Država: Malezija
Jezik: engleski
Izvor: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
GLICLAZIDE
Noripharma Sdn. Bhd.
GLICLAZIDE
60 Tablets; 100 Tablets; 120 Tablets; 500 Tablets; 1000 Tablets
Noripharma Sdn. Bhd.
_Consumer Medication Information Leaflet (RiMUP)_ _ _ NICRON 80MG TABLET Gliclazide 80mg 1 | P a g e WHAT IS IN THIS LEAFLET? 1. What NICRON 80mg used for 2. How NICRON 80mg works 3. Before you use NICRON 80mg 4. How to use NICRON 80mg 5. While you are using it 6. Side effects 7. Storage and Disposal of NICRON 80mg 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision. WHAT NICRON 80MG USED FOR NICRON 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 NICRON 80MG WORKS NICRON is a medicine that reduces blood sugar levels (oral antidiabetic medicine belonging to the sulfonylurea group). BEFORE YOU USE NICRON 80MG -_WHEN YOU MUST NOT USE IT_ Do not take NICRON : - if you are allergic to Gliclazide, to other sulfonylureas or sulfonamides or to one of excipients included, - if you have diabetes requiring treatment with insulin, - in case of diabetes complicated by ketoacidosis, diabetic precoma, - if you suffer from severe liver or kidney disease, - if you are presently taking a treatment with miconazole (Refer to “Taking other medicines”), - if you are breast-feeding. Pregnancy and breastfeeding If you are pregnant, your diabetes should be treated with insulin. If you discover that you are pregnant while taking this medication, you should discontinue your treatment. Tell your doctor, who will adjust your hypoglycemic treatment. This medication is contraindicated when breast-feeding. Ask your doctor or your pharmacist for advice before taking any medicine. _- BEFORE YOU START TO USE IT _ WARNINGS Hypoglycaemia: (decrease in blood sugar levels) You may suffer from hypoglycemia in the course of your treatment. If this happens, it may be necessary to hospitalize you to restore your sugar levels. After a hypoglycemic episode, your doctor will monitor you closely for at least 24 hours. The following information is necessary to avoid epis Pročitajte cijeli dokument
NICRON 80MG TABLET COMPOSITION Gliclazide 80mg/tablet PRODUCT DESCRIPTION A white to off white round shaped tablet with double score line on one side and plain on other side. PHARMACODYNAMICS Gliclazide is a second generation sulphonylurea oral hypoglycaemic agent. Gliclazide reduces blood glucose levels by stimulating the insulin secretion βcells in the islets of Langerhans. Unstimulated and stimulated insulin secretion from pancreatic β-cells are increased following administration of Gliclazide. This occurs via the binding of Gliclazide to specific receptor on pancreatic β- cells which results in a decrease in potassium efflux and causes depolarisation of the cell. Subsequently, calcium channels open, leading to an increase in intracellular calcium and induction of insulin release. In addition, Gliclazide increases the sensitivity of β-cells to glucose. 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 the 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:_ Gliclazide is rapidly absorbed from the gastrointestinal tract and maximum blood concentrations are attained between the 11th and the 14th hour. _Distribution: _In humans, binding to proteins is 94.2%. Metabolism is extensive and all the metabolites are devoid of hypoglycaemic activity. _Elimination: _As the apparent terminal elimination half-life for Gliclazide is 20 hours in humans, the drug can be administered in two daily doses. Elimination is mainly in the urine: less than 1% of the dose ingested is found unchanged in the urine. INDICATION Non-insulin dependent diabetes, in association with an adapted diet, in cases where dietary measures Pročitajte cijeli dokument