Insulin lispro Sanofi

Informazzjoni prinċipali

  • Isem kummerċjali:
  • Insulin lispro Sanofi
  • Dominju tal-mediċina:
  • Bnedmin
  • Tip ta 'mediċina:
  • Droga allopatika

Dokumenti

Lokalizzazzjoni

  • Disponibbli fi:
  • Insulin lispro Sanofi
    Unjoni Ewropea
  • Lingwa:
  • Ingliż

Informazzjoni terapewtika

  • Grupp terapewtiku:
  • Drugs used in diabetes,
  • Żona terapewtika:
  • Diabetes Mellitus
  • Indikazzjonijiet terapewtiċi:
  • For the treatment of adults and children with diabetes mellitus who require insulin for the maintenance of normal glucose homeostasis. Insulin lispro Sanofi is also indicated for the initial stabilisation of diabetes mellitus.,
  • Sommarju tal-prodott:
  • Revision: 4

Status

  • Sors:
  • EMA - European Medicines Agency
  • L-istatus ta 'awtorizzazzjoni:
  • Authorised
  • Numru ta 'awtorizzazzjoni:
  • EMEA/H/C/004303
  • Data ta 'l-awtorizzazzjoni:
  • 17-07-2017
  • Kodiċi EMEA:
  • EMEA/H/C/004303
  • L-aħħar aġġornament:
  • 24-07-2019

Rapport ta 'Valutazzjoni Pubblika

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© European Medicines Agency, 2017. Reproduction is authorised provided the source is acknowledged.

EMA/353032/2017

EMEA/H/C/004303

EPAR summary for the public

Insulin lispro Sanofi

insulin lispro

This is a summary of the European public assessment report (EPAR) for Insulin lispro Sanofi. It

explains how the Agency assessed the medicine to recommend its authorisation in the EU and its

conditions of use. It is not intended to provide practical advice on how to use Insulin lispro Sanofi.

For practical information about using Insulin lispro Sanofi, patients should read the package leaflet or

contact their doctor or pharmacist.

What is Insulin lispro Sanofi and what is it used for?

Insulin lispro Sanofi is a medicine used to control blood glucose (sugar) levels in adults and children

with diabetes who need insulin. It contains the active substance insulin lispro.

Insulin lispro Sanofi is a ‘biosimilar medicine’. This means that it is highly similar to a biological

medicine (also known as the ‘reference medicine’) that is already authorised in the European Union

(EU). The reference medicine for Insulin lispro Sanofi is Humalog 100 U/ml solution. For more

information on biosimilar medicines, see here

How is Insulin lispro Sanofi used?

Insulin lispro Sanofi is given as an injection under the skin in the upper arm, thigh, buttock or belly. It

can also be given with an infusion pump. In some circumstances, such as when blood acid levels are

dangerously high (ketoacidosis), the medicine may be given into a vein.

Because Insulin lispro Sanofi is a fast-acting insulin, it is usually given shortly before a meal and, when

necessary, soon after a meal. The dose of Insulin lispro Sanofi is worked out for each patient and

depends on the patient’s blood glucose level. The doctor should instruct the patient on how to use the

medicine properly.

The medicine can only be obtained with a prescription. For further information, see the package leaflet.

Insulin lispro Sanofi

EMA/353032/2017

Page 2/3

How does Insulin lispro Sanofi work?

In diabetes, patients have high levels of blood glucose either because the body does not produce

enough insulin or the body is unable to use insulin effectively.

The active substance in Insulin lispro Sanofi is a form of insulin which is absorbed more quickly by the

body than human regular insulin, and can therefore act faster. It helps control blood glucose levels,

thereby alleviating symptoms and reducing the risk of complications of diabetes.

What benefits of Insulin lispro Sanofi have been shown in studies?

Laboratory studies comparing Insulin lispro Sanofi with the reference medicine Humalog have shown

that the active substance in Insulin lispro Sanofi is highly similar in terms of structure, purity and

biological activity to that of Humalog. In addition, studies have shown that both medicines produce

similar levels of the active substance in the body.

Two further studies in a total of 1,012 patients compared Insulin lispro Sanofi with Humalog and found

them to be similarly effective at reducing blood levels of a substance called glycosylated haemoglobin

(HbA1c), which gives an indication of how well blood glucose levels are controlled over time. In one

study, in patients with type 1 diabetes, HbA1c reduced by 0.44 and 0.46 percentage points with Insulin

lispro Sanofi and Humalog respectively after 26 weeks; in the second study, in patients with type 2

diabetes, the corresponding figures were 0.93 versus 0.88 percentage points.

What are the risks associated with Insulin lispro Sanofi?

Insulin lispro Sanofi may cause hypoglycaemia (low blood glucose levels) and must not be given to

patients whose blood glucose is already low. Severe hypoglycaemia can lead to loss of consciousness

and, in very extreme cases, to death. Hypoglycaemia may be due to the medicine itself or other

factors such as diet and exercise.

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

Why is Insulin lispro Sanofi approved?

The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance

with EU requirements for biosimilar medicines, Insulin lispro Sanofi has a highly similar structure,

purity and biological activity to Humalog and is distributed in the body in the same way. In addition,

studies show that both medicines have similar effects in reducing blood glucose levels and similar side

effects. Therefore, the CHMP’s view was that, as for Humalog, the benefits of Insulin lispro Sanofi

outweigh its risks and recommended that it be given marketing authorisation.

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

Insulin lispro Sanofi?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe

and effective use of Insulin lispro Sanofi have been included in the summary of product characteristics

and the package leaflet.

Other information about Insulin lispro Sanofi

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

Insulin lispro Sanofi on 19 July 2017.

Insulin lispro Sanofi

EMA/353032/2017

Page 3/3

The full EPAR for Insulin lispro Sanofi 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 Insulin lispro Sanofi, read the package leaflet (also part of the EPAR) or contact your

doctor or pharmacist.

This summary was last updated in 07-2017.

Fuljett ta 'Informazzjoni għall-Pazjent: prodott - kompożizzjoni, indikazzjonijiet, effetti sekondarji, dożaġġ, interazzjonijiet, reazzjonijiet avversi, tqala, treddigħ

B. PACKAGE LEAFLET

Package leaflet: information for the user

Insulin lispro Sanofi 100 units/ml solution for injection in vial

Insulin lispro

This medicine is subject to additional monitoring. This will allow quick identification of new

safety information. You can help by reporting any side effects you may get. See the end of section 4

for how to report side effects.

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 Insulin lispro Sanofi is and what it is used for

What you need to know before you use Insulin lispro Sanofi

How to use Insulin lispro Sanofi

Possible side effects

How to store Insulin lispro Sanofi

Contents of the pack and other information

1.

What Insulin lispro Sanofi is and what it is used for

Insulin lispro Sanofi 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. Insulin lispro Sanofi 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 Insulin lispro Sanofi within 15 minutes of a meal.

Your doctor may tell you to use Insulin lispro Sanofi 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.

Insulin lispro Sanofi is suitable for use in adults and children.

2.

What you need to know before you use Insulin lispro Sanofi

Do not use Insulin lispro Sanofi

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 use more Insulin lispro Sanofi than you

need).

if you are

allergic

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

section 6).

Warnings and precautions

Record the brand name (“Insulin lispro Sanofi”) and Lot number (included on the outer cartons and

labels of each vial, cartridge and pre-filled pen) of the product you are using and provide this

information when reporting any side effects.

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?

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 Insulin lispro Sanofi

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.

Tell your doctor if you are taking, have recently taken or might take any other medicines (see also

section “Warnings and precautions”).

Insulin lispro Sanofi with alcohol

Your blood sugar levels may change if you drink alcohol. Therefore the amount of insulin needed may

change.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask

your doctor for advice before taking this medicine.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.

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 Insulin lispro Sanofi

This medicine contains less than 1 mmol (23 mg) sodium per dose, i.e. it is essentially “sodium-free”.

3.

How to use Insulin lispro Sanofi

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 Insulin lispro Sanofi that your

doctor has told you

to use.

Always use this medicine exactly as your doctor has told you. Check with your doctor if you are not

sure.

Dosage

You should normally inject Insulin lispro Sanofi 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 an

Insulin lispro Sanofi product), you may have to use 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 Insulin lispro Sanofi under the skin (subcutaneous use or “SC”). You should only inject it

into a muscle if your doctor has told you to.

Preparing Insulin lispro Sanofi

Insulin lispro Sanofi is already dissolved in water, so you do not need to mix it. But you must

use it

only

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

each time you inject yourself.

Injecting Insulin lispro Sanofi

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

Insulin lispro Sanofi 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 injected the whole dose. Do

not rub the area you have just injected. Make sure you inject a

t 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 Insulin

lispro Sanofi injection will still work quicker than soluble human insulin.

Your doctor will tell you if you have to mix Insulin lispro Sanofi with one of the human insulins.

For example if you do need to inject a mixture, draw the Insulin lispro Sanofi 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 Insulin lispro Sanofi with one of the mixtures of human insulins.

You should never mix Insulin lispro Sanofi with insulins produced by other manufacturers or

animal insulins.

You must not administer Insulin lispro Sanofi by the intravenous route (IV). Inject Insulin lispro

Sanofi as your physician or nurse has taught you. Only your physician can administer Insulin

lispro Sanofi 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 Insulin lispro Sanofi in an infusion pump

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

infusing insulin lispro, the manufacturer’s 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, Insulin lispro Sanofi should not be mixed with any

other insulin.

If you use more Insulin lispro Sanofi than you should

If you use more Insulin lispro Sanofi 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 Insulin lispro Sanofi

If you use less Insulin lispro Sanofi 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 Hypoglycaemia and Hyperglycaemia and

diabetic ketoacidosis in section 4 “Possible Side Effects”).

Three simple steps

to avoid hypoglycaemia or hyperglycaemia are:

Always keep spare syringes and a spare vial of Insulin lispro Sanofi

Always carry something to show you are diabetic.

Always carry sugar with you.

If you stop using Insulin lispro Sanofi

If you use less Insulin lispro Sanofi 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.

Systemic 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 Insulin lispro Sanofi, tell your 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 inject too much Insulin lispro Sanofi 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, e.g. 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 using your Insulin lispro Sanofi or other insulin;

using 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 Insulin lispro Sanofi

Keep out of the reach and sight of children.

Do not use Insulin lispro Sanofi 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 medicine in a refrigerator (2°C – 8°C). Do not freeze.

Keep the vial in the outer carton in order to protect from light.

Keep your vial in use at room temperature (below 30°C) and dispose of after 4 weeks. Do not store the

vial in a refrigerator. Keep the vial in the outer carton in order to protect from light.

Do not use Insulin lispro Sanofi if it is coloured or it has solid pieces in it. You must use it

only

if it

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

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to

throw away medicines you no longer use. These measures will help to protect the environment.

6.

Contents of the pack and other information

What Insulin lispro Sanofi contains

The active substance is insulin lispro. One ml of the solution contains 100 units (equivalent to

3.5 mg) of insulin lispro. Each vial contains 10 ml of solution for injection, equivalent to

1,000 units.

The other ingredients are: metacresol, glycerol, disodium hydrogen phosphate heptahydrate, zinc

oxide and water for injection. Sodium hydroxide or hydrochloric acid may have been used to

adjust the acidity.

What Insulin lispro Sanofi looks like and contents of the pack

Insulin lispro Sanofi, solution for injection in a vial is a clear, colourless, aqueous solution

Each vial contains 10 ml.

The Insulin lispro Sanofi in a vial comes in a pack of 1 vial or 5 vials. Not all pack sizes may be

marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

sanofi-aventis groupe, 54 rue La Boétie, F - 75008 Paris, France

Manufacturer:

Sanofi-Aventis Deutschland GmbH, D-65926 Frankfurt am Main, Germany.

For any information about this medicine, please contact the local representative of the Marketing

Authorisation Holder.

België/Belgique/Belgien

Sanofi Belgium

Tél/Tel: +32 (0)2 710 54 00

Lietuva

UAB « SANOFI-AVENTIS LIETUVA »

Tel: +370 5 2755224

България

SANOFI BULGARIA EOOD

Тел.: +359 (0)2 970 53 00

Luxembourg/Luxemburg

Sanofi Belgium

Tél/Tel: +32 (0)2 710 54 00 (Belgique/Belgien)

Česká republika

sanofi-aventis, s.r.o.

Tel: +420 233 086 111

Magyarország

SANOFI-AVENTIS Zrt.,

Tel.: +36 1 505 0050

Danmark

Sanofi A/S

Tlf: +45 45 16 70 00

Malta

Sanofi Malta Ltd.

Tel: +356 21493022

Deutschland

Sanofi-Aventis Deutschland GmbH

Tel.: 0800 52 52 010

Tel. aus dem Ausland: +49 69 305 21 131

Nederland

sanofi-aventis Netherlands B.V.

Tel: +31 20 245 4000

Eesti

sanofi-aventis Estonia OÜ

Tel: +372 627 34 88

Norge

sanofi-aventis Norge AS

Tlf: +47 67 10 71 00

Ελλάδα

sanofi-aventis AEBE

Τηλ: +30 210 900 16 00

Österreich

sanofi-aventis GmbH

Tel: +43 1 80 185 – 0

España

sanofi-aventis, S.A.

Tel: +34 93 485 94 00

Polska

sanofi-aventis Sp. z o.o.

Tel.: +48 22 280 00 00

France

sanofi-aventis France

Tél: 0 800 222 555

Appel depuis l’étranger : +33 1 57 63 23 23

Portugal

Sanofi - Produtos Farmacêuticos, Lda

Tel: +351 21 35 89 400

Hrvatska

sanofi-aventis Croatia d.o.o.

Tel: +385 1 600 34 00

România

Sanofi Romania SRL

Tel: +40 (0) 21 317 31 36

Ireland

sanofi-aventis Ireland Ltd. T/A SANOFI

Tel: +353 (0) 1 403 56 00

Slovenija

sanofi-aventis d.o.o.

Tel: +386 1 560 48 00

Ísland

Vistor hf.

Sími: +354 535 7000

Slovenská republika

sanofi-aventis Pharma Slovakia s.r.o.

Tel: +421 2 33 100 100

Italia

Sanofi S.p.A.

Tel: 800 13 12 12 (domande di tipo tecnico)

800.536389 (altre domande)

Suomi/Finland

Sanofi Oy

Puh/Tel: +358 (0) 201 200 300

Κύπρος

sanofi-aventis Cyprus Ltd.

Τηλ: +357 22 871600

Sverige

Sanofi AB

Tel: +46 (0)8 634 50 00

Latvija

sanofi-aventis Latvia SIA

Tel: +371 67 33 24 51

United Kingdom

Sanofi

Tel: +44 (0) 845 372 7101

This leaflet was last revised in

Other source of information

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

Insulin lispro Sanofi 100 units/ml solution for injection in cartridge

Insulin lispro

This medicine is subject to additional monitoring. This will allow quick identification of new

safety information. You can help by reporting any side effects you may get. See the end of section 4

for how to report side effects.

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 Insulin lispro Sanofi is and what it is used for

What you need to know before you use Insulin lispro Sanofi

How to use Insulin lispro Sanofi

Possible side effects

How to store Insulin lispro Sanofi

Contents of the pack and other information

1.

What Insulin lispro Sanofi is and what it is used for

Insulin lispro Sanofi 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. Insulin lispro Sanofi 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 Insulin lispro Sanofi within 15 minutes of a meal.

Your doctor may tell you to use Insulin lispro Sanofi 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.

Insulin lispro Sanofi is suitable for use in adults and children.

2.

What you need to know before you use Insulin lispro Sanofi

Do not use Insulin lispro Sanofi

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 use more Insulin lispro Sanofi than you

need).

if you are

allergic

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

section 6).

Warnings and precautions

Insulin lispro Sanofi in cartridges is only suitable for injecting just under the skin using a reusable pen

(see also section 3). Speak to your doctor if you need to inject your insulin by another method.

Record the brand name (“Insulin lispro Sanofi”) and Lot number (included on the outer cartons and

labels of each vial, cartridge and pre-filled pen) of the product you are using and provide this

information when reporting any side effects.

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?

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 Insulin lispro Sanofi

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.

Tell your doctor if you are taking, have recently taken or might take any other medicines. (see also

section “Warnings and precautions”).

nsulin lispro Sanofi with alcohol

Your blood sugar levels may change if you drink alcohol. Therefore the amount of insulin needed may

change.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask

your doctor for advice before taking this medicine.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.

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 Insulin lispro Sanofi

This medicine contains less than 1 mmol (23 mg) sodium per dose, i.e. it is essentially “sodium-free”.

3.

How to use Insulin lispro Sanofi

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

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

when you get

it from your pharmacy. Make sure you get the Insulin lispro Sanofi that your

doctor has told

you to use.

Always use this medicine exactly as your doctor has told you. 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 Insulin lispro Sanofi 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 an

Insulin lispro Sanofi product), you may have to use 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 Insulin lispro Sanofi under the skin (subcutaneous use or “SC”). You should only inject it

into a muscle if your doctor has told you to.

Preparing Insulin lispro Sanofi

Insulin lispro Sanofi is already dissolved in water, so you do not need to mix it. But you must

use it

only

if 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.

The 3 ml cartridge only fits the 3 ml pen. Insulin lispro Sanofi in cartridges is only suitable for

injecting just under the skin using a reusable pen. Speak to your doctor if you need to inject your

insulin by another method. To ensure you get the accurate dose, the Insulin lispro Sanofi

cartridges are to be used only with the following pens:

JuniorSTAR which delivers doses in steps of 0.5 units

Tactipen, AllStar and AllStar PRO which deliver doses in steps of 1 unit.

Not all of these pens may be marketed in your country.

Follow the instructions that come with the pen. The manufacturer’s instructions for using the

pen must be followed carefully for loading the cartridge, attaching the needle, and administering

the insulin injection.

Always perform a safety test before each injection.

Injecting Insulin lispro Sanofi

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 ten seconds to make sure you have injected 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 Insulin lispro Sanofi injection

will still work quicker than soluble human insulin.

You must not administer Insulin lispro Sanofi by the intravenous route (IV). Inject Insulin lispro

Sanofi as your physician or nurse has taught you. Only your physician can administer Insulin

lispro Sanofi 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.

Do not share your needles

. Do not share your pen. Replace the cap on your pen. Leave the

cartridge in the pen.

Further injections

Always use a new sterile needle for each injection. Always perform a safety test

before each injection.

Do not mix any other insulin in an Insulin lispro Sanofi cartridge. Once the cartridge is empty,

do not use it again.

If you use more Insulin lispro Sanofi than you should

If you use more Insulin lispro Sanofi 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 Insulin lispro Sanofi

If you use less Insulin lispro Sanofi 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 Hypoglycaemia and Hyperglycaemia and

diabetic ketoacidosis in section 4 “Possible Side Effects”).

Three simple steps

to avoid hypoglycaemia or hyperglycaemia are:

Always keep spare syringes and a spare vial of Insulin lispro Sanofi, 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 Insulin lispro Sanofi

If you use less Insulin lispro Sanofi 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.

Systemic 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 Insulin lispro Sanofi, tell your 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 inject too much Insulin lispro Sanofi 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, e.g. 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 using your Insulin lispro Sanofi or other insulin;

using 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 Insulin lispro Sanofi

Keep out of the reach and sight of children.

Do not use Insulin lispro Sanofi 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 Insulin lispro Sanofi in a refrigerator (2°C – 8°C). Do not freeze. Keep

the cartridge in the outer carton in order to protect from light.

Keep your cartridge in use at room temperature (below 30°C) and dispose of after 4 weeks. 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.

Do not use Insulin lispro Sanofi, if it is coloured or it has solid pieces in it. You must use it

only

if it

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

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to

throw away medicines you no longer use. These measures will help to protect the environment.

6.

Contents of the pack and other information

What Insulin lispro Sanofi contains

The active substance is insulin lispro. One ml of the solution contains 100 units (equivalent to

3.5 mg) of insulin lispro. Each cartridge contains 3 ml of solution for injection, equivalent to

300 units.

The other ingredients are: metacresol, glycerol, disodium hydrogen phosphate heptahydrate, zinc

oxide and water for injection. Sodium hydroxide or hydrochloric acid may have been used to

adjust the acidity.

What Insulin lispro Sanofi looks like and contents of the pack

Insulin lispro Sanofi, solution for injection is a clear, colourless, aqueous solution.

Each cartridge contains 3 ml.

The Insulin lispro Sanofi cartridges come in a pack of 5 or 10 cartridges. Not all pack sizes may be

marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

sanofi-aventis groupe, 54 rue La Boétie, F - 75008 Paris, France

Manufacturer:

Sanofi-Aventis Deutschland GmbH, D-65926 Frankfurt am Main, Germany.

For any information about this medicine, please contact the local representative of the Marketing

Authorisation Holder.

België/Belgique/Belgien

Sanofi Belgium

Tél/Tel: +32 (0)2 710 54 00

Lietuva

UAB « SANOFI-AVENTIS LIETUVA »

Tel: +370 5 2755224

България

SANOFI BULGARIA EOOD

Тел.: +359 (0)2 970 53 00

Luxembourg/Luxemburg

Sanofi Belgium

Tél/Tel: +32 (0)2 710 54 00 (Belgique/Belgien)

Česká republika

sanofi-aventis, s.r.o.

Tel: +420 233 086 111

Magyarország

SANOFI-AVENTIS Zrt.,

Tel.: +36 1 505 0050

Danmark

Sanofi A/S

Tlf: +45 45 16 70 00

Malta

Sanofi Malta Ltd.

Tel: +356 21493022

Deutschland

Sanofi-Aventis Deutschland GmbH

Tel.: 0800 52 52 010

Tel. aus dem Ausland: +49 69 305 21 131

Nederland

sanofi-aventis Netherlands B.V.

Tel: +31 20 245 4000

Eesti

sanofi-aventis Estonia OÜ

Tel: +372 627 34 88

Norge

sanofi-aventis Norge AS

Tlf: +47 67 10 71 00

Ελλάδα

sanofi-aventis AEBE

Τηλ: +30 210 900 16 00

Österreich

sanofi-aventis GmbH

Tel: +43 1 80 185 – 0

España

sanofi-aventis, S.A.

Tel: +34 93 485 94 00

Polska

sanofi-aventis Sp. z o.o.

Tel.: +48 22 280 00 00

France

sanofi-aventis France

Tél: 0 800 222 555

Appel depuis l’étranger : +33 1 57 63 23 23

Portugal

Sanofi - Produtos Farmacêuticos, Lda

Tel: +351 21 35 89 400

Hrvatska

sanofi-aventis Croatia d.o.o.

Tel: +385 1 600 34 00

România

Sanofi Romania SRL

Tel: +40 (0) 21 317 31 36

Ireland

sanofi-aventis Ireland Ltd. T/A SANOFI

Tel: +353 (0) 1 403 56 00

Slovenija

sanofi-aventis d.o.o.

Tel: +386 1 560 48 00

Ísland

Vistor hf.

Sími: +354 535 7000

Slovenská republika

sanofi-aventis Pharma Slovakia s.r.o.

Tel: +421 2 33 100 100

Italia

Sanofi S.p.A.

Tel: 800 13 12 12 (domande di tipo tecnico)

800.536389 (altre domande)

Suomi/Finland

Sanofi Oy

Puh/Tel: +358 (0) 201 200 300

Κύπρος

sanofi-aventis Cyprus Ltd.

Τηλ: +357 22 871600

Sverige

Sanofi AB

Tel: +46 (0)8 634 50 00

Latvija

sanofi-aventis Latvia SIA

Tel: +371 67 33 24 51

United Kingdom

Sanofi

Tel: +44 (0) 845 372 7101

This leaflet was last revised in

Other source of information

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

Insulin lispro Sanofi 100 units/ml solution for injection in a pre-filled pen

Insulin lispro

Each pre-filled pen delivers 1-80 units in steps of 1 unit.

This medicine is subject to additional monitoring. This will allow quick identification of new

safety information. You can help by reporting any side effects you may get. See the end of section 4

for how to report side effects.

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 Insulin lispro Sanofi is and what it is used for

What you need to know before you use Insulin lispro Sanofi

How to use Insulin lispro Sanofi

Possible side effects

How to store Insulin lispro Sanofi

Contents of the pack and other information

1.

What Insulin lispro Sanofi is and what it is used for

Insulin lispro Sanofi 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. Insulin lispro Sanofi 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 Insulin lispro Sanofi within 15 minutes of a meal.

Your doctor may tell you to use Insulin lispro Sanofi 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.

Insulin lispro Sanofi is suitable for use in adults and children.

Insulin lispro Sanofi SoloStar is a disposable pre-filled pen containing 3 ml (300 units, 100 units/ml)

of insulin lispro. One Insulin lispro Sanofi pre-filled pen contains multiple doses of insulin. The

Insulin lispro Sanofi pre-filled pen 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 80 units in a single

injection.

If your dose is more than 80 units, you will need to give yourself more than one

injection.

2.

What you need to know before you use Insulin lispro Sanofi

Do not use Insulin lispro Sanofi

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 use more Insulin lispro Sanofi than you

need).

if you are

allergic

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

section 6).

Warnings and precautions

Insulin lispro Sanofi in pre-filled pen is only suitable for injecting just under the skin (see also

section 3). Speak to your doctor if you need to inject your insulin by another method.

Record the brand name (“Insulin lispro Sanofi”) and Lot number (included on the outer cartons and

labels of each vial, cartridge and pre-filled pen) of the product you are using and provide this

information when reporting any side effects.

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? 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 Insulin lispro Sanofi

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.

Tell your doctor if you are taking, have recently taken or might take any other medicines. (see also

section “Warnings and precautions”).

Insulin lispro Sanofi with alcohol

Your blood sugar levels may change if you drink alcohol. Therefore the amount of insulin needed may

change.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask

your doctor for advice before taking this medicine. 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.

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 Insulin lispro Sanofi

This medicine contains less than 1 mmol (23 mg) sodium per dose, i.e. it is essentially “sodium-free”.

3.

How to use Insulin lispro Sanofi

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 Insulin lispro Sanofi that your

doctor has told you to use.

Always use this medicine exactly as your doctor has told you. 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 Insulin lispro Sanofi 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 an

Insulin lispro Sanofi product), you may have to use 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 Insulin lispro Sanofi under the skin (subcutaneous use or “SC”). You should only inject it

into a muscle if your doctor has told you to.

Preparing Insulin lispro Sanofi

Insulin lispro Sanofi is already dissolved in water, so you do not need to mix it. But you must

use it

only

if 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 SoloStar pre-filled pen ready to use (Please see user manual)

Insulin lispro Sanofi in pre-filled pen is only suitable for in

jecting just under the skin. Speak to

your doctor if you need to inject your insulin by another method.

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).

Always perform a safety test before each injection.

Injecting Insulin lispro Sanofi

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 ten seconds to make sure you have injected 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 Insulin lispro Sanofi injection

will still work quicker than soluble human insulin.

You must not administer Insulin lispro Sanofi by the intravenous route (IV). Inject Insulin lispro

Sanofi as your physician or nurse has taught you. Only your physician can administer Insulin

lispro Sanofi 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 pre-filled pen using the

outer needle cap.

Do not share your needles

. Do not share your pen. Replace the cap on your

pen.

Further injections

Every time you use a pre-filled pen you must use a new needle. Always perform a safety test

before each injection. You can see roughly how many units of insulin are left by looking at

where the plunger is on the insulin scale.

Do not mix any other insulin in your pre-filled pen. Once the pre-filled pen 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 use more Insulin lispro Sanofi than you should

If you use more Insulin lispro Sanofi 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 Insulin lispro Sanofi

If you use less Insulin lispro Sanofi 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 Hypoglycaemia and Hyperglycaemia and

diabetic ketoacidosis in section 4 “Possible Side Effects”).

Three simple steps

to avoid hypoglycaemia or hyperglycaemia are:

Always keep spare syringes and a spare vial of Insulin lispro Sanofi, or a spare pen and

cartridges, in case you lose your SoloStar pre-filled pen or it gets damaged.

Always carry something to show you are diabetic.

Always carry sugar with you.

If you stop using Insulin lispro Sanofi

If you use less Insulin lispro Sanofi 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.

Systemic 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 Insulin lispro Sanofi, tell your 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 inject too much Insulin lispro Sanofi 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, e.g. 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 using your Insulin lispro Sanofi or other insulin;

using 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 Insulin lispro Sanofi

Keep out of the reach and sight of children.

Do not use Insulin lispro Sanofi in a pre-filled pen 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 medicine pre-filled pen in a refrigerator (2°C – 8°C). Do not freeze.

Keep the pre-filled pen in the outer carton in order to protect from light.

Keep your Insulin lispro Sanofi pre-filled pen in use at room temperature (below 30°C) and dispose of

after 4 weeks. Do not keep the pre-filled pen that you are using in the fridge. The pre-filled pen should

not be stored with the needle attached. Always keep the cap on the pre-filled pen when you are not

using it in order to protect from light.

Do not use Insulin lispro Sanofi pre-filled pen if the solution is coloured or it has solid pieces in it.

You must use it

only

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

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to

throw away medicines you no longer use. These measures will help to protect the environment.

6.

Contents of the pack and other information

What Insulin lispro Sanofi contains

The active substance is insulin lispro. Each ml of the solution contains 100 units (equivalent to

3.5 mg) of insulin lispro. Each pre-filled pen contains 3 ml of solution for injection, equivalent

to 300 units.

The other ingredients are: metacresol, glycerol, disodium hydrogen phosphate heptahydrate, zinc

oxide and water for injection. Sodium hydroxide or hydrochloric acid may have been used to

adjust the acidity.

What Insulin lispro Sanofi looks like and contents of the pack

Insulin lispro Sanofi, solution for injection is a clear, colourless, aqueous solution.

Each pre-filled pen contains 3 ml.

The Insulin lispro Sanofi in a pre-filled pen (SoloStar) comes in a pack of 1, 3, 5 or 10 pre-filled pens.

Not all pack sizes may be marketed.

The Insulin lispro Sanofi in your pre-filled pen is the same as the Insulin lispro Sanofi, which comes in

separate Insulin lispro Sanofi cartridges. The pre-filled pen simply has a built in cartridge. When the

pre-filled pen is empty you cannot use it again.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

sanofi-aventis groupe, 54 rue La Boétie, F - 75008 Paris, France

Manufacturer:

Sanofi-Aventis Deutschland GmbH, D-65926 Frankfurt am Main, Germany.

For any information about this medicine, please contact the local representative of the Marketing

Authorisation Holder.

België/Belgique/Belgien

Sanofi Belgium

Tél/Tel: +32 (0)2 710 54 00

Lietuva

UAB « SANOFI-AVENTIS LIETUVA »

Tel: +370 5 2755224

България

SANOFI BULGARIA EOOD

Тел.: +359 (0)2 970 53 00

Luxembourg/Luxemburg

Sanofi Belgium

Tél/Tel: +32 (0)2 710 54 00 (Belgique/Belgien)

Česká republika

sanofi-aventis, s.r.o.

Tel: +420 233 086 111

Magyarország

SANOFI-AVENTIS Zrt.,

Tel.: +36 1 505 0050

Danmark

Sanofi A/S

Tlf: +45 45 16 70 00

Malta

Sanofi Malta Ltd.

Tel: +356 21493022

Deutschland

Sanofi-Aventis Deutschland GmbH

Tel.: 0800 52 52 010

Tel. aus dem Ausland: +49 69 305 21 131

Nederland

sanofi-aventis Netherlands B.V.

Tel: +31 20 245 4000

Eesti

sanofi-aventis Estonia OÜ

Tel: +372 627 34 88

Norge

sanofi-aventis Norge AS

Tlf: +47 67 10 71 00

Ελλάδα

sanofi-aventis AEBE

Τηλ: +30 210 900 16 00

Österreich

sanofi-aventis GmbH

Tel: +43 1 80 185 – 0

España

sanofi-aventis, S.A.

Tel: +34 93 485 94 00

Polska

sanofi-aventis Sp. z o.o.

Tel.: +48 22 280 00 00

France

sanofi-aventis France

Tél: 0 800 222 555

Appel depuis l’étranger : +33 1 57 63 23 23

Portugal

Sanofi - Produtos Farmacêuticos, Lda

Tel: +351 21 35 89 400

Hrvatska

sanofi-aventis Croatia d.o.o.

Tel: +385 1 600 34 00

România

Sanofi Romania SRL

Tel: +40 (0) 21 317 31 36

Ireland

sanofi-aventis Ireland Ltd. T/A SANOFI

Tel: +353 (0) 1 403 56 00

Slovenija

sanofi-aventis d.o.o.

Tel: +386 1 560 48 00

Ísland

Vistor hf.

Sími: +354 535 7000

Slovenská republika

sanofi-aventis Pharma Slovakia s.r.o.

Tel: +421 2 33 100 100

Italia

Sanofi S.p.A.

Tel: 800 13 12 12 (domande di tipo tecnico)

800.536389 (altre domande)

Suomi/Finland

Sanofi Oy

Puh/Tel: +358 (0) 201 200 300

Κύπρος

sanofi-aventis Cyprus Ltd.

Τηλ: +357 22 871600

Sverige

Sanofi AB

Tel: +46 (0)8 634 50 00

Latvija

sanofi-aventis Latvia SIA

Tel: +371 67 33 24 51

United Kingdom

Sanofi

Tel: +44 (0) 845 372 7101

This leaflet was last revised in

Other source of information

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

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

Insulin lispro Sanofi solution for injection in a pre-filled pen (SoloStar)

INSTRUCTIONS FOR USE

Read this first

Important information

Never share your pen – it is only for you.

Never use your pen if it is damaged or if you are not sure that it is working properly.

Always perform a safety test

Always carry a spare pen and spare needles in case they got lost or stop working.

Never re-use needles.

If you do you might not get your dose (underdosing) or get too much

(overdosing) as the needle could block.

Learn to inject

Talk with your doctor, pharmacist or nurse about how to inject, before using your pen.

Ask for help if you have problems handling the pen, for example if you have problems with your

sight.

This pen is not recommended for use by the blind or visually impaired without the help of

someone trained to use the pen.

Read all of these instructions before using your pen. If you do not follow all of these instructions,

you may get too much or too little insulin.

Need help?

If you have any questions about your pen or about diabetes, ask your doctor, pharmacist or nurse or

call sanofi-aventis number on the front of this leaflet.

Extra items you will need:

a new sterile needle (see STEP 2).

a puncture resistant container for used needles and pens (see

Throwing your pen away

Get to know your pen

* You will not see the plunger until you have injected a few doses.

STEP 1: Check your pen

Take a new pen out of the fridge at least 1 hour before you inject. Cold insulin is more painful to

inject.

Cartridge holder

Insulin name

Dose window

Dose pointer

Injection button

Dose selector

Plunger

Insulin

scale

Rubber

seal

Pen cap

A

Check the name and expiration date on the label of your pen.

Make sure you have the correct insulin. This is especially important if you have other

injector pens.

Never use your pen after the expiration date.

B

Pull off the pen cap.

C

Check that the insulin is clear.

Do not use the pen if the insulin looks cloudy, coloured or contains particles.

STEP 2: Attach a new needle

Always use a new sterile needle for each injection. This helps stop blocked needles, contamination

and infection.

Only use needles that are compatible for use with Insulin lispro Sanofi (e.g. needles from BD,

Ypsomed, Artsana or Owen Mumford).

A

Take a new needle and peel off the protective seal.

B

Keep the needle straight and screw it onto the pen until fixed. Do not overtighten.

C

Pull off the outer needle cap. Keep this for later.

D

Pull off the inner needle cap and throw away.

Handling needles

Take care when handling needles – this is to prevent needle injury and cross-infection.

STEP 3: Do a safety test

Always do a safety test before each injection – this is to:

check your pen and the needle are working properly.

make sure that you get the correct insulin dose.

A

Select 2 units by turning the dose selector until the dose pointer is at the 2 mark.

B

Press the injection button all the way in.

When insulin comes out of the needle tip, your pen is working correctly.

If no insulin appears:

You may need to repeat this step up to 3 times before seeing insulin.

If no insulin comes out after the third time, the needle may be blocked. If this happens:

change the needle (see STEP 6 and STEP 2),

then repeat the safety test (STEP 3).

Do not use your pen if there is still no insulin coming out of the needle tip. Use a new pen.

Never use a syringe to remove insulin from your pen.

If you see air bubbles

You may see air bubbles in the insulin. This is normal, they will not harm you.

STEP 4: Select the dose

Never select a dose or press the injection button without a needle attached. This may damage your

pen.

A

Make sure a needle is attached and the dose is set to ‘0’.

B

Turn the dose selector until the dose pointer lines up with your dose.

If you turn past your dose, you can turn back down.

If there are not enough units left in your pen for your dose, the dose selector will stop at the

number of units left.

If you cannot select your full prescribed dose, use a new pen or inject the remaining units and

use a new pen to complete your dose.

How to read the dose window

Even numbers are shown in line with the dose pointer:

20 units selected

Odd numbers are shown as a line between even numbers:

21 units selected

Units of insulin in your pen

Your pen contains a total of 300 units of insulin. You can select doses from 1 to 80 units in

steps of 1 unit. Each pen contains more than one dose.

You can see roughly how many units of insulin are left by looking at where the plunger is on

the insulin scale.

STEP 5: Inject your dose

If you find it hard to press the injection button in, do not force it as this may break your pen. See

section below for help.

A

Choose a place to inject as shown in the picture

B

Push the needle into your skin as shown by your doctor, pharmacist or nurse.

Do not touch the injection button yet

C

Place your thumb on the injection button. Then press all the way in and hold.

Do not press at an angle – your thumb could block the dose selector from turning.

Upper arms

Thighs

Stomach

Buttocks

D

Keep the injection button held in and when you see "0" in the dose window, slowly count to

10.

This will make sure you get your full dose.

E

After holding and slowly counting to 10, release the injection button. Then remove the needle

from your skin.

If you find it hard to press the button in:

Change the needle (see STEP 6 and STEP 2) then do a safety test (see STEP 3).

If you still find it hard to press in, get a new pen.

Never use a syringe to remove insulin from your pen.

STEP 6: Remove the needle

Take care when handling needles – this is to prevent needle injury and cross-infection.

Never put the inner needle cap back on.

A

Put the outer needle cap back on the needle, and use it to unscrew the needle from the pen

To reduce the risk of accidental needle injury, never replace the inner needle cap.

If your injection is given by another person, or if you are giving an injection to another

person, special caution must be taken by this person when removing and disposing of the

needle.

Follow recommended safety measures for removal and disposal of needles (contact your

doctor, pharmacist or nurse) in order to reduce the risk of accidental needle injury and

transmission of infectious diseases.

B

Throw away the used needle in a puncture resistant container, or as told by your pharmacist

or local authority.

C

Put the pen cap back on.

Do not put the pen back in the fridge.

Use by

Only use your pen for up to 28 days after its first use.

How to store your pen

Before first use

Keep new pens in a fridge, at

2°C to 8°C

Do not freeze.

After first use

Keep your pen at room temperature,

below 30°C.

Never put your pen back in the fridge.

Never store your pen with the needle attached.

Store your pen with the pen cap on.

How to care for your pen

Handle your pen with care

Do not drop your pen or knock it against hard surfaces.

If you think that your pen may be damaged, do not try to repair it, use a new one.

Protect your pen from dust and dirt

You can clean the outside of your pen by wiping it with a damp cloth (water only). Do not

soak, wash or lubricate your pen – this may damage it.

Throwing your pen away

Remove the needle before throwing your pen away.

Throw away your used pen as told by your pharmacist or local authority.