ABASAGLAR 100 units/mL KwikPen prefilled pen injector solution

Introduction

Package Leaflet: Information for the User

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

insulin glargine

Read all of this leaflet carefully, including the Instructions for Use for ABASAGLAR KwikPenpre-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 symptoms are the same as yours.
• If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is ABASAGLAR and what is it used for
2. What you need to know before you use ABASAGLAR
3. How to use ABASAGLAR
4. Possible side effects
5. Storing ABASAGLAR
6. Contents of the pack and other information

1. What is ABASAGLAR and what is it used for

ABASAGLAR contains insulin glargine. This is a modified insulin, very similar to human insulin.

ABASAGLAR is used to treat diabetes mellitus in adult, adolescent, and child patients from 2 years of age.

Diabetes mellitus is a disease in which your body does not produce enough insulin to control the level of sugar in the blood. Insulin glargine has a long-acting, constant effect on reducing blood sugar levels.

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 6).

Warnings and precautions

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

Strictly follow the instructions for dosage, control (blood and urine tests), diet, and physical activity (work and exercise) as agreed with your doctor.

If your blood sugar is too low (hypoglycaemia), follow the guidance on hypoglycaemia (see the box at the end of this leaflet).

Changes in the skin at the injection site.

The injection site should be rotated to avoid changes in the skin, such as lumps under the skin. Insulin may not work well if injected into a thickened area of skin (see How to use ABASAGLAR). Contact your doctor if you are currently injecting into a thickened area of skin before you start injecting into a different area. Your doctor may advise you to check your blood sugar levels more closely and adjust your insulin dose or the dose of your other anti-diabetic medications.

Travel

Before travelling, consult your doctor. You may need to discuss:

• the availability of your insulin in the country you are visiting,
• insulin supplies, etc.,
• the correct storage of insulin during travel,
• meal times and insulin administration during travel,
• the possible effects of crossing time zones,
• new health risks in the countries you are visiting,
• what to do in emergency situations when you are ill or become unwell.

Illnesses and injuries

The management of your diabetes may require special care in the following situations (e.g. adjustment of insulin dose, blood and urine tests):

• If you are ill or have a serious injury, your blood sugar level may increase (hyperglycaemia).
  • If you do not eat enough, your blood sugar level may become too low (hypoglycaemia).

In most cases, you will need a doctor. Make sure to consult a doctor immediately.

If you have type 1 diabetes (insulin-dependent diabetes mellitus), do not stop taking your insulin and continue to take enough carbohydrates. Always inform the people treating you that you need insulin.

Treatment with insulin can cause your body to produce antibodies against insulin (substances that act against insulin). In rare cases, this may require a change in your insulin dose.

Some patients with long-standing type 2 diabetes mellitus and pre-existing 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 or rapid weight gain or localised swelling (oedema).

Insulin confusion

You must always check the packaging and label of your insulin before each injection to avoid mix-ups 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 change your blood sugar levels (lower, increase, or both depending on the situation). In each case, it may be necessary to adjust your insulin dose to avoid too low or too high blood sugar levels. Be careful when you start taking another medicine, and also when you stop taking it.

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Ask your doctor before taking a medicine if it can affect your blood sugar level and what action you should take, if necessary.

Among the medicines that can cause a decrease in your blood sugar level (hypoglycaemia) are:

• all other medicines for treating diabetes,
• ACE inhibitors (used to treat certain heart diseases or high blood pressure),
• disopyramide (used to treat certain heart diseases),
• fluoxetine (used to treat depression),
• fibrates (used to lower high blood lipid levels),
• monoamine oxidase inhibitors (MAOIs) (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 a rare disease in which too much growth hormone is produced),
• sulphonamide antibiotics.

Among the medicines that can cause an increase in your blood sugar level (hyperglycaemia) are:

• 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 excess fluid retention),
• glucagon (a pancreatic hormone used to treat severe hypoglycaemia),
• isoniazid (used to treat tuberculosis),
• oestrogens and progestogens (such as the contraceptive pill used for birth control),
• phenothiazine derivatives (used to treat psychiatric diseases),
• somatropin (growth hormone),
• sympathomimetic medicines (such as 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 increase or decrease if you take:

• beta-blockers (used to treat high blood pressure),
• clonidine (used to treat high blood pressure),
• lithium salts (used to treat psychiatric diseases).

Pentamidine (used to treat some parasitic infections) can cause hypoglycaemia, which may sometimes be followed by hyperglycaemia.

Beta-blockers, like other sympatholytic medicines (such as clonidine, guanethidine, and reserpine), can mask or completely suppress the first warning symptoms of hypoglycaemia that could help you recognise it.

If you are not sure if you are taking any of these medicines, consult your doctor or pharmacist.

Using ABASAGLAR with alcohol

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

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Tell your doctor if you are planning to have a baby or if you are already pregnant. Your insulin dose may need to change during pregnancy and after delivery. Close monitoring of your diabetes and prevention of hypoglycaemia are important for your baby's health.

If you are breast-feeding, consult your doctor as you may need to adjust your insulin dose and 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 vision problems.

Be aware of this possible problem, considering all situations that may put you or others at risk (such as driving a vehicle or using machines). You should ask your doctor for advice on driving if:

• you have frequent episodes of hypoglycaemia,
• the first warning symptoms of hypoglycaemia have decreased or disappeared.

ABASAGLAR contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per dose, which is essentially "sodium-free".

3. How to use ABASAGLAR

Follow exactly the instructions for administration of this medicine given by your doctor. If you are not sure, 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. Switching from one insulin treatment to another requires medical prescription, supervision, and blood glucose monitoring. For more information, consult your doctor.

Dose

Based on your lifestyle and the results of your blood glucose (sugar) tests and previous insulin treatment, your doctor:

• will determine the dose of ABASAGLAR you need each day and at what time,
• will tell you when to test your blood sugar level, and if you need to carry out urine tests,
• will tell you when you may need to inject a higher or lower dose of ABASAGLAR.

ABASAGLAR is a long-acting insulin. Your doctor may advise you to use it in combination with a short-acting insulin or with tablets to treat high blood sugar levels.

Many factors can influence your blood sugar level. You should know these factors so that you can react correctly 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 from 2 years of age. Use this medicine exactly as your doctor has told you.

Frequency of administration

You need to inject ABASAGLAR once a day, at the same time every day.

Method of administration

ABASAGLAR is injected under the skin. DO NOT inject ABASAGLAR into a vein, as this will change its action and may cause hypoglycaemia.

Your doctor will show you which area of the skin to inject ABASAGLAR into. With each injection, change the injection site within the area of skin you are using.

How to handle ABASAGLAR KwikPen

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

Read carefully the "Instructions for Use of ABASAGLAR KwikPen" provided with this leaflet. You must use the pen as described in these Instructions for Use.

Before each use, insert a new needle. Only use needles compatible for use with ABASAGLAR KwikPen (see "Instructions for Use of ABASAGLAR KwikPen").

Before each injection, perform a safety test.

Inspect the cartridge before using the pen. Do not use ABASAGLAR KwikPen if you notice particles in it. Only use ABASAGLAR KwikPen if the solution is clear, colourless, and aqueous. Do not shake or mix before use.

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

Make sure 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 getting worse unexpectedly. If you think you may have a problem with ABASAGLAR KwikPen, consult your doctor, pharmacist, or nurse.

Empty pens must not be refilled and should be disposed of properly.

Do not use ABASAGLAR KwikPen if it is damaged or not working properly, it should be discarded and a new KwikPen used.

If you use more ABASAGLAR than you should

• If you have injected too much ABASAGLARor are not sure how much you have injected, your blood sugar level may become too low (hypoglycaemia). Check your blood sugar level frequently. In general, to prevent hypoglycaemia, you should eat more and check your blood sugar level. For more information on treating hypoglycaemia, see the 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 or are not sure how much you have injected, your blood sugar level may increase too much (hyperglycaemia). Check your blood sugar level frequently. For more information on treating hyperglycaemia, see the box at the end of this leaflet.
• Do not take a double dose to make up for forgotten doses.

After injection

If you are not sure how much you have injected, check your blood sugar level before deciding if you need another injection.

If you stop using ABASAGLAR

This could lead to severe hyperglycaemia (very high blood sugar levels) and ketoacidosis (increased acid in the blood because the body is breaking down fat instead of sugar). Do not stop your treatment with ABASAGLAR without consulting your doctor, he will tell you what to do.

If you have any further questions on 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 all people suffer from them.

If you notice signs that your blood sugar level is too low (hypoglycemia),act immediatelyto raise your blood sugar levels. Hypoglycemia (low blood sugar level) can be very serious and is very common during insulin treatment (it can affect more than 1 in 10 people). Low blood sugar means that there is not enough sugar in the blood. If your blood sugar level drops too low, you may faint (lose consciousness). Severe hypoglycemia can cause brain damage and can be life-threatening. For more information, see the box at the end of the prospectus.

Severe allergic reactions(rare, can affect up to 1 in 1,000 people) – the signs may include large-scale 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 can be life-threatening. Inform your doctor immediately if you notice signs of a severe allergic reaction.

Changes in the skin at the injection site

If insulin is injected too frequently in the same place, the fatty tissue can shrink (lipoatrophy, can affect up to 1 in 100 people) or become thicker (lipohypertrophy, can affect up to 1 in 10 people). Lumps under the skin can also occur due to the accumulation of a protein called amyloid (cutaneous amyloidosis, the frequency of which is unknown). Insulin may not work very well if injected into a lumpy area. Change the injection site with each injection to help avoid these skin changes.

Common Adverse Effects(can affect up to 1 in 10 people)

• Skin reactions and allergic reactions at the injection site

The signs may include redness, intense pain when injecting, itching, hives, swelling, or inflammation. These reactions can spread around the injection site. Most mild reactions to insulin disappear usually within a few days or weeks.

Rare Adverse Effects(can affect up to 1 in 1,000 people)

• Eye reactions

A significant change (improvement or worsening) in blood sugar control can temporarily alter your vision. If you have proliferative retinopathy (a vision disease related to diabetes), severe hypoglycemic attacks can cause temporary vision loss.

• General disorders

In rare cases, insulin treatment can also cause temporary water retention in the body, with swelling of the ankles and feet.

Very Rare Adverse Effects(can affect up to 1 in 10,000 people)

In very rare cases, it can cause dysgeusia (taste disorders) and myalgia (muscle pain).

Other Adverse Effects in Children and Adolescents

In general, the adverse effects in children and adolescents under 18 years of age are similar to those in adults.

Claims of reactions at the injection site (injection site pain, injection site reaction) and skin reactions (rash, hives) have been reported more frequently in children and adolescents under 18 years of age than in adults.

Reporting of Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting adverse effects, you can contribute to providing 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 expiration date that appears on the box and the cartridge label after "EXP". The expiration date is 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 cold pack.

Store the pre-filled pen in the outer packaging to protect it from light.

Pens in use

Prefilled pens in use or to be carried as a reserve can be stored for a maximum of 28 days up to 30°C and protected from direct heat or direct light. The pen in use should not be stored in the refrigerator. Do not use after this time period. The pen cap should be placed back on the pen after each injection to protect it from light.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of the packaging and medicines that are no longer needed. This will help protect the environment.

6. Package Contents and Additional Information

Composition of ABASAGLAR

• The active ingredient is insulin glargine. Each milliliter of solution contains 100 units of the active ingredient insulin glargine (equivalent to 3.64 mg).
• The other ingredients are: zinc oxide, metacresol, glycerol, sodium hydroxide (see section 2 "ABASAGLAR contains sodium"), hydrochloric acid, and water for injectable preparations.

Appearance of the Product and Package Contents

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

ABASAGLAR is available in packs of 5 pre-filled pens and in multipacks of 2 boxes, each containing 5 pre-filled pens.

Not all pack sizes may be marketed.

Marketing Authorization Holder

Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, Netherlands.

Manufacturer

Lilly France S.A.S., rue du Colonel Lilly, F-67640 Fegersheim, France.

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Spain

Lilly S.A.

Tel: + 34-91 663 50 00

Date of the Last Revision of this Prospectus: July 2020

Other Sources of Information

Detailed information about this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.

HYPERGLYCEMIA AND HYPOGLYCEMIA

Always carry something sweet with you (at least 20grams).

Always carry some information that indicates you are diabetic.

HYPERGLYCEMIA (high blood sugar levels)

If you have high blood sugar levels (hyperglycemia), you may not have injected enough insulin.

Why does hyperglycemia occur?

Some examples are:

• you did not inject your insulin or did not inject enough, or if its effect has decreased, for example due to incorrect storage,
• your insulin pen is not working properly,
• you are doing less exercise than usual or are under stress (emotional distress, nervousness), or you are suffering from an injury, surgery, infection, or fever,
• you are taking or have taken certain medications (see section 2, "Use of ABASAGLAR with other medications").

Warning signs of hyperglycemia

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

What should you do if you suffer from hyperglycemia?

You should analyze your blood sugar level and your acetone level in the urine as soon as any of the above symptoms occur.Severe hyperglycemia or ketoacidosis should always be treated by a doctor, usually in a hospital.

HYPOGLYCEMIA (low blood sugar levels)

If your blood sugar level drops too low, you may lose consciousness. Severe hypoglycemia can cause a heart attack or brain damage and can be life-threatening. You should usually be able to recognize when your blood sugar level is dropping too low to take the necessary measures.

Why does hypoglycemia occur?

Some examples are:

• you inject too much insulin,
• you miss meals or delay them,
• you do not eat enough, or you eat foods that contain less carbohydrates than usual (sugar and similar substances are called carbohydrates; however, artificial sweeteners are NOT carbohydrates),
• you lose carbohydrates due to vomiting or diarrhea,
• you drink alcohol, especially 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 surgery or other types of stress,
• you are recovering from an illness or fever,
• you are taking or have stopped taking certain medications (see section 2, "Use of ABASAGLAR with other medications").

It is also more likely that hypoglycemia will occur if

• you have just started insulin treatment or changed to another insulin preparation (when you change from your previous basal insulin to ABASAGLAR, if hypoglycemia occurs, it is more likely to happen in the morning than at night),

• your blood sugar levels are almost normal or unstable,
• you change the skin injection site (for example from the thigh to the upper arm),
• you have a serious kidney or liver disease, or another disease such as hypothyroidism.

Warning signs of hypoglycemia

• In your body

Examples of symptoms that indicate your blood sugar level is dropping too low or too quickly: sweating, damp and sticky skin, anxiety, rapid heartbeat, high blood pressure, palpitations, and irregular heartbeat. These symptoms often occur before the symptoms of low blood sugar in the brain appear.

• In your brain

Examples of symptoms that indicate low blood sugar in the brain: headaches, intense hunger, nausea, vomiting, fatigue, drowsiness, sleep disorders, restlessness, aggressive behavior, concentration problems, altered reactions, depression, confusion, speech disorders (sometimes total loss of speech), visual disorders, tremors, paralysis, tingling sensations (paresthesia), numbness and tingling sensations in the mouth area, dizziness, loss of self-control, inability to take care of yourself, convulsions, loss of consciousness.

The first symptoms that alert you to hypoglycemia ("warning symptoms") can change, weaken, or be absent if

• you are an elderly person, have had diabetes for a long time, or suffer from a certain type of nerve disease (autonomic diabetic neuropathy),
• you have recently had a hypoglycemic episode (for example the day before) or if it develops gradually,
• you have almost normal or at least much improved blood sugar levels,
• you have recently changed from an animal insulin to a human insulin like ABASAGLAR,
• you are taking or have taken certain medications (see section 2, "Use of ABASAGLAR with other medications").

In such cases, you may experience severe hypoglycemia (and even faint) before you realize the problem. Always be familiar with your warning symptoms. If necessary, performing blood sugar analyses more frequently can help identify mild hypoglycemic episodes that would otherwise go unnoticed. If you are not sure you can recognize your warning symptoms, avoid situations (such as driving a car) that could put you or others in danger due to hypoglycemia.

What should you do if you suffer from hypoglycemia?

1. Do not inject insulin. Immediately ingest 10 to 20 grams of sugar, such as glucose, sugar cubes, or a sugary drink. Note: Artificial sweeteners and foods with artificial sweeteners instead of sugar (such as diet drinks) do not help treat hypoglycemia.

1. Then, eat something that increases your blood sugar level in the long term (such as bread or pasta). Your doctor or nurse should have discussed this with you beforehand.

Recovery from hypoglycemia may be delayed because ABASAGLAR has a prolonged action.

1. If hypoglycemia recurs, take another 10 to 20 grams of sugar.

1. Consult a doctor immediately if you are unable to control hypoglycemia or if it recurs. Inform your family, friends, and close ones:

If you are unable to swallow or lose consciousness, you will need a glucose or glucagon injection (a medication that increases blood sugar levels). These injections are justified even if you are not sure you have hypoglycemia.

It is recommended to analyze your blood sugar level immediately after ingesting glucose to confirm that you actually have hypoglycemia.