Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
GLIBENCLAMIDE; METFORMIN HYDROCHLORIDE
LABORATORIES TORRENT (MALAYSIA) SDN. BHD.
GLIBENCLAMIDE; METFORMIN HYDROCHLORIDE
10tablet Tablets; 100tablet Tablets; 100tablet Tablets; 120tablet Tablets
TORRENT PHARMACEUTICALS LTD
GLIBETA TABLETS (5MG + 500MG) _ _ Glibenclamide and Metformin Hydrochloride (5mg + 500mg) _ _ _ _ 1 _ CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ WHAT IS IN THIS LEAFLET 1. What is GLIBETA used for 2. How GLIBETA works 3. Before you use GLIBETA 4. How to use GLIBETA 5. While you are using it 6. Side effects 7. Storage and Disposal of GLIBETA 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT GLIBETA IS USED FOR Your doctor has prescribed GLIBETA to treat your type 2 diabetes. This is also known as non-insulin-dependent diabetes mellitus. HOW GLIBETA WORKS GLIBETA combines 2 glucose lowering drugs, glibenclamide and metformin. These 2 drugs work together to improve the different metabolic defects found in type 2 diabetes. Glibenclamide lowers blood sugar primarily by causing more of the body’s own insulin to be released, and metformin lowers blood sugar, in part, by helping your body use your own insulin more effectively. Together, they are efficient in helping you to achieve better glucose control. BEFORE YOU USE GLIBETA - _When you must not use it _ Do not take GLIBETA if you: • Are allergic (hypersensitive) to glibenclamide, metformin other sulphonylureas or any of the other ingredients in Tablets. • Suffer from early onset or type I diabetes (requiring insulin). • Suffer from severe kidney disease. • Suffer from liver problems. • Are suffering from any condition likely to make controlling your blood sugar difficult. • Are due to undergo surgery. • Are pregnant. • Have reduced consciousness or coma resulting from your diabetes. • Are elderly (over 70 years of age). • Have reduced kidney function. • 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 seve Baca dokumen lengkap
1 For the use of a Registered Medical Practitioner or a Hospital or a Laboratory GLIBETA TABLETS (5 MG + 500 MG) (GLIBENCLAMIDE AND METFORMIN HYDROCHLORIDE TABLETS USP) BRAND OR PRODUCT NAME GLIBETA TABLETS (5 mg + 500 mg) NAME AND STRENGTH OF ACTIVE SUBSTANCE(S) GLIBETA TABLETS (5 mg + 500 mg) Each film coated tablet contains: Glibenclamide USP…………………5 mg Metformin Hydrochloride USP…….500 mg Colours: Yellow oxide of Iron & Titanium Dioxide PRODUCT DESCRIPTION Yellow colored, capsule shaped, biconvex, film coated tablets debossed with “5” on one side and plain on other side. DOSAGE FORM Film coated tablet CLINICAL PHARMACOLOGY PHARMACODYNAMICS Glibeta tablet combines Glibenclamide and metformin hydrochloride, 2 antihyperglycemic agents with complementary mechanisms of action, to improve glycemic control in patients with type 2 diabetes. Glibenclamide appears to lower blood glucose acutely by stimulating the release of insulin from the pancreas, an effect dependent upon functioning beta cells in the pancreatic islets. The mechanism by which Glibenclamide lowers blood glucose during long-term administration has not been clearly established. With chronic administration in patients with type 2 diabetes, the blood glucose-lowering effect persists despite a gradual decline in the insulin secretory response to the drug. Extra pancreatic effects may be involved in the mechanism of action of oral sulfonylurea hypoglycemic drugs. Metformin hydrochloride is an antihyperglycemic agent that improves glucose tolerance in patients with type 2 diabetes, lowering both basal and postprandial plasma glucose. Metformin hydrochloride decreases hepatic glucose production, decreases intestinal absorption of glucose, and improves insulin sensitivity by increasing peripheral glucose uptake and utilization. PHARMACOKINETICS Absorption and Bioavailability _FDC METFORMIN AND GLIBENCLAMIDE _ Following administration of a single FDC Metformin and Glibenclamide 5 mg/500 mg tablets with either a 20% glucose solution or a 2 Baca dokumen lengkap