Država: Malta
Jezik: angleščina
Source: Malta Medicines Authority
Doc Generici srl Via Turati, 40-20121, Milano, Italy
A10BA02
METFORMIN HYDROCHLORIDE 750 mg
PROLONGED-RELEASE TABLET
METFORMIN HYDROCHLORIDE 750 mg
POM
DRUGS USED IN DIABETES
Licence number in the source country: NOT APPLICAPABLE
Authorised
2022-11-07
Page 1 of 6 PACKAGE LEAFLET: INFORMATION FOR THE USER METFORMIN DOC GENERICS 500 MG, PROLONGED-RELEASE TABLETS METFORMIN DOC GENERICS 750 MG, PROLONGED-RELEASE TABLETS METFORMIN DOC GENERICS 1000 MG, PROLONGED-RELEASE TABLETS 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 or pharmacist. - 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What METFORMIN DOC GENERICS is and what it is used for 2. What you need to know before you take METFORMIN DOC GENERICS 3. How to take METFORMIN DOC GENERICS 4. Possible side effects 5. How to store METFORMIN DOC GENERICS 6. Contents of the pack and other information 1. WHAT METFORMIN DOC GENERICS IS AND WHAT IT IS USED FOR METFORMIN DOC GENERICS contains metformin, a drug used to treat diabetes. It belongs to a group of drugs called biguanides. Insulin is a hormone produced by the pancreas, which allows the body to take glucose (sugar) from the blood. The body uses glucose to generate energy or stores it for later use. In diabetic patients, the pancreas does not produce enough insulin, or the body is unable to make proper use of the insulin produced. This leads to an excessive increase in blood glucose levels. METFORMIN DOC GENERICS helps to reduce blood glucose levels to values as close to normal as possible. In overweight adults, long-term use of METFORMIN DOC GENERICS also reduces the risk of diabetic complications. METFORMIN DOC GENERICS is used in the treatment of patients with type 2 diabetes (also known as "insulin-dependent" diabetes) when dietary management and exercise alone does not result in adequate glycaemic control. Preberite celoten dokument
Page 1 of 11 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT METFORMIN DOC GENERICS 500 mg, prolonged-release tablets METFORMIN DOC GENERICS 750 mg, prolonged-release tablets METFORMIN DOC GENERICS 1000 mg, prolonged-release tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION METFORMIN DOC GENERICS 500 mg, prolonged-release tablets. One prolonged-release tablet contains 500 mg of metformin hydrochloride, which corresponds to 390 mg of metformin. METFORMIN DOC GENERICS 750 mg, prolonged-release tablets. One prolonged-release tablet contains 750 mg of metformin hydrochloride, which corresponds to 585 mg of metformin. METFORMIN DOC GENERICS 1000 mg, prolonged-release tablets. One prolonged-release tablet contains 1000 mg of metformin hydrochloride, which corresponds to 780 mg of metformin. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Prolonged-release tablets. METFORMIN DOC GENERICS 500 mg, prolonged-release tablets White to off-white, round (12.10mm - 12.50mm), debossed tablet with “16” and “C”. METFORMIN DOC GENERICS 750 mg, prolonged-release tablets White, to off-white and capsule shaped (18.80mm X 9.30mm - 19.20mm X 9.70mm), debossed tablet with “15” and “C”. METFORMIN DOC GENERICS 1000 mg, prolonged-release tablets White, to off-white and capsule shaped ,(22.30mm X 10.30 mm – 22.70mm X 10.70 mm) , debossed tablet with “14” and “C” 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS: Treatment of type 2 diabetes in adults, especially in overweight patients when dietary management and exercise alone does not result in adequate glycaemic control. METFORMIN DOC GENERICS can be used in monotherapy or in combination with other oral antidiabetics or insulin. In adult patients with type 2 diabetes and overweight treated with metformin, used as a first-line drug in case of dietary failure, a reduction in the number of complications of diabetes has been demonstrated (see section 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION: Page 2 of 11 Posology _ Preberite celoten dokument