Abasaglar 100 units/ml KwikPen solution for injection in pre-filled pen
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
ABASAGLAR 100 units/ml KwikPen pre-filled pen injection solution
insulin glargine
Read the entire leaflet carefully, including the Instructions for Use of the ABASAGLAR KwikPen pre-filled pen, before you start using this medicine as it contains important information for you.
- Keep this leaflet as 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, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
- If you experience any adverse reactions, consult your doctor, pharmacist or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.
Contents of the leaflet
- What ABASAGLAR is and what it is used for
- What you need to know before using ABASAGLAR
- How to use ABASAGLAR
- Possible adverse 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 in the treatment of diabetes mellitus in adult, adolescent, and pediatric patients aged 2 years and older.
Diabetes mellitus is a condition in which your body does not produce enough insulin to control blood glucose levels. Insulin glargine has a prolonged and consistent blood glucose-lowering effect.
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 components of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before starting to use ABASAGLAR.
Strictly follow the instructions regarding dosage, monitoring (blood and urine tests), diet, and physical activity (physical work and exercise) established by your doctor.
If your blood sugar is too low (hypoglycemia), follow the hypoglycemia guidance (see the box at the end of this leaflet).
Skin changes at the injection site.
Rotate your injection site to avoid skin changes such as lumps under the skin. Insulin may not work well if injected into a lumpy area (see How to use Abasaglar). Contact your doctor if you are currently injecting into a lumpy area before switching to a different site. Your doctor may advise you to monitor your blood sugar levels more closely and may adjust your insulin dose or that of your other antidiabetic medications.
Travel
Before traveling, consult your doctor. You may need advice on:
- the availability of your insulin in the country you are visiting,
- carrying sufficient insulin supplies,
- proper storage of insulin during travel,
- meal and insulin administration schedules while traveling,
- possible effects of traveling across time zones,
- potential new health risks in the countries you are visiting,
- what to do in emergency situations if you become ill.
Illness and injury
Managing your diabetes may require special care in the following situations (for example, adjustment of insulin dose, blood and urine testing):
- If you are ill or suffer a serious injury, 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, you will need medical attention. Be sure to consult a doctor immediately.
If you have type 1 diabetes (insulin-dependent diabetes mellitus), do not stop taking your insulin or consuming sufficient carbohydrates. Always inform healthcare providers involved in your care that you require insulin.
Insulin treatment may cause your body to produce antibodies against insulin (substances that act against insulin). Rarely, this may require a change in your insulin dose.
Some patients with long-standing type 2 diabetes mellitus and prior heart disease or stroke who were treated with pioglitazone and insulin developed heart failure. Inform your doctor as soon as possible if you experience symptoms of heart failure such as unusual shortness of breath, rapid weight gain, or localized swelling (edema).
Insulin mix-ups
Always check the carton and label of the 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.
Using ABASAGLAR with other medicines
Some medicines can affect your blood sugar levels (lowering, raising, or both, depending on the situation). In each case, your insulin dose may need to be adjusted to prevent blood sugar levels from becoming too low or too high. Be cautious when starting or stopping any other medicine.
Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. Ask your doctor before taking any medicine whether it could affect your blood sugar level and what steps you should take, if any.
Medicines that may cause a decrease in your blood sugar level (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 reduce high lipid levels in the blood),
- monoamine oxidase inhibitors (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 excess growth hormone),
- sulfonamide antibiotics.
Medicines that may cause an increase in your blood sugar level (hyperglycemia) include:
- corticosteroids (such as "cortisone", used to treat inflammation),
- danazol (a medicine that affects 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 gland disorders),
- atypical antipsychotics (such as clozapine, olanzapine),
- protease inhibitors (used to treat HIV).
Your blood sugar level may 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 certain parasitic infections) may cause hypoglycemia, which may sometimes be followed by hyperglycemia.
Beta-blockers, as well as other sympatholytic medicines (such as clonidine, guanethidine, and reserpine), may weaken or completely suppress the early warning symptoms that help you recognize hypoglycemia.
If you are unsure whether you are taking any of these medicines, consult your doctor or pharmacist.
Using ABASAGLAR with alcohol
Your blood sugar levels may rise or fall if you drink alcohol.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Inform your doctor if you are planning a pregnancy or are already pregnant. Your insulin dose may need to be adjusted during pregnancy and after delivery. Careful control of your diabetes and prevention of hypoglycemia are important for your baby's health.
If you are breastfeeding, consult your doctor, as you may need adjustments to your insulin doses and diet.
Driving and using machines
Your ability to concentrate or react may be reduced if:
- you have hypoglycemia (low blood sugar),
- you have hyperglycemia (high blood sugar),
- you have vision problems.
Be aware of this potential issue, especially in situations that could pose a risk to yourself or others (such as driving or operating machinery). Ask your doctor for advice on your ability to drive if:
- you have frequent episodes of hypoglycemia,
- 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 and is therefore considered essentially "sodium-free".
3. How to use ABASAGLAR
Follow exactly the administration instructions for this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.
Although ABASAGLAR contains the same active substance as Toujeo (insulin glargine 300 units/ml), these medicines are not interchangeable. Changing from one insulin treatment to another requires medical prescription, medical supervision, and blood glucose monitoring. For more information, consult your doctor.
Dosage
Depending on your lifestyle, blood sugar (glucose) test results, and previous insulin treatment, your doctor will:
- determine the dose of ABASAGLAR you need each day and at what time,
- advise you when to check your blood sugar levels, and whether you need to carry out urine tests,
- inform you when you may need to inject a higher or lower dose of ABASAGLAR.
ABASAGLAR is a long-acting insulin. Your doctor may instruct you to use it in combination with a short-acting insulin or with tablets to treat elevated blood sugar levels.
Many factors can influence your blood sugar level. You should be aware of these factors, as this will help you respond appropriately to changes in your blood sugar level and avoid it becoming too high or too low. For more information, see the box 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
You need one injection of ABASAGLAR every day, always at the same time.
Method of administration
ABASAGLAR is injected under the skin. DO NOT inject ABASAGLAR into a vein, as this will alter its action and may cause hypoglycemia.
Your doctor will show you which area of skin to inject ABASAGLAR into. With each injection, you must change the injection site within the specific skin area you are using.
How to handle 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 exactly as described in these Instructions for Use.
Before each use, a new needle must be attached. Use only needles compatible for use with ABASAGLAR KwikPen (see “Instructions for Use of ABASAGLAR KwikPen”).
Before each injection, you must perform a safety test.
Inspect the cartridge before using the pen. Do not use ABASAGLAR KwikPen if you see particles inside. Only use ABASAGLAR KwikPen if the solution is clear, colorless, and watery. Do not shake or mix before use.
To prevent possible transmission of disease, each pen must be used exclusively by a single patient.
Ensure that the insulin is not contaminated with alcohol or other disinfectants, or with other substances.
Always use a new pen if you notice that your blood sugar control is unexpectedly worsening. If you think you may have any problem with ABASAGLAR KwikPen, consult your doctor, pharmacist, or nurse.
Empty pens must not be refilled and should be properly discarded.
Do not use ABASAGLAR KwikPen if it is damaged or not functioning properly; it should be discarded and a new KwikPen used.
If you use more ABASAGLAR than you should
- If you have injected too much ABASAGLAR or are unsure how much you have injected, your blood sugar level may become too low (hypoglycemia). Check your blood sugar frequently. In general, to prevent hypoglycemia, you should eat more and monitor your blood sugar level. For more information on the treatment of hypoglycemia, see the box 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 level may become too high (hyperglycemia). Check your blood sugar frequently. For more information on the treatment of hyperglycemia, see the box at the end of this leaflet.
- Do not take a double dose to make up for missed doses.
After injection
If you are unsure how much you have injected, check your blood sugar levels before deciding whether you need another injection.
If you stop using ABASAGLAR
This could lead to severe hyperglycemia (very high blood sugar levels) and ketoacidosis (increased acid in the blood due to the body breaking down fat instead of sugar). Do not stop your treatment with ABASAGLAR without consulting your doctor; your doctor will advise you what to do.
If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone gets them.
If you notice signs that your blood sugar level is too low (hypoglycaemia), act immediately to raise your blood sugar levels. Hypoglycaemia (low blood sugar) can be very serious and is very common during insulin treatment (it may affect more than 1 in 10 people). Low blood sugar means there is not enough sugar in the blood. If your blood sugar level drops too low, you may faint (lose consciousness). Severe hypoglycaemia 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), difficulty breathing, drop in blood pressure with rapid heartbeat and sweating. Severe allergic reactions to insulin may be life-threatening. Inform your doctor immediately if you notice signs of a severe allergic reaction.
Skin changes at the injection site
If you inject insulin too frequently in the same place, fatty tissue may shrink (lipoatrophy, may affect up to 1 in 100 people) or become thicker (lipohypertrophy, may affect up to 1 in 10 people). Lumps under the skin may also occur due to the accumulation of a protein called amyloid (cutaneous amyloidosis, frequency unknown). Insulin may not work as well if injected into a lumpy area. Change the injection site with each injection to help prevent these skin changes.
Common adverse effects (may affect up to 1 in 10 people)
- Skin reactions and allergic reactions at the injection site
Signs may include redness, unusually severe pain on injection, itching, hives, swelling or inflammation. These reactions may spread around the injection site. Most mild reactions to insulin usually disappear within a few days or weeks.
Rare adverse effects (may affect up to 1 in 1,000 people)
- Eye reactions
A significant change (improvement or worsening) in blood sugar control may temporarily affect your vision. 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 fluid retention in the body, with swelling of the calves and ankles.
Very rare adverse effects (may affect up to 1 in 10,000 people)
In very rare cases, it may cause dysgeusia (taste disturbances) and myalgia (muscle pain).
Other adverse effects in children and adolescents
In general, adverse 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 more frequently reported in children and adolescents aged 18 years or younger than in adults.
Reporting of adverse effects
If you experience any type of adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of ABASAGLAR
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and cartridge label after “EXP”. The expiry date refers to the last day of the month indicated.
Unused pens
Store in a refrigerator (between 2°C and 8°C). Do not freeze.
Do not place ABASAGLAR near the freezer compartment or next to a cooling element.
Keep the pre-filled pen in its outer packaging to protect it from light.
Pens in use
Pre-filled pens in use or carried as a spare may be kept for up to 28 days at a temperature not exceeding 30°C, and must be protected from direct heat and light. Pens in use must not be stored in the refrigerator. Do not use after this period. The pen cap should be replaced after each injection to protect the pen from light.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of ABASAGLAR
- The active substance is insulin glargine. Each milliliter 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.
Appearance of the product and contents of the container
ABASAGLAR 100 units/ml solution for injection in a prefilled pen, KwikPen, is a clear, colourless solution.
ABASAGLAR is available in packs of 5 prefilled pens and in multiple packs of 2 boxes, each containing 5 prefilled pens.
Only some 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, contact the local representative of the Marketing Authorisation Holder:
Spain
Lilly S.A.
Tel: + 34-91 663 50 00
Date of the most recent revision of this leaflet: July 2020
Other sources of information
Detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu.
HYPERGLYCAEMIA AND HYPOGLYCAEMIA
Always carry some sugar with you (at least 20 grams).
Carry information indicating that you are diabetic.
HYPERGLYCAEMIA (high blood sugar levels)
If your blood sugar level is too high (hyperglycaemia), you may not have injected enough insulin.
Why does hyperglycaemia occur?
Examples include:
- you have not injected your insulin or have not injected enough, or its effect has decreased, for example due to incorrect storage,
- your insulin pen is not working properly,
- you are doing less physical activity than usual, are under stress (emotional distress, nervousness), or have an injury, surgery, infection, or fever,
- you are taking or have taken certain medicines (see section 2, "Use of ABASAGLAR with other medicines").
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 and ketone bodies in the urine. Stomach pain, deep and rapid breathing, drowsiness, or even loss of consciousness may be signs of a serious condition (ketoacidosis) due to lack of insulin.
What should you do if you experience hyperglycaemia?
You should test your blood sugar level and your urine for acetone as soon as any of the symptoms described above occur. Severe hyperglycaemia or ketoacidosis must always be treated by a doctor, usually in a hospital.
HYPOGLYCAEMIA (low blood sugar levels)
If your blood sugar level drops too low, you may lose consciousness. Severe hypoglycaemia can cause a heart attack or brain damage and may be life-threatening. You should normally be able to recognise when your blood sugar level is dropping too low so that you can take appropriate action.
Why does hypoglycaemia occur?
Examples include:
- you inject too much insulin,
- you miss or delay meals,
- you do not eat enough, or eat foods containing fewer carbohydrates than usual (sugars and sugar-like substances are called carbohydrates; however, artificial sweeteners are NOT carbohydrates),
- you lose carbohydrates due to vomiting or diarrhoea,
- you drink alcohol, especially if you are not eating much,
- you do more physical activity than usual or a different type of physical activity,
- you are recovering from an injury, surgery, or other types of stress,
- you are recovering from an illness or fever,
- you are taking or have stopped taking certain medicines (see section 2, "Use of ABASAGLAR with other medicines").
Hypoglycaemia is also more likely if
- you have just started insulin treatment or have switched to another insulin preparation (when switching from your previous basal insulin to ABASAGLAR, if hypoglycaemia occurs, it is more likely to happen in the morning than at night),
- your blood sugar levels are nearly normal or unstable,
- you change the injection site on your skin (e.g. from the thigh to the upper arm),
- you have severe kidney or liver disease, or other conditions such as hypothyroidism.
Warning signs of hypoglycaemia
- In your body
Examples of symptoms indicating that your blood sugar level is dropping too low or too quickly: sweating, moist and clammy skin, anxiety, rapid heartbeat, high blood pressure, palpitations, and irregular heartbeat. These symptoms often occur before symptoms related to low brain sugar appear.
- In your brain
Examples of symptoms indicating low sugar in the brain: headache, intense hunger, nausea, vomiting, fatigue, drowsiness, sleep disturbances, restlessness, aggressive behaviour, difficulty concentrating, altered reactions, depression, confusion, speech disturbances (sometimes complete loss of speech), visual disturbances, tremor, paralysis, tingling sensations (paraesthesia), numbness and tingling around the mouth, dizziness, loss of self-control, inability to care for yourself, seizures, loss of consciousness.
The early warning symptoms of hypoglycaemia ("warning symptoms") may change, become milder, or disappear completely if
- you are elderly, have had diabetes for a long time, or suffer from a certain type of nerve disease (autonomic diabetic neuropathy),
- you have recently experienced an episode of hypoglycaemia (e.g. the day before) or if it develops gradually,
- you have nearly normal or significantly improved blood sugar levels,
- you have recently switched from animal insulin to human insulin such as ABASAGLAR,
- you are taking or have taken certain medicines (see section 2, "Use of ABASAGLAR with other medicines").
In such cases, you may experience severe hypoglycaemia (or even fainting) before you realise there is a problem. Always be aware of your warning symptoms. If necessary, more frequent blood sugar testing may help identify mild hypoglycaemic episodes that might otherwise go unnoticed. If you are unsure whether you can recognise your warning symptoms, avoid situations (such as driving a car) that could put you or others at risk due to hypoglycaemia.
What should you do if you experience hypoglycaemia?
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Do not inject insulin. Immediately consume 10 to 20 g of sugar, such as glucose tablets, sugar lumps, or a sugary drink. Warning: Artificial sweeteners and foods containing artificial sweeteners instead of sugar (such as diet drinks) are not helpful in treating hypoglycaemia.
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Afterwards, eat something that will raise your blood sugar level over the long term (such as bread or pasta). Your doctor or nurse should have discussed this with you previously.
Recovery from hypoglycaemia may be delayed because ABASAGLAR has a prolonged action.
-
If hypoglycaemia recurs, take another 10 to 20 g of sugar.
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Contact a doctor immediately if you are unable to control the hypoglycaemia or if it recurs. Inform your family, friends, and close contacts:
If you are unable to swallow or lose consciousness, you will need an injection of glucose or glucagon (a medicine that increases blood sugar levels). Such injections are justified even if you are not certain that you have hypoglycaemia.
It is advisable to test your blood sugar level immediately after glucose ingestion to confirm that you actually have hypoglycaemia.