Kraj: Wielka Brytania
Język: angielski
Źródło: MHRA (Medicines & Healthcare Products Regulatory Agency)
Metformin hydrochloride
Actavis UK Ltd
A10BA02
Metformin hydrochloride
1gram
Modified-release tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 06010202; GTIN: 5012617022035 5012617022042
PACKAGE LEAFLET: INFORMATION FOR THE USER Metformin 1000 mg 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 is and what it is used for 2. What you need to know before you take Metformin 3. How to take Metformin 4. Possible side effects 5. How to store Metformin 6. Contents of the pack and other information 1. WHAT METFORMIN IS AND WHAT IT IS USED FOR Metformin 1000mg prolonged release tablets called Metformin for short throughout the leaflet, 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 is 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 is used for the treatment of Type 2 diabetes when diet and exercise changes alone have not been enough to control blood glucose (sugar). Insulin is Przeczytaj cały dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Metabet SR 1000 mg prolonged release tablets Bolamyn SR 1000 mg prolonged release tablets Metformin 1000 mg prolonged release tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each prolonged release tablet contains: Metformin hydrochloride 1000 mg corresponding to 780 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 with score line on one side and plain on other side. 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 / Bolamyn SR / Metformin 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 / Bolamyn SR / Metformin 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 shoul Przeczytaj cały dokument