Quốc gia: Liên Minh Châu Âu
Ngôn ngữ: Tiếng Anh
Nguồn: EMA (European Medicines Agency)
linagliptin, metformin
Boehringer Ingelheim International GmbH
A10BD11
linagliptin / metformin hydrochloride
Drugs used in diabetes,
Diabetes Mellitus, Type 2
Treatment of adult patients with type-2 diabetes mellitus:Jentadueto is indicated as an adjunct to diet and exercise to improve glycaemic control in adult patients inadequately controlled on their maximal tolerated dose of metformin alone, or those already being treated with the combination of linagliptin and metformin.Jentadueto is indicated in combination with a sulphonylurea (i.e. triple combination therapy) as an adjunct to diet and exercise in adult patients inadequately controlled on their maximal tolerated dose of metformin and a sulphonylurea.
Revision: 17
Authorised
2012-07-19
48 B. PACKAGE LEAFLET 49 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT JENTADUETO 2.5 MG / 850 MG FILM-COATED TABLETS JENTADUETO 2.5 MG / 1,000 MG FILM-COATED TABLETS linagliptin/metformin hydrochloride 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 Jentadueto is and what it is used for 2. What you need to know before you take Jentadueto 3. How to take Jentadueto 4. Possible side effects 5. How to store Jentadueto 6. Contents of the pack and other information 1. WHAT JENTADUETO IS AND WHAT IT IS USED FOR The name of your tablet is Jentadueto. It contains two different active substances linagliptin and metformin. - Linagliptin belongs to a class of medicines called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors). - Metformin belongs to a class of medicines called biguanides. HOW JENTADUETO WORKS The two active substances work together to control blood sugar levels in adult patients with a form of diabetes called ‘type 2 diabetes mellitus’. Along with diet and exercise, this medicine helps to improve the levels and effects of insulin after a meal and lowers the amount of sugar made by your body. This medicine can be used alone or with certain other medicines for diabetes like sulphonylureas, empagliflozin, or insulin. WHAT IS TYPE 2 DIABETES? Type 2 diabetes is a condition in which your body does not make enough insulin, and the insulin that your body produces does not work as well as it should. Your body can also make too much sugar. When this happens, sugar (glucose) buil Đọc toàn bộ tài liệu
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Jentadueto 2.5 mg/850 mg film-coated tablets Jentadueto 2.5 mg/1,000 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Jentadueto 2.5 mg/850 mg film-coated tablets Each tablet contains 2.5 mg of linagliptin and 850 mg of metformin hydrochloride. Jentadueto 2.5 mg/1,000 mg film-coated tablets Each tablet contains 2.5 mg of linagliptin and 1,000 mg of metformin hydrochloride. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet). Jentadueto 2.5 mg/850 mg film-coated tablets Oval, biconvex, light orange, film-coated tablet of 19.2 mm x 9.4 mm debossed with "D2/850" on one side and the company logo on the other. Jentadueto 2.5 mg/1,000 mg film-coated tablets Oval, biconvex, light pink, film-coated tablet of 21.1 mm x 9.7 mm debossed with ”D2/1000" on one side and the company logo on the other. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Jentadueto is indicated in adults with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control: • in patients inadequately controlled on their maximally tolerated dose of metformin alone • in combination with other medicinal products for the treatment of diabetes, including insulin, in patients inadequately controlled with metformin and these medicinal products • in patients already being treated with the combination of linagliptin and metformin as separate tablets. (see sections 4.4, 4.5 and 5.1 for available data on different combinations). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults with normal renal function (GFR ≥90 ml/min)_ The dose of antihyperglycaemic therapy with Jentadueto should be individualised on the basis of the patient’s current regimen, effectiveness, and tolerability, while not exceeding the maximum recommended daily dose of 5 mg linagliptin plus 2,000 mg of metformin hydrochloride. _Patients inadequately controlled on maximal tolerated dose of metformin mon Đọc toàn bộ tài liệu