Abasaglar: detailed information

Package leaflet: Information for the user

ABASAGLAR 100 units/mL solution for injection in a cartridge

insulin glargine
Please read all of this leaflet carefully before you start using this medicine because it contains important information for you. Instructions for use of the insulin pen are provided with the insulin pen itself. Please refer to them before using the medicine.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor, pharmacist or nurse.
This medicine has been prescribed for you only. Do not pass it on to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

What ABASAGLAR is and what it is used for
What you need to know before using 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 contains insulin glargine. This is a modified insulin that is very similar to human insulin.
ABASAGLAR is used to treat diabetes mellitus in adults, adolescents, and children from the age of 2 years.
Diabetes mellitus is a disease in which the body does not produce enough insulin to control blood sugar levels. Insulin glargine has a constant and prolonged action and lowers elevated blood sugar levels.

2. What you need to know before using ABASAGLAR

Do not use ABASAGLAR
If you are allergic to insulin glargine or to any of the other ingredients of this medicine
(listed in section 6).
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using ABASAGLAR.
Carefully follow the instructions your doctor has given you regarding dosage, monitoring (blood and urine tests), diet, and physical activity (work and exercise).
If your blood sugar level is too low (hypoglycaemia), follow the guidance for hypoglycaemia
(see the box at the end of this leaflet).
Changes at the injection site
Rotate your injection site to prevent skin changes, such as the appearance of lumps under the skin. Insulin may not work as effectively if you inject into an area with lumps (see section How to use Abasaglar). If you currently inject into an area with lumps, consult your doctor before starting to inject in a different area. Your doctor may advise you to monitor your blood glucose more closely and possibly adjust your insulin dose or that of other antidiabetic medicines.
Travel
Before travelling, consult your doctor. You may need to discuss the following:

availability of insulin in your destination country,
sufficient insulin supplies,
proper storage of insulin during travel,
intervals between meals and insulin administration while travelling,
possible effects of time zone changes,
potential risks of contracting new illnesses in the countries visited,
what to do in emergency situations if you feel unwell or become ill.

Illness and injury
In the following situations, diabetes control may require special attention (e.g., adjustment of insulin dose, blood and urine tests):

If you are ill or have serious injuries, your blood sugar level may rise (hyperglycaemia).
If you do not eat enough, your blood sugar level may drop too low (hypoglycaemia). In most cases, medical advice is needed. Contact your doctor promptly.

If you have type 1 diabetes (insulin-dependent diabetes mellitus), do not stop insulin treatment or stop consuming carbohydrates in sufficient amounts. Always inform people close to you or those involved in your care that you require insulin.
Treatment with insulin may lead to the formation of anti-insulin antibodies (substances that act against insulin). However, very rarely, this necessitates an adjustment in insulin dosage.
Some patients with long-standing type 2 diabetes and heart disease or a history of stroke, treated with pioglitazone and insulin, have developed heart failure. Inform your doctor as soon as possible if you experience signs of heart failure such as unusually shortness of breath, rapid weight gain, or localized swelling (oedema).
Switching insulins
Always check the packaging and label of your insulin before each injection to avoid confusion between ABASAGLAR and other insulins.
Children
There is no experience with the use of ABASAGLAR in children under 2 years of age.
Other medicines and ABASAGLAR
Some medicines can cause changes in blood sugar levels (either lowering or raising, or both, depending on the situation). In any case, insulin dosage may need to be adjusted to avoid blood sugar levels that are too low or too high. Be cautious when starting or stopping any other medicine.
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine. Before taking any medicine, ask your doctor whether and how it may affect your blood glucose levels and whether you need to take any precautions.
Medicines that may lower blood sugar levels (hypoglycaemia)
include:

all other medicines used 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 fats in the blood),
monoamine oxidase (MAO) inhibitors (used to treat depression),
pentoxifylline, propoxyphene, salicylates (such as aspirin, used to relieve pain and reduce fever),
somatostatin analogues (such as octreotide, used to treat a rare condition involving excessive growth hormone production),
sulfonamide antibiotics.

Medicines that may raise blood sugar levels (hyperglycaemia)
include:

corticosteroids (such as "cortisone", used to treat inflammation),
danazol (a medicine affecting ovulation),
diazoxide (used to treat high blood pressure),
diuretics (used to treat high blood pressure or excessive fluid retention),
glucagon (a pancreatic hormone used to treat severe hypoglycaemia),
isoniazid (used to treat tuberculosis),
oestrogens and progestogens (such as in oral contraceptives 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 disorders),
atypical antipsychotics (such as clozapine, olanzapine),
protease inhibitors (used to treat HIV).

Blood sugar levels may decrease or increase 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 certain parasitic infections) may cause hypoglycaemia, sometimes followed by hyperglycaemia.
Beta-blockers, as well as other sympatholytic medicines (such as clonidine, guanethidine, and reserpine), may reduce or completely mask the warning signs that help you recognize hypoglycaemia.
If you are unsure whether you are taking any of these medicines, ask your doctor or pharmacist.
ABASAGLAR and alcohol
Blood sugar levels may decrease or increase if you drink alcohol.
Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any other medicine.
Inform your doctor if you are planning a pregnancy or if you are already pregnant. Your insulin dose may need to be adjusted during pregnancy and after childbirth. It is important to carefully monitor your diabetes and prevent hypoglycaemia for your baby's health.
If you are breastfeeding, consult your doctor, as adjustments to your insulin dose and diet may be necessary.
Driving and using machines
Your ability to concentrate or react may be reduced if you have:

hypoglycaemia (low blood sugar levels),
hyperglycaemia (high blood sugar levels),
vision problems. Consider this possibility in any situation where it could pose a risk to yourself or others (such as when driving a car or operating machinery). You should consult your doctor for advice on whether it is safe for you to drive if:
you experience frequent hypoglycaemic episodes,
your early warning symptoms of hypoglycaemia are reduced or absent.

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

3. How to use ABASAGLAR

Use this medicine exactly as your doctor has told you. If you have any doubts, consult your doctor or pharmacist.
Although ABASAGLAR contains the same active substance as Toujeo (insulin glargine 300 units/mL), these medicines are not interchangeable. Switching from one insulin therapy to another requires medical prescription, medical supervision, and blood glucose monitoring. Consult your doctor for further information.

Dose
Based on your lifestyle, blood sugar test results (blood glucose), and previous insulin use, your doctor will:

determine the daily dose of ABASAGLAR you need and the time of day to take it,
advise you when to check your blood glucose and whether additional urine tests are needed,
inform you whether you need a lower or higher dose of ABASAGLAR.

ABASAGLAR is a long-acting insulin. Your doctor will advise you whether it needs to be used in combination with a short-acting insulin or with tablets used to treat high blood sugar levels.
Many factors can affect blood sugar levels. You should be aware of these factors so that you can respond appropriately to changes in blood sugar levels and thus avoid them becoming too high or too low. For further information, see the section at the end of this leaflet.

Use in children and adolescents
ABASAGLAR can be used in adolescents and children aged 2 years and older. Use this medicine exactly as your doctor has instructed.

Frequency of administration
One injection of ABASAGLAR is required every day, at the same time each day.

Method of administration
ABASAGLAR is injected under the skin. ABASAGLAR must NOT be injected into a vein, as this route of administration would alter its action and could lead to hypoglycaemia.
Your doctor will tell you where on the skin to inject ABASAGLAR. For each injection, change the injection site within the chosen skin area.

How to use the cartridges
To ensure correct dosing, ABASAGLAR cartridges must only be used with Lilly insulin pens. Not all pens may be available in your country.
The pens must be used in accordance with the recommendations provided in the instructions.
Follow the pen instructions carefully for loading the cartridge, attaching the needle, and administering the insulin injection. To prevent possible transmission of disease, each pen must be used by only one patient.
Carefully inspect the cartridge before use. Use it only if the solution appears clear, colourless, water-like, and free from visible particles. Do not shake or mix before use.
Always use a new cartridge if you notice that your blood sugar control has unexpectedly worsened. 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 precautions before injection
Before use, remove all air bubbles (see the pen instructions for use).
Ensure that neither alcohol nor other disinfectants or other substances contaminate the insulin.
Do not refill or reuse empty cartridges. Do not add other types of insulin to the cartridges. Do not mix ABASAGLAR with any other insulin or medicine, and do not dilute it, as mixing or dilution could alter the action of ABASAGLAR.

Problems with the insulin pen?
Refer to the instructions for use of the pen.
If the insulin pen is damaged or not working properly (due to mechanical defects), it must be discarded and a new insulin pen used.

If you use more ABASAGLAR than you should

If you have injected too high a dose of ABASAGLAR or are unsure of how much you have injected, your blood sugar levels may become too low (hypoglycaemia). Check your blood sugar frequently. In general, to prevent hypoglycaemia, eat more substantial meals and monitor your blood sugar. For information on the treatment of hypoglycaemia, see the section at the end of this leaflet.

If you forget to use ABASAGLAR

If you have forgotten a dose of ABASAGLAR, if you have not injected enough insulin, or if you are unsure how much you have injected, your blood sugar levels may become too high (hyperglycaemia). Check your blood sugar frequently. For information on the treatment of hyperglycaemia, see the section at the end of this leaflet.
Do not take a double dose to make up for a forgotten dose.

After injection
If you are unsure how much medicine you have injected, check your blood sugar levels before deciding whether you need another injection.

If you stop using ABASAGLAR
This may lead to severe hyperglycaemia (very high blood sugar levels) and ketoacidosis (build-up of acid in the blood due to the body metabolising fat instead of sugar). Do not stop using ABASAGLAR without consulting a doctor, who will advise you what to do.
If you have any doubts about using this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
If you notice that your blood sugar levels are too low (hypoglycaemia), act immediately to raise your blood sugar levels. Hypoglycaemia (low blood sugar levels) can be very serious and is very common with insulin treatment (may affect more than 1 in 10 people). Low blood sugar means there is not enough sugar in the blood. If blood sugar levels drop too low, you may faint (lose consciousness). Severe hypoglycaemic episodes can cause brain damage and may be life-threatening. For more information, see the box at the end of this leaflet.
Severe allergic reactions (rare, may affect up to 1 in 1,000 people): signs may include widespread skin reactions (rash and itching all over the body), severe swelling of the skin or mucous membranes (angioedema) caused by fluid accumulation, shortness of breath, low blood pressure with rapid heartbeat and sweating. A severe allergic reaction to insulin may be life-threatening. Inform your doctor immediately if you notice signs of severe allergic reactions.
Skin changes at the injection site
If you inject insulin too often in the same spot, fatty tissue may thin (lipoatrophy, may affect up to 1 in 100 people) or thicken (lipohypertrophy, may affect up to 1 in 10 people). Lumps under the skin may also be caused by the buildup of a protein called amyloid (cutaneous amyloidosis; frequency not known). Insulin may not work well if you inject into an area with lumps. Change your injection site with each injection to prevent these skin changes.
Common side effects (may affect up to 1 in 10 people)

Skin and allergic reactions at the injection site Signs may include redness, unusually painful injection, itching, hives, swelling, and inflammation. These reactions may spread to the area around the injection site. Most minor reactions to insulin usually go away within a few days or weeks.

Rare side effects (may affect up to 1 in 1,000 people)

Eye-related reactions
A marked change (improvement or worsening) in blood sugar levels may temporarily affect vision. If you have proliferative retinopathy (a diabetes-related eye disease), severe hypoglycaemic episodes may cause temporary loss of vision.
Systemic disorders
In rare cases, insulin treatment may lead to a temporary increase in fluid retention in the body, causing swelling in the calves and ankles.
Very rare side effects (may affect up to 1 in 10,000 people)
In very rare cases, dysgeusia (altered taste) and myalgia (muscle pain) may occur.
Use in children and adolescents
In general, side effects in children and adolescents aged 18 years and younger are similar to those seen in adults.
Reports of injection site reactions (injection site pain, injection site reaction) and skin reactions (rash, hives) have been relatively more frequent in children and adolescents aged 18 years and younger compared to adults.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system listed in Annex 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 stated on the packaging and on the cartridge label after "Exp". The expiry date refers to the last day of that month.

Unopened cartridges
Store in the refrigerator (2°C–8°C). Do not freeze.
Do not place ABASAGLAR in the freezer or in direct contact with cooling packs.
Keep the cartridge in its outer packaging to protect the medicine from light.

Cartridges in use
Cartridges in use (in the insulin pen) or kept as spare may be stored for up to 28 days at a temperature not exceeding 30°C, away from direct heat or light. Cartridges in use must not be stored in the refrigerator. Do not use after this period.

Do not use ABASAGLAR if you see particles inside the cartridge. Use ABASAGLAR only if the solution is clear, colourless, and looks like water.

Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This 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 solution contains 100 units of the active substance insulin glargine (equivalent to 3.64 mg).
The other components are: zinc oxide, metacresol, glycerol, sodium hydroxide (see section 2 “ABASAGLAR contains sodium”), hydrochloric acid and water for injections.

Description of the appearance of ABASAGLAR and contents of the pack
ABASAGLAR 100 units/mL solution for injection in a cartridge is a clear and colourless solution.
ABASAGLAR is supplied in a cartridge specifically designed to be used only with a Lilly insulin pen. Each cartridge contains 3 mL of injectable solution (equivalent to 300 units), and packs of 5 and 10 cartridges 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.
Eli Lilly Italia S.p.A., Via Gramsci 731-733, 50019 Sesto Fiorentino, (FI) Italy.

For further information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
Eli Lilly Benelux S.A./N.V. Eli Lilly Lietuva
Tél/Tel: + 32-(0)2 548 84 84 Tel. +370 (5) 2649600

България Luxembourg/Luxemburg
ТП "Ели Лили Недерланд" Б.В. - България Eli Lilly Benelux S.A./N.V.
тел. +359 2 491 41 40 Tél/Tel: + 32-(0)2 548 84 84

Česká republika Magyarország
ELI LILLY ČR, s.r.o. Lilly Hungária Kft.
Tel: + 420 234 664 111 Tel: + 36 1 328 5100

Danmark Malta
Eli Lilly Danmark A/S Charles de Giorgio Ltd.
Tlf: +45 45 26 60 00 Tel: + 356 25600 500

Deutschland Nederland
Lilly Deutschland GmbH Eli Lilly Nederland B.V.
Tel. + 49-(0) 6172 273 2222 Tel: + 31-(0) 30 60 25 800

Eesti Norge
Eli Lilly Nederland B.V. Eli Lilly Norge A.S.
Tel: +372 6 817 280 Tlf: + 47 22 88 18 00

Ελλάδα Österreich
ΦΑΡΜΑΣΕΡΒ-ΛΙΛΛΥ Α.Ε.Β.Ε. Eli Lilly Ges.m.b.H.
Τηλ: +30 210 629 4600 Tel: + 43-(0) 1 711 780

España Polska
Lilly S.A. Eli Lilly Polska Sp. z o.o.
Tel: + 34-91 663 50 00 Tel: +48 22 440 33 00

France Portugal
Lilly France SAS Lilly Portugal Produtos Farmacêuticos, Lda
Tél: +33-(0) 1 55 49 34 34 Tel: + 351-21-4126600

Hrvatska România
Eli Lilly Hrvatska d.o.o. Eli Lilly România S.R.L.
Tel: +385 1 2350 999 Tel: + 40 21 4023000

Ireland Slovenija
Eli Lilly and Company (Ireland) Limited Eli Lilly farmacevtska družba, d.o.o.
Tel: + 353-(0) 1 661 4377 Tel: +386 (0)1 580 00 10

Ísland Slovenská republika
Icepharma hf. Eli Lilly Slovakia s.r.o.
Sími + 354 540 8000 Tel: + 421 220 663 111

Italia Suomi/Finland
Eli Lilly Italia S.p.A. Oy Eli Lilly Finland Ab
Tel: + 39- 055 42571 Puh/Tel: + 358-(0) 9 85 45 250

Κύπρος Sverige
Phadisco Ltd Eli Lilly Sweden AB
Τηλ: +357 22 715000 Tel: + 46-(0) 8 7378800

Latvija United Kingdom
Eli Lilly (Suisse) S.A Pārstāvniecība Latvijā Eli Lilly and Company Limited
Tel: + 371 67364000 Tel: + 44-(0) 1256 315000

Other sources of information
More detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu

HYPERGLYCAEMIA AND HYPOGLYCAEMIA

Always carry some sugar with you (at least 20 grams).
Carry identification indicating that you are diabetic.

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

Why does hyperglycaemia occur?
Examples include:

you have not injected insulin or have injected an insufficient amount, or if insulin has become less effective, for example due to improper storage,
the insulin pen is not working properly,
you are doing less physical exercise than usual, or are under emotional or physical stress, or have an injury, undergone surgery, or have an infection or fever,
you are taking or have taken certain other medicines (see section 2, “Other medicines and ABASAGLAR”).

Warning signs of hyperglycaemia
Thirst, increased need to urinate, fatigue, dry skin, flushed face, loss of appetite, low blood pressure, rapid heartbeat, and presence of glucose or ketone bodies in the urine. Stomach pain, deep and rapid breathing, drowsiness or even loss of consciousness may indicate a serious condition (ketoacidosis) due to insulin deficiency.

What you should do in case of hyperglycaemia
Check your blood sugar and test for ketones in your urine as soon as possible if any of the above symptoms occur. Severe hyperglycaemia or ketoacidosis must always be treated by a doctor, usually in a hospital setting.

HYPOGLYCAEMIA (low blood sugar levels)
If your blood sugar drops too low, you may lose consciousness. Severe hypoglycaemic episodes can cause heart attack or brain damage and may be life-threatening.
You should generally be able to recognise when your blood sugar is dropping too low, so that you can take appropriate precautions.

Why does hypoglycaemia occur?
Examples include:

you have injected too much insulin,
you have skipped or delayed meals,
you are not eating enough, or your food contains fewer carbohydrates than usual (carbohydrates are sugars and sugar-like substances; however, artificial sweeteners are NOT carbohydrates),
you have lost carbohydrates due to vomiting or diarrhoea,
you drink alcoholic beverages, especially if you are not eating enough,
you are doing more physical exercise than usual, or a different type of physical activity,
you are recovering from an injury, surgery or stress,
you are recovering from illness or fever,
you are taking or have taken certain other medicines (see section 2, “Other medicines and ABASAGLAR”).

Hypoglycaemia may also occur more easily if

you have just started insulin treatment or have switched to a different type of insulin (when switching from a previous basal insulin to ABASAGLAR, if hypoglycaemia occurs, it will likely occur more often in the morning than at night),
your blood sugar levels are close to normal or show fluctuations,
you have changed the skin area where you inject insulin (e.g. from the thigh to the upper arm),
you suffer from severe kidney or liver disease, or other conditions such as hypothyroidism.

Warning signs of hypoglycaemia

In the body Examples of symptoms indicating that blood sugar levels are dropping too low or too quickly: sweating, moist skin, anxiety, rapid heartbeat, high blood pressure, palpitations and irregular heartbeat. These symptoms often develop before those indicating reduced sugar levels in the brain.
In the brain Examples of symptoms indicating reduced sugar levels in the brain: headache, intense hunger, nausea, vomiting, fatigue, drowsiness, sleep disturbances, restlessness, aggression, difficulty concentrating, reduced reaction ability, depressed mood, confusion, speech difficulties (sometimes complete loss of speech), vision disturbances, tremor, paralysis, sensory disturbances (paraesthesia), tingling and numbness around the mouth, dizziness, loss of self-control, inability to care for oneself, seizures, loss of consciousness. The characteristic early symptoms of hypoglycaemia ("warning symptoms") may vary, be less pronounced or even completely absent
if you are elderly, have had diabetes for a long time, or suffer from a certain type of neurological disease (diabetic autonomic neuropathy),
after a recent hypoglycaemic episode (e.g. the day before) or if hypoglycaemia develops slowly,
if blood glucose levels are nearly normal or at least significantly improved,
if you have recently switched from animal insulin to a human insulin such as ABASAGLAR,
if you are taking or have taken certain other medicines (see section 2, “Other medicines and ABASAGLAR”). In these cases, severe hypoglycaemia (even leading to unconsciousness) may develop before you can recognise it. Therefore, learn to recognise the warning symptoms of hypoglycaemia. If necessary, more frequent blood glucose checks may help identify mild hypoglycaemic episodes that might otherwise go unnoticed. If you are unable to recognise the warning symptoms of hypoglycaemia, avoid situations (such as driving) that could be dangerous for you and others due to hypoglycaemia.

What you should do in case of hypoglycaemia?

Do not inject insulin. Immediately take 10–20 g of sugar, such as glucose, sugar cubes, or a sugar-sweetened drink. Caution: artificial sweeteners and foods containing artificial sweeteners (such as diet drinks) do not help treat hypoglycaemia.
Then eat food that will raise your blood sugar over a longer period (such as bread or pasta). Your doctor or nurse should have previously discussed these measures with you. Normalisation after hypoglycaemia may be delayed because ABASAGLAR has a long duration of action.
If another episode of hypoglycaemia occurs, take another 10–20 g of sugar.
Speak to your doctor as soon as you notice that you are unable to control hypoglycaemia or if it recurs. Inform your family, friends and colleagues close to you that:

If you are unable to swallow or lose consciousness, treatment with an injection of glucose or glucagon (a medicine that raises blood sugar levels) is required. Such injections are justified even if it is not certain that a hypoglycaemic event has occurred.
It is advisable to check blood glucose immediately after taking sugar to confirm that a hypoglycaemic episode was occurring.

Package leaflet: information for the user

ABASAGLAR 100 units/mL KwikPen injectable solution in a pre-filled pen

insulin glargine
Please read this leaflet carefully, which includes Instructions for Use of the pre-filled pen

ABASAGLAR KwikPen, before using this medicine because it contains important

information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor, pharmacist or nurse.
This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it may be harmful.
If any side effect occurs, including those not listed in this leaflet, contact your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

What ABASAGLAR is and what it is used for
What you need to know before using 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

2. What you should know before using ABASAGLAR

Do not use ABASAGLAR
If you are allergic to insulin glargine or to any of the other ingredients of this medicine
(listed in section 6).

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using ABASAGLAR.
Carefully follow the instructions your doctor has given you regarding dosage, monitoring (blood and urine tests), diet, and physical activity (work and exercise).
If your blood sugar level is too low (hypoglycemia), follow the guidance for hypoglycemia
(see the box at the end of this leaflet).

Skin changes at the injection site
Rotate your injection site to prevent skin changes such as the formation of lumps under the skin. Insulin may not work as effectively if you inject into an area with lumps (see section How to use ABASAGLAR). If you currently inject into an area with lumps, consult your doctor before switching to a different injection site. Your doctor may advise you to monitor your blood glucose more closely and possibly adjust your insulin dose or that of other antidiabetic medicines.

Travel
Before traveling, consult your doctor. You may need to discuss the following:

availability of insulin in your destination country,
sufficient insulin supplies,
proper insulin storage during travel,
timing between meals and insulin administration during travel,
possible effects of time zone changes,
risk of contracting new illnesses in the countries visited,
what to do in emergency situations if you feel unwell or become ill.

Illness and injury
In the following situations, diabetes control may require special attention (e.g., adjustment of insulin dose, blood and urine tests):

If you are ill or have serious injuries, your blood sugar level may rise (hyperglycemia).
If you do not eat enough, your blood sugar level may drop too low (hypoglycemia). In most cases, medical advice is needed. Contact your doctor promptly.

Switching insulins
Always check the packaging and label of the insulin before each injection to avoid accidentally using a different insulin instead of ABASAGLAR.

Children
There is no experience with the use of ABASAGLAR in children under 2 years of age.

Other medicines and ABASAGLAR
Some medicines can affect your blood sugar levels (either lowering or raising them, or both, depending on the situation). In such cases, insulin dosage adjustments may be needed to avoid blood sugar levels that are too low or too high. Be cautious when starting or stopping any other medicine.
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Before taking any medicine, ask your doctor whether and how it may affect your blood sugar and whether you need to take any precautions.

Medicines that may lower blood sugar levels (hypoglycemia) include:

all other medicines used 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 fats in the blood),
monoamine oxidase (MAO) inhibitors (used to treat depression),
pentoxifylline, propoxyphene, salicylates (such as aspirin, used to relieve pain and reduce fever),
somatostatin analogues (such as octreotide, used to treat a rare condition involving excessive growth hormone production),
sulfonamide antibiotics.

Medicines that may raise blood sugar levels (hyperglycemia) include:

corticosteroids (such as "cortisone", used to treat inflammation),
danazol (a medicine affecting ovulation),
diazoxide (used to treat high blood pressure),
diuretics (used to treat high blood pressure or fluid retention),
glucagon (a pancreatic hormone used to treat severe hypoglycemia),
isoniazid (used to treat tuberculosis),
estrogens and progestogens (such as in oral contraceptives 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 disorders),
atypical antipsychotics (such as clozapine, olanzapine),
protease inhibitors (used to treat HIV).

Blood sugar levels may decrease or increase 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 certain parasitic infections) may cause hypoglycemia, sometimes followed by hyperglycemia.
Beta-blockers, as well as other sympatholytic medicines (such as clonidine, guanethidine, and reserpine), may reduce or completely mask the warning signs that help you recognize hypoglycemia.
If you are unsure whether you are taking any of these medicines, ask your doctor or pharmacist.

ABASAGLAR and alcohol
Your blood sugar levels may decrease or increase if you drink alcohol.

Pregnancy and breastfeeding
Consult your doctor or pharmacist before taking any other medicine.
Inform your doctor if you are planning a pregnancy or if you are already pregnant. Your insulin dose may need to be adjusted during pregnancy and after delivery. It is important to carefully control your diabetes and prevent hypoglycemia for your baby's health.
If you are breastfeeding, consult your doctor, as adjustments to your insulin dose and diet may be necessary.

Driving and using machines
Your ability to concentrate or react may be reduced if you have:

hypoglycemia (low blood sugar levels),
hyperglycemia (high blood sugar levels),
vision problems.
Consider this possibility in any situation where it could pose a risk to yourself or others (such as when driving a car or operating machinery). Consult your doctor for advice on whether it is safe for you to drive if:
you experience frequent hypoglycemic episodes,
your early warning symptoms of hypoglycemia are reduced or absent.

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

3. How to use ABASAGLAR

Use this medicine exactly as instructed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
Although ABASAGLAR contains the same active substance as Toujeo (insulin glargine
300 units/mL), these medicines are not interchangeable. Switching from one insulin therapy
to another requires a medical prescription, medical supervision, and blood glucose monitoring.
Please consult your doctor for further information.
Dose
Based on your lifestyle, blood glucose test results, and previous insulin use, your doctor will:

determine the daily dose of ABASAGLAR you need and the time of day to take it,
advise you when to check your blood glucose levels and whether you need to perform additional urine tests,
inform you whether you need a lower or higher dose of ABASAGLAR.

ABASAGLAR is a long-acting insulin. Your doctor will advise whether you need to use it in combination
with a short-acting insulin or with oral antidiabetic medications used to treat high blood glucose levels.
Many factors can affect your blood glucose levels. It is important that you are aware of these factors so
you can take appropriate action if your blood glucose levels change, thereby avoiding levels that are too
high or too low. For further information, see the box at the end of this leaflet.
Use in children and adolescents
ABASAGLAR can be used in adolescents and children from the age of 2 years. Use this
medicine exactly as your doctor has told you.
Frequency of administration
One injection of ABASAGLAR is required every day, at the same time each day.
Method of administration
ABASAGLAR is injected under the skin. ABASAGLAR must not be injected into a vein, as
intravenous administration would alter its action and could lead to hypoglycaemia.
Your doctor will indicate where on your skin you should inject ABASAGLAR. For each injection,
rotate the injection site within the chosen skin area.
How to use ABASAGLAR KwikPen
ABASAGLAR KwikPen is a disposable pre-filled pen containing insulin glargine.
Read carefully the “Instructions for use of ABASAGLAR KwikPen” included with this
leaflet. You must use the pen as described in these Instructions for use.
A new needle must be attached before each use. Use only needles compatible for use with ABASAGLAR KwikPen (see the “Instructions for use of

ABASAGLAR KwikPen").

A safety test must be performed before each injection.
Check the cartridge before using the pen. Do not use ABASAGLAR KwikPen if you see
particles inside. Use ABASAGLAR KwikPen only if the solution appears clear, colourless, and
watery. Do not shake or mix before use.
To prevent possible transmission of diseases, each pen must be used by only one patient.
Take care 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 has unexpectedly worsened. If you think you have a problem with ABASAGLAR KwikPen, consult your doctor, pharmacist, or nurse.
Empty pens must not be refilled and must be properly disposed of.
Do not use ABASAGLAR KwikPen if it is damaged or does not function properly. It must be discarded and a new KwikPen used.

If you use more ABASAGLAR than you should

If you have injected too high a dose of ABASAGLAR or are unsure of how much you have injected, your blood sugar levels may become too low (hypoglycaemia). Check your blood sugar frequently. In general, to prevent hypoglycaemia, you should consume more substantial meals and monitor your blood sugar. For information on the treatment of hypoglycaemia, see the box at the end of this leaflet.

If you forget to use ABASAGLAR

If you have forgotten a dose of ABASAGLAR, have not injected enough insulin, or are unsure of how much you have injected, your blood sugar levels may become too high (hyperglycaemia). Check your blood sugar frequently. For information on the treatment of hyperglycaemia, see the box at the end of this leaflet.
Do not take a double dose to make up for a forgotten dose.

After injection
If you are unsure how much medicine you have injected, check your blood sugar levels before
deciding whether you need another injection.

If you stop using ABASAGLAR
This may lead to severe hyperglycaemia (very high blood sugar levels) and ketoacidosis
(build-up of acid in the blood due to the body metabolising fat instead of sugar). Do not stop ABASAGLAR without consulting a doctor, who will advise you on what steps to take.
If you have any doubts about using this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you notice that your blood sugar levels are too low (hypoglycaemia), act immediately to raise your blood sugar levels. Hypoglycaemia (low blood sugar) can be very serious and is very common with insulin treatment (may affect more than 1 in 10 people). Low blood sugar means there is not enough sugar in the blood. If blood sugar levels drop too low, you may faint (lose consciousness). Severe hypoglycaemic episodes can cause brain damage and may be life-threatening. For more information, see the boxed warning at the end of this leaflet.
Severe allergic reactions (rare, may affect up to 1 in 1,000 people): signs may include widespread skin reactions (rash and itching over the whole body), severe swelling of the skin or mucous membranes (angioedema) caused by fluid accumulation, shortness of breath, low blood pressure with rapid heartbeat and sweating. A severe allergic reaction to insulin could be life-threatening. Inform your doctor immediately if you notice signs of severe allergic reactions.
Skin changes at the injection site
If you inject insulin too often in the same spot, fatty tissue may become thinner (lipoatrophy, may affect up to 1 in 100 people) or thicker (lipohypertrophy, may affect up to 1 in 10 people). Lumps under the skin may also be caused by the build-up of a protein called amyloid (cutaneous amyloidosis; frequency not known). Insulin may not work as well if you inject into an area with lumps. Change the injection site with each injection to prevent these skin changes.
Common side effects (may affect up to 1 in 10 people)

Skin and allergic reactions at the injection site Signs may include redness, unusually painful injection, itching, urticaria, oedema, and inflammation. These reactions may spread to the area surrounding the injection site. Most minor reactions to insulin usually disappear within a few days or weeks.

Rare side effects (may affect up to 1 in 1,000 people)

Eye reactions A marked change (improvement or worsening) in blood sugar levels may temporarily affect vision. If you have proliferative retinopathy (a diabetes-related eye disease), severe hypoglycaemic episodes may cause temporary loss of vision.
Systemic disorders In rare cases, insulin treatment may lead to a temporary increase in fluid retention in the body, causing swelling of the calves and ankles.

Very rare side effects (may affect up to 1 in 10,000 people)
In very rare cases, dysgeusia (altered taste) and myalgia (muscle pain) may occur.
Use in children and adolescents
In general, side effects in children and adolescents aged 18 years or younger are similar to those seen in adults.
Reports of injection site reactions (injection site pain, injection site reaction) and skin reactions (rash, urticaria) have been relatively more frequent in children and adolescents aged 18 years or younger compared to adults.
Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system listed in Annex 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 pack and on the label of the pen after "Exp". The expiry date refers to the last day of that month.

Pens not in use
Store in the refrigerator (2°C - 8°C). Do not freeze.
Do not place ABASAGLAR in the freezer or in direct contact with cooling packs.
Keep the pre-filled pen in its outer packaging to protect the medicine from light.

Pens in use
Pens in use or kept as "backup" may be stored for up to 28 days at a temperature not exceeding 30°C, away from direct heat or direct light. The pen in use must not be stored in the refrigerator. Do not use it after this period. The pen cap should be replaced on the pen after each injection to protect the medicine from light.

Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What ABASAGLAR contains

The active substance is insulin glargine. Each millilitre of solution contains 100 units of the active substance insulin glargine (equivalent to 3.64 mg).
The other components are: zinc oxide, metacresol, glycerol, sodium hydroxide (see section 2 “ABASAGLAR contains sodium”), hydrochloric acid and water for injections.

Description of the appearance of ABASAGLAR and contents of the pack
ABASAGLAR 100 units/mL solution for injection in a pre-filled pen, KwikPen, is a
clear, colourless solution.
ABASAGLAR is available in packs of 5 pre-filled pens and in multiple packs containing 2 packs, each with 5 pre-filled pens.
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 further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder: