Trajenta

Patient Information Leaflet: Information for the User

Trajenta 5 mg film-coated tablets

linagliptin
Please read all of this leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

1. What Trajenta is and what it is used for

Trajenta contains the active substance linagliptin, which belongs to a class of medicines called
"oral antidiabetics". Oral antidiabetics are used to treat high blood sugar levels. These medicines
work by helping the body reduce blood sugar levels.
Trajenta is used in "type 2 diabetes" in adults when the disease cannot be adequately controlled with
an oral antidiabetic medicine (metformin or sulfonylureas) or with diet and exercise alone. Trajenta
may be used in combination with other antidiabetic medicines, such as metformin, sulfonylureas (e.g.
glimepiride, glipizide), empagliflozin or insulin.
It is important that you continue to follow your doctor's or nurse's advice regarding diet and
exercise.

2. What you should know before taking Trajenta

Do not take Trajenta

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

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking Trajenta if:

• you have type 1 diabetes (your body does not produce insulin) or diabetic ketoacidosis (a diabetes complication with high blood sugar levels, rapid weight loss, nausea or vomiting). Trajenta must not be used to treat these conditions.
• you are taking an antidiabetic medicine known as a “sulfonylurea” (e.g. glimepiride, glipizide), your doctor may decide to reduce the dose of the sulfonylurea when taken together with Trajenta, to avoid blood sugar levels becoming too low.
• you have had allergic reactions to any other medicine you take to control your blood sugar levels.
• you have a history of pancreatic disease or have had it in the past.

If you experience symptoms of acute pancreatitis, such as persistent and severe stomach pain (abdominal pain), you must consult a doctor.
If blisters appear on the skin, they may be a sign of a condition called bullous pemphigoid. Your doctor may ask you to stop treatment with Trajenta.
Skin lesions typical of diabetes are a common complication of this disease. It is recommended that you follow the advice given to you by your doctor or nurse regarding skin and foot care.

Children and adolescents
Trajenta is not recommended for children and adolescents under 18 years of age. It is not effective in children and adolescents aged between 10 and 17 years. It is unknown whether this medicine is safe and effective when used in children under 10 years of age.

Other medicines and Trajenta
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, you must inform your doctor if you are taking medicines containing any of the following active substances:

• carbamazepine, phenobarbital, or phenytoin. These may be used to control epileptic seizures or chronic pain.
• rifampicin. This is an antibiotic used to treat infections such as tuberculosis.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
It is not known whether Trajenta is harmful to the fetus. Therefore, it is preferable to avoid taking Trajenta during pregnancy.
It is not known whether Trajenta passes into human breast milk. Your doctor will decide whether to discontinue breastfeeding or to discontinue/abandon treatment with Trajenta.

Driving and using machines
Trajenta does not affect or affects negligibly the ability to drive and use machines.
However, taking Trajenta in combination with medicines called sulfonylureas and/or insulin may cause blood sugar levels to become too low (hypoglycaemia), which may affect the ability to drive and use machines or to work without protective barriers. You may therefore be advised to monitor your blood glucose levels more frequently to minimize the risk of hypoglycaemia, especially when used in combination with sulfonylureas and/or insulin.

3. How to take Trajenta

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
The recommended dose of Trajenta is one 5 mg tablet once daily.
You may take Trajenta with or without food.
Your doctor may prescribe Trajenta in combination with another oral antidiabetic medicine. Remember to take all medicines as prescribed by your doctor to achieve the best possible health outcomes.

If you take more Trajenta than you should
If you take more Trajenta than you should, contact your 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 almost time for your next dose, skip the missed dose.
• Do not take a double dose to make up for the forgotten dose. Never take two doses on the same day.

If you stop taking Trajenta
Do not stop treatment with Trajenta without first consulting your doctor. Blood sugar levels may rise when you stop treatment with Trajenta.
If you have any questions about the use of this medicine, consult 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 require immediate medical attention.
You must stop taking Trajenta and contact your doctor immediately if you experience the following symptoms due to low blood sugar levels: trembling, 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 known side effect when Trajenta is taken with metformin and a sulphonylurea.

Some patients have experienced allergic reactions (hypersensitivity; frequency: not common, may affect up to 1 in 100 people) while taking Trajenta alone or in combination with other diabetes medicines, which may be severe and may include wheezing and shortness of breath (bronchial hyperreactivity; frequency not known, frequency cannot be estimated based on available data). Some patients have developed skin rash (frequency: not common), hives (frequency: rare, may affect up to 1 in 1,000 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 the above signs of illness, stop taking Trajenta and contact your doctor immediately. Your doctor may prescribe a medicine to treat the allergic reaction and a different medicine for diabetes.

Some patients have developed inflammation of the pancreas (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 immediately if you notice any of the following serious side effects:

• Severe, persistent pain in the abdomen (stomach area), which may extend to the back, along with nausea and vomiting, as these may be signs of an inflamed pancreas (pancreatitis).

Some patients experienced the following side effects when taking Trajenta alone or in combination with other diabetes medicines:

• Common: increased levels of the enzyme lipase in the blood.
• Not common: inflammation of nose or throat (nasopharyngitis), cough, constipation (in combination with insulin), increased levels of the enzyme amylase in the blood.
• Rare: skin rash with blisters (bullous pemphigoid).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly through the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Trajenta

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack and 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 you notice that the packaging is damaged or shows signs of tampering.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Trajenta contains

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

Description of the appearance of Trajenta and package contents

• Trajenta 5 mg tablets are round, 8 mm in diameter, light red film-coated tablets, imprinted with "D5" on one side and the Boehringer Ingelheim logo on the other.
• Trajenta is available in unit dose, divisible blisters made of aluminium/aluminium. The packs contain 10 × 1, 14 × 1, 28 × 1, 30 × 1, 56 × 1, 60 × 1, 84 × 1, 90 × 1, 98 × 1, 100 × 1 and 120 × 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 medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
Boehringer Ingelheim SComm Boehringer Ingelheim RCV GmbH & Co KG
Tél/Tel: +32 2 773 33 11 Lietuvos filialas
Tel: +370 5 2595942

България Luxembourg/Luxemburg
Бьорингер Ингелхайм РЦВ ГмбХ и Ко КГ – Boehringer Ingelheim SComm
клон България Tél/Tel: +32 2 773 33 11
Тел: +359 2 958 79 98

Česká republika Magyarország
Boehringer Ingelheim spol. s r.o. Boehringer Ingelheim RCV GmbH & Co KG
Tel: +420 234 655 111 Magyarországi Fióktelepe
Tel.: +36 1 299 8900

Danmark Malta
Boehringer Ingelheim Danmark A/S Boehringer Ingelheim Ireland Ltd.
Tlf: +45 39 15 88 88 Tel: +353 1 295 9620

Deutschland Nederland
Boehringer Ingelheim Pharma GmbH & Co. KG Boehringer Ingelheim B.V.
Tel: +49 (0) 800 77 90 900 Tel: +31 (0) 800 22 55 889

Eesti Norge
Boehringer Ingelheim RCV GmbH & Co KG Boehringer Ingelheim Norway KS
Eesti filiaal Tlf: +47 66 76 13 00
Tel: +372 60 80 940

Ελλάδα Österreich
Boehringer Ingelheim Ελλάς Μονοπρόσωπη Α.Ε. Boehringer Ingelheim RCV GmbH & Co KG
Tηλ: +30 2 10 89 06 300 Tel: +43 1 80 105‑7870

España Polska
Boehringer Ingelheim España, S.A. Boehringer Ingelheim Sp.zo.o.
Tel: +34 93 404 51 00 Tel.: +48 22 699 0 699

France Portugal
Boehringer Ingelheim France S.A.S. Boehringer Ingelheim Portugal, Lda.
Tél: +33 3 26 50 45 33 Tel: +351 21 313 53 00

Hrvatska România
Boehringer Ingelheim Zagreb d.o.o. Boehringer Ingelheim RCV GmbH & Co KG
Tel: +385 1 2444 600 Vienna - Bucharest Branch
Tel: +40 21 302 28 00

Ireland Slovenija
Boehringer Ingelheim Ireland Ltd. Boehringer Ingelheim RCV GmbH & Co KG,
Tel: +353 1 295 9620 Ljubljana Branch
Tel: +386 1 586 40 00

Ísland Slovenská republika
Vistor hf. Boehringer Ingelheim RCV GmbH & Co KG,
Sími: +354 535 7000 organisational unit
Tel: +421 2 5810 1211

Italia Suomi/Finland
Boehringer Ingelheim Italia S.p.A. Boehringer Ingelheim Finland Ky
Tel: +39 02 5355 1 Puh/Tel: +358 10 3102 800

Κύπρος Sverige
Boehringer Ingelheim Ελλάς Μονοπρόσωπη Α.Ε. Boehringer Ingelheim AB
Tηλ: +30 2 10 89 06 300 Tel: +46 8 721 21 00

Latvija United Kingdom (Northern Ireland)
Boehringer Ingelheim RCV GmbH & Co KG Boehringer Ingelheim Ireland Ltd.
Latvijas filiāle Tel: +353 1 295 9620
Tel: +371 67 240 011

More detailed information on this medicinal product is available on the website of the European Medicines Agency, http://www.ema.europa.eu.