Land: Maleisië
Taal: Engels
Bron: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
METFORMIN HYDROCHLORIDE
DUOPHARMA (M) SDN. BHD.
METFORMIN HYDROCHLORIDE
1000 Tablets; 100 Tablet Tablets
DUOPHARMA (M) SDN. BHD.
GLUCOXIT TABLET 500 MG Active Ingredient: Metformin Hydrochloride 500 mg 1 _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ WHAT IS IN THIS LEAFLET 1. What Glucoxit Tablet 500mg is used for 2. How Glucoxit Tablet 500mg works 3. Before you use Glucoxit Tablet 500mg 4. How to use Glucoxit Tablet 500mg 5. While you are using it 6. Side effects 7. Storage and Disposal of Glucoxit Tablet 500mg 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision 11. Serial Number WHAT GLUCOXIT TABLET 500MG IS USED FOR Glucoxit Tablet 500mg contains metformin hydrochloride. Metformin hydrochloride is used in the treatment of non-insulin-dependent diabetes mellitus (NIDDM) to control high blood sugar that cannot be controlled adequately by diet management, exercise or weight reduction. The medicine can be used alone or in combination with other medications. HOW GLUCOXIT TABLET 500MG WORKS Metformin hydrochloride increases the sensitivity of target cells to insulin (hormone which regulates the amount of sugar in the blood) to reduce blood sugar level. Since metformin hydrochloride does not stimulate the secretion of insulin, insulin must be present for the medicine to work properly. BEFORE YOU USE GLUCOXIT TABLET 500MG _- When you must not use it _ Do not take Glucoxit Tablet 500mg: • If you have severely reduced kidney function. • If 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 blood and which can lead to diabetic pre-coma. Symptoms of acidosis may include stomach pain, abnormal breathing and drowsiness (if severe). • You have very low kidney function (GFR <30 mL/min) • You have sudden metabolic acidosis (A condition when your body produces too much acid or when the kidneys are not removing enough acid from the body) • You have allergy to Metformin • You have any medical condition that requires close blood sugar control, suc Lees het volledige document
[DUOPHARMA (M) SDN BHD] 1/2 [Revision Date: (29.03.2019)] GLUCOXIT TABLET 500 MG DESCRIPTION: 11mm, round, bi-convex, scored on one side, marked 'MET, white tablet. COMPOSITION: Each tablet contains Metformin Hydrochloride 500mg. PHARMACODYNAMICS: Metformin hydrochloride does not stimulate pancreatic beta cells of insulin; insulin secretion must be present for metformin to work properly. Metformin hydrochloride may increase the number and/or affinity of insulin receptors on cell surface membranes, especially at peripheral receptor sites, and help to correct down regulation of the insulin receptor. This effect increases the sensitivity to insulin at receptor and post receptor binding sites and increases uptake peripherally. Insulin concentrations remain unchanged or are slightly reduced as glucose metabolism improves. In addition, metformin's metabolic effects increase hepatic glycogen stores in diabetic patients (but not in non-diabetic patients). Decrease intestinal glucose absorption, and reduce fatty acid oxidation and acetyl co-enzyme A formation. Glucose uptake or free fatty acid oxidation is effects considered to be caused by non-insulin mediated mechanisms. PHARMACOKINETICS: Metformin hydrochloride is absorbed over a period of 6 hours with bioavailability between 50%-60% under fasting condition. Presence of food will delay the absorption, lowers the peak concentration by 40% and decreases the bioavailability by 25%. Peak serum concentration at steady state is 1 to 2 mcg/ml, achieved within 2 hours. The main sites of concentration without accumulation are the intestinal mucosa and the salivary glands; also, the erythrocyte mass may be a compartment of distribution. It has a plasma half-life of about 3 hours and it is not bound to plasma proteins. Metformin hydrochloride does not undergo hepatic metabolism and up to 90% of a dose of metformin is excreted unchanged in the urine. About 30% of a dose is eliminated in the feces. Haemodialysis with a clearance of 170 ml/minute prevents accumulation of metformin. Lees het volledige document