LINAGLIPTIN 5 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the User
2. Linagliptin TZF, 5 mg, Film-Coated Tablets
   1. Read the Package Leaflet Carefully Before Taking the Medicinal Product
   2. Table of Contents of the Package Leaflet
3. What is Linagliptin TZF and What is it Used For
4. Important Information Before Taking Linagliptin TZF
   1. When Not to Take Linagliptin TZF
   2. Warnings and Precautions
   3. Children and Adolescents
   4. Linagliptin TZF with Other Medicinal Products
   5. Pregnancy and Breast-Feeding
   6. Driving and Using Machines
5. How to Take Linagliptin TZF
   1. If You Take More Linagliptin TZF Than You Should
   2. If You Forget to Take Linagliptin TZF
   3. If You Stop Taking Linagliptin TZF
6. Possible Side Effects
   1. Reporting Side Effects
7. How to Store Linagliptin TZF
8. Contents of the Package and Other Information
   1. What Linagliptin TZF Contains
   2. What Linagliptin TZF Looks Like and Contents of the Package
   3. Marketing Authorization Holder and Manufacturer
   4. This Medicinal Product is Authorized in the Member States of the European Economic Area Under the Following Names:

Package Leaflet: Information for the User

Linagliptin TZF, 5 mg, Film-Coated Tablets

Linagliptinum

Read the Package Leaflet Carefully Before Taking the Medicinal Product

• Keep this package leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicinal product has been prescribed for you. 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. See section 4.

Table of Contents of the Package Leaflet

• 1. What is Linagliptin TZF and What is it Used For
• 2. Important Information Before Taking Linagliptin TZF
• 3. How to Take Linagliptin TZF
• 4. Possible Side Effects
• 5. How to Store Linagliptin TZF
• 6. Contents of the Package and Other Information

1. What is Linagliptin TZF and What is it Used For

Linagliptin TZF contains the active substance linagliptin, which belongs to a group of medicinal products called "oral anti-diabetic medicinal products". Oral anti-diabetic medicinal products are used to treat high blood sugar levels. These medicinal products help the body to reduce the amount of sugar in the blood. Linagliptin TZF is used to treat type 2 diabetes in adults when the disease cannot be controlled by diet and exercise or by using another oral anti-diabetic medicinal product (metformin or sulphonylurea) alone. Linagliptin TZF can be used in combination with other anti-diabetic medicinal products, such as metformin, sulphonylurea (e.g. glimepiride, glipizide), empagliflozin, or insulin. It is important to continue with the diet and exercise as recommended by your doctor or nurse.

2. Important Information Before Taking Linagliptin TZF

When Not to Take Linagliptin TZF

if you are allergic to linagliptin or any of the other ingredients of this medicinal product (listed in section 6).

Warnings and Precautions

Before taking Linagliptin TZF, talk to your doctor, pharmacist, or nurse if: you have type 1 diabetes (your body does not produce insulin) or diabetic ketoacidosis (a complication of diabetes characterized by high blood sugar levels, rapid weight loss, nausea, or vomiting). Linagliptin TZF should not be used to treat these conditions. you are taking a sulphonylurea medicinal product (e.g. glimepiride, glipizide), your doctor may advise you to reduce the dose of the sulphonylurea medicinal product if you are also taking Linagliptin TZF, to avoid too low blood sugar levels. you have had an allergic reaction to any other medicinal product used to reduce blood sugar levels. you have or have had pancreatic disease. If you experience symptoms of acute pancreatitis, such as severe and persistent abdominal pain, you should contact your doctor. If you develop blisters on your skin, this may be a sign of a condition called bullous pemphigoid. Your doctor may advise you to stop taking Linagliptin TZF. Diabetic skin changes are common complications of diabetes. You should follow the recommendations for skin and foot care given by your doctor or nurse.

Children and Adolescents

Linagliptin TZF is not recommended for use in children and adolescents below 18 years of age.

Linagliptin TZF with Other Medicinal Products

Tell your doctor or pharmacist about all the medicinal products you are taking or have recently taken, and about any medicinal products you plan to take. In particular, tell your doctor if you are taking medicinal products containing any of the following active substances: carbamazepine, phenobarbital, or phenytoin. These medicinal products may be used to treat epilepsy 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 medicinal product. It is not known if Linagliptin TZF is harmful to the unborn child. Therefore, it is recommended to avoid taking Linagliptin TZF during pregnancy. It is not known if Linagliptin TZF passes into breast milk. Your doctor will decide whether you should stop breast-feeding or stop/ interrupt Linagliptin TZF therapy.

Driving and Using Machines

Linagliptin TZF has no or negligible influence on the ability to drive and use machines. When taking Linagliptin TZF in combination with sulphonylurea and/or insulin, you may experience too low blood sugar levels (hypoglycaemia), which may affect your ability to drive and use machines or work without strong support for your legs. However, it is recommended to check your blood sugar levels more frequently to minimize the risk of hypoglycaemia, especially when taking Linagliptin TZF in combination with sulphonylurea and/or insulin.

3. How to Take Linagliptin TZF

Always take this medicinal product exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist. The recommended dose of Linagliptin TZF is one 5 mg tablet once a day. You can take Linagliptin TZF with or without food. Your doctor may advise you to take Linagliptin TZF in combination with another oral anti-diabetic medicinal product. Take all the medicinal products as recommended by your doctor to get the best results.

If You Take More Linagliptin TZF Than You Should

If you take more Linagliptin TZF than you should, contact your doctor immediately.

If You Forget to Take Linagliptin TZF

If you forget to take a dose, 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 a forgotten dose. Never take two doses on the same day.

If You Stop Taking Linagliptin TZF

Do not stop taking Linagliptin TZF without talking to your doctor first. If you stop taking Linagliptin TZF, your blood sugar levels may increase. If you have any further questions on the use of this medicinal product, ask your doctor, pharmacist, or nurse.

4. Possible Side Effects

Like all medicinal products, Linagliptin TZF can cause side effects, although not everybody gets them. Some symptoms require immediate medical attention. Stop taking Linagliptin TZF and contact your doctor immediately if you experience any of the following symptoms related to low blood sugar levels: shaking, sweating, anxiety, blurred vision, tingling of the lips, paleness, mood changes, or confusion (hypoglycaemia). Hypoglycaemia (very common, occurs in more than 1 in 10 people) is a known side effect of Linagliptin TZF when taken in combination with metformin and sulphonylurea. Some patients have experienced allergic reactions (hypersensitivity; uncommon, occurs in less than 1 in 100 people) while taking Linagliptin TZF alone or in combination with other anti-diabetic medicinal products, which may be severe, including wheezing and shortness of breath (bronchospasm; frequency not known, cannot be estimated from the available data). Some patients have experienced rash (uncommon), urticaria (rare, occurs in less than 1 in 1000 people), and swelling of the face, lips, tongue, and throat, which may cause difficulty breathing or swallowing (angioedema; rare). If you experience any of these symptoms, stop taking Linagliptin TZF and contact your doctor immediately. Your doctor may prescribe a medicinal product to treat the allergic reaction and another anti-diabetic medicinal product. While taking Linagliptin TZF alone or in combination with other anti-diabetic medicinal products, some patients have experienced pancreatitis (pancreatitis; rare, occurs in less than 1 in 1000 people). STOP taking Linagliptin TZF and contact your doctor immediately if you experience any of the following severe side effects: severe and persistent abdominal pain (in the stomach area), which may radiate to the back, as well as nausea and vomiting, as these may be symptoms of pancreatitis. While taking Linagliptin TZF alone or in combination with other anti-diabetic medicinal products, some patients have experienced the following side effects: Common: increased lipase activity in the blood. Uncommon: nasal or throat inflammation, cough, constipation (when taken with insulin), increased amylase activity in the blood. Rare: blistering of the skin (bullous pemphigoid).

Reporting Side Effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. Side effects can also be reported to the Department of Medicinal Product Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicinal product.

5. How to Store Linagliptin TZF

Keep this medicinal product out of the sight and reach of children. Do not use this medicinal product after the expiry date which is stated on the blister and carton after EXP and the expiry date (EXP). The expiry date refers to the last day of the month. There are no special storage instructions for this medicinal product. Do not use Linagliptin TZF if the packaging is damaged or shows signs of tampering. Medicinal products should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicinal products that are no longer needed. This will help protect the environment.

6. Contents of the Package and Other Information

What Linagliptin TZF Contains

The active substance is linagliptin. Each film-coated tablet contains 5 mg of linagliptin. The other ingredients are: Tablet core: mannitol, maize starch, copovidone, magnesium stearate. Tablet coating: hypromellose 2910, 5 cP, titanium dioxide (E171), talc, macrogol 6000, red iron oxide (E172).

What Linagliptin TZF Looks Like and Contents of the Package

Linagliptin TZF film-coated tablets are light red, round, biconvex, with beveled edges, and a diameter of 8 mm, with the inscription "L5" on one side and smooth on the other side. Linagliptin TZF is available in single-dose perforated blisters made of OPA/Aluminium/PVC/Aluminium in a cardboard box. The pack sizes are 10 x 1, 14 x 1, 28 x 1, 30 x 1, 56 x 1, 60 x 1, 84 x 1, 90 x 1, 98 x 1, 100 x 1 film-coated tablets. Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder: Tarchomińskie Zakłady Farmaceutyczne "Polfa" Spółka Akcyjna ul. A. Fleminga 2 03-176 Warsaw Manufacturer/Importer: Laboratori Fundació Dau C/ C, 12-14 Pol. Ind. Zona Franca 08040 Barcelona Spain Pharmadox Healthcare Limited KW20A Kordin Industrial Estate PLA 3000, Paola Malta

This Medicinal Product is Authorized in the Member States of the European Economic Area Under the Following Names:

Greece: Linagliptin Intas 5mg επικαλυμμένα με λεπτό υμένιο δισκία Poland: Linagliptin TZF, 5 mg, film-coated tablets Netherlands: Linagliptin Intas 5 mg filmomhulde tabletten Italy: Linagliptin Intas 5 mg compresse rivestite con film Spain: Linagliptina Intas 5 mg comprimidos recubiertos con película EFG Date of Last Revision of the Package Leaflet:September 2024