TINGAPLA 5 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the User
2. Tingapla, 5 mg, coated tablets
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Package Leaflet Contents
3. What is Tingapla and what is it used for
4. Important information before taking Tingapla
   1. When not to take Tingapla
   2. Warnings and precautions
   3. Children and adolescents
   4. Tingapla and other medicines
   5. Pregnancy and breastfeeding
   6. Driving and using machines
5. How to take Tingapla
   1. If you take more Tingapla than you should
   2. If you forget to take Tingapla
   3. If you stop taking Tingapla
6. Possible side effects
   1. Reporting side effects
7. How to store Tingapla
8. Contents of the pack and other information
   1. What Tingapla contains
   2. What Tingapla looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. This medicine is authorized in the Member States of the European Economic Area under the following names:
   6. Date of last revision of the package leaflet:

Package Leaflet: Information for the User

Tingapla, 5 mg, coated tablets

Linagliptin

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• 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 experience any side effects, including those not listed in this package leaflet, please inform your doctor, pharmacist, or nurse. See section 4.

Package Leaflet Contents

• 1. What is Tingapla and what is it used for
• 2. Important information before taking Tingapla
• 3. How to take Tingapla
• 4. Possible side effects
• 5. How to store Tingapla
• 6. Contents of the pack and other information

1. What is Tingapla and what is it used for

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

2. Important information before taking Tingapla

When not to take Tingapla

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

Warnings and precautions

Before taking Tingapla, discuss with 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). Tingapla should not be used to treat these conditions.
• if you are taking a sulfonylurea derivative (e.g., glimepiride, glipizide), your doctor may recommend reducing the dose of the sulfonylurea derivative if you are also taking Tingapla, to avoid too low blood sugar levels.
• if you have had an allergic reaction to any other medicines used to lower blood sugar levels in the past.
• if you have or have had pancreatitis in the past.

If you experience symptoms of acute pancreatitis, such as severe and persistent abdominal pain, contact your doctor immediately. If you develop blisters on your skin, it may be a sign of a condition called bullous pemphigoid. Your doctor may recommend stopping Tingapla. Diabetic skin changes are common complications of diabetes. Follow the skin and foot care recommendations given by your doctor or nurse.

Children and adolescents

Tingapla should not be used in children and adolescents under 18 years of age. It is not effective in children and adolescents aged 10 to 17 years. It is not known if this medicine is safe and effective when used in children under 10 years of age.

Tingapla and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take, including:

• carbamazepine, phenobarbital, or phenytoin, which may be used to treat epilepsy or chronic pain.
• rifampicin, an antibiotic used to treat infections such as tuberculosis.

Pregnancy and breastfeeding

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 Tingapla is harmful to unborn babies, so it is recommended to avoid taking Tingapla during pregnancy. It is not known if Tingapla passes into breast milk. Your doctor will decide whether you should stop breastfeeding or stop/withhold Tingapla treatment.

Driving and using machines

Tingapla has no or negligible influence on the ability to drive and use machines. When taking Tingapla in combination with sulfonylurea derivatives and/or insulin, it may cause too low blood sugar levels (hypoglycemia), 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 glucose levels more frequently to minimize the risk of hypoglycemia, especially when taking Tingapla in combination with sulfonylurea derivatives and/or insulin.

3. How to take Tingapla

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist. The recommended dose of Tingapla is one 5 mg tablet once a day. You can take Tingapla with or without food. Your doctor may recommend taking Tingapla with another oral anti-diabetic medicine. Take all medicines as recommended by your doctor to get the best results.

If you take more Tingapla than you should

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

If you forget to take Tingapla

• 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 Tingapla

Do not stop taking Tingapla without consulting your doctor. If you stop taking Tingapla, your blood sugar levels may increase. 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, Tingapla can cause side effects, although not everybody gets them. Some symptoms require immediate medical attention. Stop taking Tingapla 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 (hypoglycemia). Hypoglycemia (frequency: may occur very often, occurs in more than 1 in 10 people) is a known side effect of Tingapla treatment when taken in combination with metformin and sulfonylurea derivatives. Some patients experienced allergic reactions (hypersensitivity; frequency not very common, occurs in less than 1 in 100 people) while taking Tingapla alone or in combination with other diabetes medicines, which may be severe, including wheezing and shortness of breath (bronchospasm; frequency unknown, cannot be estimated from the available data). Some patients experienced rash (frequency not very common), urticaria (frequency 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; frequency rare). If you experience any of these symptoms, stop taking Tingapla and contact your doctor immediately. Your doctor may prescribe a medicine to treat the allergic reaction and another medicine to treat diabetes. While taking Tingapla alone or in combination with other diabetes medicines, some patients experienced pancreatitis (frequency rare, occurs in less than 1 in 1000 people). Stop taking Tingapla 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 Tingapla alone or in combination with other diabetes medicines, some patients experienced the following side effects:

• Common: increased lipase activity in the blood.
• Uncommon: rhinitis or pharyngitis (frequency uncommon, occurs in less than 1 in 100 people), 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, including those not listed in this package leaflet, please inform your doctor or pharmacist. You can also report side effects directly to the national reporting system via the contact details listed below. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Tingapla

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 and carton after EXP. The expiry date refers to the last day of that month. There are no special storage requirements. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Tingapla contains

• The active substance is linagliptin. Each tablet contains 5 mg of linagliptin.
• The other ingredients are: Tablet core: mannitol (E421), crospovidone (type B) (E1202), hypromellose (2910, 5mPas) (E464), crospovidone (type A) (E1202), silica colloidal anhydrous (E551), and magnesium stearate (E470b). Tablet coating: hypromellose (2910, 5mPas) (E464), titanium dioxide (E171), talc (E553b), macrogol 6000 (E1521), and iron oxide red (E172).

What Tingapla looks like and contents of the pack

Tingapla 5 mg coated tablets are light pink, round, biconvex, film-coated tablets, approximately 8 mm in diameter, with the symbol "5" embossed on one side. Tingapla is available in aluminum blisters. The pack sizes are 10, 14, 28, 30, 60, 90, 100, and 120 tablets. Tingapla is also available in single-dose blisters with aluminum foil. The pack sizes are 10 x 1, 14 x 1, 28 x 1, 30 x 1, 60 x 1, 90 x 1, 100 x 1, and 120 x 1 tablets. Tingapla is also available in a plastic bottle with a child-resistant plastic cap and a desiccant in the form of silica gel. The pack size is 120 tablets. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder: Sandoz Polska Sp. z o.o., ul. Domaniewska 50C, 02-672 Warszawa, tel. 22 209 70 00. Manufacturer: PharOS MT Ltd., HF62X, Hal Far Industrial Estate, Birzebbuga, BBG3000, Malta; Lek Pharmaceuticals d.d., Verovškova ulica 57, 1526 Ljubljana, Slovenia; PharOS Pharmaceutical Oriented Services Ltd., Lesvou Street End, Thesi Loggos Industrial Zone 144 52 Metamorfossi, Greece.

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

Hungary: Tingapla 5 mg filmtabletta, Cyprus: TINGAPLA 5 mg επικαλυμμένα με λεπτό υμένιο δισκία, Estonia: TINGAPLA, Greece: TINGAPLA, Croatia: Tingapla 5 mg filmom obložene tablete, Lithuania: Tingapla 5 mg plėvele dengtos tabletės, Latvia: Tingapla 5 mg apvalkotās tabletes, Poland: Tingapla.

Date of last revision of the package leaflet: