देश: मलेशिया
भाषा: अंग्रेज़ी
स्रोत: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
GLICLAZIDE
IDAMAN PHARMA MANUFACTURING SDN BHD
GLICLAZIDE
6 x 10’s Tablets; 10 x 10’s Tablets; 50 x 10’s Tablets
IDAMAN PHARMA MANUFACTURING SDN BHD
Page 1 of 2 _ _ _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ _ _ IDAMAN PHARMA GLICLAZIDE TABLET 80MG Gliclazide (80mg) WHAT IS IN THIS LEAFLET 1. What Idaman Pharma Gliclazide Tablet is used for 2. How Idaman Pharma Gliclazide Tablet works 3. Before you use Idaman Pharma Gliclazide Tablet 4. How to use Idaman Pharma Gliclazide Tablet 5. While you are using it 6. Side effects 7. Storage and Disposal of Idaman Pharma Gliclazide Tablet 8. Product Description 9. Product Registration Holder & Manufacturer 10. Date of Revision WHAT IDAMAN PHARMA GLICLAZIDE TABLET IS USED FOR This medicine used for adults with type 2 diabetes, when diet, exercise and weight loss alone do not have an adequate effect on keeping blood sugar at the correct level. HOW IDAMAN PHARMA GLICLAZIDE TABLET WORKS Gliclazide is an oral antidiabetic medicine belonging to the sulfonylurea group, which reduces blood glucose levels by stimulating the secretion of insulin. BEFORE YOU USE IDAMAN PHARMA GLICLAZIDE TABLET - _When you must not use it_ _ _ Do not take: - If you are allergic to Gliclazide or other sulfonylureas or sulfonamides or to any of excipients as listed at the end of this leaflet - If you have diabetes requiring treatment with insulin, - In case of diabetes complicated by keto- acidosis, diabetic pre-coma, - If you suffer from severe liver or kidney disease, - If you are in a treatment with miconazole, phenylbutazone, danazol or medicine containing alcohol - If you are breast-feeding _Pregnancy and breast-feeding _ There is no data concerning the use of Gliclazide in pregnant woman; even though there are few data with other sulfonylurea. Studies in animals have shown reproductive toxicity. As a precautionary measure, it is preferable to avoid the use of Gliclazide during pregnancy. Control of diabetes should be obtained before the time of conception to reduce the risk of congenital abnormalities due to uncontrolled diabetes. During pregnancy, oral hypoglycemic agents are not suitable, so insulin is the first choice for the treatmen पूरा दस्तावेज़ पढ़ें
IDAMAN PHARMA MANUFACTURING IDAMAN PHARMA GLICLAZIDE TABLET 80MG DESCRIPTION White to off white, round, flat, bevelled- edge tablet and scored on one side. EACH TABLET CONTAINS: Gliclazide 80mg ROUTE OF ADM I N I STRAT I ON Oral PHARMACODYNAM I CS Pharmacotherapeutic group: sulphonamides, urea derivatives. ATC code: A10BB09 _MECHANISM OF ACTION _ Gliclazide is a hypoglycaemic sulfonylurea antidiabetic active substance differing from other related compounds by an N- containing heterocyclic ring with an endocyclic bond. Gliclazide reduces blood glucose levels by stimulating insulin secretion from the β-cells of the islets of Langerhans. Increase in postprandial insulin and C-peptide secretion persists after two years of treatment. In addition to these metabolic properties, gliclazide has haemovascular properties. _EFFECTS ON INSULIN RELEASE _ In type 2 diabetics, gliclazide restores the first peak of insulin secretion in response to glucose and increases the second phase of insulin secretion. A significant increase in insulin response is seen in response to stimulation induced by a meal or glucose. _HAEMOVASCULAR PROPERTIES _ Gliclazide decreases microthrombosis by two mechanisms which may be involved in complications of diabetes: • A partial inhibition of platelet aggregation and adhesion, with a decrease in the markers of platelet activation (beta thromboglobulin, thromboxane B2), • An action on the vascular endothelium fibrinolytic activity with an increase in tPA activity. PHARMACOK I NET I CS _ABSORPTION _ Plasma levels increase reaching maximal concentrations between 2 and 6 hours. Gliclazide is well absorbed. Food intake does not affect the rate or degree of absorption. _DISTRIBUTION _ Plasma protein binding is approximately 95%. The volume of distribution is around 19 liters. _BIOTRANSFORMATION _ Gliclazide is mainly metabolised in the liver and excreted in the urine; less than 1% of the dose is excreted unchanged in the urine. No active metabolites have been detected in plasma. _ELIMINATION _ The elim पूरा दस्तावेज़ पढ़ें