국가: 말레이시아
언어: 영어
출처: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
GLICLAZIDE
PHARMANIAGA MANUFACTURING BERHAD
GLICLAZIDE
3 x10 Tablets
PHARMANIAGA MANUFACTURING BERHAD
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ PLECAZ MR TABLET 60MG Gliclazide 60mg Page 1 of 3 WHAT IS IN THIS LEAFLET 1. What Plecaz MR 60mg is used for 2. How Plecaz MR 60mg works 3. Before you use Plecaz MR 60mg 4. How to use Plecaz MR 60mg 5. While you are using Plecaz MR 60mg 6. Side Effects 7. Storage and Disposal of Plecaz MR 60mg 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision WHAT PLECAZ MR 60MG IS USED FOR _Plecaz MR _ is a tablet that contains gliclazide as the active ingredient. _Plecaz MR _ is used for 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 PLECAZ MR 60MG WORKS _Plecaz MR _ is a medicine that reduces blood sugar levels (oral antidiabetic medicine belonging to the sulfonylurea group). BEFORE YOU USE PLECAZ MR 60MG _-When you must not use it_ Do not take _Plecaz MR _ if you: ▪ if you are allergic to gliclazide or any of the other ingredients of _Plecaz MR_ , or to other medicines of the same group (sulfonylurea), or to other related medicines (hypoglycaemic 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 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. ▪ if you are breastfeeding. _- Before you start to use it_ If you are not sure if any of these apply to you, talk to your doctor or pharmacist before taking _Plecaz MR_ . Low blood sugar (Hypoglycaemia) may occur: ▪ if you take meals irregularly or skip meals altogether ▪ if you are fasting ▪ if you are malnourished ▪ if you change your diet ▪ if you increase your physical activity and carbohydrate intake does not match this increase ▪ if you refuse to co-operate especially in elderly patient. ▪ if you take other medicines or natural remedies at the same time ▪ i 전체 문서 읽기
Gliclazide _PLECAZ MR_ PRODUCT NAME: Plecaz MR Tablet 60 mg DESCRIPTION 15 mm length, white to off white uncoated oblong tablet, plain on one side and Pharmaniaga logo on the other side. PLECAZ MR 60 mg should not be split into half. COMPOSITION Each modified release tablet contains Gliclazide 60 mg. PHARMACODYNAMICS Gliclazide is a hypoglycaemic sulphonylurea oral antidiabetic active substances 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 in insulin release response to stimulation induced by a meal or glucose. In type 2 diabetics, gliclazide restores the first peak of insulin secretion in response to glucose and increase 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 compilations 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 6 to 12 hours 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 litres. A single daily intake of Plecaz MR Tablet maintains effective gliclazide plasma concentrations over 24 hou 전체 문서 읽기