Država: Malezija
Jezik: angleščina
Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
GLICLAZIDE
PHARMAFORTE (MALAYSIA) SDN. BHD.
GLICLAZIDE
100 Tablets; 30 Tablets
APOTEX INC
APO-GLICLAZIDE MR TABLETS Gliclazide (30mg, 60mg) 1 _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ WHAT IS IN THIS LEAFLET 1. What Apo-Gliclazide is used for 2. How Apo-Gliclazide works 3. Before you use Apo-Gliclazide 4. How to use Apo-Gliclazide 5. While you are using it 6. Side effects 7. Storage and Disposal of Apo- Gliclazide 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT APO-GLICLAZIDE IS USED FOR Apo-Gliclazide consist the active ingredient gliclazide, which 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 APO-GLICLAZIDE WORKS Gliclazide is a medicine that reduces blood sugar levels (oral antidiabetic medicine belonging to the sulphonylurea group). BEFORE YOU USE APO-GLICLAZIDE - _When you must not use it_ _ _ You should not take Apo-Gliclazide: - if you have any allergies to gliclazide, or any ingredients in this medication. - if you have insulin-dependent diabetes (type 1) - if you have ketone bodies and sugar in your urine, a diabetic pre-coma, or coma - if you have severe kidney and liver diseases - if you are under treatment with miconazole (for fungal). _ _ _Pregnancy and lactation _ Do not take Apo-Gliclazide if you are pregnant, trying to get pregnant or think you may be pregnant. Do not take Apo-Gliclazide if you are breast-feeding. Ask your doctor or pharmacist for advice before taking any medicine. _ _ - _Before you start to use it_ _ _ Before you start to use this medication, make sure that your doctor knows that: - if you have any other medical conditions, including kidney and liver diseases. - if you have low blood glucose - if you have G6PD-deficiency with sulphonylurea agents (medicine used for blood glucose) - _Taking other medicines _ Tell your doctor if you are taking any other medicines, including any that you buy without a prescription from a pharmacy, supermarket or health food shop. So Preberite celoten dokument
APO‐GLICLAZIDE MR 60MG TABLETS GLICLAZIDE MODIFIED RELEASE TABLETS GLICLAZIDE 60MG HYPOGLYCEMIC SULFONYLUREA ‐ ORAL ANTIDIABETIC AGENT PRODUCT DESCRIPTION APO‐GLICLAZIDE MR 60 mg tablets: White to off‐white, oval shaped biconvex tablets. Engraved “GL” bisect “60” on one side, “APO” bisect “APO” on the other side. PHARMACOLOGY Pharmacodynamics Gliclazide is a hypoglycaemic sulphonylurea 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 B 2 ). • 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 litres. A single daily intake of Bilxona maintains effective gliclazide plasma concent Preberite celoten dokument