Država: Velika Britanija
Jezik: angleščina
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Metformin hydrochloride
Actavis UK Ltd
A10BA02
Metformin hydrochloride
500mg
Modified-release tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 06010202; GTIN: 5012617021267 5012617021274
PACKAGE LEAFLET: INFORMATION FOR THE USER Metformin 500mg Prolonged Release Tablets Metformin hydrochloride This medicine is intended for ADULT patients only. 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 500mg Prolonged-Release Tablets are and what they are used for 2. What you need to know before you take Metformin 500mg Prolonged-Release Tablets 3. How to take Metformin 500mg Prolonged-Release Tablets 4. Possible side effects 5. How to store Metformin 500mg Prolonged-Release Tablets 6. Contents of the pack and other information 1. WHAT METFORMIN 500MG PROLONGED-RELEASE TABLETS ARE AND WHAT THEY ARE USED FOR Metformin 500mg prolonged release tablets contain the active ingredient metformin hydrochloride and belong to a group of medicines called biguanides, used in the treatment of Type 2 (non-insulin dependent) diabetes mellitus. Metformin 500mg Prolonged-Release Tablets are used together with diet and exercise to lower the risk of developing Type 2 diabetes in overweight adults, when diet and exercise alone for 3 to 6 months have not been enough to control blood glucose (sugar). You are at high risk of developing Type 2 diabetes if you have additional conditions like high blood pressure, age above 40 years, an abnormal amount of lipids (fat) in the blood or a history of diabetes during pregnancy. The medicine is particularly effective if you are aged below 45 years, are very overweight, have high blood glucose levels after a meal or developed diabetes during pregnancy. Metformin 5 Preberite celoten dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Metabet SR 500mg prolonged release tablets Metformin 500mg prolonged release tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each prolonged release tablet contains: Metformin hydrochloride 500 mg corresponding to 390 mg metformin base. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Prolonged release tablet . Off-white coloured, oval, biconvex film-coated tablets plain on both sides. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS • Reduction in the risk or delay of the onset of type 2 diabetes mellitus in adult, overweight patients with IGT* and/or IFG*, and/or increased HbA1C who are: - at high risk for developing overt type 2 diabetes mellitus (see section 5.1) and - still progressing towards type 2 diabetes mellitus despite implementation of intensive lifestyle change for 3 to 6 months. Treatment with Metabet SR/Metformin prolonged release tablets must be based on a risk score incorporating appropriate measures of glycaemic control and including evidence of high cardiovascular risk (see section 5.1). Lifestyle modifications should be continued when metformin is initiated, unless the patient is unable to do so because of medical reasons. *IGT: Impaired Glucose Tolerance; IFG: Impaired Fasting Glucose • Treatment of type 2 diabetes mellitus in adults, particularly in overweight patients, when dietary management and exercise alone does not result in adequate glycaemic control. Metabet SR/Metformin prolonged release tablets may be used as monotherapy or in combination with other oral antidiabetic agents, or with insulin. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY ADULTS WITH NORMAL RENAL FUNCTION (GFR ≥ 90 ML/MIN): _Reduction in the risk or delay of the onset of type 2 diabetes _ • Metformin should only be considered where intensive lifestyle modifications for 3 to 6 months have not resulted in adequate glycaemic control. • The therapy should be initiated with one tablet Metabet SR/Metformin prolonge Preberite celoten dokument