Land: Malaysia
Språk: engelsk
Kilde: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
GLICLAZIDE
RANBAXY (MALAYSIA) SDN. BHD.
GLICLAZIDE
10x10tablet Tablets; 10X10tablet Tablets; 3x10 Tablets; 3x10 Tablets; 6x10 Tablets; 6x10 Tablets
RANBAXY (MALAYSIA) SDN. BHD.
_CONSUMER MEDICATION INFORMATION LEAFLET _ OZICLIDE MR _ _ Gliclazide Modified Release (60 mg) _ _ Page 1 of 4 WHAT IS IN THIS LEAFLET 1. What OZICLIDE MR is used for 2. How OZICLIDE MR works 3. Before you use OZICLIDE MR 4. How to use OZICLIDE MR 5. While you are using OZICLIDE MR 6. Side Effects 7. Storage and Disposal of OZICLIDE MR 8. Product Description 9. Manufacturer & Product Registration Holder 10. Date of revision 11. Serial Number WHAT OZICLIDE MR IS USED FOR OZICLIDE MR is used to control blood sugar level 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. Follow all directions given to you by your doctor carefully. HOW OZICLIDE MR WORKS OZICLIDE MR contains gliclazide which belongs to a group of medicines called sulphonylureas. Sulphonylureas work by reducing blood sugar levels. Gliclazide in OZICLIDE MR is in a “modified release” form. This means the tablet releases active ingredient gradually and therefore you only have to take the tablet once a day BEFORE YOU USE OZICLIDE MR S - _When you must not use it _ DO NOT USE OZICLIDE MR : If you are allergic to gliclazide or any of the other ingredients of OZICLIDE MR , or to other medicines of the same group (sulphonylureas) or to other related medicines (sulphonamides). If you have insulin-dependent diabetes (type 1) If you have ketone bodies and sugar in your urine (this may mean you have diabetic keto-acidosis, a diabetic pre-coma or coma If you have severe kidney or liver disease If you are taking medicines to treat fungal infections (miconazole) If you are breastfeeding Do not take this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering. If it has expired or is damaged, return it to your pharmacist for disposal. - _Before you start to use it _ Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes. Les hele dokumentet
PRESCRIBING INFORMATION FOR THE USE ONLY OF A REGISTERED MEDICAL PRACTITIONER OZICLIDE MR TABLETS (Gliclazide Modified Release Tablets 60 mg) COMPOSITION Each modified release tablet contains: Gliclazide …………60 mg Excipients: Magnesium Stearate, Hypromellose, Pregelatinized starch, Sodium citrate, Lactose, Purified Water. PRODUCT DESRIPTION White to off white oblong tablets, engraved with ‘Z’ and ‘I’ on one side and plain on the other side. DESCRIPTION OZICLIDE MR TABLETS contain gliclazide. Gliclazide is a hypoglycaemic sulfonylurea oral antidiabetic drug. It is chemically designated as 1-(hexahydrocyclopenta[c]pyrrol-2(1H)-yl)-3-[(4- methylphenyl)sulphonyl]urea. The molecular formula of gliclazide is C15H21N3O3S and its molecular weight 323.4. STRUCTURAL FOMULA GLICLAZIDE PHARMACODYNAMIC AND PHARMACOKINETIC PROPERTIES PHARMACODYNAMICS Gliclazide is a hypoglycaemic 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 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. PHARMACOKINETICS Absorp Les hele dokumentet