LINAGLIPTIN MEDOCHEMIE 5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Linagliptina Medochemie 5 mg Film-Coated Tablets EFG

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

• Keep this package 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 get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Linagliptina Medochemie and what is it used for
2. What you need to know before you take Linagliptina Medochemie
3. How to take Linagliptina Medochemie
4. Possible side effects
5. Storage of Linagliptina Medochemie
6. Package Contents and Additional Information

1. What is Linagliptina Medochemie and what is it used for

Linagliptina Medochemie contains the active substance linagliptin, which belongs to a group of medicines known as "oral antidiabetics". Oral antidiabetics are used to treat high blood sugar levels. They work by helping your body to lower your blood sugar level.

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 antidiabetic medicines, e.g., metformin, sulfonylureas (e.g., glimepiride, glipizide), empagliflozin, or insulin.

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

2. What you need to know before you take Linagliptina Medochemie

Do not takelinagliptina

• 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 linagliptina 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 your blood sugar levels.
• have or have had pancreatic disease.

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 skin and foot care recommendations given 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. It is not known if this medicine is safe and effective when used in children under 10 years of age.

Other Medicines and Linagliptina Medochemie

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

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

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

Pregnancy andBreastfeeding

If you are pregnant or breastfeeding, 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 will decide whether you should stop breastfeeding or stop taking linagliptina.

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 Linagliptina Medochemie

Follow exactly the administration instructions of this medicine given by your doctor.

In case of doubt, consult your doctor or pharmacist again.

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 directed by your doctor to achieve the best results for your health.

If You Take More Linagliptina Medochemie Than You Should

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

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

If You Forget to TakeLinagliptina Medochemie

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 Taking Linagliptina Medochemie

Do not stop taking this medicine 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

You should stop taking linagliptina and see your doctor immediately if you experience the following symptoms of low blood sugar: shaking, sweating, anxiety, blurred vision, tingling of the lips, paleness, 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 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 consult a doctor immediately if you observe 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 an inflamed pancreas (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 experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible side effects not listed in this package leaflet. You can also report side effects directly through the Spanish Medicines Agency's website (www.notificaRAM.es). By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Linagliptina Medochemie

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 packaging after EXP. The expiry date refers to the last day of the month shown.

This medicine does not require any special storage conditions.

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. Package Contents and Additional Information

Composition of Linagliptina Medochemie

• The active substance is linagliptin. Each film-coated tablet contains 5 mg of linagliptin.
• The other ingredients are mannitol, pregelatinized starch, corn starch, copovidone K-28, magnesium stearate, hypromellose 2910/6, titanium dioxide E171, macrogol 4000, talc, iron oxide red E172.

Appearance of the Product and Package Contents

Red, round, biconvex, smooth film-coated tablets, 8 mm in diameter.

Aluminum/polyamide/aluminum/PVC blisters

Pack sizes of 30 and 90 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Medochemie Ltd.

1-10 Constantinoupoleos Street

3011 Limassol

Cyprus

Manufacturer

Medochemie Ltd.

Factory Az, Agios Athanassios Industrial Area, Michali Irakleous 2,

Agios Athanasios,

4101 Limassol,

Cyprus

This medicine is authorized in the EEA member states with the following names:

Date of Last Revision of this Package Leaflet:June 2024

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/).