Abasaglar (previously Abasria)

Helstu upplýsingar

  • Heiti vöru:
  • Abasaglar (previously Abasria)
  • Lyf við lungum:
  • Mannfólk
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  • Allópatísk lyf

Skjöl

Staðsetning

  • Fáanlegt í:
  • Abasaglar (previously Abasria)
    Evrópusambandið
  • Tungumál:
  • enska

Meðferðarupplýsingar

  • Meðferðarhópur:
  • Drugs used in diabetes,
  • Lækningarsvæði:
  • Diabetes Mellitus
  • Ábendingar:
  • Treatment of diabetes mellitus in adults, adolescents and children aged 2 years and above.
  • Vörulýsing:
  • Revision: 6

Staða

  • Heimild:
  • EMA - European Medicines Agency
  • Leyfisstaða:
  • Authorised
  • Leyfisnúmer:
  • EMEA/H/C/002835
  • Leyfisdagur:
  • 09-09-2014
  • EMEA númer:
  • EMEA/H/C/002835
  • Síðasta uppfærsla:
  • 16-01-2019

Opinber matsskýrsla

EMA/760389/2014

EMEA/H/C/002835

EPAR summary for the public

Abasaglar

insulin glargine

This is a summary of the European public assessment report (EPAR) for Abasaglar. 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 Abasaglar.

For practical information about using Abasaglar, patients should read the package leaflet or contact

their doctor or pharmacist.

What is Abasaglar and what is it used for?

Abasaglar is a medicine that contains the active substance insulin glargine. It is used in adults and

children over the age of two for the treatment of diabetes.

Abasaglar is a ‘biosimilar medicine’. This means that Abasaglar is similar to a biological medicine (also

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

reference medicine for Abasaglar is Lantus. For more information on biosimilar medicines, see the

question-and-answer document here.

How is Abasaglar used?

Abasaglar is available as cartridges and prefilled disposable pens (KwikPen) and can only be obtained

with a prescription. It is given by injection under the skin in the abdominal wall (tummy), the thigh, or

the deltoid region (upper arm). The site of injection should be changed with each injection to avoid

changes to the skin (such as thickening) that can make the insulin work less well than expected.

Abasaglar is given once a day at the same time each day. The dose is adjusted individually, and the

patient’s blood glucose (sugar) should be regularly tested to find the lowest effective dose. Abasaglar

can also be given together with diabetes medicines taken by mouth in patients who have type-2

diabetes.

Previously known as Abasria

30 Churchill Place

Canary Wharf

London E14 5EU

United Kingdom

An agency of the European Union

Telephone

+44 (0)20 3660 6000

Facsimile

+44 (0)20 3660 5555

Send a question via our website

www.ema.europa.eu/contact

© European Medicines Agency, 2015. Reproduction is authorised provided the source is acknowledged.

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

For further information, see the package leaflet.

How does Abasaglar work?

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

glucose. Abasaglar is a replacement insulin that is very similar to the insulin made by the body. 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.

The active substance in Abasaglar, insulin glargine, is produced by a method known as ‘recombinant

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

able to produce insulin glargine.

Insulin glargine is slightly different from human insulin. The change means that it is absorbed more

slowly and regularly by the body after an injection, and that it has a long duration of action.

What benefits of Abasaglar have been shown in studies?

Studies were carried out to show that the way Abasaglar is absorbed into the body and the way it acts

on blood glucose were similar to Lantus. In addition, treatment with once-daily Abasaglar has been

shown to be comparable to the reference medicine, Lantus, in two supportive studies involving a total

of 1,295 adults with diabetes. In both studies, the main measure of effectiveness was the change after

6 months of treatment in the level in the blood of a substance called glycosylated haemoglobin

(HbA

), which gives an indication of how well blood glucose is controlled.

In one study, Abasaglar was compared with Lantus when added to short-acting insulin treatment in

536 patients with type 1 diabetes. Their average HbA

before treatment was 7.8% and the

average fall after 6 months was similar (0.35% in the Abasaglar group and 0.46% in the Lantus

group); 34.5% of those given Abasaglar, and 32.2% of those given Lantus were below the target

of 7%.

In the second study, treatment with Abasaglar or Lantus was compared in 759 patients with type 2

diabetes, as an addition to diabetes medicines taken by mouth. Average starting HbA

was 8.3%,

and this fell to below 7% in 48.8% of those given Abasaglar, and 52.5% of those given Lantus,

with an average percentage point fall of 1.29 and 1.34 respectively.

What are the risks associated with Abasaglar?

The most common side effect with Abasaglar (which may affect more than 1 in 10 people) is

hypoglycaemia (low blood glucose). Reactions at the site of the injection (redness, pain, itching and

swelling) and skin reactions (rash) have been seen more often in children than in adults. For the full

list of all side effects and restrictions with Abasaglar, see the package leaflet.

Why is Abasaglar approved?

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

with EU requirements for biosimilar medicines, Abasaglar has been shown to have a comparable

quality, safety and effectiveness to Lantus. Therefore, the CHMP’s view was that, as for Lantus, the

benefit outweighs the identified risk. The Committee recommended that Abasaglar be given marketing

authorisation.

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EMA/760389/2014

Page 2/3

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

Abasaglar?

A risk management plan has been developed to ensure that Abasaglar 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 Abasaglar, including the appropriate precautions to be followed by healthcare

professionals and patients.

Further information can be found in the summary of the risk management plan.

Other information about Abasaglar

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

Abasria on 9 September 2014. The name of the medicine was changed to Abasaglar on 3 December

2014.

The full EPAR and risk management plan summary for Abasaglar 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 Abasaglar, read the package leaflet (also part of the EPAR) or

contact your doctor or pharmacist.

This summary was last updated in 01-2015.

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EMA/760389/2014

Page 3/3

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

B. PACKAGE LEAFLET

Package leaflet: Information for the user

ABASAGLAR 100 units/mL solution for injection

in a cartridge

Insulin glargine

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. The instructions for using the insulin pen are provided with your

insulin pen. Refer to them before using your medicine.

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

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

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, pharmacist or nurse. This includes any possible

side effects not listed in this leaflet. See section 4.

What is in this leaflet

What ABASAGLAR is and what it is used for

What you need to know before you use ABASAGLAR

How to use ABASAGLAR

Possible side effects

How to store ABASAGLAR

Contents of the pack and other information

1.

What ABASAGLAR is and what it is used for

ABASAGLAR is a solution for injection containing insulin glargine. Insulin glargine is a modified

insulin, very similar to human insulin.

ABASAGLAR is used to treat diabetes mellitus in adults, adolescents and children aged 2 years and

above.

Diabetes mellitus is a disease where your body does not produce enough insulin to control the level of

blood sugar. Insulin glargine has a long and steady blood-sugar-lowering action.

2.

What you need to know before you use ABASAGLAR

Do not use ABASAGLAR

If you are allergic to insulin glargine or any of the other ingredients of this medicine (listed in section

Warnings and precautions

Talk to your doctor, pharmacist or nurse before using ABASAGLAR.

Follow closely the instructions for posology, monitoring (blood and urine tests), diet and physical

activity (physical work and exercise) as discussed with your doctor.

If your blood sugar is too low (hypoglycaemia), follow the guidance for hypoglycaemia (see box at the

end of this leaflet).

Travel

Before travelling consult your doctor. You may need to talk about:

the availability of your insulin in the country you are visiting,

supplies of insulin etc.

correct storage of your insulin while travelling,

timing of meals and insulin administration while travelling,

the possible effects of changing to different time zones,

possible new health risks in the countries to be visited,

what you should do in emergency situations when you feel unwell or become ill.

Illnesses and injuries

In the following situations, the management of your diabetes may require a lot of care (for example,

adjustment to insulin dose, blood and urine tests):

If you are ill or have a major injury then your blood sugar level may increase (hyperglycaemia).

If you are not eating enough your blood sugar level may become too low (hypoglycaemia).

In most cases you will need a doctor.

Make sure that you contact a doctor early.

If you have type 1 diabetes (insulin dependent diabetes mellitus), do not stop your insulin and continue

to get enough carbohydrates. Always tell people who are caring for you or treating you that you

require insulin.

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 ABASAGLAR

Some medicines cause changes in the blood sugar level (decrease, increase or both depending on the

situation). In each case, it may be necessary to adjust your insulin dose to avoid blood sugar levels that

are either too low or too high. Be careful when you start or stop taking another medicine.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other

medicines. Before taking a medicine ask your doctor if it can affect your blood sugar level and what

action, if any, you need to take.

Medicines that may cause your blood sugar level to fall (hypoglycaemia) include:

all other medicines to treat diabetes,

angiotensin converting enzyme (ACE) inhibitors (used to treat certain heart conditions or high

blood pressure),

disopyramide (used to treat certain heart conditions),

fluoxetine (used to treat depression),

fibrates (used to lower high levels of blood lipids),

monoamine oxidase (MAO) inhibitors (used to treat depression),

pentoxifylline, propoxyphene, salicylates (such as aspirin, used to relieve pain and lower fever),

somatostatin analogues (such as octreotide, used to treat an uncommon condition in which you

make too much growth hormone),

sulphonamide antibiotics.

Medicines that may cause your blood sugar level to rise (hyperglycaemia) include:

corticosteroids (such as "cortisone" used to treat inflammation),

danazol (medicine acting on ovulation),

diazoxide (used to treat high blood pressure),

diuretics (used to treat high blood pressure or excessive fluid retention),

glucagon (pancreas hormone used to treat severe hypoglycaemia),

isoniazid (used to treat tuberculosis),

oestrogens and progestogens (such as in the contraceptive pill used for birth control),

phenothiazine derivatives (used to treat psychiatric disorders),

somatropin (growth hormone),

sympathomimetic medicines (such as epinephrine [adrenaline], salbutamol, terbutaline used to

treat asthma),

thyroid hormones (used to treat thyroid gland disorders),

atypical antipsychotic medicines (such as clozapine, olanzapine),

protease inhibitors (used to treat HIV).

Your blood sugar level may either rise or fall if you take:

beta-blockers (used to treat high blood pressure),

clonidine (used to treat high blood pressure),

lithium salts (used to treat psychiatric disorders).

Pentamidine (used to treat some infections caused by parasites) may cause hypoglycaemia which may

sometimes be followed by hyperglycaemia.

Beta-blockers like other sympatholytic medicines (such as clonidine, guanethidine, and reserpine) may

weaken or suppress entirely the first warning symptoms which help you to recognise a hypoglycaemia.

If you are not sure whether you are taking one of those medicines ask your doctor or pharmacist.

ABASAGLAR with alcohol

Your blood sugar levels may either rise or fall if you drink alcohol.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine.

Inform your doctor if you are planning to become pregnant, or if you are already pregnant. Your

insulin dose may need to be changed during pregnancy and after giving birth. Particularly careful

control of your diabetes, and prevention of hypoglycaemia, is important for the health of your baby.

If you are breast-feeding consult your doctor as you may require adjustments in your insulin doses and

your diet.

Driving and using machines

Your ability to concentrate or react may be reduced if:

you have hypoglycaemia (low blood sugar levels),

you have hyperglycaemia (high blood sugar levels),

you have problems with your sight.

Keep this possible problem in mind in all situations where you might put yourself and others at risk

(such as driving a car or operating machines). You should contact your doctor for advice on driving if:

you have frequent episodes of hypoglycaemia,

the first warning symptoms which help you to recognise hypoglycaemia are reduced or absent.

Important information about some of the ingredients of ABASAGLAR

This medicine contains less than 1 mmol (23 mg) sodium per dose, which means it is essentially

‘sodium-free’.

3.

How to use ABASAGLAR

Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if

you are not sure.

Although ABASAGLAR contains the same active substance as Toujeo (insulin glargine

300 units/mL), these medicines are not interchangeable. The switch from one insulin therapy to

another requires medical prescription, medical supervision and blood glucose monitoring. Please

consult your doctor for further information.

Dose

Based on your life-style and the results of your blood sugar (glucose) tests and your previous insulin

usage, your doctor will:

determine how much ABASAGLAR per day you will need and at what time,

tell you when to check your blood sugar level, and whether you need to carry out urine tests,

tell you when you may need to inject a higher or lower dose of ABASAGLAR.

ABASAGLAR is a long-acting insulin. Your doctor may tell you to use it in combination with a short-

acting insulin or with tablets used to treat high blood sugar levels.

Many factors may influence your blood sugar level. You should know these factors so that you are

able to react correctly to changes in your blood sugar level and to prevent it from becoming too high

or too low. See the box at the end of this leaflet for further information.

Use in children and adolescents

ABASAGLAR can be used in adolescents and children aged 2 years and above. There is no

experience with the use of ABASAGLAR in children below the age of 2 years.

Frequency of administration

You need one injection of ABASAGLAR every day, at the same time of the day.

Method of administration

ABASAGLAR is injected under the skin. Do NOT inject ABASAGLAR in a vein, since this will

change its action and may cause hypoglycaemia.

Your doctor will show you in which area of the skin you should inject ABASAGLAR. With each

injection, change the puncture site within the particular area of skin that you are using.

How to handle the cartridges

The ABASAGLAR cartridges are to be used only in Lilly insulin pens to ensure you get the correct

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

The pen should be used as recommended in the information provided.

The instructions for using the pen must be followed carefully for loading the cartridge, attaching the

needle, and administering the insulin injection.

To prevent the possible transmission of disease, each pen must be used by one patient only.

Look at the cartridge before you use it. Only use it if the solution is clear, colourless and water-like,

and has no visible particles in it. Do not shake or mix it before use.

Always use a new cartridge if you notice that your blood sugar control is unexpectedly getting worse.

This is because the insulin may have lost some of its effectiveness. If you think you may have a

problem with ABASAGLAR, have it checked by your doctor or pharmacist.

Special care before injection

Before injection remove any air bubbles (see instructions for using the pen).

Make sure that neither alcohol nor other disinfectants or other substances contaminate the insulin.

Do not re-fill and re-use empty cartridges. Do not add any other insulin to the cartridge. Do not mix

ABASAGLAR with any other insulins or medicines. Do not dilute it. Mixing or diluting may change

the action of ABASAGLAR.

Problems with the insulin pen?

Refer to the instructions for using the pen.

If the insulin pen is damaged or not working properly (due to mechanical defects) it has to be

discarded, and a new insulin pen has to be used.

If you use more ABASAGLAR than you should

If you

have injected too much ABASAGLAR

, your blood sugar level may become too low

(hypoglycaemia). Check your blood sugar frequently. In general, to prevent hypoglycaemia you

must eat more food and monitor your blood sugar. For information on the treatment of

hypoglycaemia, see box at the end of this leaflet.

If you forget to use ABASAGLAR

If you have missed a dose of ABASAGLAR or if you have not injected enough insulin, your

blood sugar level may become too high (hyperglycaemia). Check your blood sugar frequently.

For information on the treatment of hyperglycaemia, see box at the end of this leaflet.

Do not take a double dose to make up for a forgotten dose.

If you stop using ABASAGLAR

This could lead to severe hyperglycaemia (very high blood sugar) and ketoacidosis (build-up of acid in

the blood because the body is breaking down fat instead of sugar). Do not stop ABASAGLAR without

speaking to a doctor, who will tell you what needs to be done.

Insulin Mix-ups

You must always check the insulin label before each injection to avoid mix-ups between

ABASAGLAR and other insulins.

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

4.

Possible side effects

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

Hypoglycaemia (low blood sugar) can be very serious

. If your blood sugar level falls too much you

may become unconscious. Serious hypoglycaemia may cause brain damage and may be life-

threatening. If you have symptoms of low blood sugar, take actions to increase your blood sugar level

immediately.

If you experience the following symptoms, contact your doctor immediately:

large-scale skin

reactions (rash and itching all over the body), severe swelling of skin or mucous membranes

(angiooedema), shortness of breath, a fall in blood pressure with rapid heartbeat and sweating. These

could be symptoms of

severe allergic reactions to insulins and may become life threatening.

Very common side effects

(may affect more than 1 in 10 people)

Hypoglycaemia

As with all insulin therapy, the most frequent side effect is

hypoglycaemia

Hypoglycaemia (low blood sugar) means that there is not enough sugar in the blood.

For further

information on the side effects of low blood sugar or high blood sugar, see the box at the end of this

leaflet.

Common side effects

(may affect up to 1 in 10 people)

Skin changes at the injection site

If you inject your insulin too often at the same skin site, fatty tissue under the skin at this site may

either shrink (lipoatrophy) or thicken (lipohypertrophy). Thickening of fatty tissue may occur in 1 to

2 % of patients while shrinking may occur uncommonly. Insulin that you inject in such a site may not

work very well. Changing the injection site with each injection may help to prevent such skin changes.

Skin and allergic reactions

3 to 4 % of patients may experience reactions at the injection site (such as reddening, unusually

intense pain on injection, itching, hives, swelling or inflammation). They can also spread around the

injection site. Most minor reactions to insulins usually resolve in a few days to a few weeks.

Rare side effects

(may affect up to 1 in 1,000 people)

Severe allergic reactions to insulins

Associated symptoms may include large-scale skin reactions (rash and itching all over the body),

severe swelling of skin or mucous membranes (angiooedema), shortness of breath, a fall in blood

pressure with rapid heartbeat and sweating. These could be symptoms of

severe allergic reactions to

insulins and may become life-threatening

Eye reactions

A marked change (improvement or worsening) in your blood sugar control can disturb your vision

temporarily. If you have proliferative retinopathy (an eye disease related to diabetes) severe

hypoglycaemic attacks may cause temporary loss of vision.

General disorders

In rare cases, insulin treatment may also cause temporary build-up of water in the body, with swelling

in the calves and ankles.

Very rare side-effects

(may affect up to1 in10,000 people)

In very rare cases, dysgeusia (taste disorders) and myalgia (muscular pain) can occur.

Other side effects with frequency not known

(frequency cannot be estimated from available data)

Insulin treatment can cause the body to produce antibodies to insulin (substances that act against

insulin). Rarely, this may require a change to your insulin dose.

Use in children and adolescents

In general, the side effects in children and adolescents of 18 years of age or less are similar to those

seen in adults.

Complaints of injection site reactions (injection site pain, injection site reaction) and skin reactions

(rash, urticaria) are reported relatively more frequently in children and adolescents of 18 years of age

or less than in adults.

Clinical study safety data are not available for children under 2 years.

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.

5.

How to store ABASAGLAR

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 carton and on the label of the

cartridge after “EXP”. The expiry date refers to the last day of that month.

Unopened cartridges

Store in a refrigerator (2°C - 8°C). Do not freeze.

Do not put ABASAGLAR next to the freezer compartment or a freezer pack.

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

In-use cartridges

Cartridges in use (in the insulin pen) or carried as a spare may be stored for a maximum of 28 days up

to 30°C and away from direct heat or direct light. The cartridge in use must not be stored in a

refrigerator. Do not use it after this time period.

Do not use ABASAGLAR if you notice particles in it. Only use ABASAGLAR if the solution is clear,

colourless and water like.

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 protect the environment.

6.

Contents of the pack and other information

What ABASAGLAR contains

The active substance is insulin glargine. Each millilitre of the solution contains 100 units of the

active substance insulin glargine (equivalent to 3.64 mg).

The other ingredients are: zinc oxide, metacresol, glycerol, sodium hydroxide (see section 2

“Important information about some of the ingredients of ABASAGLAR”), hydrochloric acid

and water for injections.

What ABASAGLAR looks like and contents of the pack

ABASAGLAR 100 units/mL solution for injection in a cartridge is a clear and colourless solution.

ABASAGLAR comes in a special cartridge to be used only in a Lilly insulin pen. Each cartridge

contains 3 mL of solution for injection (equivalent to 300 units) and they are available in packs of 1, 2,

5, 10 and a multipack with 2 x 5 cartridges.

Not all pack sizes may be marketed.

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, F-67640 Fegersheim, France.

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

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

Authorisation Holder:

België/Belgique/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 60 00

Malta

Charles de Giorgio Ltd.

Tel: + 356 25600 500

Deutschland

Lilly Deutschland GmbH

Tel. + 49-(0) 6172 273 2222

Boehringer Ingelheim Pharma GmbH & Co. KG

Tel: +49 (0) 800 77 90 900

Nederland

Eli Lilly Nederland B.V.

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

Eesti

Eli Lilly Holdings Limited Eesti filiaal

Tel: +372 6 817 280

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

Boehringer Ingelheim España S.A.

Tel: +34 93 404 51 00

Polska

Eli Lilly Polska Sp. z o.o.

Tel: +48 22 440 33 00

France

Lilly France SAS

Tél: +33-(0) 1 55 49 34 34

Boehringer Ingelheim France S.A.S.

Tél: +33 3 26 50 45 33

Portugal

Lilly Portugal Produtos Farmacêuticos, Lda

Tel: + 351-21-4126600

Boehringer Ingelheim, Lda.

Tel: +351 21 313 53 00

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

Boehringer Ingelheim Ireland Ltd.

Tel: +353 1 295 9620

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

Boehringer Ingelheim Italia S.p.A.

Tel: +39 02 5355 1

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

Boehringer Ingelheim Ltd.

Tel: +44 1344 424 600

This leaflet was last revised in

Other sources of information

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

http://www.ema.europa.eu

HYPERGLYCAEMIA AND HYPOGLYCAEMIA

Always carry some sugar (at least 20 grams) with you.

Carry some information with you to show you are diabetic.

HYPERGLYCAEMIA (high blood sugar levels)

If your blood sugar is too high (hyperglycaemia), you may not have injected enough insulin.

Why does hyperglycaemia occur?

Examples include:

you have not injected your insulin or not injected enough, or if it has become less effective, for

example through incorrect storage,

your insulin pen does not work properly,

you are doing less exercise than usual, you are under stress (emotional distress, excitement), or

you have an injury, operation, infection or fever,

you are taking or have taken certain other medicines (see section 2, "Other medicines and

ABASAGLAR").

Warning symptoms of hyperglycaemia

Thirst, increased need to urinate, tiredness, dry skin, reddening of the face, loss of appetite, low blood

pressure, fast heartbeat, and glucose and ketone bodies in urine. Stomach pain, fast and deep

breathing, sleepiness or even loss of consciousness may be signs of a serious condition (ketoacidosis)

resulting from lack of insulin.

What should you do if you experience hyperglycaemia?

Test your blood sugar level and your urine for ketones as soon as any of the above symptoms

occur.

Severe hyperglycaemia or ketoacidosis must always be treated by a doctor, normally in a

hospital.

HYPOGLYCAEMIA (low blood sugar levels)

If your blood sugar level falls too much you may become unconscious. Serious hypoglycaemia may

cause a heart attack or brain damage and may be life-threatening. You normally should be able to

recognise when your blood sugar is falling too much so that you can take the right actions.

Why does hypoglycaemia occur?

Examples include:

you inject too much insulin,

you miss meals or delay them,

you do not eat enough, or eat food containing less carbohydrate than normal (sugar and

substances similar to sugar are called carbohydrates; however, artificial sweeteners are NOT

carbohydrates),

you lose carbohydrates due to vomiting or diarrhoea,

you drink alcohol, particularly if you are not eating much,

you are doing more exercise than usual or a different type of physical activity,

you are recovering from an injury or operation or other stress,

you are recovering from an illness or from fever,

you are taking or have stopped taking certain other medicines (see section 2, "Other medicines

and ABASAGLAR").

Hypoglycaemia is also more likely to occur if

you have just begun insulin treatment or changed to another insulin preparation (when changing

from your previous basal insulin to ABASAGLAR, hypoglycaemia, if it occurs, may be more

likely to occur in the morning than at night),

your blood sugar levels are almost normal or are unstable,

you change the area of skin where you inject insulin (for example from the thigh to the upper

arm),

you suffer from severe kidney or liver disease, or some other disease such as hypothyroidism.

Warning symptoms of hypoglycaemia

- In your body

Examples of symptoms that tell you that your blood sugar level is falling too much or too fast:

sweating, clammy skin, anxiety, fast heart beat, high blood pressure, palpitations and irregular

heartbeat. These symptoms often develop before the symptoms of a low sugar level in the brain.

- In your brain

Examples of symptoms that indicate a low sugar level in the brain: headaches, intense hunger, nausea,

vomiting, tiredness, sleepiness, sleep disturbances, restlessness, aggressive behaviour, lapses in

concentration, impaired reactions, depression, confusion, speech disturbances (sometimes total loss of

speech), visual disorders, trembling, paralysis, tingling sensations (paraesthesia), numbness and

tingling sensations in the area of the mouth, dizziness, loss of self-control, inability to look after

yourself, convulsions, loss of consciousness.

The first symptoms which alert you to hypoglycaemia ("warning symptoms") may change, be weaker

or may be missing altogether if

you are elderly, if you have had diabetes for a long time or if you suffer from a certain type of

nervous disease (diabetic autonomic neuropathy),

you have recently suffered hypoglycaemia (for example the day before) or if it develops slowly,

you have almost normal or, at least, greatly improved blood sugar levels,

you have recently changed from an animal insulin to a human insulin such as ABASAGLAR,

you are taking or have taken certain other medicines (see section 2, "Other medicines and

ABASAGLAR").

In such a case, you may develop severe hypoglycaemia (and even faint) before you are aware of the

problem. Be familiar with your warning symptoms. If necessary, more frequent blood sugar testing

can help to identify mild hypoglycaemic episodes that may otherwise be overlooked. If 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.

What should you do if you experience hypoglycaemia?

1. Do not inject insulin. Immediately take about 10 to 20 g sugar, such as glucose, sugar cubes or a

sugar-sweetened beverage. Caution: Artificial sweeteners and foods with artificial sweeteners (such as

diet drinks) are of no help in treating hypoglycaemia.

2. Then eat something that has a long-acting effect in raising your blood sugar (such as bread or pasta).

Your doctor or nurse should have discussed this with you previously.

The recovery of hypoglycaemia may be delayed because ABASAGLAR has a long action.'

3. If the hypoglycaemia comes back again, take another 10 to 20 g sugar.

4. Speak to a doctor immediately if you are not able to control the hypoglycaemia or if it recurs. Tell

your relatives, friends and close colleagues the following:

If you are not able to swallow or if you are unconscious, you will require an injection of glucose or

glucagon (a medicine which increases blood sugar). These injections are justified even if it is not

certain that you have hypoglycaemia.

It is advisable to test your blood sugar immediately after taking glucose to check that you really have

hypoglycaemia.

Package leaflet: Information for the user

ABASAGLAR 100 units/mL solution for injection in a pre-filled pen

Insulin glargine

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 including the Instructions for Use of the ABASAGLAR

KwikPen pre-filled pen, 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, pharmacist or nurse.

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, pharmacist or nurse. This includes any possible

side effects not listed in this leaflet. See section 4.

What is in this leaflet

What ABASAGLAR is and what it is used for

What you need to know before you use ABASAGLAR

How to use ABASAGLAR

Possible side effects

How to store ABASAGLAR

Contents of the pack and other information

1.

What ABASAGLAR is and what it is used for

ABASAGLAR is a solution for injection containing insulin glargine. Insulin glargine is a modified

insulin, very similar to human insulin.

ABASAGLAR is used to treat diabetes mellitus in adults, adolescents and children aged 2 years and

above.

Diabetes mellitus is a disease where your body does not produce enough insulin to control the level of

blood sugar. Insulin glargine has a long and steady blood-sugar-lowering action.

2.

What you need to know before you use ABASAGLAR

Do not use ABASAGLAR

If you are allergic to insulin glargine or any of the other ingredients of this medicine (listed in section

Warnings and precautions

Talk to your doctor, pharmacist or nurse before using ABASAGLAR.

Follow closely the instructions for posology, monitoring (blood and urine tests), diet and physical

activity (physical work and exercise) as discussed with your doctor.

If your blood sugar is too low (hypoglycaemia), follow the guidance for hypoglycaemia (see box at the

end of this leaflet).

Travel

Before travelling consult your doctor. You may need to talk about:

the availability of your insulin in the country you are visiting,

supplies of insulin etc.

correct storage of your insulin while travelling,

timing of meals and insulin administration while travelling,

the possible effects of changing to different time zones,

possible new health risks in the countries to be visited,

what you should do in emergency situations when you feel unwell or become ill.

Illnesses and injuries

In the following situations, the management of your diabetes may require a lot of care (for example,

adjustment to insulin dose, blood and urine tests):

If you are ill or have a major injury then your blood sugar level may increase (hyperglycaemia).

If you are not eating enough your blood sugar level may become too low (hypoglycaemia).

In most cases you will need a doctor.

Make sure that you contact a doctor early.

If you have type 1 diabetes (insulin dependent diabetes mellitus), do not stop your insulin and continue

to get enough carbohydrates. Always tell people who are caring for you or treating you that you

require insulin.

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 ABASAGLAR

Some medicines cause changes in the blood sugar level (decrease, increase or both depending on the

situation). In each case, it may be necessary to adjust your insulin dose to avoid blood sugar levels that

are either too low or too high. Be careful when you start or stop taking another medicine.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other

medicines. Before taking a medicine ask your doctor if it can affect your blood sugar level and what

action, if any, you need to take.

Medicines that may cause your blood sugar level to fall (hypoglycaemia) include:

all other medicines to treat diabetes,

angiotensin converting enzyme (ACE) inhibitors (used to treat certain heart conditions or high

blood pressure),

disopyramide (used to treat certain heart conditions),

fluoxetine (used to treat depression),

fibrates (used to lower high levels of blood lipids),

monoamine oxidase (MAO) inhibitors (used to treat depression),

pentoxifylline, propoxyphene, salicylates (such as aspirin, used to relieve pain and lower fever),

somatostatin analogues (such as octreotide, used to treat an uncommon condition in which you

make too much growth hormone),

sulphonamide antibiotics.

Medicines that may cause your blood sugar level to rise (hyperglycaemia) include:

corticosteroids (such as "cortisone" used to treat inflammation),

danazol (medicine acting on ovulation),

diazoxide (used to treat high blood pressure),

diuretics (used to treat high blood pressure or excessive fluid retention),

glucagon (pancreas hormone used to treat severe hypoglycaemia),

isoniazid (used to treat tuberculosis),

oestrogens and progestogens (such as in the contraceptive pill used for birth control),

phenothiazine derivatives (used to treat psychiatric disorders),

somatropin (growth hormone),

sympathomimetic medicines (such as epinephrine [adrenaline], salbutamol, terbutaline used to

treat asthma),

thyroid hormones (used to treat thyroid gland disorders),

atypical antipsychotic medicines (such as clozapine, olanzapine),

protease inhibitors (used to treat HIV).

Your blood sugar level may either rise or fall if you take:

beta-blockers (used to treat high blood pressure),

clonidine (used to treat high blood pressure),

lithium salts (used to treat psychiatric disorders).

Pentamidine (used to treat some infections caused by parasites) may cause hypoglycaemia which may

sometimes be followed by hyperglycaemia.

Beta-blockers like other sympatholytic medicines (such as clonidine, guanethidine, and reserpine) may

weaken or suppress entirely the first warning symptoms which help you to recognise a hypoglycaemia

If you are not sure whether you are taking one of those medicines ask your doctor or pharmacist.

ABASAGLAR with alcohol

Your blood sugar levels may either rise or fall if you drink alcohol.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine.

Inform your doctor if you are planning to become pregnant, or if you are already pregnant. Your

insulin dose may need to be changed during pregnancy and after giving birth. Particularly careful

control of your diabetes, and prevention of hypoglycaemia, is important for the health of your baby.

If you are breast-feeding consult your doctor as you may require adjustments in your insulin doses and

your diet.

Driving and using machines

Your ability to concentrate or react may be reduced if:

you have hypoglycaemia (low blood sugar levels),

you have hyperglycaemia (high blood sugar levels),

you have problems with your sight.

Keep this possible problem in mind in all situations where you might put yourself and others at risk

(such as driving a car or operating machines). You should contact your doctor for advice on driving if:

you have frequent episodes of hypoglycaemia,

the first warning symptoms which help you to recognise hypoglycaemia are reduced or absent.

Important information about some of the ingredients of ABASAGLAR

This medicine contains less than 1 mmol (23 mg) sodium per dose, which means it is essentially

‘sodium-free’.

3.

How to use ABASAGLAR

Always use this medicine exactly as you doctor has told you. Check with your doctor or pharmacist if

you are not sure.

Although ABASAGLAR contains the same active substance as Toujeo (insulin glargine

300 units/mL), these medicines are not interchangeable. The switch from one insulin therapy to

another requires medical prescription, medical supervision and blood glucose monitoring. Please

consult your doctor for further information.

Dose

Based on your life-style and the results of your blood sugar (glucose) tests and your previous insulin

usage, your doctor will:

determine how much ABASAGLAR per day you will need and at what time,

tell you when to check your blood sugar level, and whether you need to carry out urine tests,

tell you when you may need to inject a higher or lower dose of ABASAGLAR.

ABASAGLAR is a long-acting insulin. Your doctor may tell you to use it in combination with a short-

acting insulin or with tablets used to treat high blood sugar levels.

Many factors may influence your blood sugar level. You should know these factors so that you are

able to react correctly to changes in your blood sugar level and to prevent it from becoming too high

or too low. See the box at the end of this leaflet for further information.

Use in children and adolescents

ABASAGLAR can be used in adolescents and children aged 2 years and above. There is no

experience with the use of ABASAGLAR in children below the age of 2 years.

Frequency of administration

You need one injection of ABASAGLAR every day, at the same time of the day.

Method of administration

ABASAGLAR is injected under the skin. Do NOT inject ABASAGLAR in a vein, since this will

change its action and may cause hypoglycaemia.

Your doctor will show you in which area of the skin you should inject ABASAGLAR. With each

injection, change the puncture site within the particular area of skin that you are using.

How to handle ABASAGLAR KwikPen

ABASAGLAR KwikPen is a pre-filled disposable pen containing insulin glargine.

Read carefully the "ABASAGLAR KwikPen Instructions for Use" included with this package

leaflet. You must use the pen as described in these Instructions for Use.

A new needle must be attached before each use. Only use needles that are compatible for use with

ABASAGLAR KwikPen (see “ABASAGLAR KwikPen Instructions for Use”).

A safety test must be performed before each injection.

Look at the cartridge before you use the pen. Do not use ABASAGLAR KwikPen if you notice

particles in it. Only use ABASAGLAR KwikPen if the solution is clear, colourless and water-like. Do

not shake or mix it before use.

To prevent the possible transmission of disease, each pen must be used by one patient only.

Make sure that neither alcohol nor other disinfectants or other substances contaminate the insulin.

Always use a new pen if you notice that your blood sugar control is unexpectedly getting worse. If you

think you may have a problem with ABASAGLAR KwikPen, consult your doctor, pharmacist or

nurse.

Empty pens must not be re-filled and must be properly discarded.

Do not use ABASAGLAR KwikPen if it is damaged or not working properly, it has to be discarded

and a new KwikPen has to be used.

If you use more ABASAGLAR than you should

If you

have injected too much ABASAGLAR

, your blood sugar level may become too low

(hypoglycaemia). Check your blood sugar frequently. In general, to prevent hypoglycaemia you

must eat more food and monitor your blood sugar. For information on the treatment of

hypoglycaemia, see box at the end of this leaflet.

If you forget to use ABASAGLAR

If you have missed a dose of ABASAGLAR or if you have not injected enough insulin, your

blood sugar level may become too high (hyperglycaemia). Check your blood sugar frequently.

For information on the treatment of hyperglycaemia, see box at the end of this leaflet.

Do not take a double dose to make up for a forgotten dose.

If you stop using ABASAGLAR

This could lead to severe hyperglycaemia (very high blood sugar) and ketoacidosis (build-up of acid in

the blood because the body is breaking down fat instead of sugar). Do not stop ABASAGLAR without

speaking to a doctor, who will tell you what needs to be done.

Insulin Mix-ups

You must always check the insulin label before each injection to avoid mix-ups between

ABASAGLAR and other insulins.

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

4.

Possible side effects

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

Hypoglycaemia (low blood sugar) can be very serious

. If your blood sugar level falls too much you

may become unconscious. Serious hypoglycaemia may cause brain damage and may be life-

threatening. If you have symptoms of low blood sugar, take actions to increase your blood sugar level

immediately.

If you experience the following symptoms, contact your doctor immediately:

large-scale skin

reactions (rash and itching all over the body), severe swelling of skin or mucous membranes

(angiooedema), shortness of breath, a fall in blood pressure with rapid heartbeat and sweating. These

could be symptoms of

severe allergic reactions to insulins and may become life threatening.

Very common side effects

(may affect more than 1 in 10 people)

Hypoglycaemia

As with all insulin therapy, the most frequent side effect is

hypoglycaemia

Hypoglycaemia (low blood sugar) means that there is not enough sugar in the blood.

For further

information on the side effects of low blood sugar or high blood sugar, see the box at the end of this

leaflet.

Common side effects

(may affect up to 1 in 10 people)

Skin changes at the injection site

If you inject your insulin too often at the same skin site, fatty tissue under the skin at this site may

either shrink (lipoatrophy) or thicken (lipohypertrophy). Thickening of fatty tissue may occur in 1 to

2 % of patients while shrinking may occur uncommonly. Insulin that you inject in such a site may not

work very well. Changing the injection site with each injection may help to prevent such skin changes.

Skin and allergic reactions

3 to 4 % of patients may experience reactions at the injection site (such as reddening, unusually

intense pain on injection, itching, hives, swelling or inflammation). They can also spread around the

injection site. Most minor reactions to insulins usually resolve in a few days to a few weeks.

Rare side effects

(may affect up to 1 in 1,000 people)

Severe allergic reactions to insulins

Associated symptoms may include large-scale skin reactions (rash and itching all over the body),

severe swelling of skin or mucous membranes (angiooedema), shortness of breath, a fall in blood

pressure with rapid heartbeat and sweating. These could be symptoms of

severe allergic reactions to

insulins and may become life-threatening

Eye reactions

A marked change (improvement or worsening) in your blood sugar control can disturb your vision

temporarily. If you have proliferative retinopathy (an eye disease related to diabetes) severe

hypoglycaemic attacks may cause temporary loss of vision.

General disorders

In rare cases, insulin treatment may also cause temporary build-up of water in the body, with swelling

in the calves and ankles.

Very rare side-effects

(may affect up to1 in10,000 people)

In very rare cases, dysgeusia (taste disorders) and myalgia (muscular pain) can occur.

Other side effects with frequency not known

(frequency cannot be estimated from available data)

Insulin treatment can cause the body to produce antibodies to insulin (substances that act against

insulin). Rarely, this may require a change to your insulin dose.

Use in children and adolescents

In general, the side effects in children and adolescents of 18 years of age or less are similar to those

seen in adults.

Complaints of injection site reactions (injection site pain, injection site reaction) and skin reactions

(rash, urticaria) are reported relatively more frequently in children and adolescents of 18 years of age

or less than in adults.

Clinical study safety data are not available for children under 2 years.

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.

5.

How to store ABASAGLAR

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 carton and on the label of the pen

after “EXP”. The expiry date refers to the last day of that month.

Not in-use pens

Store in a refrigerator (2°C - 8°C). Do not freeze.

Do not put ABASAGLAR next to the freezer compartment or a freezer pack.

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

In-use pens

Pre-filled pens in use or carried as a spare may be stored for a maximum of 28 days up to 30°C and

away from direct heat or direct light. The pen in use must not be stored in the refrigerator. Do not use

it after this time period. The pen cap must be put back on the pen after each injection in order to

protect from light.

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 protect the environment.

6.

Contents of the pack and other information

What ABASAGLAR contains

The active substance is insulin glargine. Each millilitre of the solution contains 100 units of the

active substance insulin glargine (equivalent to 3.64 mg).

The other ingredients are: zinc oxide, metacresol, glycerol, sodium hydroxide (see section 2

“Important information about some of the ingredients of ABASAGLAR”), hydrochloric acid

and water for injections.

What ABASAGLAR looks like and contents of the pack

ABASAGLAR 100 units/mL solution for injection in a pre-filled pen, KwikPen, is a clear and

colourless solution.

Each pen contains 3 mL of solution for injection (equivalent to 300 units). Packs of 1, 2, 5 and a

multipack with 2 x 5 pre-filled pens of 3 mL are available.

Not all pack sizes may be marketed.

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, F-67640 Fegersheim, France.

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

Authorisation Holder:

België/Belgique/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 60 00

Malta

Charles de Giorgio Ltd.

Tel: + 356 25600 500

Deutschland

Lilly Deutschland GmbH

Tel. + 49-(0) 6172 273 2222

Boehringer Ingelheim Pharma GmbH & Co. KG

Tel: +49 (0) 800 77 90 900

Nederland

Eli Lilly Nederland B.V.

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

Eesti

Eli Lilly Holdings Limited Eesti filiaal

Tel: +372 6 817 280

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

Boehringer Ingelheim España S.A.

Tel: +34 93 404 51 00

Polska

Eli Lilly Polska Sp. z o.o.

Tel: +48 22 440 33 00

France

Lilly France SAS

Tél: +33-(0) 1 55 49 34 34

Boehringer Ingelheim France S.A.S.

Tél: +33 3 26 50 45 33

Portugal

Lilly Portugal Produtos Farmacêuticos, Lda

Tel: + 351-21-4126600

Boehringer Ingelheim, Lda.

Tel: +351 21 313 53 00

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

Boehringer Ingelheim Ireland Ltd.

Tel: +353 1 295 9620

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

Boehringer Ingelheim Italia S.p.A.

Tel: +39 02 5355 1

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

Boehringer Ingelheim Ltd.

Tel: +44 1344 424 600

This leaflet was last revised in

Other sources of information

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

http://www.ema.europa.eu

HYPERGLYCAEMIA AND HYPOGLYCAEMIA

Always carry some sugar (at least 20 grams) with you.

Carry some information with you to show you are diabetic.

HYPERGLYCAEMIA (high blood sugar levels)

If your blood sugar is too high (hyperglycaemia), you may not have injected enough insulin.

Why does hyperglycaemia occur?

Examples include:

you have not injected your insulin or not injected enough, or if it has become less effective, for

example through incorrect storage,

your insulin pen does not work properly,

you are doing less exercise than usual, you are under stress (emotional distress, excitement), or

you have an injury, operation, infection or fever,

you are taking or have taken certain other medicines (see section 2, "Other medicines and

ABASAGLAR").

Warning symptoms of hyperglycaemia

Thirst, increased need to urinate, tiredness, dry skin, reddening of the face, loss of appetite, low blood

pressure, fast heartbeat, and glucose and ketone bodies in urine. Stomach pain, fast and deep

breathing, sleepiness or even loss of consciousness may be signs of a serious condition (ketoacidosis)

resulting from lack of insulin.

What should you do if you experience hyperglycaemia?

Test your blood sugar level and your urine for ketones as soon as any of the above symptoms

occur.

Severe hyperglycaemia or ketoacidosis must always be treated by a doctor, normally in a

hospital.

HYPOGLYCAEMIA (low blood sugar levels)

If your blood sugar level falls too much you may become unconscious. Serious hypoglycaemia may

cause a heart attack or brain damage and may be life-threatening. You normally should be able to

recognise when your blood sugar is falling too much so that you can take the right actions.

Why does hypoglycaemia occur?

Examples include:

you inject too much insulin,

you miss meals or delay them,

you do not eat enough, or eat food containing less carbohydrate than normal (sugar and

substances similar to sugar are called carbohydrates; however, artificial sweeteners are NOT

carbohydrates),

you lose carbohydrates due to vomiting or diarrhoea,

you drink alcohol, particularly if you are not eating much,

you are doing more exercise than usual or a different type of physical activity,

you are recovering from an injury or operation or other stress,

you are recovering from an illness or from fever,

you are taking or have stopped taking certain other medicines (see section 2, "Other medicines

and ABASAGLAR").

Hypoglycaemia is also more likely to occur if

you have just begun insulin treatment or changed to another insulin preparation (when changing

from your previous basal insulin to ABASAGLAR, hypoglycaemia, if it occurs, may be more

likely to occur in the morning than at night),

your blood sugar levels are almost normal or are unstable,

you change the area of skin where you inject insulin (for example from the thigh to the upper

arm),

you suffer from severe kidney or liver disease, or some other disease such as hypothyroidism.

Warning symptoms of hypoglycaemia

- In your body

Examples of symptoms that tell you that your blood sugar level is falling too much or too fast:

sweating, clammy skin, anxiety, fast heart beat, high blood pressure, palpitations and irregular

heartbeat. These symptoms often develop before the symptoms of a low sugar level in the brain.

- In your brain

Examples of symptoms that indicate a low sugar level in the brain: headaches, intense hunger, nausea,

vomiting, tiredness, sleepiness, sleep disturbances, restlessness, aggressive behaviour, lapses in

concentration, impaired reactions, depression, confusion, speech disturbances (sometimes total loss of

speech), visual disorders, trembling, paralysis, tingling sensations (paraesthesia), numbness and

tingling sensations in the area of the mouth, dizziness, loss of self-control, inability to look after

yourself, convulsions, loss of consciousness.

The first symptoms which alert you to hypoglycaemia ("warning symptoms") may change, be weaker

or may be missing altogether if

you are elderly, if you have had diabetes for a long time or if you suffer from a certain type of

nervous disease (diabetic autonomic neuropathy),

you have recently suffered hypoglycaemia (for example the day before) or if it develops slowly,

you have almost normal or, at least, greatly improved blood sugar levels,

you have recently changed from an animal insulin to a human insulin such as ABASAGLAR,

you are taking or have taken certain other medicines (see section 2, "Other medicines and

ABASAGLAR").

In such a case, you may develop severe hypoglycaemia (and even faint) before you are aware of the

problem. Be familiar with your warning symptoms. If necessary, more frequent blood sugar testing

can help to identify mild hypoglycaemic episodes that may otherwise be overlooked. If 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.

What should you do if you experience hypoglycaemia?

1. Do not inject insulin. Immediately take about 10 to 20 g sugar, such as glucose, sugar cubes or a

sugar-sweetened beverage. Caution: Artificial sweeteners and foods with artificial sweeteners (such as

diet drinks) are of no help in treating hypoglycaemia.

2. Then eat something that has a long-acting effect in raising your blood sugar (such as bread or pasta).

Your doctor or nurse should have discussed this with you previously.

The recovery of hypoglycaemia may be delayed because ABASAGLAR has a long action.'

3. If the hypoglycaemia comes back again, take another 10 to 20 g sugar.

4. Speak to a doctor immediately if you are not able to control the hypoglycaemia or if it recurs. Tell

your relatives, friends and close colleagues the following:

If you are not able to swallow or if you are unconscious, you will require an injection of glucose or

glucagon (a medicine which increases blood sugar). These injections are justified even if it is not

certain that you have hypoglycaemia.

It is advisable to test your blood sugar immediately after taking glucose to check that you really have

hypoglycaemia.

Instructions for use

KwikPen

ABASAGLAR 100 units/mL solution for injection in a pre-filled pen

Insulin glargine

PLEASE READ THESE INSTRUCTIONS BEFORE USE

Read the instructions for use before you start taking ABASAGLAR and each time you get another

ABASAGLAR 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.

ABASAGLAR KwikPen (“Pen”) is a disposable pen containing 300 units (3 mL) of insulin glargine.

You can give yourself multiple doses using one pen. The pen dials 1 unit at a time. You can give from

1 to 60 80 units in a single injection.

If your dose is more than 60 80 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

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

with

green ring

Needle

Outer Needle

Shield

Inner Needle

Shield

Paper Tab

How to recognise your ABASAGLAR KwikPen

:

Pen colour:

Light grey

Dose Knob:

Light grey with green ring on the end

Labels:

Light grey with green colour bars

Supplies needed to give your injection:

ABASAGLAR KwikPen

KwikPen compatible needle (BD [Becton, Dickinson and Company] pen needles

recommended).

Swab

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.

ABASAGLAR 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 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 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 6080 units in a single injection.

If your dose is more than 6080 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.

Keep

Throw Away

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 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)

Step 9:

Choose your injection site.

ABASAGLAR is injected under

the skin (subcutaneously) of your

stomach area, buttocks, upper legs

or upper arms.

Prepare your skin as

recommended by your healthcare

professional.

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.

- If you normally need to give 2

injections for your full dose, be

sure to give your second injection.

5sec

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 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 directed by your healthcare

professional.

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 closable, puncture-resistant sharps container.

Do not recycle the filled sharps container.

Ask your healthcare professional about options to dispose of the pens and 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 ABASAGLAR.

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 [below 30 ° C] and away from 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 it 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.

If you have any questions or problems with your ABASAGLAR KwikPen, contact your healthcare

professional for assistance.

This leaflet was last revised in <

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