Šalis: Europos Sąjunga
kalba: anglų
Šaltinis: EMA (European Medicines Agency)
linagliptin
Boehringer Ingelheim International GmbH
A10BH05
linagliptin
Drugs used in diabetes
Diabetes Mellitus, Type 2
Trajenta is indicated in the treatment of type 2 diabetes mellitus to improve glycaemic control in adults:as monotherapyin patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to intolerance, or contraindicated due to renal impairment.as combination therapyin combination with metformin when diet and exercise plus metformin alone do not provide adequate glycaemic control.in combination with a sulphonylurea and metformin when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control.in combination with insulin with or without metformin, when this regimen alone, with diet and exercise, does not provide adequate glycaemic control.
Revision: 19
Authorised
2011-08-23
24 B. PACKAGE LEAFLET 25 PACKAGE LEAFLET: INFORMATION FOR THE USER TRAJENTA 5 MG 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. WHAT IS IN THIS LEAFLET: 1. What Trajenta is and what it is used for 2. What you need to know before you take 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 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. 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 you: have type 1 diabetes (your body does not produce any insulin) or diabetic ketoacidosis Perskaitykite visą dokumentą
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Trajenta 5 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 5 mg of linagliptin. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet). 8 mm diameter round, light red film-coated tablet debossed with “D5” on one side and the Boehringer Ingelheim logo on the other. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Trajenta is indicated in adults with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control as: monotherapy • when metformin is inappropriate due to intolerance, or contraindicated due to renal impairment. combination therapy • in combination with other medicinal products for the treatment of diabetes, including insulin, when these do not provide adequate glycaemic control (see sections 4.4, 4.5 and 5.1 for available data on different combinations). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The dose of linagliptin is 5 mg once daily. When linagliptin is added to metformin, the dose of metformin should be maintained, and linagliptin administered concomitantly. When linagliptin is used in combination with a sulphonylurea or with insulin, a lower dose of the sulphonylurea or insulin, may be considered to reduce the risk of hypoglycaemia (see section 4.4) _Special populations_ _Renal impairment_ For patients with renal impairment, no dose adjustment for linagliptin is required. _Hepatic impairment_ Pharmacokinetic studies suggest that no dose adjustment is required for patients with hepatic impairment but clinical experience in such patients is lacking. _Elderly_ No dose adjustment is necessary based on age. _Paediatric population_ A clinical trial did not establish efficacy in paediatric patients 10 to 17 years of age (see section 4.8, 5.1 and 5.2). Therefore, treatment of children and adolescents with linagliptin is not recommended. Linagliptin has not been studied in paediatric patients und Perskaitykite visą dokumentą