TRAJENTA 5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Trajenta 5mg film-coated tablets

linagliptin

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

• Keep this 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 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 pack

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

1. What is Trajenta and what is it used for

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

Trajenta is used to treat type 2 diabetes in adults when the disease cannot be controlled by diet and exercise or by diet and exercise combined with another oral anti-diabetic medicine (metformin or sulphonylureas). Trajenta can be used alone or in combination with other anti-diabetic medicines, such as metformin, sulphonylureas (e.g. glimepiride, glipizide), empagliflozin, or insulin.

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

2. What you need to know before you take Trajenta

Do not take Trajenta

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

Warnings and precautions

Tell your doctor, pharmacist, or nurse before you start taking Trajenta 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). Trajenta should not be used to treat these conditions.
• are taking a sulphonylurea medicine (e.g. glimepiride, glipizide); your doctor may want to reduce your dose of sulphonylurea when taken with Trajenta to avoid your blood sugar levels falling too low.
• have had an allergic reaction to any other medicine you take to control the amount of sugar in your blood.
• have or have had a disease of the pancreas.

If you have symptoms of acute pancreatitis, such as severe and persistent stomach pain (abdominal pain), you should contact your doctor.

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

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

Children and adolescents

Trajenta 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 have not been established.

Other medicines and Trajenta

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 may be used to control epilepsy (seizures) 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 Trajenta is harmful to the unborn baby. Therefore, it is preferable to avoid using Trajenta if you are pregnant.

It is not known if Trajenta passes into breast milk. Your doctor will decide whether you should stop breast-feeding or stop taking Trajenta.

Driving and using machines

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

Taking Trajenta in combination with the medicines called sulphonylureas and/or insulin may cause your blood sugar levels to fall too low (hypoglycaemia), which may affect your ability to drive and use machines or work without a safe support. However, more frequent blood glucose monitoring may be recommended to reduce the risk of hypoglycaemia, especially when Trajenta is combined with a sulphonylurea and/or insulin.

3. How to take Trajenta

Take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

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

You can take Trajenta with or without food.

Your doctor may prescribe Trajenta along with another oral anti-diabetic medicine. Remember to take all your medicines as your doctor has told you to get the best results for your health.

If you take more Trajenta than you should

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

If you forget to take Trajenta

• If you forget to take a dose of Trajenta, take it as soon as you remember. However, if it is nearly 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 Trajenta

Do not stop taking Trajenta without first talking to your doctor. Your blood sugar levels may increase when you stop taking Trajenta.

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 Trajenta and contact a 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 (hypoglycaemia). Hypoglycaemia (frequency: very common, may affect more than 1 in 10 people) is a side effect identified when Trajenta is taken with metformin and a sulphonylurea.

Some patients have experienced allergic reactions (hypersensitivity; frequency: uncommon, may affect up to 1 in 100 people) while taking Trajenta alone or in combination with other diabetes medicines, which can be serious, including wheezing (“whistling” while breathing) and shortness of breath (bronchial hyperreactivity; frequency: not known, cannot be estimated from the available data). Some patients have experienced skin reactions (frequency: uncommon), hives (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 Trajenta 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 Trajenta alone or in combination with other diabetes medicines.

Stop taking Trajenta and contact a doctor immediatelyif you notice any of the following serious side effects:

• Severe and persistent stomach pain (abdominal pain), which may radiate to your 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 Trajenta alone or in combination with other diabetes medicines:

• Common: elevated levels of the enzyme lipase in the blood.
• Uncommon: inflammation of the nose or throat (nasopharyngitis), cough, constipation (in combination with insulin), elevated levels of the enzyme amylase 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 national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Trajenta

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 on the carton after EXP. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

Do not use Trajenta 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 Trajenta contains

• The active substance is linagliptin.

Each film-coated tablet contains 5 mg of linagliptin.

• The other ingredients are:

Core: mannitol, pregelatinised maize starch, maize starch, copovidone, magnesium stearate.

Coating: hypromellose, titanium dioxide (E171), talc, macrogol (6000), red iron oxide (E172).

Appearance and packaging of Trajenta

• Trajenta 5 mg film-coated tablets are red, round, 8 mm in diameter, and engraved with the code “D5” on one side and the Boehringer Ingelheim logo on the other.

• Trajenta is available in single-dose, pre-cut aluminium/aluminium blister packs. 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, and 120 x 1 tablets.

Not all pack sizes may be marketed in your country.

Marketing authorisation holder

Boehringer Ingelheim International GmbH

Binger Strasse 173

55216 Ingelheim am Rhein

Germany

Manufacturer

Boehringer Ingelheim Pharma GmbH & Co. KG

Binger Strasse 173

55216 Ingelheim am Rhein

Germany

Boehringer Ingelheim Hellas Single Member S.A.

5th km Paiania – Markopoulo

Koropi Attiki, 19441

Greece

Dragenopharm Apotheker Püschl GmbH

Göllstraße 1

84529 Tittmoning

Germany

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

Date of last revision of this leaflet:

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.