Label: information for the user

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

insulin glargina

Read this label carefully, including the Instructions for Use of ABASAGLAR KwikPenpre-filled pen, before starting to use this medication because it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they do not appear in this label. See section 4.

1. What is ABASAGLAR and how it is used

2. What you need to know before starting to use ABASAGLAR

3. How to use ABASAGLAR

4. Possible adverse effects

5. Storage of ABASAGLAR

6. Contents of the package and additional information

ABASAGLARcontains insulin glargina. This is a modified insulin, very similar to human insulin.

ABASAGLARis used in the treatment of type 2 diabetes in adult, adolescent, and pediatric patients aged 2 years and older.

Type 2 diabetes is a disease in which your body does not produce enough insulin to control blood sugar levels. Insulin glargina has a prolonged and constant action of reducing blood sugar levels.

Do not use ABASAGLAR

If you are allergic to insulin glargina or any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use ABASAGLAR.

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

If your blood sugar is too low (hypoglycemia), follow the guide on hypoglycemia (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 in a swollen area (see How to use Abasaglar). Contact your doctor if you are currently injecting in a swollen area, before starting to inject in a different area. Your doctor may instruct you to check your blood sugar levels more closely, and adjust the insulin or your other diabetes medications.

Travel

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

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

-insulin reservations, etc.,

-correct storage of insulin during the trip,

-meal and insulin administration schedules during the trip,

-possible effects of traveling to areas with time zone differences,

-possible new health risks in the countries you are visiting,

-what to do in emergency situations when you are ill or become sick.

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 severe injury, your blood sugar level may increase (hyperglycemia).

• If you do not eat enough, your blood sugar level may be too low (hypoglycemia).

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

If you have type 1 diabetes (insulin-dependent diabetes), do not stop administering your insulin and do not stop taking enough carbohydrates. Always inform the people taking care of you or treating you that you need insulin.

The treatment with insulin may 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 and a history of heart disease or previous stroke who were treated with pioglitazone and insulin have experienced heart failure. Inform your doctor as soon as possible if you experience symptoms of heart failure such as shortness of breath or rapid weight gain or localized swelling (edema).

Insulin mix-ups

Always check the box and label of 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.

Use of ABASAGLAR with other medications

Some medications can cause changes in blood sugar levels (decrease, increase, or both depending on the situation). In each case, you may need to adjust your insulin dose to avoid low or high blood sugar levels. Be careful when starting another medication, and also when stopping it.

Inform your doctor or pharmacist if you are taking,have taken recentlyor may need to take any other medication. Ask your doctor before taking a medication if it can affect your blood sugar level, and what measures to take in your case.

Medications that can cause a decrease in your blood sugar level (hypoglycemia) include:

-all other diabetes medications,

-angiotensin-converting enzyme (ACE) inhibitors (used to treat certain heart or high blood pressure diseases),

-disopyramide (used to treat certain heart diseases),

-fluoxetine (used to treat depression),

-fibrates (used to reduce high levels of lipids in the blood),

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

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

-analogues of somatostatin (such as octreotide, used to treat a rare disease in which too much growth hormone is produced),

-sulfonamide antibiotics.

Medications that can cause an increase in your blood sugar level (hyperglycemia) include:

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

-danazol (a medication that acts on 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 hypoglycemia),

-isoniazid (used to treat tuberculosis),

-estrogens and progestogens (such as in birth control pills used for contraception),

-phenothiazine derivatives (used to treat psychiatric diseases),

-somatropin (growth hormone),

-sympathomimetics (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 diseases).

Pentamidine (used to treat some parasitic infections) may cause hypoglycemia, which may sometimes be followed by hyperglycemia.

Beta-blockers, like other sympatholytic medications (such as clonidine, guanethidine, and reserpine), may attenuate or suppress the early warning symptoms that could help you recognize hypoglycemia.

If you are unsure whether you are taking any of these medications, consult your doctor or pharmacist.

Use of ABASAGLAR with alcohol

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

Inform your doctor if you are planning to become pregnant or if you are already pregnant. Your insulin dose may need to be adjusted during pregnancy and after delivery. Close monitoring 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 to adjust your insulin dose and diet.

Driving and operating machinery

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 possible problem, considering all situations that may pose a risk to you or others (such as driving a vehicle or operating machinery). You should ask your doctor for advice on driving if:

-you have frequent episodes of hypoglycemia,

-your early warning symptoms of hypoglycemia have decreased or do not appear.

ABASAGLAR contains sodium

This medication contains less than 1mmol (23mg) of sodium per dose, so it is considered essentially "sodium-free".

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Although ABASAGLAR contains the same active ingredient as Toujeo (insulin glargine 300 units/ml), these medications are not interchangeable. Changing from one insulin treatment to another requires a doctor's prescription, medical supervision, and blood glucose control. For more information, consult your doctor.

Dose

Your doctor will determine the dose of ABASAGLAR you need each day and at what time, based on your lifestyle and the results of your blood sugar (glucose) tests and your previous insulin treatment.

- Determine the dose of ABASAGLAR you need each day and at what time.

- Indicate when you should analyze your blood sugar level, and if you need to perform urine tests.

- Indicate 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 short-acting insulin or with tablets to treat elevated 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 from rising or falling too much. 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 medication exactly as your doctor has told you.

Frequency of administration

You need a daily injection of ABASAGLAR, always at the same time.

Administration form

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

Your doctor will show you where on the skin you should inject ABASAGLAR. With each injection, you should change the puncture site within the specific area of the skin you are using.

How to handle ABASAGLAR KwikPen

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

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

Before each use, insert a new needle. Use only needles compatible 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 see particles in it. Only use ABASAGLAR KwikPen if the solution is transparent, colorless, and watery. Do not shake or mix before use.

To prevent the possible transmission of diseases, each pen must be used exclusively by a single patient.

Make sure the insulin does not come into contact with alcohol or other disinfectants, or with other substances.

Always use a new pen if you notice that your blood sugar control is worsening unexpectedly. If you think you may have a problem with ABASAGLAR KwikPen, consult your doctor, pharmacist, or nurse.

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

Do not use ABASAGLAR KwikPen if it is damaged or does not work correctly. Dispose of it and use a new KwikPen.

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 level frequently. In general, to prevent hypoglycemia, you should eat more and control your blood sugar level. For more information on treating hypoglycemia, see the box at the end of this leaflet.

If you forget to use ABASAGLAR

• If you have forgotten a dose of ABASAGLAR or have not injected enough insulin or are unsure how much you have injected, your blood sugar level may become too high (hyperglycemia). Check your blood sugar level frequently. For more information on treating hyperglycemia, see the box at the end of this leaflet.
• Do not take a double dose to compensate for the missed doses.

After the injection

If you are unsure how much you have injected, check your blood sugar level before deciding if you need another injection.

If you interrupt treatment with ABASAGLAR

This could cause severe hyperglycemia (very high blood sugar levels) and ketoacidosis (an increase in 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, who will tell you what to do.

If you have any other questions about the use of this medication, ask your doctor, pharmacist, or nurse.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

If you notice signs that your blood sugar level is too low (hypoglycemia),actimmediatelyto raise your blood sugar levels. Low blood sugar (hypoglycemia) can be very serious and is very common during insulin treatment (it can 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). A severe hypoglycemia can cause brain damage and put your life at risk. 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 includelarge-scale skin reactions (rash and itching all over the body), severe skin or mucous membrane swelling (angioedema), difficulty breathing, low blood pressure with rapid heart rate and sweating. Severe allergic reactions to insulin can put your life at risk. Inform your doctor immediately if you notice signs of severe allergic reaction.

Changes in skin at the injection site

If insulin is injected too frequently in the same place, the fatty tissue may shrink (lipoatrophy, can affect up to 1 in 100 people) or become thicker (lipohypertrophy, can affect up to 1 in 10 people). Bumps under the skin may also occur due to the accumulation of a protein called amyloid (cutaneous amyloidosis, it is not known how often this occurs). Insulin may not work well if injected in a swollen area. Change the injection site with each injection to help prevent these skin changes.

Frequent side 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 on injection, itching, urticaria, 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 side effects(can affect up to 1 in 1,000 people)

• Eye reactions

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

• General disorders

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

Very rare side effects(can affect up to 1 in 10,000 people)

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

Other side effects in children and adolescents

Generally, side effects in children and adolescents under 18 years are similar to those that appear in adults.

There have been more frequent reports of complaints about reactions at the injection site (pain at the injection site, reaction at the injection site) and skin reactions (rash, urticaria) in children and adolescents under 18 years than in adults.

Reporting side effects

If you experienceany type of side effect, consult your doctor or pharmacist, even if it is apossibleside effect that does not appear in this prospectus.You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box and the cartridge label after “CAD”. The expiration date is the last day of the month indicated.

Unused Pens

Store in refrigerator (between 2°C and 8°C). Do not freeze.

Do not place ABASAGLAR near the freezer compartment or next to a cold storage unit.

Store the preloaded pen in the outer packaging to protect it from light.

Used Pens

Preloaded pens in use or for reserve can be stored for a maximum of 28days until 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 period of time. The pen cap should be placed back on the pen after each injection to protect it from light.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medicines that you no longer need. This will help protect the environment.

Composition of ABASAGLAR

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

Appearance of the product and contents of the pack

ABASAGLAR 100units/mL injectable solution in a pre-filled pen, KwikPen, is a transparent and colorless solution.

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

Only some pack sizes may be marketed.

Marketing authorization holder

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

Responsible for manufacturing

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

For further information about this medicinal product, please consult the representative of the marketing authorization holder in your country:

Spain

Lilly S.A.

Phone: + 34-91 663 50 00

Last update of the summary of product characteristics: July 2020

Other sources of information

The detailed information on this medicinal product is available on the website of the European Medicines Agency:http://www.ema.europa.eu.