Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
METFORMIN HYDROCHLORIDE
MERCK SDN. BHD.
METFORMIN HYDROCHLORIDE
100Tablet Tablets
MERCK SANTE S.A.S.
Consumer Medication Information Leaflet (RiMUP) 1 GLUCOPHAGE ® FILM-COATED TABLET Metformin hydrochloride (500mg, 850mg, 1000mg) What is in this leaflet 1. What Glucophage is used for 2. How Glucophage works 3. Before you take Glucophage 4. How to take Glucophage 5. While you are taking it 6. Side effects 7. Storage and Disposal of Glucophage 8. Product Description 9. Manufacturer and Product registration holder 10. Date of revision What Glucophage is used for Glucophage contains metformin, a medicine to treat diabetes. It belongs to a group of medicines called biguanides. Glucophage is used to treat patients with type 2 diabetes (also called 'non-insulin dependent diabetes') when diet and exercise alone have not been enough to control your blood glucose levels. It is used particularly in overweight patients. Adults can take Glucophage on its own or together with other medicines to treat diabetes (medicines taken by mouth or insulin). Children 10 years and over and adolescents can take Glucophage on its own or together with insulin. How Glucophage works Insulin is a hormone produced by the pancreas that makes your body take in glucose (sugar) from the blood. Your body uses glucose to produce energy or stores it for future use. If you have diabetes, your pancreas does not make enough insulin or your body is not able to use properly the insulin it produces. This leads to a high level of glucose in your blood. Glucophage helps to lower your blood glucose to as normal a level as possible. If you are an overweight adult, taking Glucophage over a long period of time also helps to lower the risk of complications associated with diabetes. Glucophage is associated with either a stable body weight or modest weight loss. Before you take Glucophage - When you must not take it Do not take Glucophage if you are allergic (hypersensitive) to metformin or any of the other ingredients of this medicine (see Product Description, Ingredients) if you have severely reduced kidney function if you have uncontrolled diabetes, Baca dokumen lengkap
NAME OF THE MEDICINAL PRODUCT GLUCOPHAGE 850 mg film-coated tablets QUALITATIVE AND QUANTITATIVE COMPOSITION One film-coated tablet contains 850 mg metformin hydrochloride corresponding to 662.9 mg metformin base. For a full list of excipients, see List of Excipients. PHARMACEUTICAL FORM Film-coated tablet. White, circular, convex film-coated tablets. ROUTE OF ADMINISTRATION Oral CLINICAL PARTICULARS Therapeutic indications Treatment of type 2 diabetes mellitus, when dietary management and exercise alone does not result in adequate glycaemic control. - In adults, GLUCOPHAGE® 850 mg film-coated tablet may be used as monotherapy or in combination with other oral anti-diabetic agents or with insulin. - In children from 10 years of age and adolescents, GLUCOPHAGE® 850 mg film-coated tablet may be used as monotherapy or in combination with insulin. A reduction of diabetic complications has been shown in overweight type 2 diabetic adult patients treated with metformin as first-line therapy after diet failure, see Pharmacodynamic properties. Posology and method of administration Adults with normal renal function (GFR≥ 90mL/min) Monotherapy and combination with other oral antidiabetic agents: - The usual starting dose is one tablet 2 or 3 times daily given during or after meals. After 10 to 15 days the dose should be adjusted on the basis of blood glucose measurements. A slow increase of dose may improve gastrointestinal tolerability. - The maximum recommended dose of metformin hydrochloride is 3 g daily, taken as 3 divided doses. - If transfer from another oral antidiabetic agent is intended: discontinue the other agent and initiate metformin at the dose indicated above. Combination with insulin: Metformin hydrochloride and insulin may be used in combination therapy to achieve better blood glucose control. Metformin hydrochloride is given at the usual starting dose of one tablet 2-3 times daily, while insulin dosage is adjusted on the basis of blood glucose measurements. Elderly Due to the potential for decreased re Baca dokumen lengkap