What Trajenta is and what it is used for
Trajenta contains the active substance linagliptin, which belongs to a group of medicines called "oral antidiabetic medicines". Oral antidiabetic medicines are used to treat high blood sugar levels. They act by helping the body reduce the level of sugar in your blood.
Trajenta is used in "type 2 diabetes" in adults if the disease can not be adequately controlled with an oral antidiabetic medicine (metformin or sulphonylurea) or with diet and exercise. Trajenta can be used with other antidiabetic medicines (insulin, metformin or sulphonylureas, eg glimepiride, glipizide).
It is important to follow the advice given by your doctor or nurse about diet and exercise.
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
Talk to your doctor, pharmacist or nurse before taking Trajenta if:
Have type 1 diabetes (your body does not produce 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;
(Such as glimepiride, glipizide), your doctor may wish to reduce the dose of the sulphonylurea when taken together with Trajenta to avoid very low blood sugar;
You have had allergic reactions to any other medicine you take to control the amount of your blood sugar.
Diabetic skin wounds are a common complication of diabetes. Follow the skin and leg care recommendations you received from your doctor or nurse.
Children and adolescents
Trayenza is not recommended for children and adolescents under 18 years of age.
Elderly
Experience in patients over 80 years of age is limited.
Other medicines and Trajenta
Tell your doctor or pharmacist if you are taking or may 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. They can be used to control seizures (seizures) or chronic pain;
Rifampicin. This is an antibiotic used to treat infections such as tuberculosis.
Pregnancy and breastfeeding
If you are pregnant or breast-feeding, think you may be pregnant or plan to become pregnant, talk to your doctor before taking this medicine. It is preferable to avoid using Trajenta if you are pregnant. It is not known whether Trajenta is harmful to the fetus. It is not known whether Trajenta passes into breast milk.
Driving and using machines
Trajenta is not known to have an effect on the ability to drive or use machines.
Taking Trajenta with medicines called sulphonylureas and / or insulin can cause very low blood sugar (hypoglycaemia), which may affect your ability to drive and operate machinery or work without a safe place to support .
3. How to take Trajenta
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 Trajenta is one 5 mg tablet once a day.
You can take Trajenta with or without food.
Your doctor may prescribe Trajenta with another oral anti-diabetes medicine. Remember that you should take all the medicines as directed by your doctor to get the best results for your health.
If you take more Trajenta than you should
If you take more Trajenta than you should, 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. If, however, you know, shortly before the next dose, miss the forgotten dose.
Do not take a double dose to make up for the missed dose. Never take two doses at a time.
If you stop taking Trajenta
Do not stop taking Trajenta before consulting your doctor. Your blood sugar may rise when you stop taking Trajenta.
If you have any further questions on the use of this product, ask your doctor, pharmacist or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone gets them.
Some symptoms require immediate medical attention
You should stop taking Trajenta and go to your doctor immediately if you experience any of the following symptoms of low blood sugar: trembling, sweating, anxiety, blurred vision, tingling of the lips, pallor, mood swings or confusion (hypoglycaemia). Hypoglycaemia (frequency: very common, may affect more than 1 in 10 people) is a known side effect due to the combined use of Trajenta plus metformin plus a sulphonylurea.
Some patients have had allergic reactions (hypersensitivity, unknown frequency), which may be serious, including rash, hives and swelling of the face, lips, tongue and throat, which may cause breathing or swallowing difficulties (angioedema, urticaria) And wheezing and shortness of breath (bronchial over-reactivity).
Some patients have had inflammation of the pancreas (pancreatitis, frequency not known, frequency can not be estimated from the available data). Contact your doctor if you experience severe and persistent stomach pain with or without vomiting because you may have pancreatitis.
Some patients experienced the following side effects while receiving Trajenta alone:
Uncommon (may affect up to 1 in 100 people): inflammation of the nose or throat (nasopharyngitis), cough, increased levels of the blood amylase enzyme;
Not known (can not be estimated from the available data): allergic reactions (hypersensitivity).
Some patients experienced the following side effects while taking Trajenta and metformin:
Uncommon: inflammation of the nose or throat (nasopharyngitis), allergic reactions (hypersensitivity), cough, muscle pain.
Some patients experienced the following side effects while taking Trajenta and insulin:
Uncommon: Inflammation of the nose or throat (nasopharyngitis), cough, pancreatitis, constipation, elevated blood amylase levels;
Not known: allergic reactions (hypersensitivity).
Some patients experienced the following side effects while taking Trajenta, metformin and a sulphonylurea:
Not known: inflammation of the nose or throat (nasopharyngitis), allergic reactions (hypersensitivity), cough, increased blood amylase levels.
If any of the side effects gets serious, tell your doctor, pharmacist or nurse. This includes all possible side effects not listed in this leaflet.
5. How to store Trajenta
Keep out of the reach and sight 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.
This medicine does not require any special storage conditions.
Do not use Trajenta if the pack is damaged or has a trace of opening.
Do not dispose of medicines in the sewer or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.
6. Package Contents and Additional Information
What Trajenta contains
The active substance is linagliptin.
Each film-coated tablet (tablet) contains 5 mg of linagliptin.
The other ingredients are:
Tablet core: mannitol, pregelatinized starch, corn starch, copovidone, magnesium stearate;
Film coating: hypromellose, titanium dioxide (E171), talc, macrogol, iron oxide red (E172).
What Tray looks like and what the package looks like
Trajenta 5 mg tablets are 8 mm in diameter, round, light red, film-coated tablets debossed with "D5" on one side and the Boehringer Ingelheim logo on the other.
Trajenta are available in perforated aluminum / rus / polyvinyl acetate copolymer-acrylate single dose blisters of aluminum foil.
The packs contain 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 types of packaging can be marketed in your country.