., Rue du Colonel Lilly, 67640 Fegersheim, France,

Eli Lilly Italia S.p.A., Via Gramsci 731-733, 50019 Sesto Fiorentino, (FI) Italy.

The product licence is held by: Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The

Netherlands.

For any information about this medicinal product, please contact the local representative of the

Marketing Authorisation Holder:

Belgique/België/Belgien

Eli Lilly Benelux S.A./N.V.

Tél/Tel: + 32-(0)2 548 84 84

Lietuva

Eli Lilly Holdings Limited atstovybė

Tel. +370 (5) 2649600

България

ТП "Ели Лили Недерланд" Б.В. - България

тел. + 359 2 491 41 40

Luxembourg/Luxemburg

Eli Lilly Benelux S.A./N.V.

Tél/Tel: + 32-(0)2 548 84 84

Česká republika

ELI LILLY ČR, s.r.o.

Tel: + 420 234 664 111

Magyarország

Lilly Hungária Kft.

Tel: + 36 1 328 5100

Danmark

Eli Lilly Danmark A/S

Tlf: +45 45 26 6000

Malta

Charles de Giorgio Ltd.

Tel: + 356 25600 500

Deutschland

Lilly Deutschland GmbH

Tel. + 49-(0) 6172 273 2222

Nederland

Eli Lilly Nederland B.V.

Tel: + 31-(0) 30 60 25 800

Eesti

Eli Lilly Holdings Limited Eesti filiaal

Tel:

+

372 6817 280

Norge

Eli Lilly Norge A.S.

Tlf: + 47 22 88 18 00

Ελλάδα

ΦΑΡΜΑΣΕΡΒ-ΛΙΛΛΥ Α.Ε.Β.Ε.

Τηλ: +30 210 629 4600

Österreich

Eli Lilly Ges. m.b.H.

Tel: + 43-(0) 1 711 780

España

Lilly S.A.

Tel: + 34-91 663 50 00

Polska

Eli Lilly Polska Sp. z o.o.

Tel: +48 22 440 33 00

France

Lilly France S.A.S.

Tél: +33-(0) 1 55 49 34 34

Portugal

Lilly Portugal - Produtos Farmacêuticos, Lda

Tel: + 351-21-4126600

Hrvatska

Eli Lilly Hrvatska d.o.o.

Tel: +385 1 2350 999

România

Eli Lilly România S.R.L.

Tel: + 40 21 4023000

Ireland

Eli Lilly and Company (Ireland) Limited

Tel: + 353-(0) 1 661 4377

Slovenija

Eli Lilly farmacevtska družba, d.o.o.

Tel: +386 (0) 1 580 00 10

Ísland

Icepharma hf.

Sími + 354 540 8000

Slovenská republika

Eli Lilly Slovakia, s.r.o.

Tel: + 421 220 663 111

Italia

Eli Lilly Italia S.p.A.

Tel: + 39- 055 42571

Suomi/Finland

Oy Eli Lilly Finland Ab

Puh/Tel: + 358-(0) 9 85 45 250

Κύπρος

Phadisco Ltd

Τηλ: +357 22 715000

Sverige

Eli Lilly Sweden AB

Tel: + 46-(0) 8 7378800

Latvija

Eli Lilly Holdings Limited pārstāvniecība Latvijā

Tel:

+

371 67364000

United Kingdom

Eli Lilly and Company Limited

Tel: + 44-(0) 1256 315000

This leaflet was last revised in

{MM/YYYY}.

Detailed information on this medicine is available on the European Medicines Agency web site:

http://www.ema.europa.eu/.

PACKAGE LEAFLET: INFORMATION FOR THE USER

Humalog Mix25 100 units/ml, suspension for injection in vial

insulin lispro

Read all of this leaflet carefully before you start using this medicine because it contains

important information for you.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,

even if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side

effects not listed in this leaflet. See section 4.

What is in this leaflet

What Humalog Mix25 is and what it is used for

What you need to know before you use Humalog Mix25

How to use Humalog Mix25

Possible side effects

How to store Humalog Mix25

Contents of the pack and other information

1.

What Humalog Mix25 is and what it is used for

Humalog Mix25 is used to treat diabetes. Humalog Mix25 is a premixed suspension. Its active

substance is insulin lispro. 25% of the insulin lispro in Humalog Mix25 is dissolved in water and it

works more quickly than normal human insulin because the insulin molecule has been changed

slightly. 75% of the insulin lispro in Humalog Mix25 is available in a suspension together with

protamine sulphate, so that its action is prolonged.

You get diabetes if your pancreas does not make enough insulin to control the level of glucose in

your blood. Humalog Mix25 is a substitute for your own insulin and is used to control glucose in the

long term. Humalog Mix25 works very quickly and longer than soluble insulin. You should

normally use Humalog Mix25 within 15 minutes of a meal.

Your doctor may tell you to use Humalog Mix25 as well as a longer-acting insulin. Each kind of

insulin comes with another patient information leaflet to tell you about it. Do not change your

insulin unless your doctor tells you to. Be very careful if you do change insulin.

2.

What you need to know before you use Humalog Mix25

Do NOT use Humalog Mix25

if you think

hypoglycaemia

(low blood sugar) is starting. Further in this leaflet it tells you how to

deal with mild hypoglycaemia (see Section 3: If you take more Humalog Mix25than you need).

if you are

allergic

to insulin lispro or any of the other ingredients of this medicine (listed in

section 6).

Warnings and precautions

If your blood sugar levels are well controlled by your current insulin therapy, you may not feel the

warning symptoms when your blood sugar is falling too low. Warning signs are listed later in this

leaflet. You must think carefully about when to have your meals, how often to exercise and how

much to do. You must also keep a close watch on your blood sugar levels by testing your blood

glucose often.

A few people who have had hypoglycaemia after switching from animal insulin to human insulin

have reported that the early warning symptoms were less obvious or different. If you often have

hypoglycaemia or have difficulty recognising them, please discuss this with your doctor.

If you answer YES to any of the following questions, tell your doctor, pharmacist or diabetes

nurse

Have you recently become ill?

Do you have trouble with your kidneys or liver?

Are you exercising more than usual?

The amount of insulin you need may also change if you drink alcohol.

You should also tell your doctor, pharmacist or diabetes nurse if you are planning to go abroad.

The time difference between countries may mean that you have to have your injections and meals

at different times from when you are at home.

Some patients with long-standing type 2 diabetes mellitus and heart disease or previous stroke

who were treated with pioglitazone and insulin experienced the development of heart failure.

Inform your doctor as soon as possible, if you experience signs of heart failure such as unusual

shortness of breath or rapid increase in weight or localised swelling (oedema).

Other medicines and Humalog Mix25

Your insulin needs may change if you are taking

the contraceptive pill,

steroids,

thyroid hormone replacement therapy,

oral hypoglycaemics,

acetyl salicylic acid,

sulpha antibiotics,

octreotide,

“beta

stimulants” (for example ritodrine, salbutamol or terbutaline),

beta-blockers, or

some antidepressants (monoamine oxidase inhibitors or selective serotonin reuptake inhibitors),

danazol,

some angiotensin converting enzyme (ACE) inhibitors (for example captopril, enalapril), and

angiotensin II receptor blockers.

Please tell your doctor, if you are taking or have recently taken any other medicines, including

medicines obtained without a prescription (see section “Warnings and precautions”).

Pregnancy and breast-feeding

Are you pregnant or thinking about becoming pregnant, or are you breast-feeding? The amount of

insulin you need usually falls during the first three months of pregnancy and increases for the

remaining six months. If you are breast-feeding, you may need to alter your insulin intake or diet.

Ask your doctor for advice.

Driving and using machines

Your ability to concentrate and react may be reduced if you have hypoglycaemia. Please keep this

possible problem in mind in all situations where you might put yourself and others at risk (e.g. driving

a car or operating machinery). You should contact your doctor about the advisability of driving if you

have:

frequent episodes of hypoglycaemia

reduced or absent warning signs of hypoglycaemia

Important information about some of the ingredients of Humalog Mix25

This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-

free’.

3.

How to use Humalog Mix25

Always check the pack and the vial label for the name and type of the insulin when you get it

from your pharmacy. Make sure you get the Humalog Mix25 that your doctor has told you to

use.

Always use Humalog Mix25 exactly as your doctor has told you. You should check with your doctor

if you are not sure.

Dosage

You should normally inject Humalog Mix25 within 15 minutes of a meal. If you need to, you

can inject soon after a meal. But your doctor will have told you exactly how much to use,

when to use it, and how often. These instructions are only for you. Follow them exactly and

visit your diabetes clinic regularly.

If you change the type of insulin you use (for example from a human or animal insulin to a

Humalog product), you may have to take more or less than before. This might just be for the

first injection or it may be a gradual change over several weeks or months.

Inject Humalog Mix25 under the skin. You should not administer it using a different

administration route. Under no circumstances should Humalog Mix25 be given intravenously.

Preparing Humalog Mix25

Vials containing Humalog Mix25 should be rotated in the palms of the hands before use to

resuspend insulin until it appears uniformly cloudy or milky. Do not shake vigorously as this

may cause frothing which may interfere with the correct measurement of the dose. The vials

should be examined frequently and should not be used if clumps of material are present or if

solid white particles stick to the bottom or wall of the vial, giving it a frosted appearance.

Check each time you inject yourself.

Injecting Humalog Mix25

First wash your hands.

Before you make an injection, clean your skin as you have been instructed. Clean the rubber

stopper on the vial, but do not remove the stopper.

Use a clean, sterile syringe and needle to pierce the rubber stopper and draw in the amount of

Humalog Mix25 you want. Your doctor or clinic will tell you how to do this.

Do not share

your needles and syringes.

Inject under the skin, as you were taught. Do not inject directly into a vein. After your

injection, leave the needle in the skin for five seconds to make sure you have taken the whole

dose. Do not rub the area you have just injected. Make sure you inject at least half an inch (1

cm) from the last injection and that you ‘rotate’ the places you inject, as you have been taught.

If you take more Humalog Mix25 than you need

If you take more Humalog Mix25 than you need, a low blood sugar may occur. Check your blood

sugar.

If your blood sugar is low

(mild hypoglycaemia)

, eat glucose tablets, sugar or drink a sugary drink.

Then eat fruit, biscuits, or a sandwich, as your doctor has advised you and have some rest. This will

often get you over mild hypoglycaemia or a minor insulin overdose. If you get worse and your

breathing is shallow and your skin gets pale, tell your doctor at once. A glucagon injection can treat

quite severe hypoglycaemia. Eat glucose or sugar after the glucagon injection. If you do not respond to

glucagon, you will have to go to hospital. Ask your doctor to tell you about glucagon.

If you forget to use Humalog Mix25

If you take less Humalog Mix25 than you need, a high blood sugar may occur. Check your blood

sugar

If hypoglycaemia (low blood sugar) or hyperglycaemia (high blood sugar) is not treated they can be

very serious and cause headaches, nausea, vomiting, dehydration, unconsciousness, coma or even

death (see A and B in section 4 “Possible Side Effects”).

Three simple steps

to avoid hypoglycaemia or hyperglycaemia are:

Always keep spare syringes and a spare vial of Humalog Mix25.

Always carry something to show you are diabetic.

Always carry sugar with you.

If you stop using Humalog Mix25.

If you take less Humalog Mix25 than you need, a high blood sugar may occur. Do not change your

insulin unless your doctor tells you to.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Systemic allergy is rare (

1/10,000 to <1/1,000). The symptoms are as follows:

rash over the whole body

blood pressure dropping

difficulty in breathing

heart beating fast

wheezing

sweating

If you think you are having this sort of insulin allergy with Humalog Mix25, tell your doctor at once.

Local allergy is common (

1/100 to <1/10). Some people get redness, swelling or itching around the

area of the insulin injection. This usually clears up in anything from a few days to a few weeks. If this

happens to you, tell your doctor.

Lipodystrophy (thickening or pitting of the skin) is uncommon (

1/1,000 to <1/100). If you notice

your skin thickening or pitting at the injection site, tell your doctor.

Oedema (e.g. swelling in arms, ankles; fluid retention) has been reported, particularly at the start of

insulin therapy or during a change in therapy to improve control of your blood glucose.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects

not listed in this leaflet.

You can also report side effects directly via the national reporting system

listed in Appendix V. By reporting side effects you can help provide more information on the safety of

this medicine.

Common problems of diabetes

A.

Hypoglycaemia

Hypoglycaemia (low blood sugar) means there is not enough sugar in the blood. This can be caused if:

you take too much Humalog Mix25 or other insulin;

you miss or delay meals or change your diet;

you exercise or work too hard just before or after a meal;

you have an infection or illness (especially diarrhoea or vomiting);

there is a change in your need for insulin; or

you have trouble with your kidneys or liver which gets worse.

Alcohol and some medicines can affect your blood sugar levels.

The first symptoms of low blood sugar usually come on quickly and include the following:

tiredness

rapid heartbeat

nervousness or shakiness

feeling sick

headache

cold sweat

While you are not confident about recognising your warning symptoms, avoid situations, e.g. driving a

car, in which you or others would be put at risk by hypoglycaemia.

B.

Hyperglycaemia and diabetic ketoacidosis

Hyperglycaemia (too much sugar in the blood) means that your body does not have enough insulin.

Hyperglycaemia can be brought about by:

not taking your Humalog or other insulin;

taking less insulin than your doctor tells you to;

eating a lot more than your diet allows; or

fever, infection or emotional stress.

Hyperglycaemia can lead to diabetic ketoacidosis. The first symptoms come on slowly over many

hours or days. The symptoms include the following:

feeling sleepy

no appetite

flushed face

fruity smell on the breath

thirst

feeling or being sick

Severe symptoms are heavy breathing and a rapid pulse.

Get medical help immediately.

C.

Illness

If you are ill, especially if you feel sick or are sick, the amount of insulin you need may change.

Even

when you are not eating normally, you still need insulin.

Test your urine or blood, follow your

‘sick rules’, and tell your doctor.

5.

How to store Humalog Mix25

Before the first use store your Humalog Mix25 in a refrigerator (2

C – 8

C). Do not freeze. Keep your

vial in use in a refrigerator (2°C – 8°C) or at room temperature up to 30°C and discard after 28 days.

Do not put it near heat or in the sun.

Keep out of the reach and sight of children.

Do not use this medicine after the expiry date which is stated on the label and the carton. The expiry

date refers to the last day of that month.

Do not use this medicine if you notice clumps of material are present or if solid white particles stick to

the bottom or wall of the vial, giving it a frosted appearance. Check each time you inject yourself.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to

dispose of medicines no longer required. These measures will help to protect the environment.

6.

Contents of the pack and other information

What Humalog Mix25 100 units/ml suspension for injection in vial contains

The active substance is insulin lispro. Insulin lispro is made in the laboratory by a ‘recombinant

DNA technology’ process. It is a changed form of human insulin and so is different from other

human and animal insulins. Insulin lispro is closely related to human insulin which is a natural

hormone made by the pancreas.

The other ingredients are protamine sulphate, m-cresol, phenol, glycerol, dibasic sodium

phosphate 7H

O, zinc oxide and water for injection. Sodium hydroxide or hydrochloric acid

may have been used to adjust the acidity.

What Humalog Mix25 100 units/ml suspension for injection in vial looks like and contents of the

pack

Humalog Mix25 100 units/ml suspension for injection is a white, sterile suspension and contains

100 units of insulin lispro in each millilitre (100 units/ml) suspension for injection. 25% of the

insulin lispro in Humalog Mix25 is dissolved in water. 75% of the insulin lispro in Humalog Mix25

is available in a suspension together with protamine sulphate. Each vial contains 1000 units (10

millilitres). Humalog Mix25 100 units/ml suspension for injection in vial comes in a pack of 1 vial.

Marketing Authorisation Holder and Manufacturer

Humalog Mix25 100 units/ml suspension for injection in vial is made by:

Lilly S.A., Avda. de la Industria 30, 28108 Alcobendas, Madrid, Spain.

The product licence is held by: Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The

Netherlands.

For any information about this medicinal product, please contact the local representative of the

Marketing Authorisation Holder:

Belgique/België/Belgien

Eli Lilly Benelux S.A./N.V.

Tél/Tel: + 32-(0)2 548 84 84

Lietuva

Eli Lilly Holdings Limited atstovybė

Tel. +370 (5) 2649600

България

ТП "Ели Лили Недерланд" Б.В. - България

тел. + 359 2 491 41 40

Luxembourg/Luxemburg

Eli Lilly Benelux S.A./N.V.

Tél/Tel: + 32-(0)2 548 84 84

Česká republika

ELI LILLY ČR, s.r.o.

Tel: + 420 234 664 111

Magyarország

Lilly Hungária Kft.

Tel: + 36 1 328 5100

Danmark

Eli Lilly Danmark A/S

Tlf: +45 45 26 6000

Malta

Charles de Giorgio Ltd.

Tel: + 356 25600 500

Deutschland

Lilly Deutschland GmbH

Tel. + 49-(0) 6172 273 2222

Nederland

Eli Lilly Nederland B.V.

Tel: + 31-(0) 30 60 25 800

Eesti

Eli Lilly Holdings Limited Eesti filiaal

Tel:

+

372 6817 280

Norge

Eli Lilly Norge A.S.

Tlf: + 47 22 88 18 00

Ελλάδα

ΦΑΡΜΑΣΕΡΒ-ΛΙΛΛΥ Α.Ε.Β.Ε.

Τηλ: +30 210 629 4600

Österreich

Eli Lilly Ges. m.b.H.

Tel: + 43-(0) 1 711 780

España

Lilly S.A.

Tel: + 34-91 663 50 00

Polska

Eli Lilly Polska Sp. z o.o.

Tel: +48 22 440 33 00

France

Lilly France S.A.S.

Tél: +33-(0) 1 55 49 34 34

Portugal

Lilly Portugal - Produtos Farmacêuticos, Lda

Tel: + 351-21-4126600

Hrvatska

Eli Lilly Hrvatska d.o.o.

Tel: +385 1 2350 999

România

Eli Lilly România S.R.L.

Tel: + 40 21 4023000

Ireland

Eli Lilly and Company (Ireland) Limited

Tel: + 353-(0) 1 661 4377

Slovenija

Eli Lilly farmacevtska družba, d.o.o.

Tel: +386 (0) 1 580 00 10

Ísland

Icepharma hf.

Sími + 354 540 8000

Slovenská republika

Eli Lilly Slovakia, s.r.o.

Tel: + 421 220 663 111

Italia

Eli Lilly Italia S.p.A.

Tel: + 39- 055 42571

Suomi/Finland

Oy Eli Lilly Finland Ab

Puh/Tel: + 358-(0) 9 85 45 250

Κύπρος

Phadisco Ltd

Τηλ: +357 22 715000

Sverige

Eli Lilly Sweden AB

Tel: + 46-(0) 8 7378800

Latvija

Eli Lilly Holdings Limited pārstāvniecība Latvijā

Tel:

+

371 67364000

United Kingdom

Eli Lilly and Company Limited

Tel: + 44-(0) 1256 315000

This leaflet was last revised in

{MM/YYYY}.

Detailed information on this medicine is available on the European Medicines Agency web site:

http://www.ema.europa.eu/.

PACKAGE LEAFLET: INFORMATION FOR THE USER

Humalog Mix25 100 units/ml, suspension for injection in cartridge

insulin lispro

Read all of this leaflet carefully before you start using this medicine because it contains

important information for you.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,

even if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side

effects not listed in this leaflet. See section 4.

What is in this leaflet

What Humalog Mix25 is and what it is used for

What you need to know before you use Humalog Mix25

How to use Humalog Mix25

Possible side effects

How to store Humalog Mix25

Contents of the pack and other information

1.

What Humalog Mix25 is and what it is used for

Humalog Mix25 is used to treat diabetes. Humalog Mix25 is a premixed suspension. Its active

substance is insulin lispro. 25% of the insulin lispro in Humalog Mix25 is dissolved in water and it

works more quickly than normal human insulin because the insulin molecule has been changed

slightly. 75% of the insulin lispro in Humalog Mix25 is available in a suspension together with

protamine sulphate, so that its action is prolonged.

You get diabetes if your pancreas does not make enough insulin to control the level of glucose in

your blood. Humalog Mix25 is a substitute for your own insulin and is used to control glucose in the

long term. Humalog Mix25 works very quickly and longer than soluble insulin. You should

normally use Humalog Mix25 within 15 minutes of a meal.

Your doctor may tell you to use Humalog Mix25 as well as a longer-acting insulin. Each kind of

insulin comes with another patient information leaflet to tell you about it. Do not change your

insulin unless your doctor tells you to. Be very careful if you do change insulin.

2.

What you need to know before you use Humalog Mix25

Do NOT use Humalog Mix25

if you think

hypoglycaemia

(low blood sugar) is starting. Further in this leaflet it tells you how to

deal with mild hypoglycaemia (see Section 3: If you take more Humalog Mix25 than you need).

if you are

allergic

to insulin lispro or any of the other ingredients of this medicine (listed in

section 6).

Warnings and precautions

If your blood sugar levels are well controlled by your current insulin therapy, you may not feel the

warning symptoms when your blood sugar is falling too low. Warning signs are listed later in this

leaflet. You must think carefully about when to have your meals, how often to exercise and how

much to do. You must also keep a close watch on your blood sugar levels by testing your blood

glucose often.

A few people who have had hypoglycaemia after switching from animal insulin to human insulin

have reported that the early warning symptoms were less obvious or different. If you often have

hypoglycaemia or have difficulty recognising them, please discuss this with your doctor.

If you answer YES to any of the following questions, tell your doctor, pharmacist or diabetes

nurse

Have you recently become ill?

Do you have trouble with your kidneys or liver?

Are you exercising more than usual?

The amount of insulin you need may also change if you drink alcohol.

You should also tell your doctor, pharmacist or diabetes nurse if you are planning to go abroad.

The time difference between countries may mean that you have to have your injections and meals

at different times from when you are at home.

Some patients with long-standing type 2 diabetes mellitus and heart disease or previous stroke

who were treated with pioglitazone and insulin experienced the development of heart failure.

Inform your doctor as soon as possible, if you experience signs of heart failure such as unusual

shortness of breath or rapid increase in weight or localised swelling (oedema).

Other medicines and Humalog Mix25

Your insulin needs may change if you are taking

the contraceptive pill,

steroids,

thyroid hormone replacement therapy,

oral hypoglycaemics,

acetyl salicylic acid,

sulpha antibiotics,

octreotide,

“beta

stimulants” (for example ritodrine, salbutamol or terbutaline),

beta-blockers, or

some antidepressants (monoamine oxidase inhibitors or selective serotonin reuptake inhibitors),

danazol,

some angiotensin converting enzyme (ACE) inhibitors (for example captopril, enalapril), and

angiotensin II receptor blockers.

Please tell your doctor, if you are taking or have recently taken any other medicines, including

medicines obtained without a prescription (see section “Warnings and precautions”).

Pregnancy and breast-feeding

Are you pregnant or thinking about becoming pregnant, or are you breast-feeding? The amount of

insulin you need usually falls during the first three months of pregnancy and increases for the

remaining six months. If you are breast-feeding, you may need to alter your insulin intake or diet.

Ask your doctor for advice.

Driving and using machines

Your ability to concentrate and react may be reduced if you have hypoglycaemia. Please keep this

possible problem in mind in all situations where you might put yourself and others at risk (e.g. driving

a car or operating machinery). You should contact your doctor about the advisability of driving if you

have:

frequent episodes of hypoglycaemia

reduced or absent warning signs of hypoglycaemia

Important information about some of the ingredients of Humalog Mix25

This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-

free’.

3.

How to use Humalog Mix25

The 3 ml cartridge is only for use in Lilly 3 ml pens. It is not for use in 1.5 ml pens.

Always check the pack and the cartridge label for the name and type of the insulin when you

get it from your pharmacy. Make sure you get the Humalog Mix25 that your doctor has told

you to use.

Always use Humalog Mix25 exactly as your doctor has told you. You should check with your doctor

if you are not sure. To prevent the possible transmission of disease, each cartridge must be used by

you only, even if the needle on the delivery device is changed.

Dosage

You should normally inject Humalog Mix25 within 15 minutes of a meal. If you need to, you

can inject soon after a meal. But your doctor will have told you exactly how much to use,

when to use it, and how often. These instructions are only for you. Follow them exactly and

visit your diabetes clinic regularly.

If you change the type of insulin you use (for example from a human or animal insulin to a

Humalog product), you may have to take more or less than before. This might just be for the

first injection or it may be a gradual change over several weeks or months.

Inject Humalog Mix25 under the skin. You should not administer it using a different

administration route. Under no circumstances should Humalog Mix25 be given intravenously.

Preparing Humalog Mix25

Cartridges containing Humalog Mix25 should be rotated in the palms of the hands ten times

and inverted 180° ten times immediately before use to resuspend insulin until it appears

uniformly cloudy or milky. If not, repeat the above procedure until contents are mixed.

Cartridges contain a small glass bead to assist mixing. Do not shake vigorously as this may

cause frothing which may interfere with the correct measurement of the dose. The cartridges

should be examined frequently and should not be used if clumps of material are present or if

solid white particles stick to the bottom or wall of the cartridge, giving it a frosted appearance.

Check each time you inject yourself.

Getting the pen ready to use

First wash your hands. Disinfect the rubber membrane of the cartridge.

You must only use Humalog Mix25 cartridges in Lilly insulin pens. Please make sure that

Humalog or Lilly cartridges are mentioned in the leaflet accompanying your pen. The

3 ml cartridge only fits the 3 ml pen.

Follow the instructions that come with the pen. Put the cartridge into the pen.

You will set the dose to 1 or 2 units. Then hold the pen with the needle pointing up and tap the

side of the pen so that any bubbles float to the top. With the pen still pointing up, press the

injection mechanism. Do this until a drop of Humalog Mix25 comes out of the needle. There

may still be some small air bubbles left in the pen. These are harmless, but if the air bubble is

too big, it may make the dose of your injection less accurate.

Injecting Humalog Mix25

Before you make an injection, clean your skin as you have been instructed. Inject under the

skin, as you were taught. Do not inject directly into a vein. After your injection, leave the needle

in the skin for five seconds to make sure you have taken the whole dose. Do not rub the area

you have just injected. Make sure you inject at least half an inch (1 cm) from the last injection

and that you ‘rotate’ the places you inject, as you have been taught.

After injecting

As soon as you have done the injection, take the needle off the pen using the outer needle cap.

This will keep the Humalog Mix25 sterile and prevent leaking. It will also stop air going back

into the pen and the needle clogging up.

Do not share your needles.

Do not share your pen.

Replace the cap on your pen. Leave the cartridge in the pen.

Further injections

Before every injection, dial 1 or 2 units and press the injection mechanism with the pen pointing

up until a drop of Humalog Mix25 comes out of the needle. You can see how much Humalog is

left by looking at the gauge on the side of the cartridge. The distance between each mark on the

gauge is about 20 units. If there is not enough for your dose, change the cartridge.

Do not mix any other insulin in a Humalog Mix25 cartridge. Once the cartridge is empty, do not

use it again.

If you take more Humalog Mix25 than you need

If you take more Humalog Mix25 than you need, a low blood sugar may occur. Check your blood

sugar.

If your blood sugar is low

(mild hypoglycaemia)

, eat glucose tablets, sugar or drink a sugary drink.

Then eat fruit, biscuits, or a sandwich, as your doctor has advised you and have some rest. This will

often get you over mild hypoglycaemia or a minor insulin overdose. If you get worse and your

breathing is shallow and your skin gets pale, tell your doctor at once. A glucagon injection can treat

quite severe hypoglycaemia. Eat glucose or sugar after the glucagon injection. If you do not respond to

glucagon, you will have to go to hospital. Ask your doctor to tell you about glucagon.

If you forget to use Humalog Mix25

If you take less Humalog Mix25 than you need, a high blood sugar may occur. Check your blood

sugar

If hypoglycaemia (low blood sugar) or hyperglycaemia (high blood sugar) is not treated they can be

very serious and cause headaches, nausea, vomiting, dehydration, unconsciousness, coma or even

death (see A and B in section 4 “Possible Side Effects”).

Three simple steps

to avoid hypoglycaemia or hyperglycaemia are:

Always keep spare syringes and a spare vial of Humalog Mix25, or a spare pen and cartridges,

in case you lose your pen or cartridges or they get damaged.

Always carry something to show you are diabetic.

Always carry sugar with you.

If you stop using Humalog Mix25.

If you take less Humalog Mix25 than you need, a high blood sugar may occur. Do not change your

insulin unless your doctor tells you to.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Systemic allergy is rare (

1/10,000 to <1/1,000). The symptoms are as follows:

rash over the whole body

blood pressure dropping

difficulty in breathing

heart beating fast

wheezing

sweating

If you think you are having this sort of insulin allergy with Humalog Mix25, tell your doctor at once.

Local allergy is common (

1/100 to <1/10). Some people get redness, swelling or itching around the

area of the insulin injection. This usually clears up in anything from a few days to a few weeks. If this

happens to you, tell your doctor.

Lipodystrophy (thickening or pitting of the skin) is uncommon (

1/1,000 to <1/100). If you notice

your skin thickening or pitting at the injection site, tell your doctor.

Oedema (e.g. swelling in arms, ankles; fluid retention) has been reported, particularly at the start of

insulin therapy or during a change in therapy to improve control of your blood glucose.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects

not listed in this leaflet.

You can also report side effects directly via the national reporting system

listed in Appendix V. By reporting side effects you can help provide more information on the safety of

this medicine.

Common problems of diabetes

A.

Hypoglycaemia

Hypoglycaemia (low blood sugar) means there is not enough sugar in the blood. This can be caused if:

you take too much Humalog Mix25 or other insulin;

you miss or delay meals or change your diet;

you exercise or work too hard just before or after a meal;

you have an infection or illness (especially diarrhoea or vomiting);

there is a change in your need for insulin; or

you have trouble with your kidneys or liver which gets worse.

Alcohol and some medicines can affect your blood sugar levels.

The first symptoms of low blood sugar usually come on quickly and include the following:

tiredness

rapid heartbeat

nervousness or shakiness

feeling sick

headache

cold sweat

While you are not confident about recognising your warning symptoms, avoid situations, e.g. driving a

car, in which you or others would be put at risk by hypoglycaemia.

B.

Hyperglycaemia and diabetic ketoacidosis

Hyperglycaemia (too much sugar in the blood) means that your body does not have enough insulin.

Hyperglycaemia can be brought about by:

not taking your Humalog or other insulin;

taking less insulin than your doctor tells you to;

eating a lot more than your diet allows; or

fever, infection or emotional stress.

Hyperglycaemia can lead to diabetic ketoacidosis. The first symptoms come on slowly over many

hours or days. The symptoms include the following:

feeling sleepy

no appetite

flushed face

fruity smell on the breath

thirst

feeling or being sick

Severe symptoms are heavy breathing and a rapid pulse.

Get medical help immediately.

C.

Illness

If you are ill, especially if you feel sick or are sick, the amount of insulin you need may change.

Even

when you are not eating normally, you still need insulin.

Test your urine or blood, follow your

‘sick rules’, and tell your doctor.

5.

How to store Humalog Mix25

Before the first use store your Humalog Mix25 in a refrigerator (2

C – 8

C). Do not freeze.

Keep your cartridge in use at room temperature (15° - 30°C) and discard after 28 days. Do not put it

near heat or in the sun. Do not keep your pen or the cartridges you are using in the fridge. The pen

with the inserted cartridge should not be stored with the needle attached.

Keep out of the reach and sight of children.

Do not use this medicine after the expiry date which is stated on the label and the carton. The expiry

date refers to the last day of that month.

Do not use this medicine if you notice clumps of material are present or if solid white particles stick to

the bottom or wall of the cartridge, giving it a frosted appearance. Check each time you inject yourself.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to

dispose of medicines no longer required. These measures will help to protect the environment.

6.

Contents of the pack and other information

What Humalog Mix25 100 units/ml suspension for injection in cartridge contains

The active substance is insulin lispro. Insulin lispro is made in the laboratory by a ‘recombinant

DNA technology’ process. It is a changed form of human insulin and so is different from other

human and animal insulins. Insulin lispro is closely related to human insulin which is a natural

hormone made by the pancreas.

The other ingredients are protamine sulphate, m-cresol, phenol, glycerol, dibasic sodium

phosphate 7H

O, zinc oxide and water for injection. Sodium hydroxide or hydrochloric acid

may have been used to adjust the acidity.

What Humalog Mix25 100 units/ml suspension for injection in cartridge looks like and contents

of the pack

Humalog Mix25 100 units/ml suspension for injection is a white, sterile suspension and contains

100 units of insulin lispro in each millilitre (100 units/ml) suspension for injection. 25% of the

insulin lispro in Humalog Mix25 is dissolved in water. 75% of the insulin lispro in Humalog Mix25

is available in a suspension together with protamine sulphate. Each cartridge contains 300 units (3

millilitres). The cartridges come in packs of 5 or 10 cartridges. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Humalog Mix25 100 units/ml suspension for injection in cartridge is made by:

Lilly France S.A.S., Rue du Colonel Lilly, 67640 Fegersheim, France,

Eli Lilly Italia S.p.A., Via Gramsci 731-733, 50019 Sesto Fiorentino, (FI) Italy.

The product licence is held by: Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The

Netherlands.

For any information about this medicinal product, please contact the local representative of the

Marketing Authorisation Holder:

Belgique/België/Belgien

Eli Lilly Benelux S.A./N.V.

Tél/Tel: + 32-(0)2 548 84 84

Lietuva

Eli Lilly Holdings Limited atstovybė

Tel. +370 (5) 2649600

България

ТП "Ели Лили Недерланд" Б.В. - България

тел. + 359 2 491 41 40

Luxembourg/Luxemburg

Eli Lilly Benelux S.A./N.V.

Tél/Tel: + 32-(0)2 548 84 84

Česká republika

ELI LILLY ČR, s.r.o.

Tel: + 420 234 664 111

Magyarország

Lilly Hungária Kft.

Tel: + 36 1 328 5100

Danmark

Eli Lilly Danmark A/S

Tlf: +45 45 26 6000

Malta

Charles de Giorgio Ltd.

Tel: + 356 25600 500

Deutschland

Lilly Deutschland GmbH

Tel. + 49-(0) 6172 273 2222

Nederland

Eli Lilly Nederland B.V.

Tel: + 31-(0) 30 60 25 800

Eesti

Eli Lilly Holdings Limited Eesti filiaal

Tel:

+

372 6817 280

Norge

Eli Lilly Norge A.S.

Tlf: + 47 22 88 18 00

Ελλάδα

ΦΑΡΜΑΣΕΡΒ-ΛΙΛΛΥ Α.Ε.Β.Ε.

Τηλ: +30 210 629 4600

Österreich

Eli Lilly Ges. m.b.H.

Tel: + 43-(0) 1 711 780

España

Lilly S.A.

Tel: + 34-91 663 50 00

Polska

Eli Lilly Polska Sp. z o.o.

Tel: +48 22 440 33 00

France

Lilly France S.A.S.

Tél: +33-(0) 1 55 49 34 34

Portugal

Lilly Portugal - Produtos Farmacêuticos, Lda

Tel: + 351-21-4126600

Hrvatska

Eli Lilly Hrvatska d.o.o.

Tel: +385 1 2350 999

România

Eli Lilly România S.R.L.

Tel: + 40 21 4023000

Ireland

Eli Lilly and Company (Ireland) Limited

Tel: + 353-(0) 1 661 4377

Slovenija

Eli Lilly farmacevtska družba, d.o.o.

Tel: +386 (0) 1 580 00 10

Ísland

Icepharma hf.

Sími + 354 540 8000

Slovenská republika

Eli Lilly Slovakia, s.r.o.

Tel: + 421 220 663 111

Italia

Eli Lilly Italia S.p.A.

Tel: + 39- 055 42571

Suomi/Finland

Oy Eli Lilly Finland Ab

Puh/Tel: + 358-(0) 9 85 45 250

Κύπρος

Phadisco Ltd

Τηλ: +357 22 715000

Sverige

Eli Lilly Sweden AB

Tel: + 46-(0) 8 7378800

Latvija

Eli Lilly Holdings Limited pārstāvniecība Latvijā

Tel:

+

371 67364000

United Kingdom

Eli Lilly and Company Limited

Tel: + 44-(0) 1256 315000

This leaflet was last revised in

{MM/YYYY}.

Detailed information on this medicine is available on the European Medicines Agency web site:

http://www.ema.europa.eu/.

PACKAGE LEAFLET: INFORMATION FOR THE USER

Humalog Mix50 100 units/ml, suspension for injection in cartridge

insulin lispro

Read all of this leaflet carefully before you start using this medicine because it contains

important information for you.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,

even if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side

effects not listed in this leaflet. See section 4.

What is in this leaflet

What Humalog Mix50 is and what it is used for

What you need to know before you use Humalog Mix50

How to use Humalog Mix50

Possible side effects

How to store Humalog Mix50

Contents of the pack and other information

1.

What Humalog Mix50 is and what it is used for

Humalog Mix50 is used to treat diabetes. Humalog Mix50 is a premixed suspension. Its active

substance is insulin lispro. 50% of the insulin lispro in Humalog Mix50 is dissolved in water and it

works more quickly than normal human insulin because the insulin molecule has been changed

slightly. 50% of the insulin lispro in Humalog Mix50 is available in a suspension together with

protamine sulphate, so that its action is prolonged.

You get diabetes if your pancreas does not make enough insulin to control the level of glucose in

your blood. Humalog Mix50 is a substitute for your own insulin and is used to control glucose in the

long term. Humalog Mix50 works very quickly and longer than soluble insulin. You should

normally use Humalog Mix50 within 15 minutes of a meal.

Your doctor may tell you to use Humalog Mix50 as well as a longer-acting insulin. Each kind of

insulin comes with another patient information leaflet to tell you about it. Do not change your

insulin unless your doctor tells you to. Be very careful if you do change insulin.

2.

What you need to know before you use Humalog Mix50

Do NOT use Humalog Mix50

if you think

hypoglycaemia

(low blood sugar) is starting. Further in this leaflet it tells you how to

deal with mild hypoglycaemia (see Section 3: If you take more Humalog Mix50 than you need).

if you are

allergic

to insulin lispro or any of the other ingredients of this medicine (listed in

section 6).

Warnings and precautions

If your blood sugar levels are well controlled by your current insulin therapy, you may not feel the

warning symptoms when your blood sugar is falling too low. Warning signs are listed later in this

leaflet. You must think carefully about when to have your meals, how often to exercise and how

much to do. You must also keep a close watch on your blood sugar levels by testing your blood

glucose often.

A few people who have had hypoglycaemia after switching from animal insulin to human insulin

have reported that the early warning symptoms were less obvious or different. If you often have

hypoglycaemia or have difficulty recognising them, please discuss this with your doctor.

If you answer YES to any of the following questions, tell your doctor, pharmacist or diabetes

nurse

Have you recently become ill?

Do you have trouble with your kidneys or liver?

Are you exercising more than usual?

The amount of insulin you need may also change if you drink alcohol.

You should also tell your doctor, pharmacist or diabetes nurse if you are planning to go abroad.

The time difference between countries may mean that you have to have your injections and meals

at different times from when you are at home.

Some patients with long-standing type 2 diabetes mellitus and heart disease or previous stroke

who were treated with pioglitazone and insulin experienced the development of heart failure.

Inform your doctor as soon as possible, if you experience signs of heart failure such as unusual

shortness of breath or rapid increase in weight or localised swelling (oedema).

Other medicines and Humalog Mix50

Your insulin needs may change if you are taking

the contraceptive pill,

steroids,

thyroid hormone replacement therapy,

oral hypoglycaemics,

acetyl salicylic acid,

sulpha antibiotics,

octreotide,

“beta

stimulants” (for example ritodrine, salbutamol or terbutaline),

beta-blockers, or

some antidepressants (monoamine oxidase inhibitors or selective serotonin reuptake inhibitors),

danazol,

some angiotensin converting enzyme (ACE) inhibitors (for example captopril, enalapril), and

angiotensin II receptor blockers.

Please tell your doctor, if you are taking or have recently taken any other medicines, including

medicines obtained without a prescription (see section “Warnings and precautions”).

Pregnancy and breast-feeding

Are you pregnant or thinking about becoming pregnant, or are you breast-feeding? The amount of

insulin you need usually falls during the first three months of pregnancy and increases for the

remaining six months. If you are breast-feeding, you may need to alter your insulin intake or diet.

Ask your doctor for advice.

Driving and using machines

Your ability to concentrate and react may be reduced if you have hypoglycaemia. Please keep this

possible problem in mind in all situations where you might put yourself and others at risk (e.g. driving

a car or operating machinery). You should contact your doctor about the advisability of driving if you

have:

frequent episodes of hypoglycaemia

reduced or absent warning signs of hypoglycaemia

Important information about some of the ingredients of Humalog Mix50

This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-

free’.

3.

How to use Humalog Mix50

The 3 ml cartridge is only for use in Lilly 3 ml pens. It is not for use in 1.5 ml pens.

Always check the pack and the cartridge label for the name and type of the insulin when you

get it from your pharmacy. Make sure you get the Humalog Mix50 that your doctor has told

you to use.

Always use Humalog Mix50 exactly as your doctor has told you. You should check with your doctor

if you are not sure. To prevent the possible transmission of disease, each cartridge must be used by

you only, even if the needle on the delivery device is changed.

Dosage

You should normally inject Humalog Mix50 within 15 minutes of a meal. If you need to, you

can inject soon after a meal. But your doctor will have told you exactly how much to use,

when to use it, and how often. These instructions are only for you. Follow them exactly and

visit your diabetes clinic regularly.

If you change the type of insulin you use (for example from a human or animal insulin to a

Humalog product), you may have to take more or less than before. This might just be for the

first injection or it may be a gradual change over several weeks or months.

Inject Humalog Mix50 under the skin. You should not administer it using a different

administration route. Under no circumstances should Humalog Mix50 be given intravenously.

Preparing Humalog Mix50

Cartridges containing Humalog Mix50 should be rotated in the palms of the hands ten times

and inverted 180° ten times immediately before use to resuspend insulin until it appears

uniformly cloudy or milky. If not, repeat the above procedure until contents are mixed.

Cartridges contain a small glass bead to assist mixing. Do not shake vigorously as this may

cause frothing which may interfere with the correct measurement of the dose. The cartridges

should be examined frequently and should not be used if clumps of material are present or if

solid white particles stick to the bottom or wall of the cartridge, giving it a frosted appearance.

Check each time you inject yourself.

Getting the pen ready to use

First wash your hands. Disinfect the rubber membrane of the cartridge.

You must only use Humalog Mix50 cartridges in Lilly insulin pens. Please make sure that

Humalog or Lilly cartridges are mentioned in the leaflet accompanying your pen. The

3 ml cartridge only fits the 3 ml pen.

Follow the instructions that come with the pen. Put the cartridge into the pen.

You will set the dose to 1 or 2 units. Then hold the pen with the needle pointing up and tap the

side of the pen so that any bubbles float to the top. With the pen still pointing up, press the

injection mechanism. Do this until a drop of Humalog Mix50 comes out of the needle. There

may still be some small air bubbles left in the pen. These are harmless, but if the air bubble is

too big, it may make the dose of your injection less accurate.

Injecting Humalog Mix50

Before you make an injection, clean your skin as you have been instructed. Inject under the

skin, as you were taught. Do not inject directly into a vein. After your injection, leave the needle

in the skin for five seconds to make sure you have taken the whole dose. Do not rub the area

you have just injected. Make sure you inject at least half an inch (1 cm) from the last injection

and that you ‘rotate’ the places you inject, as you have been taught.

After injecting

As soon as you have done the injection, take the needle off the pen using the outer needle cap.

This will keep the Humalog Mix50 sterile and prevent leaking. It will also stop air going back

into the pen and the needle clogging up.

Do not share your needles.

Do not share your pen.

Replace the cap on your pen. Leave the cartridge in the pen.

Further injections

Before every injection, dial 1 or 2 units and press the injection mechanism with the pen pointing

up until a drop of Humalog Mix50 comes out of the needle. You can see how much Humalog is

left by looking at the gauge on the side of the cartridge. The distance between each mark on the

gauge is about 20 units. If there is not enough for your dose, change the cartridge.

Do not mix any other insulin in a Humalog Mix50 cartridge. Once the cartridge is empty, do not

use it again.

If you take more Humalog Mix50 than you need

If you take more Humalog Mix50 than you need, a low blood sugar may occur. Check your blood

sugar.

If your blood sugar is low

(mild hypoglycaemia)

, eat glucose tablets, sugar or drink a sugary drink.

Then eat fruit, biscuits, or a sandwich, as your doctor has advised you and have some rest. This will

often get you over mild hypoglycaemia or a minor insulin overdose. If you get worse and your

breathing is shallow and your skin gets pale, tell your doctor at once. A glucagon injection can treat

quite severe hypoglycaemia. Eat glucose or sugar after the glucagon injection. If you do not respond to

glucagon, you will have to go to hospital. Ask your doctor to tell you about glucagon.

If you forget to use Humalog Mix50

If you take less Humalog Mix50 than you need, a high blood sugar may occur. Check your blood

sugar

If hypoglycaemia (low blood sugar) or hyperglycaemia (high blood sugar) is not treated they can be

very serious and cause headaches, nausea, vomiting, dehydration, unconsciousness, coma or even

death (see A and B in section 4 “Possible Side Effects”).

Three simple steps

to avoid hypoglycaemia or hyperglycaemia are:

Always keep a spare pen and cartridges, in case you lose your pen or cartridges or they get

damaged.

Always carry something to show you are diabetic.

Always carry sugar with you.

If you stop using Humalog Mix50.

If you take less Humalog Mix50 than you need, a high blood sugar may occur. Do not change your

insulin unless your doctor tells you to.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Systemic allergy is rare (

1/10,000 to <1/1,000). The symptoms are as follows:

rash over the whole body

blood pressure dropping

difficulty in breathing

heart beating fast

wheezing

sweating

If you think you are having this sort of insulin allergy with Humalog Mix50, tell your doctor at once.

Local allergy is common (

1/100 to <1/10). Some people get redness, swelling or itching around the

area of the insulin injection. This usually clears up in anything from a few days to a few weeks. If this

happens to you, tell your doctor.

Lipodystrophy (thickening or pitting of the skin) is uncommon (

1/1,000 to <1/100). If you notice

your skin thickening or pitting at the injection site, tell your doctor.

Oedema (e.g. swelling in arms, ankles; fluid retention) has been reported, particularly at the start of

insulin therapy or during a change in therapy to improve control of your blood glucose.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects

not listed in this leaflet.

You can also report side effects directly via the national reporting system

listed in Appendix V. By reporting side effects you can help provide more information on the safety of

this medicine.

Common problems of diabetes

A.

Hypoglycaemia

Hypoglycaemia (low blood sugar) means there is not enough sugar in the blood. This can be caused if:

you take too much Humalog Mix50 or other insulin;

you miss or delay meals or change your diet;

you exercise or work too hard just before or after a meal;

you have an infection or illness (especially diarrhoea or vomiting);

there is a change in your need for insulin; or

you have trouble with your kidneys or liver which gets worse.

Alcohol and some medicines can affect your blood sugar levels.

The first symptoms of low blood sugar usually come on quickly and include the following:

tiredness

rapid heartbeat

nervousness or shakiness

feeling sick

headache

cold sweat

While you are not confident about recognising your warning symptoms, avoid situations, e.g. driving a

car, in which you or others would be put at risk by hypoglycaemia.

B.

Hyperglycaemia and diabetic ketoacidosis

Hyperglycaemia (too much sugar in the blood) means that your body does not have enough insulin.

Hyperglycaemia can be brought about by:

not taking your Humalog or other insulin;

taking less insulin than your doctor tells you to;

eating a lot more than your diet allows; or

fever, infection or emotional stress.

Hyperglycaemia can lead to diabetic ketoacidosis. The first symptoms come on slowly over many

hours or days. The symptoms include the following:

feeling sleepy

no appetite

flushed face

fruity smell on the breath

thirst

feeling or being sick

Severe symptoms are heavy breathing and a rapid pulse.

Get medical help immediately.

C.

Illness

If you are ill, especially if you feel sick or are sick, the amount of insulin you need may change.

Even

when you are not eating normally, you still need insulin.

Test your urine or blood, follow your

‘sick rules’, and tell your doctor.

5.

How to store Humalog Mix50

Before the first use store your Humalog Mix50 in a refrigerator (2

C – 8

C). Do not freeze.

Keep your cartridge in use at room temperature (15° - 30°C) and discard after 28 days. Do not put it

near heat or in the sun. Do not keep your pen or the cartridges you are using in the fridge. The pen

with the inserted cartridge should not be stored with the needle attached.

Keep out of the reach and sight of children.

Do not use this medicine after the expiry date which is stated on the label and the carton. The expiry

date refers to the last day of that month.

Do not use this medicine if you notice clumps of material are present or if solid white particles stick to

the bottom or wall of the cartridge, giving it a frosted appearance. Check each time you inject yourself.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to

dispose of medicines no longer required. These measures will help to protect the environment.

6.

Contents of the pack and other information

What Humalog Mix50 100 units/ml suspension for injection in cartridge contains

The active substance is insulin lispro. Insulin lispro is made in the laboratory by a ‘recombinant

DNA technology’ process. It is a changed form of human insulin and so is different from other

human and animal insulins. Insulin lispro is closely related to human insulin which is a natural

hormone made by the pancreas.

The other ingredients are protamine sulphate, m-cresol, phenol, glycerol, dibasic sodium

phosphate 7H

O, zinc oxide and water for injection. Sodium hydroxide or hydrochloric acid

may have been used to adjust the acidity.

What Humalog Mix50 100 units/ml suspension for injection in cartridge looks like and contents

of the pack

Humalog Mix50 100 units/ml suspension for injection is a white, sterile suspension and contains

100 units of insulin lispro in each millilitre (100 units/ml) suspension for injection. 50% of the

insulin lispro in Humalog Mix50 is dissolved in water. 50% of the insulin lispro in Humalog Mix50

is available in a suspension together with protamine sulphate. Each cartridge contains 300 units (3

millilitres). The cartridges come in packs of 5 or 10 cartridges. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Humalog Mix50 100 units/ml suspension for injection in cartridge is made by:

Lilly France S.A.S., Rue du Colonel Lilly, 67640 Fegersheim, France,

Eli Lilly Italia S.p.A., Via Gramsci 731-733, 50019 Sesto Fiorentino, (FI) Italy.

The product licence is held by: Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The

Netherlands.

For any information about this medicinal product, please contact the local representative of the

Marketing Authorisation Holder:

Belgique/België/Belgien

Eli Lilly Benelux S.A./N.V.

Tél/Tel: + 32-(0)2 548 84 84

Lietuva

Eli Lilly Holdings Limited atstovybė

Tel. +370 (5) 2649600

България

ТП "Ели Лили Недерланд" Б.В. - България

тел. + 359 2 491 41 40

Luxembourg/Luxemburg

Eli Lilly Benelux S.A./N.V.

Tél/Tel: + 32-(0)2 548 84 84

Česká republika

ELI LILLY ČR, s.r.o.

Tel: + 420 234 664 111

Magyarország

Lilly Hungária Kft.

Tel: + 36 1 328 5100

Danmark

Eli Lilly Danmark A/S

Tlf: +45 45 26 6000

Malta

Charles de Giorgio Ltd.

Tel: + 356 25600 500

Deutschland

Lilly Deutschland GmbH

Tel. + 49-(0) 6172 273 2222

Nederland

Eli Lilly Nederland B.V.

Tel: + 31-(0) 30 60 25 800

Eesti

Eli Lilly Holdings Limited Eesti filiaal

Tel:

+

372 6817 280

Norge

Eli Lilly Norge A.S.

Tlf: + 47 22 88 18 00

Ελλάδα

ΦΑΡΜΑΣΕΡΒ-ΛΙΛΛΥ Α.Ε.Β.Ε.

Τηλ: +30 210 629 4600

Österreich

Eli Lilly Ges. m.b.H.

Tel: + 43-(0) 1 711 780

España

Lilly S.A.

Tel: + 34-91 663 50 00

Polska

Eli Lilly Polska Sp. z o.o.

Tel: +48 22 440 33 00

France

Lilly France S.A.S.

Tél: +33-(0) 1 55 49 34 34

Portugal

Lilly Portugal - Produtos Farmacêuticos, Lda

Tel: + 351-21-4126600

Hrvatska

Eli Lilly Hrvatska d.o.o.

Tel: +385 1 2350 999

România

Eli Lilly România S.R.L.

Tel: + 40 21 4023000

Ireland

Eli Lilly and Company (Ireland) Limited

Tel: + 353-(0) 1 661 4377

Slovenija

Eli Lilly farmacevtska družba, d.o.o.

Tel: +386 (0) 1 580 00 10

Ísland

Icepharma hf.

Sími + 354 540 8000

Slovenská republika

Eli Lilly Slovakia, s.r.o.

Tel: + 421 220 663 111

Italia

Eli Lilly Italia S.p.A.

Tel: + 39- 055 42571

Suomi/Finland

Oy Eli Lilly Finland Ab

Puh/Tel: + 358-(0) 9 85 45 250

Κύπρος

Phadisco Ltd

Τηλ: +357 22 715000

Sverige

Eli Lilly Sweden AB

Tel: + 46-(0) 8 7378800

Latvija

Eli Lilly Holdings Limited pārstāvniecība Latvijā

Tel:

+

371 67364000

United Kingdom

Eli Lilly and Company Limited

Tel: + 44-(0) 1256 315000

This leaflet was last revised in

{MM/YYYY}.

Detailed information on this medicine is available on the European Medicines Agency web site:

http://www.ema.europa.eu/.

PACKAGE LEAFLET: INFORMATION FOR THE USER

Humalog 100 units/ml KwikPen, solution for injection in a pre-filled pen

insulin lispro

Each KwikPen delivers 1 – 60 units in steps of 1 units.

Read all of this leaflet carefully before you start using this medicine because it contains

important information for you.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,

even if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side

effects not listed in this leaflet. See section 4.

What is in this leaflet

What Humalog KwikPen is and what it is used for

What you need to know before you use Humalog KwikPen

How to use Humalog KwikPen

Possible side effects

How to store Humalog KwikPen

Contents of the pack and other information

1.

What Humalog KwikPen is and what it is used for

Humalog KwikPen is used to treat diabetes. It works more quickly than normal human insulin because

the insulin molecule has been changed slightly.

You get diabetes if your pancreas does not make enough insulin to control the level of glucose in your

blood. Humalog is a substitute for your own insulin and is used to control glucose in the long term. It

works very quickly and lasts a shorter time than soluble insulin (2 to 5 hours). You should normally

use Humalog within 15 minutes of a meal.

Your doctor may tell you to use Humalog KwikPen as well as a longer-acting insulin. Each kind of

insulin comes with another patient information leaflet to tell you about it. Do not change your insulin

unless your doctor tells you to. Be very careful if you do change insulin.

Humalog is suitable for use in adults and children.

The KwikPen is a disposable pre-filled pen containing 3 ml (300 units, 100 units/ml) of insulin lispro.

One KwikPen contains multiple doses of insulin. The KwikPen dials 1 unit at a time.

The number of

units are displayed in the dose window, always check this before your injection.

You can give

from 1 to 60 units in a single injection.

If your dose is more than 60 units, you will need to give

yourself more than one injection.

2.

What you need to know before you use Humalog KwikPen

Do NOT use Humalog KwikPen

if you think

hypoglycaemia

(low blood sugar) is starting. Further in this leaflet it tells you how to

deal with mild hypoglycaemia (see Section 3: If you take more Humalog than you need).

if you are

allergic

to insulin lispro or any of the other ingredients of this medicine (listed in

section 6).

Warnings and precautions

If your blood sugar levels are well controlled by your current insulin therapy, you may not feel the

warning symptoms when your blood sugar is falling too low. Warning signs are listed later in this

leaflet. You must think carefully about when to have your meals, how often to exercise and how

much to do. You must also keep a close watch on your blood sugar levels by testing your blood

glucose often.

A few people who have had hypoglycaemia after switching from animal insulin to human insulin

have reported that the early warning symptoms were less obvious or different. If you often have

hypoglycaemia or have difficulty recognising it, please discuss this with your doctor.

If you answer YES to any of the following questions, tell your doctor, pharmacist or diabetes nurse

Have you recently become ill?

Do you have trouble with your kidneys or liver?

Are you exercising more than usual?

The amount of insulin you need may also change if you drink alcohol.

You should also tell your doctor, pharmacist or diabetes nurse if you are planning to go abroad.

The time difference between countries may mean that you have to have your injections and meals

at different times from when you are at home.

Some patients with long-standing type 2 diabetes mellitus and heart disease or previous stroke who

were treated with pioglitazone and insulin experienced the development of heart failure. Inform

your doctor as soon as possible, if you experience signs of heart failure such as unusual shortness

of breath or rapid increase in weight or localised swelling (oedema).

This Pen is not recommended for use by the blind or visually impaired without the help of someone

trained to use the Pen.

Other medicines and Humalog KwikPen

Your insulin needs may change if you are taking

the contraceptive pill,

steroids,

thyroid hormone replacement therapy,

oral hypoglycaemics,

acetyl salicylic acid,

sulpha antibiotics,

octreotide,

“beta

stimulants” (for example ritodrine, salbutamol or terbutaline),

beta-blockers, or

some antidepressants (monoamine oxidase inhibitors or selective serotonin reuptake inhibitors),

danazol,

some angiotensin converting enzyme (ACE) inhibitors (for example captopril, enalapril), and

angiotensin II receptor blockers.

Please tell your doctor, if you are taking or have recently taken any other medicines, including

medicines obtained without a prescription (see section “Warnings and precautions”).

Pregnancy and breast-feeding

Are you pregnant or thinking about becoming pregnant, or are you breast-feeding? The amount of

insulin you need usually falls during the first three months of pregnancy and increases for the

remaining six months. If you are breast-feeding, you may need to alter your insulin intake or diet.

Ask your doctor for advice.

Driving and using machines

Your ability to concentrate and react may be reduced if you have hypoglycaemia. Please keep this

possible problem in mind in all situations where you might put yourself and others at risk (e.g. driving

a car or operating machinery). You should contact your doctor about the advisability of driving if you

have:

frequent episodes of hypoglycaemia

reduced or absent warning signs of hypoglycaemia

Important information about some of the ingredients of Humalog KwikPen

This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-

free’.

3.

How to use Humalog KwikPen

Always check the pack and the label of the pre-filled pen for the name and type of the insulin

when you get it from your pharmacy. Make sure you get the Humalog KwikPen that your

doctor has told you to use.

Always use Humalog KwikPen exactly as your doctor has told you. You should check with your

doctor if you are not sure. To prevent the possible transmission of disease, each pen must be used by

you only, even if the needle is changed.

Dosage

You should normally inject Humalog within 15 minutes of a meal. If you need to, you can inject

soon after a meal. But your doctor will have told you exactly how much to use, when to use it,

and how often. These instructions are only for you. Follow them exactly and visit your diabetes

clinic regularly.

If you change the type of insulin you use (for example from a human or animal insulin to a

Humalog product), you may have to take more or less than before. This might just be for the

first injection or it may be a gradual change over several weeks or months.

Humalog KwikPen is only suitable for injecting just under the skin. Speak to your doctor if you

need to inject your insulin by another method.

Preparing Humalog KwikPen

Humalog is already dissolved in water, so you do not need to mix it. But you must use it

only

it looks like water. It must be clear, have no colour and no solid pieces in it. Check each time

you inject yourself.

Getting the KwikPen ready to use (Please see user manual)

First wash your hands.

Read the instructions on how to use your pre-filled insulin pen. Please follow the instructions

carefully. Here are some reminders.

Use a clean needle. (Needles are not included).

Prime your KwikPen before each use. This checks that insulin comes out and clears the air

bubbles from your KwikPen. There may still be some small air bubbles left in the pen - these

are harmless. But if the air bubbles are too large it may affect the insulin dose.

Injecting Humalog

Before you make an injection, clean your skin as you have been instructed. Inject under the

skin, as you were taught. Do not inject directly into a vein. After your injection, leave the needle

in the skin for five seconds to make sure you have taken the whole dose. Do not rub the area

you have just injected. Make sure you inject at least half an inch (1 cm) from the last injection

and that you ‘rotate’ the places you inject, as you have been taught. It doesn’t matter which

injection site you use, either upper arm, thigh, buttock or abdomen, your Humalog injection will

still work quicker than soluble human insulin.

You must not administer Humalog by the intravenous route. Inject Humalog as your physician

or nurse has taught you. Only your physician can administer Humalog by the intravenous route.

He will only do this under special circumstances such as surgery or if you are ill and your

glucose levels are too high.

After injecting

As soon as you have done the injection, unscrew the needle from the KwikPen using the outer

needle cap. This will keep the insulin sterile and stop it leaking. It also stops air entering the pen

and your needle clogging.

Do not share your needles

. Do not share your pen. Replace the cap

on your pen.

Further injections

Every time you use a KwikPen you must use a new needle. Before every injection, clear any air

bubbles. You can see how much insulin is left by holding the KwikPen with the needle pointing

up. The scale on the cartridge shows about how many units you have left.

Do not mix any other insulin in your disposable pen. Once the KwikPen is empty, do not use it

again. Please get rid of it carefully - your pharmacist or diabetes nurse will tell you how to do

this.

Using Humalog in an infusion pump

KwikPen is only suitable for injecting just under the skin. Do not use the pen to administer

Humalog by a different way. Other forms of Humalog 100 unit /ml are available if this is

necessary. Speak to your doctor if this applies to you.

If you take more Humalog than you need

If you take more Humalog than you need, a low blood sugar may occur. Check your blood sugar.

If your blood sugar is low

(mild hypoglycaemia)

, eat glucose tablets, sugar or drink a sugary drink.

Then eat fruit, biscuits, or a sandwich, as your doctor has advised you and have some rest. This will

often get you over mild hypoglycaemia or a minor insulin overdose. If you get worse and your

breathing is shallow and your skin gets pale, tell your doctor at once. A glucagon injection can treat

quite severe hypoglycaemia. Eat glucose or sugar after the glucagon injection. If you do not respond to

glucagon, you will have to go to hospital. Ask your doctor to tell you about glucagon.

If you forget to use Humalog

If you take less Humalog than you need, a high blood sugar may occur. Check your blood sugar

If hypoglycaemia (low blood sugar) or hyperglycaemia (high blood sugar) is not treated they can be

very serious and cause headaches, nausea, vomiting, dehydration, unconsciousness, coma or even

death (see A and B in section 4 “Possible Side Effects”).

Three simple steps

to avoid hypoglycaemia or hyperglycaemia are:

Always keep spare syringes and a spare vial of Humalog, or a spare pen and cartridges, in case

you lose your KwikPen or it gets damaged.

Always carry something to show you are diabetic.

Always carry sugar with you.

If you stop using Humalog.

If you take less Humalog than you need, a high blood sugar may occur. Do not change your insulin

unless your doctor tells you to.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Systemic allergy is rare (

1/10,000 to <1/1,000). The symptoms are as follows:

rash over the whole body

blood pressure dropping

difficulty in breathing

heart beating fast

wheezing

sweating

If you think you are having this sort of insulin allergy with Humalog, tell your doctor at once.

Local allergy is common (

1/100 to <1/10). Some people get redness, swelling or itching around the

area of the insulin injection. This usually clears up in anything from a few days to a few weeks. If this

happens to you, tell your doctor.

Lipodystrophy (thickening or pitting of the skin) is uncommon (

1/1,000 to <1/100). If you notice

your skin thickening or pitting at the injection site, tell your doctor.

Oedema (e.g. swelling in arms, ankles; fluid retention) has been reported, particularly at the start of

insulin therapy or during a change in therapy to improve control of your blood glucose.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects

not listed in this leaflet.

You can also report side effects directly via the national reporting system

listed in Appendix V. By reporting side effects you can help provide more information on the safety of

this medicine.

Common problems of diabetes

A.

Hypoglycaemia

Hypoglycaemia (low blood sugar) means there is not enough sugar in the blood. This can be caused if:

you take too much Humalog or other insulin;

you miss or delay meals or change your diet;

you exercise or work too hard just before or after a meal;

you have an infection or illness (especially diarrhoea or vomiting);

there is a change in your need for insulin; or

you have trouble with your kidneys or liver which gets worse.

Alcohol and some medicines can affect your blood sugar levels.

The first symptoms of low blood sugar usually come on quickly and include the following:

tiredness

rapid heartbeat

nervousness or shakiness

feeling sick

headache

cold sweat

While you are not confident about recognising your warning symptoms, avoid situations, e.g. driving a

car, in which you or others would be put at risk by hypoglycaemia.

B.

Hyperglycaemia and diabetic ketoacidosis

Hyperglycaemia (too much sugar in the blood) means that your body does not have enough insulin.

Hyperglycaemia can be brought about by:

not taking your Humalog or other insulin;

taking less insulin than your doctor tells you to;

eating a lot more than your diet allows; or

fever, infection or emotional stress.

Hyperglycaemia can lead to diabetic ketoacidosis. The first symptoms come on slowly over many

hours or days. The symptoms include the following:

feeling sleepy

no appetite

flushed face

fruity smell on the breath

thirst

feeling or being sick

Severe symptoms are heavy breathing and a rapid pulse.

Get medical help immediately.

C.

Illness

If you are ill, especially if you feel sick or are sick, the amount of insulin you need may change.

Even

when you are not eating normally, you still need insulin.

Test your urine or blood, follow your

‘sick rules’, and tell your doctor.

5.

How to store Humalog KwikPen

Before the first use store your Humalog KwikPen in a refrigerator (2

C – 8

C). Do not freeze.

Keep your Humalog KwikPen in use at room temperature (15° - 30°C) and discard after 28 days. Do

not put it near heat or in the sun. Do not keep the KwikPen that you are using in the fridge. The

KwikPen should not be stored with the needle attached.

Keep out of the reach and sight of children.

Do not use this medicine after the expiry date which is stated on the label and the carton. The expiry

date refers to the last day of that month.

Do not use this medicine if you notice the solution is coloured or it has solid pieces in it. You must use

only

if it looks like water. Check this each time you inject yourself.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to

dispose of medicines no longer required. These measures will help to protect the environment.

6.

Contents of the pack and other information

What Humalog 100 units/ml KwikPen solution for injection contains

The active substance is insulin lispro. Insulin lispro is made in the laboratory by a ‘recombinant

DNA technology’ process. It is a changed form of human insulin and so is different from other

human and animal insulins. Insulin lispro is closely related to human insulin which is a natural

hormone made by the pancreas.

The other ingredients are m-cresol, glycerol, dibasic sodium phosphate 7 H

O, zinc oxide and

water for injection. Sodium hydroxide or hydrochloric acid may have been used to adjust the

acidity.

What Humalog KwikPen looks like and contents of the pack

Humalog 100 units/ml KwikPen, solution for injection is a sterile, clear, colourless, aqueous solution

and contains 100 units of insulin lispro in each millilitre (100 units/ml) solution for injection. Each

Humalog KwikPen contains 300 units (3 millilitres). The Humalog KwikPen comes in a pack of 5 pre-

filled pens or a multipack of 2 x 5 pre-filled pens. Not all pack sizes may be marketed. The Humalog

in your pre-filled pen is the same as the Humalog, which comes in separate Humalog cartridges. The

KwikPen simply has a built in cartridge. When the pre-filled pen is empty you cannot use it again.

Marketing Authorisation Holder and Manufacturer

Humalog 100 units/ml KwikPen, solution for injection is made by:

Lilly France S.A.S., Rue du Colonel Lilly, 67640 Fegersheim, France,

Eli Lilly Italia S.p.A., Via Gramsci 731-733, 50019 Sesto Fiorentino, (FI) Italy.

The product licence is held by: Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The

Netherlands.

For any information about this medicinal product, please contact the local representative of the

Marketing Authorisation Holder:

Belgique/België/Belgien

Eli Lilly Benelux S.A./N.V.

Tél/Tel: + 32-(0)2 548 84 84

Lietuva

Eli Lilly Holdings Limited atstovybė

Tel. +370 (5) 2649600

България

ТП "Ели Лили Недерланд" Б.В. - България

тел. + 359 2 491 41 40

Luxembourg/Luxemburg

Eli Lilly Benelux S.A./N.V.

Tél/Tel: + 32-(0)2 548 84 84

Česká republika

ELI LILLY ČR, s.r.o.

Tel: + 420 234 664 111

Magyarország

Lilly Hungária Kft.

Tel: + 36 1 328 5100

Danmark

Eli Lilly Danmark A/S

Tlf: +45 45 26 6000

Malta

Charles de Giorgio Ltd.

Tel: + 356 25600 500

Deutschland

Lilly Deutschland GmbH

Tel. + 49-(0) 6172 273 2222

Nederland

Eli Lilly Nederland B.V.

Tel: + 31-(0) 30 60 25 800

Eesti

Eli Lilly Holdings Limited Eesti filiaal

Tel:

+

372 6817 280

Norge

Eli Lilly Norge A.S.

Tlf: + 47 22 88 18 00

Ελλάδα

ΦΑΡΜΑΣΕΡΒ-ΛΙΛΛΥ Α.Ε.Β.Ε.

Τηλ: +30 210 629 4600

Österreich

Eli Lilly Ges. m.b.H.

Tel: + 43-(0) 1 711 780

España

Lilly S.A.

Tel: + 34-91 663 50 00

Polska

Eli Lilly Polska Sp. z o.o.

Tel: +48 22 440 33 00

France

Lilly France S.A.S.

Tél: +33-(0) 1 55 49 34 34

Portugal

Lilly Portugal - Produtos Farmacêuticos, Lda

Tel: + 351-21-4126600

Hrvatska

Eli Lilly Hrvatska d.o.o.

Tel: +385 1 2350 999

România

Eli Lilly România S.R.L.

Tel: + 40 21 4023000

Ireland

Eli Lilly and Company (Ireland) Limited

Tel: + 353-(0) 1 661 4377

Slovenija

Eli Lilly farmacevtska družba, d.o.o.

Tel: +386 (0) 1 580 00 10

Ísland

Icepharma hf.

Sími + 354 540 8000

Slovenská republika

Eli Lilly Slovakia, s.r.o.

Tel: + 421 220 663 111

Italia

Eli Lilly Italia S.p.A.

Tel: + 39- 055 42571

Suomi/Finland

Oy Eli Lilly Finland Ab

Puh/Tel: + 358-(0) 9 85 45 250

Κύπρος

Phadisco Ltd

Τηλ: +357 22 715000

Sverige

Eli Lilly Sweden AB

Tel: + 46-(0) 8 7378800

Latvija

Eli Lilly Holdings Limited pārstāvniecība Latvijā

Tel:

+

371 67364000

United Kingdom

Eli Lilly and Company Limited

Tel: + 44-(0) 1256 315000

This leaflet was last revised in

{MM/YYYY}.

USER MANUAL

Please see manual text later.

Detailed information on this medicine is available on the European Medicines Agency web site:

http://www.ema.europa.eu/.

PACKAGE LEAFLET: INFORMATION FOR THE USER

Humalog Mix25 100 units/ml KwikPen, suspension for injection in a pre-filled pen

insulin lispro

Each KwikPen delivers 1 – 60 units in steps of 1 units.

Read all of this leaflet carefully before you start using this medicine because it contains

important information for you.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,

even if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side

effects not listed in this leaflet. See section 4.

What is in this leaflet

What Humalog Mix25 KwikPen is and what it is used for

What you need to know before you use Humalog Mix25 KwikPen

How to use Humalog Mix25 KwikPen

Possible side effects

How to store Humalog Mix25 KwikPen

Contents of the pack and other information

1.

What Humalog Mix25 KwikPen is and what it is used for

Humalog Mix25 KwikPen is used to treat diabetes. It is a premixed suspension. Its active substance is

insulin lispro. 25% of the insulin lispro in Humalog Mix25 KwikPen is dissolved in water and it

works more quickly than normal human insulin because the insulin molecule has been changed

slightly. 75% of the insulin lispro in Humalog Mix25 KwikPen is available in a suspension together

with protamine sulphate, so that its action is prolonged.

You get diabetes if your pancreas does not make enough insulin to control the level of glucose in

your blood. Humalog Mix25 is a substitute for your own insulin and is used to control glucose in the

long term. Humalog Mix25 works very quickly and longer than soluble insulin. You should

normally use Humalog Mix25 within 15 minutes of a meal.

Your doctor may tell you to use Humalog Mix25 KwikPen as well as a longer-acting insulin. Each

kind of insulin comes with another patient information leaflet to tell you about it. Do not change

your insulin unless your doctor tells you to. Be very careful if you do change insulin.

The KwikPen is a disposable pre-filled pen containing 3 ml (300 units, 100 units/ml) of insulin lispro.

One KwikPen contains multiple doses of insulin. The KwikPen dials 1 unit at a time.

The number of

units are displayed in the dose window, always check this before your injection.

You can give

from 1 to 60 units in a single injection.

If your dose is more than 60 units, you will need to give

yourself more than one injection.

2.

What you need to know before you use Humalog Mix25 KwikPen

Do NOT use Humalog Mix25 KwikPen

if you think

hypoglycaemia

(low blood sugar) is starting. Further in this leaflet it tells you how to

deal with mild hypoglycaemia (see Section 3: If you take more Humalog Mix25 than you need).

if you are

allergic

to insulin lispro or any of the other ingredients of this medicine (listed in

section 6).

Warnings and precautions

If your blood sugar levels are well controlled by your current insulin therapy, you may not feel the

warning symptoms when your blood sugar is falling too low. Warning signs are listed later in this

leaflet. You must think carefully about when to have your meals, how often to exercise and how

much to do. You must also keep a close watch on your blood sugar levels by testing your blood

glucose often.

A few people who have had hypoglycaemia after switching from animal insulin to human insulin

have reported that the early warning symptoms were less obvious or different. If you often have

hypoglycaemia or have difficulty recognising them, please discuss this with your doctor.

If you answer YES to any of the following questions, tell your doctor, pharmacist or diabetes

nurse

Have you recently become ill?

Do you have trouble with your kidneys or liver?

Are you exercising more than usual?

The amount of insulin you need may also change if you drink alcohol.

You should also tell your doctor, pharmacist or diabetes nurse if you are planning to go abroad.

The time difference between countries may mean that you have to have your injections and meals

at different times from when you are at home.

Some patients with long-standing type 2 diabetes mellitus and heart disease or previous stroke

who were treated with pioglitazone and insulin experienced the development of heart failure.

Inform your doctor as soon as possible, if you experience signs of heart failure such as unusual

shortness of breath or rapid increase in weight or localised swelling (oedema).

This Pen is not recommended for use by the blind or visually impaired without the help of

someone trained to use the Pen.

Other medicines and Humalog Mix25 KwikPen

Your insulin needs may change if you are taking

the contraceptive pill,

steroids,

thyroid hormone replacement therapy,

oral hypoglycaemics,

acetyl salicylic acid,

sulpha antibiotics,

octreotide,

“beta

stimulants” (for example ritodrine, salbutamol or terbutaline),

beta-blockers, or

some antidepressants (monoamine oxidase inhibitors or selective serotonin reuptake inhibitors),

danazol,

some angiotensin converting enzyme (ACE) inhibitors (for example captopril, enalapril), and

angiotensin II receptor blockers.

Please tell your doctor, if you are taking or have recently taken any other medicines, including

medicines obtained without a prescription (see section “Warnings and precautions”).

Pregnancy and breast-feeding

Are you pregnant or thinking about becoming pregnant, or are you breast-feeding? The amount of

insulin you need usually falls during the first three months of pregnancy and increases for the

remaining six months. If you are breast-feeding, you may need to alter your insulin intake or diet.

Ask your doctor for advice.

Driving and using machines

Your ability to concentrate and react may be reduced if you have hypoglycaemia. Please keep this

possible problem in mind in all situations where you might put yourself and others at risk (e.g. driving

a car or operating machinery). You should contact your doctor about the advisability of driving if you

have:

frequent episodes of hypoglycaemia

reduced or absent warning signs of hypoglycaemia

Important information about some of the ingredients of Humalog Mix25 KwikPen

This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-

free’.

3.

How to use Humalog Mix25 KwikPen

Always check the pack and the label of the pre-filled pen for the name and type of the insulin

when you get it from your pharmacy. Make sure you get the Humalog Mix25 KwikPen that

your doctor has told you to use.

Always use Humalog Mix25 KwikPen exactly as your doctor has told you. You should check with

your doctor if you are not sure. To prevent the possible transmission of disease, each pen must be used

by you only, even if the needle is changed.

Dosage

You should normally inject Humalog Mix25 within 15 minutes of a meal. If you need to, you

can inject soon after a meal. But your doctor will have told you exactly how much to use,

when to use it, and how often. These instructions are only for you. Follow them exactly and

visit your diabetes clinic regularly.

If you change the type of insulin you use (for example from a human or animal insulin to a

Humalog product), you may have to take more or less than before. This might just be for the

first injection or it may be a gradual change over several weeks or months.

Humalog Mix25 KwikPen is only suitable for injecting just under the skin. Speak to your

doctor if you need to inject your insulin by another method.

Preparing Humalog Mix25 KwikPen

The KwikPen should be rotated in the palms of the hands ten times and inverted 180° ten times

immediately before use to resuspend insulin until it appears uniformly cloudy or milky. If not,

repeat the above procedure until contents are mixed. Cartridges contain a small glass bead to

assist mixing. Do not shake vigorously as this may cause frothing which may interfere with

the correct measurement of the dose. The cartridges should be examined frequently and should

not be used if clumps of material are present or if solid white particles stick to the bottom or

wall of the cartridge, giving it a frosted appearance. Check each time you inject yourself.

Getting the KwikPen ready to use (Please see user manual)

First wash your hands.

Read the instructions on how to use your pre-filled insulin pen. Please follow the instructions

carefully. Here are some reminders.

Use a clean needle. (Needles are not included).

Prime your KwikPen before each use. This checks that insulin comes out and clears the air

bubbles from your KwikPen. There may still be some small air bubbles left in the pen - these

are harmless. But if the air bubbles are too large it may affect the insulin dose.

Injecting Humalog Mix25

Before you make an injection, clean your skin as you have been instructed. Inject under the

skin, as you were taught. Do not inject directly into a vein. After your injection, leave the

needle in the skin for five seconds to make sure you have taken the whole dose. Do not rub the

area you have just injected. Make sure you inject at least half an inch (1 cm) from where you

last injected and that you ‘rotate’ the places you inject, as you have been taught.

After injecting

As soon as you have done the injection, unscrew the needle from the KwikPen using the outer

needle cap. This will keep the insulin sterile and stop it leaking. It also stops air entering the

pen and your needle clogging

. Do not share your needles

. Do not share your pen. Replace

the cap on the pen.

Further injections

Every time you use a KwikPen you must use a new needle. Before every injection, clear any air

bubbles. You can see how much insulin is left by holding the KwikPen with the needle

pointing up. The scale on the cartridge shows about how many units you have left.

Do not mix any other insulin in your disposable pen. Once the KwikPen is empty, do not use it

again. Please get rid of it carefully - your pharmacist or diabetes nurse will tell you how to do

this.

If you take more Humalog Mix25 than you need

If you take more Humalog Mix25 than you need, a low blood sugar may occur. Check your blood

sugar.

If your blood sugar is low

(mild hypoglycaemia)

, eat glucose tablets, sugar or drink a sugary drink.

Then eat fruit, biscuits, or a sandwich, as your doctor has advised you and have some rest. This will

often get you over mild hypoglycaemia or a minor insulin overdose. If you get worse and your

breathing is shallow and your skin gets pale, tell your doctor at once. A glucagon injection can treat

quite severe hypoglycaemia. Eat glucose or sugar after the glucagon injection. If you do not respond to

glucagon, you will have to go to hospital. Ask your doctor to tell you about glucagon.

If you forget to use Humalog Mix25

If you take less Humalog Mix25 than you need, a high blood sugar may occur. Check your blood

sugar

If hypoglycaemia (low blood sugar) or hyperglycaemia (high blood sugar) is not treated they can be

very serious and cause headaches, nausea, vomiting, dehydration, unconsciousness, coma or even

death (see A and B in section 4 “Possible Side Effects”).

Three simple steps

to avoid hypoglycaemia or hyperglycaemia are:

Always keep spare syringes and a spare vial of Humalog Mix25, or a spare pen and cartridges,

in case you lose your KwikPen or it gets damaged.

Always carry something to show you are diabetic.

Always carry sugar with you.

If you stop using Humalog Mix25.

If you take less Humalog Mix25 than you need, a high blood sugar may occur. Do not change your

insulin unless your doctor tells you to.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Systemic allergy is rare (

1/10,000 to <1/1,000). The symptoms are as follows:

rash over the whole body

blood pressure dropping

difficulty in breathing

heart beating fast

wheezing

sweating

If you think you are having this sort of insulin allergy with Humalog Mix25, tell your doctor at once.

Local allergy is common (

1/100 to <1/10). Some people get redness, swelling or itching around the

area of the insulin injection. This usually clears up in anything from a few days to a few weeks. If this

happens to you, tell your doctor.

Lipodystrophy (thickening or pitting of the skin) is uncommon (

1/1,000 to <1/100). If you notice

your skin thickening or pitting at the injection site, tell your doctor.

Oedema (e.g. swelling in arms, ankles; fluid retention) has been reported, particularly at the start of

insulin therapy or during a change in therapy to improve control of your blood glucose.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects

not listed in this leaflet.

You can also report side effects directly via the national reporting system

listed in Appendix V. By reporting side effects you can help provide more information on the safety of

this medicine.

Common problems of diabetes

A.

Hypoglycaemia

Hypoglycaemia (low blood sugar) means there is not enough sugar in the blood. This can be caused if:

you take too much Humalog Mix25 or other insulin;

you miss or delay meals or change your diet;

you exercise or work too hard just before or after a meal;

you have an infection or illness (especially diarrhoea or vomiting);

there is a change in your need for insulin; or

you have trouble with your kidneys or liver which gets worse.

Alcohol and some medicines can affect your blood sugar levels.

The first symptoms of low blood sugar usually come on quickly and include the following:

tiredness

rapid heartbeat

nervousness or shakiness

feeling sick

headache

cold sweat

While you are not confident about recognising your warning symptoms, avoid situations, e.g. driving a

car, in which you or others would be put at risk by hypoglycaemia.

B.

Hyperglycaemia and diabetic ketoacidosis

Hyperglycaemia (too much sugar in the blood) means that your body does not have enough insulin.

Hyperglycaemia can be brought about by:

not taking your Humalog or other insulin;

taking less insulin than your doctor tells you to;

eating a lot more than your diet allows; or

fever, infection or emotional stress.

Hyperglycaemia can lead to diabetic ketoacidosis. The first symptoms come on slowly over many

hours or days. The symptoms include the following:

feeling sleepy

no appetite

flushed face

fruity smell on the breath

thirst

feeling or being sick

Severe symptoms are heavy breathing and a rapid pulse.

Get medical help immediately.

C.

Illness

If you are ill, especially if you feel sick or are sick, the amount of insulin you need may change.

Even

when you are not eating normally, you still need insulin.

Test your urine or blood, follow your

‘sick rules’, and tell your doctor.

5.

How to store Humalog Mix25 KwikPen

Before the first use store your Humalog Mix25 KwikPen in a refrigerator (2

C – 8

C). Do not freeze.

Keep your Humalog Mix25 KwikPen in use at room temperature (15° - 30°C) and discard after 28

days. Do not put it near heat or in the sun. Do not keep the KwikPen that you are using in the fridge.

The KwikPen should not be stored with the needle attached.

Keep out of the reach and sight of children.

Do not use this medicine after the expiry date which is stated on the label and the carton. The expiry

date refers to the last day of that month.

Do not use this medicine if you notice clumps of material are present or if solid white particles stick to

the bottom or wall of the cartridge, giving it a frosted appearance. Check each time you inject yourself.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to

dispose of medicines no longer required. These measures will help to protect the environment.

6.

Contents of the pack and other information

What Humalog Mix25 100 units/ml KwikPen, suspension for injection contains

The active substance is insulin lispro. Insulin lispro is made in the laboratory by a ‘recombinant

DNA technology’ process. It is a changed form of human insulin and so is different from other

human and animal insulins. Insulin lispro is closely related to human insulin which is a natural

hormone made by the pancreas.

The other ingredients are protamine sulphate, m-cresol, phenol, glycerol, dibasic sodium

phosphate 7H

O, zinc oxide and water for injection. Sodium hydroxide or hydrochloric acid

may have been used to adjust the acidity.

What Humalog Mix25 100 units/ml KwikPen, suspension for injection looks like and contents of

the pack

Humalog Mix25 100 units/ KwikPen, suspension for injection is a white, sterile suspension and

contains 100 units of insulin lispro in each millilitre (100 units/ml) suspension for injection. 25% of

the insulin lispro in Humalog Mix25 is dissolved in water. 75% of the insulin lispro in Humalog

Mix25 is available in a suspension together with protamine sulphate. Each Humalog Mix25 KwikPen

contains 300 units (3 millilitres). The Humalog Mix25 KwikPen comes in a pack of 5 pre-filled pens

or a multipack of 2 x 5 pre-filled pens. Not all pack sizes may be marketed. The Humalog Mix25 in

your KwikPen is the same as the Humalog Mix25, which comes in separate Humalog Mix25

cartridges. The KwikPen simply has a built in cartridge. When the KwikPen is empty you cannot use

it again.

Marketing Authorisation Holder and Manufacturer

Humalog Mix25 100 units/ml KwikPen, suspension for injection is made by:

Lilly France S.A.S., Rue du Colonel Lilly, 67640 Fegersheim, France,

Eli Lilly Italia S.p.A., Via Gramsci 731-733, 50019 Sesto Fiorentino, (FI) Italy.

The product licence is held by: Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The

Netherlands.

For any information about this medicinal product, please contact the local representative of the

Marketing Authorisation Holder:

Belgique/België/Belgien

Eli Lilly Benelux S.A./N.V.

Tél/Tel: + 32-(0)2 548 84 84

Lietuva

Eli Lilly Holdings Limited atstovybė

Tel. +370 (5) 2649600

България

ТП "Ели Лили Недерланд" Б.В. - България

тел. + 359 2 491 41 40

Luxembourg/Luxemburg

Eli Lilly Benelux S.A./N.V.

Tél/Tel: + 32-(0)2 548 84 84

Česká republika

ELI LILLY ČR, s.r.o.

Tel: + 420 234 664 111

Magyarország

Lilly Hungária Kft.

Tel: + 36 1 328 5100

Danmark

Eli Lilly Danmark A/S

Tlf: +45 45 26 6000

Malta

Charles de Giorgio Ltd.

Tel: + 356 25600 500

Deutschland

Lilly Deutschland GmbH

Tel. + 49-(0) 6172 273 2222

Nederland

Eli Lilly Nederland B.V.

Tel: + 31-(0) 30 60 25 800

Eesti

Eli Lilly Holdings Limited Eesti filiaal

Tel:

+

372 6817 280

Norge

Eli Lilly Norge A.S.

Tlf: + 47 22 88 18 00

Ελλάδα

ΦΑΡΜΑΣΕΡΒ-ΛΙΛΛΥ Α.Ε.Β.Ε.

Τηλ: +30 210 629 4600

Österreich

Eli Lilly Ges. m.b.H.

Tel: + 43-(0) 1 711 780

España

Lilly S.A.

Tel: + 34-91 663 50 00

Polska

Eli Lilly Polska Sp. z o.o.

Tel: +48 22 440 33 00

France

Lilly France S.A.S.

Tél: +33-(0) 1 55 49 34 34

Portugal

Lilly Portugal - Produtos Farmacêuticos, Lda

Tel: + 351-21-4126600

Hrvatska

Eli Lilly Hrvatska d.o.o.

Tel: +385 1 2350 999

România

Eli Lilly România S.R.L.

Tel: + 40 21 4023000

Ireland

Eli Lilly and Company (Ireland) Limited

Tel: + 353-(0) 1 661 4377

Slovenija

Eli Lilly farmacevtska družba, d.o.o.

Tel: +386 (0) 1 580 00 10

Ísland

Icepharma hf.

Sími + 354 540 8000

Slovenská republika

Eli Lilly Slovakia, s.r.o.

Tel: + 421 220 663 111

Italia

Eli Lilly Italia S.p.A.

Tel: + 39- 055 42571

Suomi/Finland

Oy Eli Lilly Finland Ab

Puh/Tel: + 358-(0) 9 85 45 250

Κύπρος

Phadisco Ltd

Τηλ: +357 22 715000

Sverige

Eli Lilly Sweden AB

Tel: + 46-(0) 8 7378800

Latvija

Eli Lilly Holdings Limited pārstāvniecība Latvijā

Tel:

+

371 67364000

United Kingdom

Eli Lilly and Company Limited

Tel: + 44-(0) 1256 315000

This leaflet was last revised in

{MM/YYYY}.

USER MANUAL

Please see manual text later.

Detailed information on this medicine is available on the European Medicines Agency web site:

http://www.ema.europa.eu/.

PACKAGE LEAFLET: INFORMATION FOR THE USER

Humalog Mix50 100 units/ml KwikPen, suspension for injection in a pre-filled pen

insulin lispro

Each KwikPen delivers 1 – 60 units in steps of 1 units.

Read all of this leaflet carefully before you start using this medicine because it contains

important information for you.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,

even if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side

effects not listed in this leaflet. See section 4.

What is in this leaflet

What Humalog Mix50 KwikPen is and what it is used for

What you need to know before you use Humalog Mix50 KwikPen

How to use Humalog Mix50 KwikPen

Possible side effects

How to store Humalog Mix50 KwikPen

Contents of the pack and other information

1.

What Humalog Mix50 KwikPen is and what it is used for

Humalog Mix50 KwikPen is used to treat diabetes. It is a premixed suspension. Its active substance is

insulin lispro. 50% of the insulin lispro in Humalog Mix50 KwikPen is dissolved in water and it

works more quickly than normal human insulin because the insulin molecule has been changed

slightly. 50% of the insulin lispro in Humalog Mix50 KwikPen is available in a suspension together

with protamine sulphate, so that its action is prolonged.

You get diabetes if your pancreas does not make enough insulin to control the level of glucose in

your blood. Humalog Mix50 is a substitute for your own insulin and is used to control glucose in the

long term. Humalog Mix50 works very quickly and longer than soluble insulin. You should

normally use Humalog Mix50 within 15 minutes of a meal.

Your doctor may tell you to use Humalog Mix50 KwikPen as well as a longer-acting insulin. Each

kind of insulin comes with another patient information leaflet to tell you about it. Do not change

your insulin unless your doctor tells you to. Be very careful if you do change insulin.

The KwikPen is a disposable pre-filled pen containing 3 ml (300 units, 100 units/ml) of insulin lispro.

One KwikPen contains multiple doses of insulin. The KwikPen dials 1 unit at a time.

The number of

units are displayed in the dose window, always check this before your injection.

You can give

from 1 to 60 units in a single injection.

If your dose is more than 60 units, you will need to give

yourself more than one injection.

2.

What you need to know before you use Humalog Mix50 KwikPen

Do NOT use Humalog Mix50 KwikPen

if you think

hypoglycaemia

(low blood sugar) is starting. Further in this leaflet it tells you how to

deal with mild hypoglycaemia (see Section 3: If you take more Humalog Mix50 than you need).

if you are

allergic

to insulin lispro or any of the other ingredients of this medicine (listed in

section 6).

Warnings and precautions

If your blood sugar levels are well controlled by your current insulin therapy, you may not feel the

warning symptoms when your blood sugar is falling too low. Warning signs are listed later in this

leaflet. You must think carefully about when to have your meals, how often to exercise and how

much to do. You must also keep a close watch on your blood sugar levels by testing your blood

glucose often.

A few people who have had hypoglycaemia after switching from animal insulin to human insulin

have reported that the early warning symptoms were less obvious or different. If you often have

hypoglycaemia or have difficulty recognising them, please discuss this with your doctor.

If you answer YES to any of the following questions, tell your doctor, pharmacist or diabetes

nurse

Have you recently become ill?

Do you have trouble with your kidneys or liver?

Are you exercising more than usual?

The amount of insulin you need may also change if you drink alcohol.

You should also tell your doctor, pharmacist or diabetes nurse if you are planning to go abroad.

The time difference between countries may mean that you have to have your injections and meals

at different times from when you are at home.

Some patients with long-standing type 2 diabetes mellitus and heart disease or previous stroke

who were treated with pioglitazone and insulin experienced the development of heart failure.

Inform your doctor as soon as possible, if you experience signs of heart failure such as unusual

shortness of breath or rapid increase in weight or localised swelling (oedema).

This Pen is not recommended for use by the blind or visually impaired without the help of

someone trained to use the Pen.

Other medicines and Humalog Mix50 KwikPen

Your insulin needs may change if you are taking

the contraceptive pill,

steroids,

thyroid hormone replacement therapy,

oral hypoglycaemics,

acetyl salicylic acid,

sulpha antibiotics,

octreotide,

“beta

stimulants” (for example ritodrine, salbutamol or terbutaline),

beta-blockers, or

some antidepressants (monoamine oxidase inhibitors or selective serotonin reuptake inhibitors),

danazol,

some angiotensin converting enzyme (ACE) inhibitors (for example captopril, enalapril), and

angiotensin II receptor blockers.

Please tell your doctor, if you are taking or have recently taken any other medicines, including

medicines obtained without a prescription (see section “Warnings and precautions”).

Pregnancy and breast-feeding

Are you pregnant or thinking about becoming pregnant, or are you breast-feeding? The amount of

insulin you need usually falls during the first three months of pregnancy and increases for the

remaining six months. If you are breast-feeding, you may need to alter your insulin intake or diet.

Ask your doctor for advice.

Driving and using machines

Your ability to concentrate and react may be reduced if you have hypoglycaemia. Please keep this

possible problem in mind in all situations where you might put yourself and others at risk (e.g. driving

a car or operating machinery). You should contact your doctor about the advisability of driving if you

have:

frequent episodes of hypoglycaemia

reduced or absent warning signs of hypoglycaemia

Important information about some of the ingredients of Humalog Mix50 KwikPen

This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-

free’.

3.

How to use Humalog Mix50 KwikPen

Always check the pack and the label of the pre-filled pen for the name and type of the insulin

when you get it from your pharmacy. Make sure you get the Humalog Mix50 KwikPen that

your doctor has told you to use.

Always use Humalog Mix50 KwikPen exactly as your doctor has told you. You should check with

your doctor if you are not sure. To prevent the possible transmission of disease, each pen must be used

by you only, even if the needle is changed.

Dosage

You should normally inject Humalog Mix50 within 15 minutes of a meal. If you need to, you

can inject soon after a meal. But your doctor will have told you exactly how much to use,

when to use it, and how often. These instructions are only for you. Follow them exactly and

visit your diabetes clinic regularly.

If you change the type of insulin you use (for example from a human or animal insulin to a

Humalog product), you may have to take more or less than before. This might just be for the

first injection or it may be a gradual change over several weeks or months.

Humalog Mix50 KwikPen is only suitable for injecting just under the skin. Speak to your

doctor if you need to inject your insulin by another method.

Preparing Humalog Mix50 KwikPen

The KwikPen should be rotated in the palms of the hands ten times and inverted 180° ten times

immediately before use to resuspend insulin until it appears uniformly cloudy or milky. If not,

repeat the above procedure until contents are mixed. Cartridges contain a small glass bead to

assist mixing. Do not shake vigorously as this may cause frothing which may interfere with

the correct measurement of the dose. The cartridges should be examined frequently and should

not be used if clumps of material are present or if solid white particles stick to the bottom or

wall of the cartridge, giving it a frosted appearance. Check each time you inject yourself.

Getting the KwikPen ready to use (Please see user manual)

First wash your hands.

Read the instructions on how to use your pre-filled insulin pen. Please follow the instructions

carefully. Here are some reminders.

Use a clean needle. (Needles are not included).

Prime your KwikPen before each use. This checks that insulin comes out and clears the air

bubbles from your KwikPen. There may still be some small air bubbles left in the pen - these

are harmless. But if the air bubbles are too large it may affect the insulin dose.

Injecting Humalog Mix50

Before you make an injection, clean your skin as you have been instructed. Inject under the

skin, as you were taught. Do not inject directly into a vein. After your injection, leave the

needle in the skin for five seconds to make sure you have taken the whole dose. Do not rub the

area you have just injected. Make sure you inject at least half an inch (1 cm) from where you

last injected and that you ‘rotate’ the places you inject, as you have been taught.

After injecting

As soon as you have done the injection, unscrew the needle from the KwikPen using the outer

needle cap. This will keep the insulin sterile and stop it leaking. It also stops air entering the

pen and your needle clogging

. Do not share your needles

. Do not share your pen. Replace

the cap on the pen.

Further injections

Every time you use a KwikPen you must use a new needle. Before every injection, clear any air

bubbles. You can see how much insulin is left by holding the KwikPen with the needle

pointing up. The scale on the cartridge shows about how many units you have left.

Do not mix any other insulin in your disposable pen. Once the KwikPen is empty, do not use it

again. Please get rid of it carefully - your pharmacist or diabetes nurse will tell you how to do

this.

If you take more Humalog Mix50 than you need

If you take more Humalog Mix50 than you need, a low blood sugar may occur. Check your blood

sugar.

If your blood sugar is low

(mild hypoglycaemia)

, eat glucose tablets, sugar or drink a sugary drink.

Then eat fruit, biscuits, or a sandwich, as your doctor has advised you and have some rest. This will

often get you over mild hypoglycaemia or a minor insulin overdose. If you get worse and your

breathing is shallow and your skin gets pale, tell your doctor at once. A glucagon injection can treat

quite severe hypoglycaemia. Eat glucose or sugar after the glucagon injection. If you do not respond to

glucagon, you will have to go to hospital. Ask your doctor to tell you about glucagon.

If you forget to use Humalog Mix50

If you take less Humalog Mix50 than you need, a high blood sugar may occur. Check your blood

sugar

If hypoglycaemia (low blood sugar) or hyperglycaemia (high blood sugar) is not treated they can be

very serious and cause headaches, nausea, vomiting, dehydration, unconsciousness, coma or even

death (see A and B in section 4 “Possible Side Effects”).

Three simple steps

to avoid hypoglycaemia or hyperglycaemia are:

Always keep a spare pen and cartridges, in case you lose your KwikPen or it gets damaged.

Always carry something to show you are diabetic.

Always carry sugar with you.

If you stop using Humalog Mix50.

If you take less Humalog Mix50 than you need, a high blood sugar may occur. Do not change your

insulin unless your doctor tells you to.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Systemic allergy is rare (

1/10,000 to <1/1,000). The symptoms are as follows:

rash over the whole body

blood pressure dropping

difficulty in breathing

heart beating fast

wheezing

sweating

If you think you are having this sort of insulin allergy with Humalog Mix50, tell your doctor at once.

Local allergy is common (

1/100 to <1/10). Some people get redness, swelling or itching around the

area of the insulin injection. This usually clears up in anything from a few days to a few weeks. If this

happens to you, tell your doctor.

Lipodystrophy (thickening or pitting of the skin) is uncommon (

1/1,000 to <1/100). If you notice

your skin thickening or pitting at the injection site, tell your doctor.

Oedema (e.g. swelling in arms, ankles; fluid retention) has been reported, particularly at the start of

insulin therapy or during a change in therapy to improve control of your blood glucose.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects

not listed in this leaflet.

You can also report side effects directly via the national reporting system

listed in Appendix V. By reporting side effects you can help provide more information on the safety of

this medicine.

Common problems of diabetes

A.

Hypoglycaemia

Hypoglycaemia (low blood sugar) means there is not enough sugar in the blood. This can be caused if:

you take too much Humalog Mix50 or other insulin;

you miss or delay meals or change your diet;

you exercise or work too hard just before or after a meal;

you have an infection or illness (especially diarrhoea or vomiting);

there is a change in your need for insulin; or

you have trouble with your kidneys or liver which gets worse.

Alcohol and some medicines can affect your blood sugar levels.

The first symptoms of low blood sugar usually come on quickly and include the following:

tiredness

rapid heartbeat

nervousness or shakiness

feeling sick

headache

cold sweat

While you are not confident about recognising your warning symptoms, avoid situations, e.g. driving a

car, in which you or others would be put at risk by hypoglycaemia.

B.

Hyperglycaemia and diabetic ketoacidosis

Hyperglycaemia (too much sugar in the blood) means that your body does not have enough insulin.

Hyperglycaemia can be brought about by:

not taking your Humalog or other insulin;

taking less insulin than your doctor tells you to;

eating a lot more than your diet allows; or

fever, infection or emotional stress.

Hyperglycaemia can lead to diabetic ketoacidosis. The first symptoms come on slowly over many

hours or days. The symptoms include the following:

feeling sleepy

no appetite

flushed face

fruity smell on the breath

thirst

feeling or being sick

Severe symptoms are heavy breathing and a rapid pulse.

Get medical help immediately.

C.

Illness

If you are ill, especially if you feel sick or are sick, the amount of insulin you need may change.

Even

when you are not eating normally, you still need insulin.

Test your urine or blood, follow your

‘sick rules’, and tell your doctor.

5.

How to store Humalog Mix50 KwikPen

Before the first use store your Humalog Mix50 KwikPen in a refrigerator (2

C – 8

C). Do not freeze.

Keep your Humalog Mix50 KwikPen in use at room temperature (15° - 30°C) and discard after 28

days. Do not put it near heat or in the sun. Do not keep the KwikPen that you are using in the fridge.

The KwikPen should not be stored with the needle attached.

Keep out of the reach and sight of children.

Do not use this medicine after the expiry date which is stated on the label and the carton. The expiry

date refers to the last day of that month.

Do not use this medicine if you notice clumps of material are present or if solid white particles stick to

the bottom or wall of the cartridge, giving it a frosted appearance. Check each time you inject yourself.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to

dispose of medicines no longer required. These measures will help to protect the environment.

6.

Contents of the pack and other information

What Humalog Mix50 100 units/ml KwikPen, suspension for injection contains

The active substance is insulin lispro. Insulin lispro is made in the laboratory by a ‘recombinant

DNA technology’ process. It is a changed form of human insulin and so is different from other

human and animal insulins. Insulin lispro is closely related to human insulin which is a natural

hormone made by the pancreas.

The other ingredients are protamine sulphate, m-cresol, phenol, glycerol, dibasic sodium

phosphate 7H

O, zinc oxide and water for injection. Sodium hydroxide or hydrochloric acid

may have been used to adjust the acidity.

What Humalog Mix50 100 units/ml KwikPen, suspension for injection looks like and contents of

the pack

Humalog Mix50 100 units/ml KwikPen, suspension for injection is a white, sterile suspension and

contains 100 units of insulin lispro in each millilitre (100 units/ml) suspension for injection. 50% of

the insulin lispro in Humalog Mix50 is dissolved in water. 50% of the insulin lispro in Humalog

Mix50 is available in a suspension together with protamine sulphate. Each Humalog Mix50 KwikPen

contains 300 units (3 millilitres). The Humalog Mix50 KwikPen comes in a pack of 5 pre-filled pens

or a multipack of 2 x 5 pre-filled pens. Not all pack sizes may be marketed. The Humalog Mix50 in

your KwikPen is the same as the Humalog Mix50, which comes in separate Humalog Mix50

cartridges. The KwikPen simply has a built in cartridge. When the KwikPen is empty you cannot use

it again.

Marketing Authorisation Holder and Manufacturer

Humalog Mix50 100 units/ml KwikPen, suspension for injection is made by:

Lilly France S.A.S., Rue du Colonel Lilly, 67640 Fegersheim, France,

Eli Lilly Italia S.p.A., Via Gramsci 731-733, 50019 Sesto Fiorentino, (FI) Italy.

The product licence is held by: Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The

Netherlands.

For any information about this medicinal product, please contact the local representative of the

Marketing Authorisation Holder:

Belgique/België/Belgien

Eli Lilly Benelux S.A./N.V.

Tél/Tel: + 32-(0)2 548 84 84

Lietuva

Eli Lilly Holdings Limited atstovybė

Tel. +370 (5) 2649600

България

ТП "Ели Лили Недерланд" Б.В. - България

тел. + 359 2 491 41 40

Luxembourg/Luxemburg

Eli Lilly Benelux S.A./N.V.

Tél/Tel: + 32-(0)2 548 84 84

Česká republika

ELI LILLY ČR, s.r.o.

Tel: + 420 234 664 111

Magyarország

Lilly Hungária Kft.

Tel: + 36 1 328 5100

Danmark

Eli Lilly Danmark A/S

Tlf: +45 45 26 6000

Malta

Charles de Giorgio Ltd.

Tel: + 356 25600 500

Deutschland

Lilly Deutschland GmbH

Tel. + 49-(0) 6172 273 2222

Nederland

Eli Lilly Nederland B.V.

Tel: + 31-(0) 30 60 25 800

Eesti

Eli Lilly Holdings Limited Eesti filiaal

Tel:

+

372 6817 280

Norge

Eli Lilly Norge A.S.

Tlf: + 47 22 88 18 00

Ελλάδα

ΦΑΡΜΑΣΕΡΒ-ΛΙΛΛΥ Α.Ε.Β.Ε.

Τηλ: +30 210 629 4600

Österreich

Eli Lilly Ges. m.b.H.

Tel: + 43-(0) 1 711 780

España

Lilly S.A.

Tel: + 34-91 663 50 00

Polska

Eli Lilly Polska Sp. z o.o.

Tel: +48 22 440 33 00

France

Lilly France S.A.S.

Tél: +33-(0) 1 55 49 34 34

Portugal

Lilly Portugal - Produtos Farmacêuticos, Lda

Tel: + 351-21-4126600

Hrvatska

Eli Lilly Hrvatska d.o.o.

Tel: +385 1 2350 999

România

Eli Lilly România S.R.L.

Tel: + 40 21 4023000

Ireland

Eli Lilly and Company (Ireland) Limited

Tel: + 353-(0) 1 661 4377

Slovenija

Eli Lilly farmacevtska družba, d.o.o.

Tel: +386 (0) 1 580 00 10

Ísland

Icepharma hf.

Sími + 354 540 8000

Slovenská republika

Eli Lilly Slovakia, s.r.o.

Tel: + 421 220 663 111

Italia

Eli Lilly Italia S.p.A.

Tel: + 39- 055 42571

Suomi/Finland

Oy Eli Lilly Finland Ab

Puh/Tel: + 358-(0) 9 85 45 250

Κύπρος

Phadisco Ltd

Τηλ: +357 22 715000

Sverige

Eli Lilly Sweden AB

Tel: + 46-(0) 8 7378800

Latvija

Eli Lilly Holdings Limited pārstāvniecība Latvijā

Tel:

+

371 67364000

United Kingdom

Eli Lilly and Company Limited

Tel: + 44-(0) 1256 315000

This leaflet was last revised in

{MM/YYYY}.

USER MANUAL

Please see manual text later.

Detailed information on this medicine is available on the European Medicines Agency web site:

http://www.ema.europa.eu/.

USER MANUAL

KwikPen pre-filled insulin pen

100 units/ml

PLEASE READ THIS USER MANUAL BEFORE USE

Read the User Manual before you start taking your insulin and each time you get another KwikPen.

There may be new information. This information does not take the place of talking to your healthcare

professional about your medical condition or your treatment.

KwikPen (“Pen”) is a disposable pre-filled pen containing 3 ml (300 units, 100 units/ml) of insulin.

You can give yourself multiple doses using one Pen. The Pen dials 1 unit at a time. You can give from

1 to 60 units in a single injection.

If your dose is more than 60 units, you will need to give yourself

more than one injection.

The plunger only moves a little with each injection, and you may not notice

that it moves. The plunger will only reach the end of the cartridge when you have used all 300 units in

the Pen.

Do not share your pen with other people, even if the needle has been changed. Do not reuse or

share needles with other people. You may give an infection to them or get an infection from

them.

This Pen is not recommended for use by the blind or visually impaired without the help of someone

trained to use the Pen.

KwikPen Parts

Cap Clip

Cartridge

Holder

Label

Dose Indicator

Dose Knob

Rubber

Seal

Plunger

Body

Dose

Window

Pen Needle Parts

(Needles Not Included)

Paper Tab

Outer Needle

Shield

Inner Needle

Shield

Needle

How to recognize your KwikPen:

Humalog

Humalog

Humalog

Mix25

Mix50

Solution

Suspension

(cloudy insulin)

Suspension

(cloudy insulin)

Pen colour:

Blue

Blue

Blue

Dose Knob:

Burgundy

Yellow

Labels:

White with

Burgundy

Colour Bar

White with

Yellow

Colour Bar

White with

Colour Bar

Supplies needed to give your injection:

KwikPen containing your insulin

KwikPen compatible Needle (BD [Becton, Dickinson and Company] Pen Needles recommended)

Swab

Needles and swab are not included.

Preparing your Pen

Wash your hands with soap and water.

Check the Pen to make sure you are taking the right type of insulin. This is especially important

if you use more than 1 type of insulin.

Do not

use your Pen past the expiration date printed on the Label. After you start using the Pen,

throw your Pen away after the in-use time specified in the Package Leaflet.

Always use a

new Needle

for each injection to help prevent infections and blocked Needles.

Step 1:

Pull the Pen Cap straight off.

Do not

remove the Pen Label.

Wipe the Rubber Seal with a swab.

Step 2:

(For HUMALOG suspensions cloudy insulins only)

Gently roll the Pen 10 times.

Invert the Pen 10 times.

Mixing is important

to make sure you get the right dose.

The insulin should look evenly mixed.

Step 3:

Check the appearance of the insulin.

HUMALOG solution should look clear and colourless. Do not use if it is cloudy, coloured,

or has particles or clumps in it.

HUMALOG suspensions - cloudy insulins - should look white after mixing.

Do not

if it looks clear or contains any clumps or particles.

Step 4:

Select a new Needle.

Pull off the Paper Tab from the Outer Needle Shield.

Step 5:

Push the capped Needle straight onto the Pen

and twist the Needle on until it is tight.

Step 6:

Pull off the Outer Needle Shield.

Do not

throw it away.

Pull off the Inner Needle Shield and throw it away.

Priming your Pen

Prime before each injection.

Priming your Pen means removing the air from the Needle and Cartridge that may collect

during normal use and ensures that the Pen is working correctly.

If you

do not

prime before each injection, you may get too much or too little insulin.

Step 7:

To prime your Pen, turn the Dose Knob to select 2 units.

Step 8:

Hold your Pen with the Needle pointing up. Tap the Cartridge

Holder gently to collect air bubbles at the top

Step 9:

Continue holding your Pen with Needle pointing

up. Push the Dose Knob in until it stops, and “0”

is seen in the Dose Window. Hold the Dose

Knob in and count to 5 slowly.

You should see insulin at the tip of the Needle.

If you

do not

see insulin, repeat the

priming steps, but not more than 4 times.

If you

still do not

see insulin, change the

Needle and repeat the priming steps.

Small air bubbles are normal and will not affect

your dose.

Selecting your dose

You can give from 1 to 60 units in a single injection.

If your dose is more than 60 units, you will need to give more than one injection.

If you need help deciding how to divide up your dose, ask your healthcare professional.

You should use a new Needle for each injection and repeat the priming step.

Step 10:

Turn the Dose Knob to select the

number of units you need to inject.

The Dose Indicator should line up

with your dose.

The Pen dials 1 unit at a time.

The Dose Knob clicks as you

turn it.

DO NOT

dial your dose by

counting the clicks because

you may dial the wrong dose.

The dose can be corrected by

turning the Dose Knob in

either direction until the correct

dose lines up with the Dose

Indicator.

The even numbers are printed

on the dial.

The odd numbers, after the

number 1, are shown as full

lines.

Always check the number in the

Dose Window to make sure you

have dialled the correct dose.

(Example: 12 units

shown in the Dose

Window)

(Example: 25 units

shown in the Dose

Window)

The Pen will not let you dial more than the number of units left in the Pen.

If you need to inject more than the number of units left in the Pen, you may either:

inject the amount left in your Pen and then use a new Pen to give the rest of your dose,

or

get a new Pen and inject the full dose.

It is normal to see a small amount of insulin left in the Pen that you cannot inject.

Giving your injection

Inject your insulin as your healthcare professional has shown you.

Change (rotate) your injection site for each injection.

Do not

try to change your dose while injecting.

Step 11:

Choose your injection site.

Your insulin is injected under the skin

(subcutaneously) of your stomach area,

buttocks, upper legs or upper arms.

Wipe your skin with a swab, and let the

injection site dry before you inject your

dose.

Step 12:

Insert the Needle into your skin.

Push the Dose Knob all the way in.

Continue to hold the Dose

Knob in and

slowly count

to 5

before removing the

Needle.

Do not

try to inject your insulin by turning the

Dose Knob. You will

NOT

receive your

insulin by turning the Dose Knob.

Step 13:

Pull the Needle out of your skin.

A drop of insulin at the Needle

tip is normal. It will not affect

your dose.

Check the number in the Dose Window

If you see “0” in the Dose

window, you have received the

full amount you dialled.

If you do not see “0” in the Dose

window, do not

redial. Insert the

needle into your skin and finish

your injection.

If you

still

do not think you

received the full amount you

dialled for your injection

, do not

start over or repeat that

injection.

Monitor your blood

glucose as instructed by your

healthcare professional.

If you normally need to give 2

injections for your full dose, be

sure to give your second

injection.

The plunger only moves a little with each

injection, and you may not notice that it

moves.

If you see blood after you take the Needle out

of your skin, press the injection site lightly

with a piece of gauze or a swab.

Do not

the area.

5 sec

After your injection

Step 14:

Carefully replace the Outer Needle Shield.

Step 15:

Unscrew the capped Needle and dispose

of it as described below (see

Disposing

of Pens and Needles

section).

Do not store the Pen with the Needle

attached to prevent leaking, blocking

the Needle, and air from entering the

Pen.

Step 16:

Replace the Pen Cap by lining up the

Cap Clip with the Dose Indicator and

pushing straight on.

Disposing of pens and needles

Put used Needles in a sharps container or a hard plastic container with a secure lid.

Do not

throw needles directly into your household waste.

Do not

recycle the filled sharps container.

Ask your healthcare professional about options to dispose of the Pen and the sharps container

properly.

The directions regarding needle handling are not intended to replace local, healthcare

professional or institutional policies.

Storing your pen

Unused pens

Store unused Pens in the refrigerator at 2°C to 8°C.

Do not

freeze your insulin.

Do not

use if it has been frozen.

Unused Pens may be used until the expiration date printed on the Label, if the Pen has been kept

in the refrigerator.

In-use Pen

Store the Pen you are currently using at room temperature up to 30°C and away from dust, food

and liquids, heat and light.

Throw away the Pen you are using after the time specified in the Package Leaflet, even if it still

has insulin left in it.

General information about the safe and effective use of your pen

Keep your Pen and Needles out of the sight and reach of children.

Do not

use your Pen if any part looks broken or damaged.

Always carry an extra Pen in case yours is lost or damaged.

Troubleshooting

If you cannot remove the Pen Cap, gently twist the cap back and forth, and then pull the cap

straight off.

If the Dose Knob is hard to push:

Pushing the Dose Knob more slowly will make it easier to inject.

Your Needle may be blocked. Put on a new Needle and prime the Pen.

You may have dust, food, or liquid inside the Pen. Throw the Pen away and get a new Pen.

You may need to get a prescription from your healthcare professional.

If you have any questions or problems with your KwikPen, call your healthcare professional for help

or contact your local Lilly affiliate

Document Revision Date:

Package leaflet: Information for the user

Humalog 200 units/ml KwikPen, solution for injection in a pre-filled pen

insulin lispro

Each KwikPen delivers 1 – 60 units in steps of 1 units.

Read all of this leaflet carefully before you start using this medicine because it contains

important information for you.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,

even if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side

effects not listed in this leaflet. See section 4.

What is in this leaflet

What Humalog 200 units/ml KwikPen is and what it is used for

What you need to know before you use Humalog 200 units/ml KwikPen

How to use Humalog 200 units/ml KwikPen

Possible side effects

How to store Humalog 200 units/ml KwikPen

Contents of the pack and other information

1.

What Humalog 200 units/ml KwikPen is and what it is used for

Humalog 200 units/ml KwikPen is used to treat diabetes. Humalog works more quickly than normal

human insulin because insulin lispro has been changed slightly in comparison to human insulin.

Insulin lispro is closely related to human insulin which is a natural hormone made by the pancreas.

You get diabetes if your pancreas does not make enough insulin to control the level of glucose in your

blood. Humalog is a substitute for your own insulin and is used to control glucose in the long term. It

works very quickly and lasts a shorter time than soluble insulin (2 to 5 hours). You should normally

use Humalog within 15 minutes of a meal.

Your doctor may tell you to use Humalog 200 units/ml KwikPen as well as a longer-acting insulin.

Each kind of insulin comes with another patient information leaflet to tell you about it. Do not change

your insulin unless your doctor tells you to.

Humalog 200 units/ml KwikPen should be reserved for the treatment of adults with diabetes requiring

daily doses of more than 20 units of rapid-acting insulin.

Humalog 200 units/ml KwikPen is a disposable pre-filled pen containing 3 ml (600 units,

200 units/ml) of insulin lispro. One KwikPen contains multiple doses of insulin. The KwikPen dials

1 unit at a time.

The number of units are displayed in the dose window, always check this before

your injection.

You can give from 1 to 60 units in a single injection.

If your dose is more than

60 units, you will need to give yourself more than one injection.

2.

What you need to know before you use Humalog 200 units/ml KwikPen

Do NOT use Humalog 200 units/ml KwikPen

if you are

allergic

to insulin lispro or any of the other ingredients of this medicine (listed in

section 6).

if you think

hypoglycaemia

(low blood sugar) is starting. Further in this leaflet it tells you how to

deal with mild hypoglycaemia (see section 3: If you take more Humalog than you need).

Warnings and precautions

The Humalog 200 units/ml solution for injection in your pre-filled pen (the KwikPen) should

ONLY be injected with this pre-filled pen.

Do not transfer the insulin lispro from your

Humalog 200 units/ml KwikPen to a syringe

. The markings on the insulin syringe will not

measure your dose correctly. A severe overdose can result, causing low blood sugar which may put

your life in danger. Do not transfer insulin from your Humalog 200 units/ml KwikPen to any other

insulin delivery devices like insulin infusion pumps.

Do NOT mix the Humalog 200 units/ml solution for injection in your pre-filled pen (the

KwikPen) with any other insulin or any other medicine.

The Humalog 200 units/ml solution for

injection should not be diluted.

If your blood sugar levels are well controlled by your current insulin therapy, you may not feel the

warning symptoms when your blood sugar is falling too low. Warning signs are listed in section 4

of this leaflet. You must think carefully about when to have your meals, how often to exercise and

how much to do. You must also keep a close watch on your blood sugar levels by testing your

blood glucose often.

A few people who have had hypoglycaemia after switching from animal insulin to human insulin

have reported that the early warning symptoms were less obvious or different. If you often have

hypoglycaemia or have difficulty recognising it, please discuss this with your doctor.

If you answer YES to any of the following questions, tell your doctor, pharmacist or diabetes nurse

Have you recently become ill?

Do you have trouble with your kidneys or liver?

Are you exercising more than usual?

You should also tell your doctor, pharmacist or diabetes nurse if you are planning to go abroad.

The time difference between countries may mean that you have to have your injections and meals

at different times from when you are at home.

Some patients with long-standing type 2 diabetes mellitus and heart disease or previous stroke who

were treated with pioglitazone and insulin experienced the development of heart failure. Inform

your doctor as soon as possible, if you experience signs of heart failure such as unusual shortness

of breath or rapid increase in weight or localised swelling (oedema).

This Pen is not recommended for use by the blind or visually impaired without the help of someone

trained to use the Pen.

Other medicines and Humalog 200 units/ml KwikPen

Your insulin needs may change if you are taking

the contraceptive pill,

steroids,

thyroid hormone replacement therapy,

oral hypoglycaemics, (e.g. metformin, acarbose, sulphonylurea agents, pioglitazone,

empagliflozin, DPP-4-inhibitors like sitagliptin or saxagliptine, ),

acetyl salicylic acid,

sulpha antibiotics,

somatostatin analogues (such as octreotide, used to treat an uncommon condition in which you

make too much growth hormone),

“beta

stimulants”such as salbutamol or terbutaline to treat asthma, or ritodrine used to stop

premature labor,

beta-blockers – to treat high blood pressure., or

some antidepressants (monoamine oxidase inhibitors or selective serotonin reuptake inhibitors),

danazol (medicine acting on ovulation),

some angiotensin converting (ACE) inhibitors, used to treat certain heart conditions or high

blood pressure (for example captopril, enalapril), and

specific medicines to treat high blood pressure, kidney damage due to diabetes, and some heart

problems (angiotensin II receptor blockers).

Please tell your doctor, if you are taking, have recently taken or might take any other medicines. (see

also section “Warnings and precautions”).

Humalog with alcohol

Your blood sugar levels may either rise or fall if you drink alcohol. Therefore the amount of insulin

needed may change.

Pregnancy and breast-feeding

Are you pregnant or thinking about becoming pregnant, or are you breast-feeding? The amount of

insulin you need usually falls during the first three months of pregnancy and increases for the

remaining six months. If you are breast-feeding, you may need to alter your insulin intake or diet.

Ask your doctor for advice.

Driving and using machines

Your ability to concentrate and react may be reduced if you have hypoglycaemia. Please keep this

possible problem in mind in all situations where you might put yourself and others at risk (e.g. driving

a car or using machines). You should contact your doctor about the advisability of driving if you have:

frequent episodes of hypoglycaemia

reduced or absent warning signs of hypoglycaemia

Important information about some of the ingredients of Humalog 200 units/ml KwikPen

This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-

free’.

3.

How to use Humalog

200 units/ml KwikPen

Always check the pack and the label of the pre-filled pen for the name and type of the insulin

when you get it from your pharmacy. Make sure you get the Humalog 200 units/ml KwikPen

that your doctor has told you to use.

Always use this medicine exactly as your doctor has told you. You should check with your doctor if

you are not sure. To prevent the possible transmission of disease, each pen must be used by you only,

even if the needle is changed.

Humalog 200 units/ml KwikPen is for patients taking more than 20 units of rapid-acting insulin a day.

Do not transfer insulin from your Humalog 200 units/ml KwikPen to a syringe. The markings on

the insulin syringe will not measure your dose correctly. A severe overdose can result, causing

low blood sugar which may put your life in danger.

Do not use Humalog 200 units/ml KwikPen solution for injection in an insulin infusion pump.

Dosage

You should normally inject Humalog within 15 minutes of a meal. If you need to, you can inject

soon after a meal. But your doctor will have told you exactly how much to use, when to use it,

and how often. These instructions are only for you. Follow them exactly and visit your diabetes

clinic regularly.

If you change the type of insulin you use (for example from a human or animal insulin to a

Humalog product), you may have to take more or less than before. This might just be for the

first injection or it may be a gradual change over several weeks or months.

Inject Humalog under the skin (subcutaneously).

Preparing Humalog 200 units/ml KwikPen

Humalog is already dissolved in water, so you do not need to mix it. But you must use it

only

it looks like water. It must be clear, have no colour and no solid pieces in it. Check each time

you inject yourself.

Getting the KwikPen ready to use (Please see user manual)

First wash your hands.

Read the instructions on how to use your pre-filled insulin pen. Please follow the instructions

carefully. Here are some reminders.

Use a clean needle. (Needles are not included).

Prime your KwikPen before each use. This checks that insulin comes out and clears the air

bubbles from your KwikPen. There may still be some small air bubbles left in the pen - these

are harmless. But if the air bubbles are too large it may affect the insulin dose.

Injecting Humalog

Before you make an injection, clean your skin as you have been instructed. Inject under the

skin, as you were taught. After your injection, leave the needle in the skin for five seconds to

make sure you have taken the whole dose. Do not rub the area you have just injected. Make sure

you inject at least half an inch (1 cm) from the last injection and that you ‘rotate’ the places you

inject, as you have been taught. It doesn’t matter which injection site you use, either upper arm,

thigh, buttock or abdomen, your Humalog injection will still work quicker than soluble human

insulin.

Do not inject Humalog 200 units/ml KwikPen solution for injection directly into a vein

(intravenously).

After injecting

As soon as you have done the injection, unscrew the needle from the KwikPen using the outer

needle cap. This will keep the insulin sterile and stop it leaking. It also stops air entering the pen

and your needle clogging.

Do not share your needles

. Do not share your pen. Replace the cap

on your pen.

Further injections

Every time you use a KwikPen you must use a new needle. Before every injection, clear any air

bubbles. You can see how much insulin is left by holding the KwikPen with the needle pointing

Once the KwikPen is empty, do not use it again. Please get rid of it carefully - your pharmacist

or diabetes nurse will tell you how to do this.

If you take more Humalog than you need

If you take more Humalog than you need, a low blood sugar may occur. Check your blood sugar.

If your blood sugar is low

(mild hypoglycaemia)

, eat glucose tablets, sugar or drink a sugary drink.

Then eat fruit, biscuits, or a sandwich, as your doctor has advised you and have some rest. This will

often get you over mild hypoglycaemia or a minor insulin overdose. If you get worse and your

breathing is shallow and your skin gets pale, tell your doctor at once. A glucagon injection can treat

quite severe hypoglycaemia. Eat glucose or sugar after the glucagon injection. If you do not respond to

glucagon, you will have to go to hospital. Ask your doctor to tell you about glucagon.

If you forget to use Humalog

If you take less Humalog than you need, a high blood sugar may occur. Check your blood sugar

If hypoglycaemia (low blood sugar) or hyperglycaemia (high blood sugar) is not treated, they can be

very serious and cause headaches, feeling sick (nausea), being sick (vomiting), loss of fluids

(dehydration), unconsciousness, coma or even death (see section 4 “Possible side effects”).

Three simple steps

to avoid hypoglycaemia or hyperglycaemia are:

Always carry a spare pen in case you lose your KwikPen or it gets damaged.

Always carry something to show you are diabetic.

Always carry sugar with you.

If you stop using Humalog.

If you take less Humalog than you need, a high blood sugar may occur. Do not change your insulin

unless your doctor tells you to.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Severe allergy is rare (may affect up to 1 in 1,000 people). The symptoms are as follows:

rash over the whole body

blood pressure dropping

difficulty in breathing

heart beating fast

wheezing

sweating

If you think you are having this sort of insulin allergy with Humalog, contact a doctor at once.

Local allergy is common (may affect up to 1 in 10 people). Some people get redness, swelling or

itching around the area of the insulin injection. This usually clears up in anything from a few days to a

few weeks. If this happens to you, tell your doctor.

Lipodystrophy (thickening or pitting of the skin) is uncommon (may affect up to 1 in 100 people). If

you notice your skin thickening or pitting at the injection site, tell your doctor.

Oedema (e.g. swelling in arms, ankles; fluid retention) has been reported, particularly at the start of

insulin therapy or during a change in therapy to improve control of your blood glucose.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects

not listed in this leaflet. You can also report side effects directly via the national reporting system

listed in Appendix V. By reporting side effects you can help provide more information on the safety of

this medicine.

Common problems of diabetes

Hypoglycaemia

Hypoglycaemia (low blood sugar) means there is not enough sugar in the blood. This can be caused if:

you take too much Humalog or other insulin;

you miss or delay meals or change your diet;

you exercise or work too hard just before or after a meal;

you have an infection or illness (especially diarrhoea or vomiting);

there is a change in your need for insulin; or

you have trouble with your kidneys or liver which gets worse.

Alcohol and some medicines can affect your blood sugar levels (see section 2).

The first symptoms of low blood sugar usually come on quickly and include the following:

tiredness

rapid heartbeat

nervousness or shakiness

feeling sick

headache

cold sweat

While you are not confident about recognising your warning symptoms, avoid situations such as

driving a car, in which you or others would be put at risk by hypoglycaemia.

Hyperglycaemia and diabetic ketoacidosis

Hyperglycaemia (too much sugar in the blood) means that your body does not have enough insulin.

Hyperglycaemia can be brought about by:

not taking your Humalog or other insulin;

taking less insulin than your doctor tells you to;

eating a lot more than your diet allows; or

fever, infection or emotional stress.

Hyperglycaemia can lead to diabetic ketoacidosis. The first symptoms come on slowly over many

hours or days. The symptoms include the following:

feeling sleepy

no appetite

flushed face

fruity smell on the breath

thirst

feeling or being sick

Severe symptoms are heavy breathing and a rapid pulse.

Get medical help immediately.

Illness

If you are ill, especially if you feel sick or are sick, the amount of insulin you need may change.

Even

when you are not eating normally, you still need insulin.

Test your urine or blood, follow your

‘sick rules’, and tell your doctor.

5.

How to store Humalog 200 units/ml KwikPen

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the label and the carton. The expiry

date refers to the last day of that month.

Before the first use store your Humalog

200 units/ml

KwikPen in a refrigerator (2

C – 8

C). Do not

freeze.

Keep your Humalog

200 units/ml

KwikPen in use at room temperature (15° - 30°C) and discard after

28 days. Do not put it near heat or in the sun. Do not keep the KwikPen that you are using in the

fridge. The KwikPen should not be stored with the needle attached.

Do not use this medicine if you notice the solution is coloured or it has solid pieces in it. You must use

only

if it looks like water. Check this each time you inject yourself.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to

dispose of medicines no longer required. These measures will help to protect the environment.

6.

Contents of the pack and other information

What Humalog 200 units/ml KwikPen solution for injection contains

The active substance is insulin lispro. Each ml of solution contains 200 units (U) of insulin

lispro. Each pre-filled pen (3 ml) contains 600 units (U) of insulin lispro.

The other ingredients are metacresol, glycerol, trometamol, zinc oxide and water for injection.

Sodium hydroxide or hydrochloric acid may have been used to adjust the acidity.

What Humalog 200 units/ml KwikPen looks like and contents of the pack

Humalog 200 units/ml KwikPen, solution for injection is a sterile, clear, colourless, aqueous solution

and contains 200 units of insulin lispro in each millilitre (200 units/ml) solution for injection. Each

Humalog

200 units/ml

KwikPen contains 600 units (3 millilitres). The Humalog

200 units/ml

KwikPen comes in a pack of 1, 2 or 5 pre-filled pens or multipacks of 2 x 5 pre-filled pens. Not all

pack sizes may be marketed. The KwikPen simply has a built in cartridge. When the pre-filled pen is

empty you cannot use it again.

Marketing Authorisation Holder

Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands.

Manufacturer

Lilly France S.A.S., Rue du Colonel Lilly, 67640 Fegersheim, France,

Eli Lilly Italia S.p.A., Via Gramsci 731-733, 50019 Sesto Fiorentino, (FI) Italy.

For any information about this medicinal product, please contact the local representative of the

Marketing Authorisation Holder:

Belgique/België/Belgien

Eli Lilly Benelux S.A./N.V.

Tél/Tel: + 32-(0)2 548 84 84

Lietuva

Eli Lilly Holdings Limited atstovybė

Tel. +370 (5) 2649600

България

ТП "Ели Лили Недерланд" Б.В. - България

тел. + 359 2 491 41 40

Luxembourg/Luxemburg

Eli Lilly Benelux S.A./N.V.

Tél/Tel: + 32-(0)2 548 84 84

Česká republika

ELI LILLY ČR, s.r.o.

Tel: + 420 234 664 111

Magyarország

Lilly Hungária Kft.

Tel: + 36 1 328 5100

Danmark

Eli Lilly Danmark A/S

Tlf: +45 45 26 6000

Malta

Charles de Giorgio Ltd.

Tel: + 356 25600 500

Deutschland

Lilly Deutschland GmbH

Tel. + 49-(0) 6172 273 2222

Nederland

Eli Lilly Nederland B.V.

Tel: + 31-(0) 30 60 25 800

Eesti

Eli Lilly Holdings Limited Eesti filiaal

Tel:

+

372 6817 280

Norge

Eli Lilly Norge A.S.

Tlf: + 47 22 88 18 00

Ελλάδα

ΦΑΡΜΑΣΕΡΒ-ΛΙΛΛΥ Α.Ε.Β.Ε.

Τηλ: +30 210 629 4600

Österreich

Eli Lilly Ges. m.b.H.

Tel: + 43-(0) 1 711 780

España

Lilly S.A.

Tel: + 34-91 663 50 00

Polska

Eli Lilly Polska Sp. z o.o.

Tel: +48 22 440 33 00

France

Lilly France S.A.S.

Tél: +33-(0) 1 55 49 34 34

Portugal

Lilly Portugal - Produtos Farmacêuticos, Lda

Tel: + 351-21-4126600

Hrvatska

Eli Lilly Hrvatska d.o.o.

Tel: +385 1 2350 999

România

Eli Lilly România S.R.L.

Tel: + 40 21 4023000

Ireland

Eli Lilly and Company (Ireland) Limited

Tel: + 353-(0) 1 661 4377

Slovenija

Eli Lilly farmacevtska družba, d.o.o.

Tel: +386 (0) 1 580 00 10

Ísland

Icepharma hf.

Sími + 354 540 8000

Slovenská republika

Eli Lilly Slovakia, s.r.o.

Tel: + 421 220 663 111

Italia

Eli Lilly Italia S.p.A.

Tel: + 39- 055 42571

Suomi/Finland

Oy Eli Lilly Finland Ab

Puh/Tel: + 358-(0) 9 85 45 250

Κύπρος

Phadisco Ltd

Τηλ: +357 22 715000

Sverige

Eli Lilly Sweden AB

Tel: + 46-(0) 8 7378800

Latvija

Eli Lilly Holdings Limited pārstāvniecība Latvijā

Tel:

+

371 67364000

United Kingdom

Eli Lilly and Company Limited

Tel: + 44-(0) 1256 315000

This leaflet was last revised in

{MM/YYYY}.

USER MANUAL

Please see manual text later.

Detailed information on this medicine is available on the European Medicines Agency web site:

http://www.ema.europa.eu/.

USER MANUAL

Humalog 200 units/ml KwikPen, solution for injection in a pre-filled pen

insulin lispro

PLEASE READ THIS USER MANUAL BEFORE USE

Read the User Manual before you start taking Humalog 200 units/ml KwikPen solution for injection

and each time you get another Humalog 200 units/ml KwikPen. There may be new information. This

information does not take the place of talking to your healthcare professional about your medical

condition or your treatment.

Humalog

200 units/ml KwikPen (“Pen”) is a disposable pre-filled pen containing 3 ml (600 units,

200 units/ml) of insulin lispro solution for injection. You can give yourself multiple doses using one

Pen. The Pen dials 1 unit at a time.

You can inject from 1 to 60 units in a single injection.

If your dose

is more than 60 units, you will need to give yourself more than one injection.

The plunger only

moves a little with each injection, and you may not notice that it moves. The plunger will only reach

the end of the cartridge when you have used all 600 units in the Pen.

This pen is designed to allow you to give more doses than other pens you may have used in the

past. Dial your usual dose as instructed by your healthcare professional.

Humalog KwikPen is available in two strengths, 100 units/ml and 200 units/ml. Inject Humalog

200 units/ml ONLY with your Pen. DO NOT transfer insulin from your Pen to another insulin

delivery device. Syringes and insulin pumps will not dose 200 units/ml insulin correctly. A severe

overdose can result, causing very low blood sugar which may put your life in danger.

Do not share your Pen with other people, even if the needle has been changed. Do not reuse or

share needles with other people.. You may give an infection to them or get an infection from

them.

This Pen is not recommended for use by the blind or visually impaired without the help of someone

trained to use the Pen.

USE ONLY IN THIS PEN, OR

SEVERE OVERDOSE CAN RESULT

KwikPen Parts

Pen Cap

Cartridge Holder

Label

Dose Indicator

Dose

Knob

Cap

Clip

Rubber Seal

Plunger

Pen Body

Dose

Window

Pen Needle Parts

(Needles Not Included)

Dose Knob

with burgundy ring

Needle

Outer Needle

Shield

Inner

Needle

Shield

Paper Tab

How to recognize your Humalog 200 units/ml KwikPen:

Pen colour:

Dark grey

Dose Knob:

Dark grey with burgundy ring on the end

Labels:

Burgundy, “200 units/ml” in yellow box.

Yellow warning on cartridge holder

Supplies needed to give your injection:

Humalog 200 units/ml KwikPen

KwikPen compatible Needle (BD [Becton, Dickinson and Company] Pen Needles

recommended)

Swab

Needles and swab are not included.

Preparing your Pen

Wash your hands with soap and water.

Check the Pen to make sure you are taking the right type of insulin. This is especially important if

you use more than 1 type of insulin.

Do not

use your Pen past the expiration date printed on the Label or for more than 28 days after

you first start using the Pen.

Always use a

new Needle

for each injection to help prevent infections and blocked Needles.

USE ONLY IN THIS PEN OR SEVERE

OVERDOSE CAN RESULT

Step 1:

Pull the Pen Cap straight off.

Do not

remove the Pen Label.

Wipe the Rubber Seal with a swab.

Humalog 200 units/ml

solution for injection

should look clear and colourless.

Do not

use if it

is cloudy, coloured, or has particles or clumps in

Step 2:

Select a new Needle.

Pull off the Paper Tab from the Outer Needle

Shield.

Step 3:

Push the capped Needle straight onto the Pen

and twist the Needle on until it is tight.

Step 4:

Pull off the Outer Needle Shield.

Do not

throw

it away.

Pull off the Inner Needle Shield and throw it

away.

USE ONLY IN THIS PEN OR

SEVERE OVERDOSE CAN RESULT

Priming your Pen

Prime before each injection.

Priming your Pen means removing the air from the Needle and Cartridge that may collect during

normal use and ensures that the Pen is working correctly.

If you do not prime before each injection, you may get too much or too little insulin.

Step 5:

To prime your Pen, turn the Dose Knob to

select

2 units

Step 6:

Hold your Pen with the Needle pointing up. Tap

the Cartridge Holder gently to collect air bubbles

at the top.

Step 7:

Continue holding your Pen with Needle pointing

up. Push the Dose Knob in until it stops, and “

0

is seen in the Dose Window. Hold the Dose Knob

in and

count to 5 slowly

You should see insulin at the tip of the

Needle.

If you

do not

see insulin, repeat the

priming steps, but not more than

8 times.

If you

still

do not

see insulin, change

the Needle and repeat the priming

steps.

Small air bubbles are normal and will not affect

your dose.

Selecting your dose

This pen has been designed to deliver the dose that is shown in the window. Dial your usual dose

as instructed by your healthcare professional.

You can give from 1 to 60 units in a single injection.

If your dose is more than 60 units, you will need to give more than one injection.

If you need help deciding how to divide up your dose, ask your healthcare professional.

You should use a new Needle for each injection and repeat the priming step.

Step 8:

Turn the Dose Knob to select the number of units

you need to inject. The Dose Indicator should

line up with your dose.

The Pen dials 1 unit at a time.

The Dose Knob clicks as you turn it.

DO NOT dial your dose by counting

the clicks because you may dial the

wrong dose.

The dose can be corrected by turning

the Dose Knob in either direction until

the correct dose lines up with the Dose

Indicator.

even

numbers are printed on the

dial.

odd

numbers, after the number 1,

are shown as full lines.

Always check the number in the Dose Window

to make sure you have dialled the correct

dose.

(Example: 12 units shown in the

Dose Window)

(Example: 25 units shown in the

Dose Window)

The Pen will not let you dial more than the number of units left in the Pen.

If you need to inject more than the number of units left in the Pen, you may either:

inject the amount left in your Pen and then use a new Pen to give the rest of your dose,

or

get a new Pen and inject the full dose.

Giving your injection

Inject your insulin as your healthcare professional has shown you.

Change (rotate) your injection site for each injection.

Do not

try to change your dose while injecting.

Step 9:

Choose your injection site.

Humalog 200 units/ml

solution for injection is

injected under the skin (subcutaneously) of your

stomach area, buttocks, upper legs or upper

arms.

Wipe your skin with a swab, and let your skin

dry before you inject your dose.

Step 10:

Insert the Needle into your skin.

Push the Dose Knob all the way in.

Continue to hold the Dose Knob in

slowly count to 5

before

removing the Needle.

Do not try to inject your insulin by turning the

Dose Knob. You will NOT receive your insulin

by turning the Dose Knob.

Step 11:

Pull the Needle out of your skin.

A drop of insulin at the Needle tip is

normal. It will not affect your dose.

Check the number in the Dose

Window.If you see “0” in the Dose

Window, you have received the full

amount you dialled.

If you do not see “0” in the Dose

Window, do not redial. Insert the

needle into your skin and finish your

injection.

If you

still

do not think you received

the full amount you dialled for your

injection,

do not start over or repeat

that injection

. Monitor your blood

glucose as instructed by your

healthcare professional.

The plunger only moves a little with each

injection and you may not notice that it moves.

If you see blood after you take the Needle out of

your skin, press the injection site lightly with a

piece of gauze or a swab.

Do not

rub the area.

After your injection

Step 12:

Carefully replace the Outer Needle Shield.

Step 13:

Unscrew the capped Needle and dispose of it as

described below (see

Disposing of Pens and

Needles

section).

Do not store the Pen with the Needle attached to

prevent leaking, blocking the Needle, and air

from entering the Pen.

Step 14:

Replace the Pen Cap by lining up the Cap Clip

with the Dose Indicator and pushing straight on.

Disposing of Pens and Needles

Put used Needles in a sharps container or hard plastic container with a secure lid. Do not

throw needles directly into your household waste.

Do not recycle the filled sharps container.

Ask your healthcare professional about options to dispose of the Pen and the sharps container

properly.

The directions regarding needle handling are not intended to replace local, healthcare

professional or institutional policies.

Storing your Pen

Unused Pens

Store unused Pens in the refrigerator at 2°C to 8°C.

Do not

freeze Humalog 200 units/ml

solution for injection.

Do not

use if it has been frozen.

Unused Pens may be used until the expiration date printed on the Label, if the Pen has been

kept in the refrigerator.

In-use Pen

Store the Pen you are currently using at room temperature (up to 30°C) and away from

dust,

food and liquids,

heat and light.

Throw away the Pen you are using after 28 days, even if it still has insulin left in it.

General information about the safe and effective use of your Pen

Keep your Pen and Needles out of the sight and reach of children.

Do not

use your Pen if any part looks broken or damaged.

Always carry an extra Pen in case yours is lost or damaged.

Troubleshooting

If you cannot remove the Pen Cap, gently twist the cap back and forth, and then pull the cap

straight off.

If the Dose Knob is hard to push;

Pushing the Dose Knob more slowly will make it easier to inject.

Your Needle may be blocked. Put on a new Needle and prime the Pen.

You may have dust, food, or liquid inside the Pen. Throw the Pen away and get a new

Pen. You may need to get a prescription from your healthcare professional.

Do not transfer insulin from the Pen to a syringe or an insulin pump. Severe overdose

can result.

If you have any questions or problems with your Humalog 200 units/ml KwikPen, call your healthcare

professional for help or contact your local Lilly affiliate.

Document revision date:

Package leaflet: Information for the user

Humalog 100 units/ml Junior KwikPen, solution for injection in a pre-filled pen

insulin lispro

Each Junior KwikPen delivers 0.5 – 30 units in steps of 0.5 units.

Read all of this leaflet carefully before you start using this medicine because it contains

important information for you.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,

even if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side

effects not listed in this leaflet. See section 4.

What is in this leaflet

What Humalog Junior KwikPen is and what it is used for

What you need to know before you use Humalog Junior KwikPen

How to use Humalog Junior KwikPen

Possible side effects

How to store Humalog Junior KwikPen

Contents of the pack and other information

1.

What Humalog Junior KwikPen is and what it is used for

Humalog Junior KwikPen is used to treat diabetes. Humalog works more quickly than normal human

insulin because insulin lispro has been changed slightly in comparison to human insulin. Insulin lispro

is closely related to human insulin which is a natural hormone made by the pancreas.

You get diabetes if your pancreas does not make enough insulin to control the level of glucose in your

blood. Humalog is a substitute for your own insulin and is used to control glucose in the long term. It

works very quickly and lasts a shorter time than soluble insulin (2 to 5 hours). You should normally

use Humalog within 15 minutes of a meal.

Your doctor may tell you to use Humalog as well as a longer-acting insulin. Each kind of insulin

comes with another patient information leaflet to tell you about it. Do not change your insulin unless

your doctor tells you to.

Humalog is suitable for use in adults and children.

Humalog 100 units/ml Junior KwikPen is a disposable pre-filled pen containing 3 ml (300 units,

100 units/ml) of insulin lispro. One KwikPen contains multiple doses of insulin. The KwikPen dials

half unit (0.5 unit) at a time.

The number of units are displayed in the dose window, always check

this before your injection.

You can give from 0.5 unit to 30 units in a single injection.

If your dose

is more than 30 units, you will need to give yourself more than one injection.

2.

What you need to know before you use Humalog Junior KwikPen

Do NOT use Humalog Junior KwikPen

if you are

allergic

to insulin lispro or any of the other ingredients of this medicine (listed in

section 6).

if you think

hypoglycaemia

(low blood sugar) is starting. Further in this leaflet it tells you how to

deal with mild hypoglycaemia (see Section 3: If you take more Humalog than you need).

Warnings and precautions

Do NOT mix the Humalog 100 units/ml solution for injection in your pre-filled pen (the

Junior KwikPen) with any other insulins or any other medicine

If your blood sugar levels are well controlled by your current insulin therapy, you may not feel the

warning symptoms when your blood sugar is falling too low. Warning signs are listed in section 4

of this leaflet. You must think carefully about when to have your meals, how often to exercise and

how much to do. You must also keep a close watch on your blood sugar levels by testing your

blood glucose often.

A few people who have had hypoglycaemia after switching from animal insulin to human insulin

have reported that the early warning symptoms were less obvious or different. If you often have

hypoglycaemia or have difficulty recognising it, please discuss this with your doctor.

If you answer YES to any of the following questions, tell your doctor, pharmacist or diabetes nurse

Have you recently become ill?

Do you have trouble with your kidneys or liver?

Are you exercising more than usual?

You should also tell your doctor, pharmacist or diabetes nurse if you are planning to go abroad.

The time difference between countries may mean that you have to have your injections and meals

at different times from when you are at home.

Some patients with long-standing type 2 diabetes mellitus and heart disease or previous stroke who

were treated with pioglitazone and insulin experienced the development of heart failure. Inform

your doctor as soon as possible, if you experience signs of heart failure such as unusual shortness

of breath or rapid increase in weight or localised swelling (oedema).

This Pen is not recommended for use by the blind or visually impaired without the help of someone

trained to use the Pen.

Other medicines and Humalog Junior KwikPen

Your insulin needs may change if you are taking

the contraceptive pill,

steroids,

thyroid hormone replacement therapy,

oral hypoglycaemics, (e.g. metformin, acarbose, sulphonylurea agents, pioglitazone,

empagliflozin, DPP-4-inhibitors like sitagliptin or saxagliptine, ),

acetyl salicylic acid,

sulpha antibiotics,

somatostatin analogues (such as octreotide, used to treat an uncommon condition in which you

make too much growth hormone),

“beta

stimulants”such as salbutamol or terbutaline to treat asthma, or ritodrine used to stop

premature labor,

beta-blockers – to treat high blood pressure., or

some antidepressants (monoamine oxidase inhibitors or selective serotonin reuptake inhibitors),

danazol (medicine acting on ovulation),

some angiotensin converting (ACE) inhibitors, used to treat certain heart conditions or high

blood pressure (for example captopril, enalapril), and

specific medicines to treat high blood pressure, kidney damage due to diabetes, and some heart

problems (angiotensin II receptor blockers).

Please tell your doctor, if you are taking, have recently taken or might take any other medicines. (see

also section “Warnings and precautions”).

Humalog with alcohol

Your blood sugar levels may either rise or fall if you drink alcohol. Therefore the amount of insulin

needed may change.

Pregnancy and breast-feeding

Are you pregnant or thinking about becoming pregnant, or are you breast-feeding? The amount of

insulin you need usually falls during the first three months of pregnancy and increases for the

remaining six months. If you are breast-feeding, you may need to alter your insulin intake or diet.

Ask your doctor for advice.

Driving and using machines

Your ability to concentrate and react may be reduced if you have hypoglycaemia. Please keep this

possible problem in mind in all situations where you might put yourself and others at risk (e.g. driving

a car or operating machinery). You should contact your doctor about the advisability of driving if you

have:

frequent episodes of hypoglycaemia

reduced or absent warning signs of hypoglycaemia

Important information about some of the ingredients of Humalog Junior KwikPen

This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-

free’.

3.

How to use Humalog Junior KwikPen

Always check the pack and the label of the pre-filled pen for the name and type of the insulin

when you get it from your pharmacy. Make sure you get the Humalog 100 units/ml Junior

KwikPen that your doctor has told you to use.

Always use this medicine exactly as your doctor has told you. You should check with your doctor if

you are not sure. To prevent the possible transmission of disease, each pen must be used by you only,

even if the needle is changed.

Dosage

The number of half units (0.5 units) is shown in the dose window of your pen. The half units

(0.5 units) are shown as lines between the numbers.

Always check the number in the dose window to make sure you have dialled the correct dose.

You should normally inject Humalog within 15 minutes of a meal. If you need to, you can inject

soon after a meal. But your doctor will have told you exactly how much to use, when to use it,

and how often. These instructions are only for you. Follow them exactly and visit your diabetes

clinic regularly.

If you change the type of insulin you use (for example from a human or animal insulin to a

Humalog product), you may have to take more or less than before. This might just be for the

first injection or it may be a gradual change over several weeks or months.

Humalog KwikPen is only suitable for injecting just under the skin. Speak to your doctor if you

need to inject your insulin by another method.

Preparing Humalog Junior KwikPen

Humalog is already dissolved in water, so you do not need to mix it. But you must use it

only

it looks like water. It must be clear, have no colour and no solid pieces in it. Check each time

you inject yourself.

Getting the Junior KwikPen ready to use (Please see user manual)

First wash your hands.

Read the instructions on how to use your pre-filled insulin pen. Please follow the instructions

carefully. Here are some reminders.

Use a clean needle. (Needles are not included).

Prime your Junior KwikPen before each use. This checks that insulin comes out and clears the

air bubbles from your Junior KwikPen . There may still be some small air bubbles left in the

pen - these are harmless. But if the air bubbles are too large it may affect the insulin dose.

Injecting Humalog

Before you make an injection, clean your skin as you have been instructed. Inject under the

skin, as you were taught. Do not inject directly into a vein. After your injection, leave the needle

in the skin for five seconds to make sure you have taken the whole dose. Do not rub the area

you have just injected. Make sure you inject at least half an inch (1 cm) from the last injection

and that you ‘rotate’ the places you inject, as you have been taught. It doesn’t matter which

injection site you use, either upper arm, thigh, buttock or abdomen, your Humalog injection will

still work quicker than soluble human insulin.

You must not administer Humalog by the intravenous route. Inject Humalog as your physician

or nurse has taught you. Only your physician can administer Humalog by the intravenous route.

He will only do this under special circumstances such as surgery or if you are ill and your

glucose levels are too high.

After injecting

As soon as you have done the injection, unscrew the needle from the Junior KwikPen using the

outer needle cap. This will keep the insulin sterile and stop it leaking. It also stops air entering

the pen and your needle clogging.

Do not share your needles

. Do not share your pen. Replace

the cap on your pen.

Further injections

Every time you use a Junior KwikPen you must use a new needle. Before every injection, clear

any air bubbles. You can see how much insulin is left by holding the Junior KwikPen with the

needle pointing up. The scale on the cartridge shows about how many units you have left.

Once the Junior KwikPen is empty, do not use it again. Please get rid of it carefully - your

pharmacist or diabetes nurse will tell you how to do this.

Using Humalog in an infusion pump

Junior KwikPen is only suitable for injecting just under the skin. Do not use the pen to

administer Humalog by a different way. Other forms of Humalog 100 units/ml are available if

this is necessary. Speak to your doctor if this applies to you.

If you take more Humalog than you need

If you take more Humalog than you need, a low blood sugar may occur. Check your blood sugar.

If your blood sugar is low

(mild hypoglycaemia)

, eat glucose tablets, sugar or drink a sugary drink.

Then eat fruit, biscuits, or a sandwich, as your doctor has advised you and have some rest. This will

often get you over mild hypoglycaemia or a minor insulin overdose. If you get worse and your

breathing is shallow and your skin gets pale, tell your doctor at once. A glucagon injection can treat

quite severe hypoglycaemia. Eat glucose or sugar after the glucagon injection. If you do not respond to

glucagon, you will have to go to hospital. Ask your doctor to tell you about glucagon.

If you forget to use Humalog

If you take less Humalog than you need, a high blood sugar may occur. Check your blood sugar

If hypoglycaemia (low blood sugar) or hyperglycaemia (high blood sugar) is not treated they can be

very serious and cause headaches, feeling sick (nausea), being sick (vomiting), loss of fluids

(dehydration), unconsciousness, coma or even death (see section 4 “Possible Side Effects”).

Three simple steps

to avoid hypoglycaemia or hyperglycaemia are:

Always carry a spare pen in case you lose your Junior KwikPen or it gets damaged.

Always carry something to show you are diabetic.

Always carry sugar with you.

If you stop using Humalog.

If you take less Humalog than you need, a high blood sugar may occur. Do not change your insulin

unless your doctor tells you to.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Severe allergy is rare (may affect up to 1 in 1,000 people). The symptoms are as follows:

rash over the whole body

blood pressure dropping

difficulty in breathing

heart beating fast

wheezing

sweating

If you think you are having this sort of insulin allergy with Humalog, contact a doctor at once.

Local allergy is common (may affect up to 1 in 10 people). Some people get redness, swelling or

itching around the area of the insulin injection. This usually clears up in anything from a few days to a

few weeks. If this happens to you, tell your doctor.

Lipodystrophy (thickening or pitting of the skin) is uncommon (may affect up to 1 in 100 people). If

you notice your skin thickening or pitting at the injection site, tell your doctor.

Oedema (e.g. swelling in arms, ankles; fluid retention) has been reported, particularly at the start of

insulin therapy or during a change in therapy to improve control of your blood glucose.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects

not listed in this leaflet.

You can also report side effects directly via the national reporting system

listed in Appendix V. By reporting side effects you can help provide more information on the safety of

this medicine.

Common problems of diabetes

Hypoglycaemia

Hypoglycaemia (low blood sugar) means there is not enough sugar in the blood. This can be caused if:

you take too much Humalog or other insulin;

you miss or delay meals or change your diet;

you exercise or work too hard just before or after a meal;

you have an infection or illness (especially diarrhoea or vomiting);

there is a change in your need for insulin; or

you have trouble with your kidneys or liver which gets worse.

Alcohol and some medicines can affect your blood sugar levels (see section 2).

The first symptoms of low blood sugar usually come on quickly and include the following:

tiredness

rapid heartbeat

nervousness or shakiness

feeling sick

headache

cold sweat

While you are not confident about recognising your warning symptoms, avoid situations such as

driving a car, in which you or others would be put at risk by hypoglycaemia.

Hyperglycaemia and diabetic ketoacidosis

Hyperglycaemia (too much sugar in the blood) means that your body does not have enough insulin.

Hyperglycaemia can be brought about by:

not taking your Humalog or other insulin;

taking less insulin than your doctor tells you to;

eating a lot more than your diet allows; or

fever, infection or emotional stress.

Hyperglycaemia can lead to diabetic ketoacidosis. The first symptoms come on slowly over many

hours or days. The symptoms include the following:

feeling sleepy

no appetite

flushed face

fruity smell on the breath

thirst

feeling or being sick

Severe symptoms are heavy breathing and a rapid pulse.

Get medical help immediately.

Illness

If you are ill, especially if you feel sick or are sick, the amount of insulin you need may change.

Even

when you are not eating normally, you still need insulin.

Test your urine or blood, follow your

‘sick rules’, and tell your doctor.

5.

How to store Humalog Junior KwikPen

Keep out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the label and the carton. The expiry

date refers to the last day of that month.

Before the first use store your Humalog Junior KwikPen in a refrigerator (2

C – 8

C). Do not freeze.

Keep your Humalog Junior KwikPen in use at room temperature (15° - 30°C) and discard after 28

days

even if some of the solution remains

. Do not put it near heat or in the sun. Do not keep the

Junior KwikPen that you are using in the fridge. The Junior KwikPen should not be stored with the

needle attached.

Do not use this medicine if you notice the solution is coloured or it has solid pieces in it. You must use

only

if it looks like water. Check this each time you inject yourself.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to

dispose of medicines no longer required. These measures will help to protect the environment.

6.

Contents of the pack and other information

What Humalog 100 units/ml Junior KwikPen solution for injection contains

The active substance is insulin lispro. Each ml of solution contains 100 units (U) of insulin

lispro. Each pre-filled pen (3 ml) contains 300 units (U) of insulin lispro.

The other ingredients are metacresol, glycerol, dibasic sodium phosphate 7 H

O, zinc oxide and

water for injections. Sodium hydroxide or hydrochloric acid may have been used to adjust the

acidity.

What Humalog 100 units/ml Junior KwikPen looks like and contents of the pack

Humalog 100 units/ml Junior KwikPen, solution for injection is a sterile, clear, colourless, aqueous

solution and contains 100 units of insulin lispro in each millilitre (100 units/ml) solution for injection.

Each Humalog Junior KwikPen contains 300 units (3 millilitres). The Humalog Junior KwikPen

comes in a pack of 1or 5 pre-filled pens or multipacks of 2 x 5 pre-filled pens. Not all pack sizes may

be marketed. The Junior KwikPen simply has a built in cartridge. When the pre-filled pen is empty

you cannot use it again. The Junior KwikPen is blue. The dose knob is blue with raised ridges. The

label is white with an orange colour bar and there is an orange to yellow, burgundy colour band. Each

Junior KwikPen delivers 0.5 – 30 units in steps of 0.5 units.

Marketing Authorisation Holder

Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands.

Manufacturer

Lilly France S.A.S., Rue du Colonel Lilly, 67640 Fegersheim, France,

For any information about this medicinal product, please contact the local representative of the

Marketing Authorisation Holder:

Belgique/België/Belgien

Eli Lilly Benelux S.A./N.V.

Tél/Tel: + 32-(0)2 548 84 84

Lietuva

Eli Lilly Holdings Limited atstovybė

Tel. +370 (5) 2649600

България

ТП "Ели Лили Недерланд" Б.В. - България

тел. + 359 2 491 41 40

Luxembourg/Luxemburg

Eli Lilly Benelux S.A./N.V.

Tél/Tel: + 32-(0)2 548 84 84

Česká republika

ELI LILLY ČR, s.r.o.

Tel: + 420 234 664 111

Magyarország

Lilly Hungária Kft.

Tel: + 36 1 328 5100

Danmark

Eli Lilly Danmark A/S

Tlf: +45 45 26 6000

Malta

Charles de Giorgio Ltd.

Tel: + 356 25600 500

Deutschland

Lilly Deutschland GmbH

Tel. + 49-(0) 6172 273 2222

Nederland

Eli Lilly Nederland B.V.

Tel: + 31-(0) 30 60 25 800

Eesti

Eli Lilly Holdings Limited Eesti filiaal

Tel:

+

372 6817 280

Norge

Eli Lilly Norge A.S.

Tlf: + 47 22 88 18 00

Ελλάδα

ΦΑΡΜΑΣΕΡΒ-ΛΙΛΛΥ Α.Ε.Β.Ε.

Τηλ: +30 210 629 4600

Österreich

Eli Lilly Ges. m.b.H.

Tel: + 43-(0) 1 711 780

España

Lilly S.A.

Tel: + 34-91 663 50 00

Polska

Eli Lilly Polska Sp. z o.o.

Tel: +48 22 440 33 00

France

Lilly France S.A.S.

Tél: +33-(0) 1 55 49 34 34

Portugal

Lilly Portugal - Produtos Farmacêuticos, Lda

Tel: + 351-21-4126600

Hrvatska

Eli Lilly Hrvatska d.o.o.

Tel: +385 1 2350 999

România

Eli Lilly România S.R.L.

Tel: + 40 21 4023000

Ireland

Eli Lilly and Company (Ireland) Limited

Tel: + 353-(0) 1 661 4377

Slovenija

Eli Lilly farmacevtska družba, d.o.o.

Tel: +386 (0) 1 580 00 10

Ísland

Icepharma hf.

Sími + 354 540 8000

Slovenská republika

Eli Lilly Slovakia, s.r.o.

Tel: + 421 220 663 111

Italia

Eli Lilly Italia S.p.A.

Tel: + 39- 055 42571

Suomi/Finland

Oy Eli Lilly Finland Ab

Puh/Tel: + 358-(0) 9 85 45 250

Κύπρος

Phadisco Ltd

Τηλ: +357 22 715000

Sverige

Eli Lilly Sweden AB

Tel: + 46-(0) 8 7378800

Latvija

Eli Lilly Holdings Limited pārstāvniecība Latvijā

Tel:

+

371 67364000

United Kingdom

Eli Lilly and Company Limited

Tel: + 44-(0) 1256 315000

This leaflet was last revised in

{MM/YYYY}.

USER MANUAL

Please see manual text later.

Detailed information on this medicine is available on the European Medicines Agency web site:

http://www.ema.europa.eu/.

Instructions for Use

Humalog 100 units/ml Junior KwikPen, solution for injection in a pre-filled pen

insulin lispro

PLEASE READ THESE INSTRUCTIONS BEFORE USE

Read the Instructions for Use before you start taking Humalog Junior KwikPen and each time you get

another Humalog Junior KwikPen. There may be new information. This information does not take the

place of talking to your healthcare professional about your medical condition or your treatment.

Humalog

100 units/ml Junior KwikPen (“Pen”) is a disposable pre-filled pen containing 3 ml

(300 units, 100 units/ml) of insulin lispro solution for injection. One pen contains multiple doses of

insulin.

Your healthcare professional will tell you how many units to give as your dose and how to

inject your prescribed dose of insulin.

The Pen dials half unit (0.5 unit) at a time. You can give from 0.5 unit to 30 units in a single

injection.

Always check the number in the dose window to make sure you have dialed the correct dose.

If your dose is more than 30 units, you will need to give yourself more than one injection.

The Plunger only moves a little with each injection, and you may not notice that it moves. When

the Plunger reaches the end of the cartridge, you have used all 300 units in the Pen.

Do not share your Pen with other people, even if the needle has been changed. Do not reuse or

share needles with other people. You may give an infection to them or get an infection from

them.

This Pen is not recommended for use by the blind or visually impaired without the help of someone

trained to use the Pen.

Humalog Junior KwikPen Parts

Pen Cap

Cartridge Holder

Label

Dose Indicator

Cap Clip

Rubber Seal

Plunger

Pen Body

Dose

Window

Dose

Knob

Pen Needle Parts

(Needles Not Included)

Dose Knob

Blue, with raised ridges

on end and side

Paper Tab

Outer Needle

Shield

Inner Needle

Shield

Needle

How to recognize your Humalog Junior KwikPen:

Pen colour:

Blue

Dose Knob:

Blue, with raised ridges on end and side

Label:

White with an orange colour bar and orange-to-yellow and burgundy colour band

Supplies needed to give your injection:

Humalog Junior KwikPen

KwikPen compatible Needle (BD [Becton, Dickinson and Company] Pen Needles recommended)

Swab

Needles and swab are not included.

Preparing your Pen

Wash your hands with soap and water.

Check the Pen to make sure you are taking the right type of insulin. This is especially important if

you use more than 1 type of insulin.

Do not

use your Pen past the expiration date printed on the Label or for more than 28 days after

you first start using the Pen.

Always use a

new Needle

for each injection to help prevent infections and blocked Needles.

Step 1:

Pull the Pen Cap straight off.

Do not

remove the Pen Label.

Wipe the Rubber Seal with a swab.

Humalog should look clear and colourless.

Do not

use if it is cloudy, coloured, or has particles or clumps

in it.

Step 2:

Select a new Needle.

Pull off the Paper Tab from the Outer Needle

Shield.

Step 3:

Push the capped Needle straight onto the Pen and

twist the Needle on until it is tight.

Step 4:

Pull off the Outer Needle Shield.

Do not

throw it

away.

Pull off the Inner Needle Shield and throw it

away.

Priming your Pen

Prime before each injection.

Priming your Pen means removing the air from the Needle and Cartridge that may collect during

normal use. It is important to prime your Pen so that it will work correctly.

If you

do not

prime before each injection, you may get too much or too little insulin.

Step 5:

To prime your Pen, turn the Dose Knob to select

2 units.

Step 6:

Hold your Pen with the Needle pointing up. Tap

the Cartridge Holder gently to collect air bubbles

at the top.

Keep

Throw

Away

Step 7:

Continue holding your Pen with the Needle

pointing up. Push the Dose Knob in until it stops,

and “

0

” is seen in the Dose Window. Hold the

Dose Knob in and

count to 5 slowly

You should see insulin at the tip of the Needle.

If you

do not

see insulin, repeat the priming

steps, but not more than 4 times.

If you

still

do not

see insulin, change the

Needle and repeat the priming steps.

Small air bubbles are normal and will not affect your

dose.

Selecting your dose

You can give from half unit (0.5 unit) to 30 units in a single injection.

Always check the number in the Dose Window to make sure you have dialled the correct dose.

If your dose is more than 30 units, you will need to give more than one injection.

Talk to your healthcare professional about how to give your dose.

Use a new Needle for each injection and repeat the priming step.

If you

usually

need more than 30 units, ask your healthcare professional if a different

Humalog KwikPen would be better for you.

Step 8:

Turn the Dose Knob to select the number of units

you need to inject. The Dose Indicator should line

up with your dose.

The Pen dials half unit (0.5 unit) at a time.

The Dose Knob clicks as you turn it.

DO NOT

dial your dose by counting the

clicks because you may dial the wrong dose.

The dose can be corrected by turning the Dose

Knob in either direction until the correct dose

lines up with the Dose Indicator.

whole unit

numbers are printed on the

dial.

half units

are shown as lines between

the numbers.

Always check the number in the Dose Window

to make sure you have dialled the correct dose.

Example: 4 units

shown in the

Dose Window

Example: 10 ½ (10.5)

units shown in the

Dose Window

The Pen will not let you dial more than the number of units left in the Pen.

If you need to inject more than the number of units left in the Pen, you may either:

inject the amount left in your Pen and then use a new Pen to give the rest of your dose,

or

get a new Pen and inject the full dose.

It is normal to see a small amount of insulin left in the Pen that you can not inject.

Giving your injection

Inject your insulin as your healthcare professional has shown you.

Change (rotate) your injection site for each injection.

Do not

try to change your dose while injecting.

Step 9:

Choose your injection site.

Humalog is injected under the skin

(subcutaneously) of your stomach area,

buttocks, upper legs or upper arms.

Wipe your skin with a swab, and let your

skin dry before you inject your dose.

Step 10:

Insert the Needle into your skin.

Push the Dose Knob all the way in.

Continue to hold the Dose

Knob in and

slowly count to 5

before removing the Needle.

Do not

try to inject your insulin by

turning the Dose Knob. You will

NOT

receive your insulin by

turning the Dose Knob.

Step 11:

Pull the Needle out of your skin.

A drop of insulin at the Needle tip is normal. It

will not affect your dose.

Check the number in the Dose Window

If you see “0” in the Dose window, you have

received the full amount you dialled.

If you do not see “0” in the Dose window, you

did not receive your full dose.

Do not

redial.

Insert the needle into your skin and finish your

injection.

If you

still

do not think you received the full

amount you dialled for your injection,

do not

start over or repeat that injection

. Monitor

your blood glucose and call your healthcare

professional for further instructions.

The plunger only moves a little with each injection,

and you may not notice that it moves.

If you see blood after you take the Needle out of your

skin, press the injection site lightly with a piece of

gauze or a swab.

Do not

rub the area.

5sec

After your injection

Step 12:

Carefully replace the Outer Needle Shield.

Step 13:

Unscrew the capped Needle and dispose of it as

described below (see

Disposing of Pens and

Needles

section).

Do not store the Pen with the Needle attached to

prevent leaking, blocking the Needle, and air

from entering the Pen.

Step 14:

Replace the Pen Cap by lining up the Cap Clip

with the Dose Indicator and pushing straight on.

Disposing of Pens and Needles

Put used Needles in a sharps container or a hard plastic container with a secure lid.

Do not

throw

needles directly into your household waste.

Do not

recycle the filled sharps container.

Ask your healthcare professional about options to dispose of the Pen and the sharps container

properly.

The directions regarding needle handling are not intended to replace local, healthcare professional

or institutional policies.

Storing your Pen

Unused Pens

Store unused Pens in the refrigerator at (2 °C to 8 °C).

Do not

freeze Humalog.

Do not

use if it has been frozen.

Unused Pens may be used until the expiration date printed on the Label, if the Pen has been kept

in the refrigerator.

In-use Pen

Store the Pen you are currently using at room temperature [up to (30 °C)] and away from dust,

food and liquids, heat and light.

Throw away the Pen you are using after 28 days, even if it still has insulin left in it.

General information about the safe and effective use of your Pen

Keep your Pen and Needles out of the sight and reach of children.

Do not

use your Pen if any part looks broken or damaged.

Always carry an extra Pen in case yours is lost or damaged.

Troubleshooting

If you can not remove the Pen Cap, gently twist the cap back and forth, and then pull the cap

straight off.

If the Dose Knob is hard to push:

Pushing the Dose Knob more slowly will make it easier to inject.

Your Needle may be blocked. Put on a new Needle and prime the Pen.

You may have dust, food, or liquid inside the Pen. Throw the Pen away and get a new Pen.

You may need to get a prescription from your healthcare professional.

If you have any questions or problems with your Humalog 100 units/ml Junior KwikPen, call your

healthcare professional for help or contact your local Lilly affiliate.

Document revision date: