Trajenta
linagliptin
Linagliptin
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.
What Trajenta is and what it is used for
What you need to know before you take Trajenta
How to take Trajenta
Possible side effects
How to store Trajenta
Contents of the pack and other information.
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 the body reduce the level of sugar in your blood.
Trajenta is used for ‘type 2 diabetes’ in adults, if the disease cannot be adequately controlled with one oral anti-diabetic medicine (metformin or sulphonylureas) or diet and exercise alone. Trajenta may be used together with other anti-diabetic medicines e.g. metformin, sulphonylureas (e.g. glimepiride, glipizide), empagliflozin, or insulin.
It is important to keep following the advice about diet and exercise that you have been given by your doctor or nurse.
if you are allergic to linagliptin or any of the other ingredients of this medicine (listed in section 6).
Talk to your doctor, pharmacist or nurse before taking Trajenta if you:
have type 1 diabetes (your body does not produce any insulin) or diabetic ketoacidosis (a complication of diabetes with high blood sugar, rapid weight loss, nausea or vomiting). Trajenta should not be used to treat these conditions.
are taking an anti-diabetic medicine known as a ‘sulphonylurea’(e.g. glimepiride, glipizide), your doctor may want to reduce your dose of sulphonylurea when you take it together with
Trajenta in order to avoid your blood sugar going too low.
have had allergic reactions to any other medicines that 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, like persistent, severe stomach ache (abdominal pain), you should consult your doctor.
If you encounter blistering of the skin it may be a sign for a condition called bullous pemphigoid. Your doctor may ask you to stop Trajenta.
Diabetic skin lesions are a common complication of diabetes. You are advised to follow the recommendations for skin and foot care that you are given by your doctor or nurse.
Trajenta is not recommended for children and adolescents under 18 years.
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 containing any of the following active substances:
Carbamazepine, phenobarbital or phenytoin. These may be used to control fits (seizures) or chronic pain.
Rifampicin. This is an antibiotic used to treat infections such as tuberculosis.
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 unknown if Trajenta is harmful to the unborn child. Therefore, it is preferable to avoid using Trajenta if you are pregnant.
It is not known if Trajenta passes into human breast milk. A decision must be made by your doctor whether to discontinue breast-feeding or to discontinue/abstain from Trajenta therapy.
Trajenta has no or negligible influence on the ability to drive and use machines.
Taking Trajenta in combination with medicines called sulphonylureas and/or insulin can cause too low blood sugar levels (hypoglycaemia), which may affect your ability to drive and use machines or work without safe foothold. However, more frequent blood glucose testing might be recommended to minimise the risk for hypoglycaemia, especially when Trajenta is combined with sulphonylurea and/or insulin.
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
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 together with another oral anti-diabetic medicine. Remember to take all medicines as directed by your doctor to achieve the best results for your health.
If you take more Trajenta than you should, talk to a doctor immediately.
If you forget to take a dose of Trajenta, take it as soon as you remember it. However, if it is nearly time for the next dose, skip the missed dose.
Do not take a double dose to make up for a forgotten dose. Never take two doses on the same day.
Do not stop taking Trajenta without first consulting 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.
Like all medicines, this medicine can cause side effects, although not everybody gets them. Somesymptomsneedimmediatemedicalattention
You should stop taking Trajenta and see your doctor immediately if you experience the following
symptoms of low blood sugar: trembling, sweating, anxiety, blurred vision, tingling lips, paleness, mood change or confusion (hypoglycaemia). Hypoglycaemia (frequency: very common, may affect
more than 1 in 10 people) is an identified side effect when Trajenta is taken together 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 medicinal products for the treatment of diabetes, which may be serious, including wheezing and shortness of breath (bronchial hyperreactivity; frequency not known, frequency cannot be estimated from the available data). Some patients experienced rash (frequency uncommon), hives (urticaria; frequency rare, may affect up to 1 in 1000 people), and swelling of the face, lips, tongue, and throat that may cause difficulty in breathing or swallowing (angioedema; frequency rare). If you experience any of the signs of illness mentioned above, stop taking Trajenta and call your doctor right away. Your doctor may prescribe a medicine to treat your allergic reaction and a different medicine for your diabetes.
Some patients have experienced inflammation of the pancreas (pancreatitis; frequency rare, may affect up to 1 in 1000 people) while taking Trajenta alone or in combination with other medicinal products for the treatment of diabetes.
STOP taking Trajenta and contact a doctor immediately if you notice any of the following serious side effects:
Severe and persistent pain in the abdomen (stomach area) which might reach through to your back, as well as nausea and vomiting, as it could be a sign of an inflamed pancreas (pancreatitis).
Some patients have had the following side effects while taking Trajenta alone or in combination with other medicinal products for the treatment of diabetes:
Common: level of lipase in the blood increased.
Uncommon: inflamed nose or throat (nasopharyngitis), cough, constipation (in combination with insulin), level of amylase in the blood increased.
Rare: blistering of skin (bullous pemphigoid).
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 thenationalreporting
system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
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 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 package is damaged or shows signs of tampering.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
The active substance is linagliptin
Each film-coated tablet (tablet) contains 5 mg of linagliptin
The other ingredients are
Tabletcore: Mannitol, pregelatinised starch (maize), maize starch, copovidone, magnesium stearate
Filmcoating: Hypromellose, titanium dioxide (E171), talc, macrogol (6000), iron oxide red
(E172)
Trajenta 5 mg tablets are 8 mm diameter round, light red film-coated tablets debossed with “D5” on one side and the Boehringer Ingelheim logo on the other.
Trajenta is available in perforated aluminium/aluminium unit dose blisters. 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.
Boehringer Ingelheim International GmbH Binger Strasse 173
D-55216 Ingelheim am Rhein Germany
Boehringer Ingelheim Pharma GmbH & Co. KG Binger Strasse 173
D-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 any information about this medicine, please contact the local representatives of the Marketing Authorisation Holder:
SCS Boehringer Ingelheim Comm.V
Tél/Tel: +32 2 773 33 11
Boehringer Ingelheim RCV GmbH & Co KG
Lietuvos filialas
Tel: +370 5 2595942
Бьорингер Ингелхайм РЦВ ГмбХ и Ко КГ -
клон България
Тел: +359 2 958 79 98
SCS Boehringer Ingelheim Comm.V
Tél/Tel: +32 2 773 33 11
Boehringer Ingelheim spol. s r.o.
Tel: +420 234 655 111
Boehringer Ingelheim RCV GmbH & Co KG
Magyarországi Fióktelepe Tel.: +36 1 299 8900
Boehringer Ingelheim Danmark A/S
Tlf: +45 39 15 88 88
Boehringer Ingelheim Ireland Ltd.
Tel: +353 1 295 9620
Boehringer Ingelheim Pharma GmbH & Co. KG Tel: +49 (0) 800 77 90 900
Boehringer Ingelheim b.v. Tel: +31 (0) 800 22 55 889
Boehringer Ingelheim RCV GmbH & Co KG Eesti filiaal
Tel: +372 60 80 940
Boehringer Ingelheim Norway KS Tlf: +47 66 76 13 00
Boehringer Ingelheim Ελλάς Μονοπρόσωπη Α.Ε. Tηλ: +30 2 10 89 06 300
Boehringer Ingelheim RCV GmbH & Co KG Tel: +43 1 80 105-7870
Boehringer Ingelheim España, S.A.
Tel: +34 93 404 51 00
Boehringer Ingelheim Sp.zo.o.
Tel.: +48 22 699 0 699
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Boehringer Ingelheim Zagreb d.o.o.
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Boehringer Ingelheim RCV GmbH & Co KG
Viena - Sucursala Bucureşti Tel: +40 21 302 28 00
Boehringer Ingelheim Ireland Ltd.
Tel: +353 1 295 9620
Boehringer Ingelheim RCV GmbH & Co KG,
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Vistor hf.
Sími: +354 535 7000
Boehringer Ingelheim RCV GmbH & Co KG, organizačná zložka
Tel: +421 2 5810 1211
Boehringer Ingelheim Italia S.p.A.
Tel: +39 02 5355 1
Boehringer Ingelheim Finland Ky
Puh/Tel: +358 10 3102 800
Boehringer Ingelheim Ελλάς Μονοπρόσωπη Α.Ε.
Tηλ: +30 2 10 89 06 300
Boehringer Ingelheim AB
Tel: +46 8 721 21 00
Boehringer Ingelheim RCV GmbH & Co KG Latvijas filiāle
Tel: +371 67 240 011
Boehringer Ingelheim Ireland Ltd. Tel: +353 1 295 9620