Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
METFORMIN HYDROCHLORIDE
HEALOL PHARMACEUTICALS SDN. BHD.
METFORMIN HYDROCHLORIDE
28tablet Tablets
Aurobindo Pharma Limited Unit - III
AURO METFORMIN _Consumer Medication Information Leaflet (RiMUP)_ Metformin Hydrochloride (500mg, 850mg, 1000mg) 1 WHAT IS IN THIS LEAFLET 1. What AURO METFORMIN is used for 2. How AURO METFORMIN works 3. Before you use AURO METFORMIN 4. How to use AURO METFORMIN 5. While you are using it 6. Side effects 7. Storage and Disposal of AURO METFORMIN 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision 11. Serial number WHAT IS AURO METFORMIN USED FOR Treatment of Type 2 Diabetes Mellitus, particularly in overweight patients, when dietary management and exercise alone does not result in adequate glucose level (glycaemia) control. In adults, AURO METFORMIN may be used as alone or in combination with other oral anti-diabetic agents or with insulin. In children from 10 years of age and adolescents, AURO METFORMIN may be used as alone or in combination with insulin. A reduction of diabetic complications has been shown in overweight Type 2 diabetic adult patients treated with AURO METFORMIN as first-line therapy after diet failure. HOW AURO METFORMIN WORKS AURO METFORMIN belongs to a group of medicines called biguanides which act by lowering blood plasma glucose (i.e. anti-hyperglycaemic effect) during both i.e before & after taking food (basal and postprandial). It does not stimulate insulin secretion and therefore does not decrease the blood glucose level (hypoglycaemia). BEFORE YOU USE AURO METFORMIN - _When you must not use it _ Do not take AURO METFORMIN: • If you have allergic (hypersensitivity) to metformin hydrochloride or to any of the excipients • If you have shortage of insulin (diabetic ketoacidosis), diabetes related to decreased glucose level (diabetic pre-coma) • If you have severely reduced kidney function • If you have lactic acidosis [too much lactic acid in the blood (see "Risk of lactic acidosis")] or ketoacidosis. Ketoacidosis is a condition in which substances called 'ketone bodies' accumulate in the blood and which can lead to diabetic pre- coma. Symptoms Baca dokumen lengkap
NAME OF DRUG PRODUCT: Metformin Tablets BP 500 mg Metformin Tablets BP 850 mg Metformin Tablets BP 1000 mg (TRADE) NAME OF PRODUCT: AURO METFORMIN 500 AURO METFORMIN 850 AURO METFORMIN 1000 STRENGTH: 500 mg, 850 mg and 000 mg. PHARMACEUTICAL DOSAGE FORM: Tablet QUALITATIVE AND QUANTITATIVE COMPOSITIONS: _Metformin Tablets BP 500 mg_ Each film-coated tablet contains: Metformin Hydrochloride Ph. Eur..................500 mg _Metformin Tablets BP 850 mg_ Each film-coated tablet contains: Metformin Hydrochloride Ph. Eur.................. 850 mg _Metformin Tablets BP1000 mg_ Each film-coated tablet contains: Metformin Hydrochloride Ph. Eur…………..1000 mg PHARMACEUTICAL FORM: _Metformin Tablets BP 500 mg: _ White, biconvex, circular shaped film coated tablets with 'A' debossed on one side and '60' debossed on the other side. _Metformin Tablets BP 850 mg:_ White, biconvex, circular shaped film coated tablets with 'A' debossed on one side and '61' debossed on the other side. _Metformin Tablets BP 1000 mg: _White, biconvex, oval shaped film coated tablets with a score line in between '6' and '2' on one side and 'A' debossed on the other side. CLINICAL PARTICULARS: PHARMACODYNAMICS/PHARMACOKINETICS PHARMACODYNAMIC PROPERTIES Metformin is a biguanide with anti hyperglycaemic effects, lowering both basal and postprandial plasma glucose. It does not stimulate insulin secretion and therefore does not produce hypoglycaemia. Metformin may act via 3 mechanisms: (1) Reduction of hepatic glucose production by inhibiting gluconeogenesis and glycogenolysis. (2) In muscle, by increasing insulin sensitivity, improving peripheral glucose uptake and utilization. (3) Delay of intestinal glucose absorption. Metformin stimulates intracellular glycogen synthesis by acting on glycogen synthase. Metformin increases the transport capacity of all types of membrane glucose transporters (GLUT). In humans, independently of its action on glycaemia, Metformin has favourable effects on lipid metabolism. Metformin reduces total cholesterol, LDL ch Baca dokumen lengkap