Šalis: Malaizija
kalba: anglų
Šaltinis: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
GLICLAZIDE
MEDISPEC (M) SDN.BHD
GLICLAZIDE
6x10 Tablets; 3x10 Tablets; 10x10 Tablets
Unison Laboratories Co. Ltd.
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ GLUCOSENSE MR 60 MG TABLET Gliclazide (60 mg) 1 WHAT IS IN THIS LEAFLET 1. What Glucosense MR 60mg is used for 2. How Glucosense MR 60mg works 3. Before you use Glucosense MR 60mg 4. How to use Glucosense MR 60mg 5. While you are using it 6. Side effects 7. Storage and Disposal of Glucosense MR 60mg 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision 11. Serial number WHAT GLUCOSENSE MR 60MG IS USED FOR Glucosense MR 60mg, modified release tablet is used in a certain form of diabetes (type 2 diabetes mellitus) in adults, when diet, exercise and weight loss alone do not have an adequate effect on keeping blood sugar at the correct level. HOW GLUCOSENSE MR 60MG WORKS Glucosense MR 60mg, modified release tablet is a medicine that contains Gliclazide which reduces blood sugar levels (oral antidiabetic medicine belonging to the sulfonylurea group). BEFORE YOU USE GLUCOSENSE MR 60MG _- When you must not use it _ • if you are allergic to Gliclazide or any of the other ingredients of Glucosense MR 60mg (listed in _Ingredients_ ), or to other medicines of the same group (sulfonylurea), or to other related medicines (hypoglycemic sulfonamides) • if you have insulin-dependent diabetes (type 1) • if you have ketone bodies and sugar in your urine (this may mean you have diabetic ketoacidosis), a diabetic pre-coma or coma • if you have severe kidney or liver disease • if you are taking medicines to treat fungal infections (Miconazole) _Pregnancy and breastfeeding _ Glucosense MR 60mg is not recommended for use during pregnancy. If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. • You must not take Glucosense MR 60mg while you are breastfeeding. _ _ _Glucosense MR 60mg_ _contains lactose _ If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this Perskaitykite visą dokumentą
1 of 3 GLUCOSENSE MR 60 MG TABLET ANTIDIABETIC Each modified release tablet contains: GLICLAZIDE 60 MG PRODUCT DESCRIPTION: White, oblong, biconvex tablet with plain on one side and engraved GZ 60 on the other MECHANISM OF ACTION: _PHARMACOLOGY_ Gliclazide is a hypoglycemic sulfonylurea oral 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 hemovascular properties. _ _ _Pharmacodynamic effects_ 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. Hemovascular 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 _PHARMACOKINETICS_ Absorption Plasma levels increase progressively during the first 6 hours, reaching a plateau which is maintained from the sixth to the twelfth hour after administration. Intra-individual variability is low. Gliclazide is completely 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 30 Liters. A single daily intake of Gliclazide MR 60 mg maintains effective Gliclazide plasma concentrations over 24 hours. Biotransformation Gliclazide is mainly metabolized in the liver and excre Perskaitykite visą dokumentą