Страна: Малта
Език: английски
Източник: Malta Medicines Authority
Clonmel Healthcare Limited Waterford Road, Clonmel, Co. Tipperary E91 D768, Ireland
A10BD11
LINAGLIPTIN 2.5 mg METFORMIN HYDROCHLORIDE 850 mg
FILM-COATED TABLET
LINAGLIPTIN 2.5 mg METFORMIN HYDROCHLORIDE 850 mg
POM
DRUGS USED IN DIABETES
Authorised
2023-08-08
Page 1 of 12 PACKAGE LEAFLET PACKAGE LEAFLET: INFORMATION FOR THE PATIENT LINAGLIPTIN/METFORMIN CLONMEL 2.5 MG/500 MG FILM-COATED TABLETS LINAGLIPTIN/METFORMIN CLONMEL 2.5 MG/850 MG FILM-COATED TABLETS LINAGLIPTIN/METFORMIN CLONMEL 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 Linagliptin/Metformin Clonmel is and what it is used for 2. What you need to know before you take Linagliptin/Metformin Clonmel 3. How to take Linagliptin/Metformin Clonmel 4. Possible side effects 5. How to store Linagliptin/Metformin Clonmel 6. Contents of the pack and other information 1. WHAT LINAGLIPTIN/METFORMIN CLONMEL IS AND WHAT IT IS USED FOR The name of your tablet is Linagliptin/Metformin Clonmel. 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 LINAGLIPTIN/METFORMIN CLONMEL 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? Прочетете целия документ
Page 1 of 33 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Linagliptin/Metformin Clonmel 2.5 mg/500 mg film-coated tablets Linagliptin/Metformin Clonmel 2.5 mg/850 mg film-coated tablets Linagliptin/Metformin Clonmel 2.5 mg/1,000 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Linagliptin/Metformin Clonmel 2.5 mg/500 mg film-coated tablets Each tablet contains 2.5 mg of linagliptin and 500 mg of metformin hydrochloride. Linagliptin/Metformin Clonmel 2.5 mg/850 mg film-coated tablets Each tablet contains 2.5 mg of linagliptin and 850 mg of metformin hydrochloride. Linagliptin/Metformin Clonmel 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). Linagliptin/Metformin Clonmel 2.5 mg/500 mg film-coated tablets Yellow, oval shaped, biconvex film-coated tablet with break-line on one side and debossed with "2.5/500" on the other side. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. Linagliptin/Metformin Clonmel 2.5 mg/850 mg film-coated tablets Beige, oval shaped, biconvex film-coated tablet with break-line on one side and debossed with "2.5/850" on the other side. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses Linagliptin/Metformin Clonmel 2.5 mg/1,000 mg film-coated tablets Pink, oval shaped, biconvex film-coated tablet with break-line on one side and debossed with "2.5/1000" on the other side. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Linagliptin/Metformin Clonmel is indicated in adults with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control: Page 2 of 33 • in patients inadequately controlled on their maximally tolerated dose of metformin alone, Прочетете целия документ