ILINPRU 5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for thepatient

Ilinpru5mg film-coated tablets EFG

linagliptina

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the package leaflet

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

1. What is Ilinpru and what is it used for

Ilinpru contains the active substance linagliptin, which belongs to a group of medicines called “oral antidiabetics”. Oral antidiabetics are used to treat high blood sugar levels. They work by helping your body to reduce the level of sugar in your blood.

Linagliptina is used to treat “type 2 diabetes” in adults, if the disease cannot be controlled adequately with an oral antidiabetic medicine (metformin or sulfonylureas) or diet and exercise alone. Linagliptina can be used in combination with other oral antidiabetic medicines, e.g., metformin, sulfonylureas (e.g., glimepiride, glipizide), empagliflozin, or insulin.

It is important that you follow the advice on diet and exercise given to you by your doctor or nurse.

2. What you need to know before you take Ilinpru

Do not takeIlinpru

• if you are allergic to linagliptina or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor, pharmacist, or nurse before taking this medicine if you:

• have type 1 diabetes (your body does not produce insulin) or diabetic ketoacidosis (a complication of diabetes with high blood sugar levels, rapid weight loss, nausea, or vomiting). Linagliptina should not be used to treat these conditions.
• are taking a sulfonylurea medicine (e.g., glimepiride, glipizide); your doctor may want to reduce your sulfonylurea dose when taken with linagliptina to avoid low blood sugar levels.
• have had allergic reactions to any other medicine you take to control the amount of sugar in your blood.
• have or have had pancreatitis.

If you experience symptoms of acute pancreatitis, such as severe and persistent stomach pain, you should consult your doctor.

If you find blisters on your skin, it could be a sign of a disease called bullous pemphigoid. Your doctor may advise you to stop taking linagliptina.

Diabetic skin lesions are a common complication of diabetes. Follow the recommendations on skin and foot care given to you by your doctor or nurse.

Children and adolescents

Linagliptina is not recommended for children and adolescents under 18 years of age. It is not effective in children and adolescents between 10 and 17 years of age. The safety and efficacy of this medicine in children under 10 years of age are not known.

Other medicines andIlinpru

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

In particular, you should inform your doctor if you are using medicines that contain any of the following active substances:

• Carbamazepine, phenobarbital, or phenytoin. These may be used to control seizures (convulsions) or chronic pain.
• Rifampicin. This is an antibiotic used to treat infections such as tuberculosis.

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 taking this medicine.

It is not known if linagliptina is harmful to the fetus. Therefore, it is preferable to avoid using linagliptina if you are pregnant.

It is not known if linagliptina passes into breast milk. Your doctor must decide whether to stop breast-feeding or stop linagliptina treatment.

Driving and using machines

Linagliptina has no or negligible influence on the ability to drive and use machines.

Taking linagliptina in combination with sulfonylureas and/or insulin may cause low blood sugar levels (hypoglycemia), which can affect your ability to drive and use machines or work without a safe support. However, more frequent blood glucose tests may be recommended to reduce the risk of hypoglycemia, especially when linagliptina is combined with a sulfonylurea and/or insulin.

3. How to take Ilinpru

Always take this medicine exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.

The recommended dose of linagliptina is one 5 mg tablet once a day.

You can take linagliptina with or without food.

Your doctor may prescribe linagliptina in combination with another oral antidiabetic medicine. Remember to take all your medicines as your doctor has instructed to get the best results for your health.

If you take moreIlinpruthan you should

If you take more linagliptina than you should, contact a doctor immediately.

In case of overdose or accidental ingestion, contact your doctor, pharmacist, or call the Toxicology Information Service, phone 91 562 04 20, stating the medicine and the amount taken.

If you forget to takeIlinpru

• If you forget to take a dose of linagliptina, take it as soon as you remember. However, if it is almost time for your next dose, do not take the missed dose.
• Do not take a double dose to make up for forgotten doses. Never take two doses on the same day.

If you stop takingIlinpru

Do not stop taking linagliptina without consulting your doctor first. Your blood sugar levels may increase when you stop taking linagliptina.

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

4. Possible side effects

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

Some symptoms need immediate medical attention

Stop taking linagliptina and contact your doctor immediately if you experience the following symptoms of low blood sugar: trembling, sweating, anxiety, blurred vision, tingling of the lips, pallor, mood changes, or confusion (hypoglycemia). Hypoglycemia (frequency: very common, may affect more than 1 in 10 people) is a side effect identified when linagliptina is taken with metformin and a sulfonylurea.

Some patients have experienced allergic reactions (hypersensitivity; frequency uncommon, may affect up to 1 in 100 people) while taking linagliptina alone or in combination with other diabetes medicines, which can be severe, including wheezing and shortness of breath (bronchial hyperreactivity; frequency not known, cannot be estimated from the available data). Some patients have experienced skin rash (frequency uncommon), hives (urticaria; frequency rare, may affect up to 1 in 1,000 people), and swelling of the face, lips, tongue, and throat that can cause difficulty breathing or swallowing (angioedema; frequency rare). If you experience any of the above-mentioned signs of illness, stop taking linagliptina and call your doctor immediately. Your doctor may prescribe a medicine to treat your allergic reaction and a different medicine for your diabetes.

Some patients have experienced pancreatitis (frequency rare, may affect up to 1 in 1,000 people) while taking linagliptina alone or in combination with other diabetes medicines.

STOPtaking linagliptina and contact a doctor immediately if you notice any of the following serious side effects:

• Severe and persistent abdominal pain (stomach area), which may radiate to the back, as well as nausea and vomiting, as this could be a sign of pancreatitis.

Some patients have experienced the following side effects while taking linagliptina alone or in combination with other diabetes medicines:

• Common: elevated lipase levels in the blood.
• Uncommon: inflammation of the nose or throat (nasopharyngitis), cough, constipation (in combination with insulin), elevated amylase levels in the blood.
• Rare: blisters on the skin (bullous pemphigoid).

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines Agency's website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Ilinpru

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 blister, bottle, and carton after “EXP”. The expiry date refers to the last day of the month shown.

This medicine does not require any special storage conditions.

Do not use this medicine if the packaging is damaged or shows signs of tampering.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Ilinpru contains

• The active substance is linagliptina. Each film-coated tablet contains 5 mg of linagliptina.
• The other ingredients are:

Core of the tablet: mannitol (E421), corn starch (E1404), copovidone, magnesium stearate (E572).

Coating material: hypromellose (type 2910), titanium dioxide (E171), macrogol 3350, talc, and red iron oxide (E172).

Appearance and packaging

Film-coated tablet, pink, round, biconvex, engraved with the inscription “M” on one side of the tablet and “LI” on the other side, with a diameter of approximately 7.6 mm.

Available in:

PVC/OPA/Al blisters containing 14, 28, 30, 90, and 100 film-coated tablets.

PVC/OPA/Al unit dose blisters containing 10 x 1, 30 x 1, and 90 x 1 film-coated tablets.

HDPE bottle with a polypropylene (PP) screw cap and a silica gel desiccant, pack sizes of 30, 90, 100, and 120 film-coated tablets in a cardboard box or provided without a box.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Manufacturer

Mylan Hungary Kft.

Mylan utca. 1

H-2900 Komárom

Hungary

This medicine is authorised in the Member States of the European Economic Area under the following names:

Austria Ilinpru 5 mg Filmtabletten

Cyprus Ilinpru 5 mg επικαλυμμ?να με λεπτ? υμ?νιο δισκ?α

Spain Ilinpru 5 mg comprimidos recubiertos con película EFG

Greece Ilinpru

Malta Ilinpru 5 mg Film-coated tablets

Czech Republic Ilinpru 5 mg

For further information about this medicine, contact the local representative of the marketing authorisation holder:

Viatris Pharmaceuticals, S.L.

C/ General Aranaz, 86

28027 - Madrid

Spain

Date of last revision of this leaflet:December 2023

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.