5 mg film-coated tablets
Linagliptin
What Trajenta is and what it is used for
Trajenta contains the active ingredient linagliptin. It belongs to a group of medicines called “oral diabetes medicines”. Oral diabetes medications are used to treat high blood sugar levels. They work by helping your body reduce blood sugar levels.
Trajenta is used for type 2 diabetes in adults if the disease cannot be adequately controlled with a diabetes medicine ( metformin or sulphonylureas) or diet and exercise alone. Trajenta can be used together with other diabetes medicines
for example metformin, sulfonylureas (eg, glimepiride, glipizide), empagliflozin, or insulin.
It is important to follow the advice on diet and exercise that you have been given by your doctor or nurse.
What you need to know before you use Trajenta
Do not use Trajenta
- if you are allergic to linagliptin or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using 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, and vomiting). Trajenta should not be used in the treatment of these conditions.
- if you use an antidiabetic medicine called a sulphonylurea (eg glimepiride, glipizide) your doctor may want to lower the dose of a sulphonylurea when you use it with Trajenta to avoid your blood sugar getting too low.
- if you have had allergic reactions to other medicines that you used to control the amount of sugar in your blood.
- have or have had a disease of the pancreas.
Contact your doctor if you have symptoms of acute pancreatitis, such as severe and persistent stomach pain (abdominal pain).
If you get blisters on your skin, it could be a sign of a condition called bullous pemphigoid. Your doctor may tell you to stop taking Trajenta.
Diabetic skin lesions are a common complication of diabetes. You should follow the skin and foot care recommendations you receive from your doctor or nurse.
Children and young people
Trajenta is not recommended for children and adolescents under the age of 18.
Other medicines and Trajenta
Tell your doctor or pharmacist if you are using, have recently used, or might be using other medicines.
It is especially important to tell the doctor if you are using medicines that contain any of the following active ingredients:
- carbamazepine, phenobarbital or phenytoin . These are medicines used for cramps or chronic pain.
- rifampicin. It is 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 using this medicine.
It is not known whether Trajenta is harmful to an unborn baby. Therefore, the use of Trajenta should be avoided if you are pregnant.
It is not known whether Trajenta passes into breast milk. Your doctor must decide if breastfeeding should be discontinued or if you should discontinue/abstain from Trajenta treatment.
Driving ability and use of machinery
Trajenta has no or negligible influence on the ability to drive or use machines.
Using Trajenta together with medicines called sulphonylureas and/or insulin can cause low blood sugar (hypoglycemia) which can affect your ability to drive and use machines and work without a secure footing. However, more frequent testing of blood glucose levels may be recommended to minimize the risk of hypoglycemia, especially when Trajenta is combined with sulfonylurea and/or insulin.
How to use Trajenta
Always use this medicine as directed by your doctor. Ask your doctor or pharmacist if you are unsure.
The recommended dose is one Trajenta tablet 5 mg once a day.
You can take Trajenta with or without food.
Your doctor may prescribe Trajenta together with another oral diabetes medicine. Remember to use all medications as directed by your doctor to achieve the best results for your health.
If you have taken too much Trajenta
Talk to your doctor immediately if you have taken more Trajenta than you should.
If you forget to use Trajenta
- If you forget to take a dose of Trajenta, take it as soon as you remember. If it is almost time for the next dose, skip the missed dose.
- Do not take a double dose to make up for a missed dose. Never take two doses on the same day.
If you stop using Trajenta
Do not stop using Trajenta without first consulting your doctor. Your blood sugar levels may increase when you stop using Trajenta.
If you have further questions about this medicine, contact your doctor, pharmacist, or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some symptoms require immediate medical attention
You should stop using Trajenta and see a doctor immediately if you experience any of the following symptoms of low blood sugar: tremors, sweating, restlessness, blurred vision, tingling lips, paleness, mood swings, or confusion (hypoglycemia). Hypoglycemia (frequency: very common, may affect more than 1 in 10 users) is an identified side effect when Trajenta is taken together with metformin and sulphonylurea.
Some patients have experienced allergic reactions (hypersensitivity, frequency: uncommon, may affect up to 1 in 100 users) when using Trajenta alone or with other diabetes medicines, which may be serious, including wheezing and shortness of breath (bronchial hyperreactivity, frequency not known, the frequency cannot be estimated from available data). Some patients have experienced skin rashes (frequency: uncommon), hives ( urticaria, frequency: rare, may affect up to 1 in 1,000 users), and swelling of the face, lips, tongue, and throat which may cause difficulty in breathing or swallowing ( angioedema, frequency: rare). If you experience any of the symptoms listed above, stop taking Trajenta and contact your doctor immediately. Your doctor may prescribe one medicine to treat your allergic reaction and another medicine for your diabetes.
Some patients have experienced inflammation of the pancreas ( pancreatitis, rare, may affect up to 1 in 1,000 users) when using Trajenta alone or with other medicines to treat diabetes.
STOP taking Trajenta and contact your doctor immediately if you notice any of the following serious side effects:
- Severe and persistent pain in the abdomen (stomach) that may radiate to the back, as well as nausea and vomiting, as this may be a sign of inflammation of the pancreas ( pancreatitis ).
Some patients have experienced the following side effects when using Trajenta alone or with other medicines to treat diabetes:
- Common: increased level of lipase in the blood.
- Uncommon: inflammation of the nose or throat ( nasopharyngitis ), cough, constipation (in combination with insulin ), increased level of amylase in the blood.
- Rare: blistering of the skin (bullous pemphigoid ).
How to store Trajenta
Keep this medicine out of the sight and reach of children.
Use before the expiry date which is stated on the carton and blister cards after EXP. The expiration date is the last day of the specified month.
This medicine does not require any special storage conditions.
Do not use Trajenta if the package is damaged or the seal is broken.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to deal with medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
- The active substance is linagliptinEach film-coated tablet (tablet) contains 5 mg of linagliptin
- Other ingredients are tablet core: Mannitol, pregelatinized starch (corn), corn starch, copovidone, magnesium stearate film coating: Hypromellose, titanium dioxide (E171), talc, macrogol (6000), red iron oxide (E172)
Appearance and package sizes of the medicine
- 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 side.
- Trajenta is available in perforated aluminum/aluminum single-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.
Marketing Authorisation Holder:
Boehringer Ingelheim International GmbH
Binger Strasse 173
D-55216 Ingelheim am Rhein
Germany
Manufacturer
Boehringer Ingelheim Pharma GmbH & Co. KG
Binger Strasse 173
D-55216 Ingelheim am Rhein
Germany
alternatively
Boehringer Ingelheim Hellas Single Member SA
5th km Paiania – Markopoulo
Koropi Attiki, 19441
Greece
alternatively
Dragenopharm Apotheker Püschl GmbH
Göllstrasse 1
84529 Tittmoning
Germany
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