Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
METFORMIN HYDROCHLORIDE
SYNERRV SDN BHD
METFORMIN HYDROCHLORIDE
28 Tablets
IND-SWIFT LIMITED
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ METSWIFT XR 500 METSWIFT XR 750 METSWIFT XR 1000 Metformin Hydrochloride (500mg, 750mg & 1000mg) 1 WHAT IS IN THIS LEAFLET 1. What METSWIFT XR is used for 2. How METSWIFT XR works 3. Before you use METSWIFT XR 4. How to use METSWIFT XR 5. While you are using it 6. Side effects 7. Storage and Disposal of METSWIFT XR 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision 11. Serial number WHAT IS METSWIFT XR USED FOR METSWIFT XR prolonged release tablets contain the active ingredient metformin hydrochloride and belong to a group of medicines called biguanides, used in the treatment of diabetes. METSWIFT XR is used to delay the onset and treat Type 2 (non-insulin dependent) diabetes mellitus when diet and exercise changes alone have not been enough to control blood glucose (sugar). HOW METSWIFT XR 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. METSWIFT XR makes the body more sensitive to insulin and helps return to normal the way your body uses glucose. METSWIFT XR is associated with either a stable body weight or modest weight loss. METSWIFT XR prolonged release tablets are specially made to release the drug slowly in your body and therefore are different to many other types of tablet containing metformin. BEFORE YOU USE METSWIFT XR _-When you must not use it _ Do not take METSWIFT XR if: • You are allergic to metformin or to any of the other ingredients which are listed later on in the leaflet. • You have lactic acidosis [too much lactic acid in the blood (see “Risk of lactic acidosis” below)] or ketoacidosis. Ketoacidosis is a condition in which substances called ‘ketone bodies’ accumulate in the blo Baca dokumen lengkap
Aw. No.: 20000XXXX Metswift 1000 Leaflet Front Back COMPOSITION: Each Prolonged Release Tablet Contains Metformin hydrochloride Ph. Eur. 1000mg equivalent to 779.876mg of metformin base PRESENTATION: Box of 28 tablets (2 blisters of 14 tablets each) PRESENTATION: White to off white, capsule shaped, biconvex, tablets, debossed on one side with '1000' and other side plain. The tablets are approximately 22.6mm in length and 10.6mm in breadth PHARMACODYNAMICS: ORAL ANTI-DIABETICS (A10BA02 – Gastrointestinal tract and metabolism) 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. Mechanism of action Metformin may act via 3 mechanisms: - reduction of hepatic glucose production by inhibiting gluconeogenesis and glycogenolysis. - in muscle, by increasing insulin sensitivity, improving peripheral glucose uptake and utilisation - and 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). Pharmacodynamic effects The major non glycaemic effect of metformin is either weight stability or modest weight loss. In humans, independently of its action on glycaemia, immediate release metformin has favourable effects on lipid metabolism. This has been shown at therapeutic doses: immediate release metformin reduces total cholesterol, LDL cholesterol and triglyceride levels. A similar action has not been demonstrated with the prolonged release formulation, possibly due to the evening administration, and an increase in triglycerides may occur. PHARMACOKINETICS: Absorption After an oral dose of the prolonged release tablet, metformin absorption is significantly delayed compared to the immediate release tablet with a T at 7 hours (T for the immediate release max max tablet is 2.5 hours). At steady state, similar to the immediate Baca dokumen lengkap