Ország: Malajzia
Nyelv: angol
Forrás: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
GLIMEPIRIDE
HOVID BERHAD
GLIMEPIRIDE
30Tablet Tablets
HOVID BERHAD
-1- _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ GLIMARYL TABLET 2 MG _Glimepiride Tablet 2 mg _ WHAT IS IN THIS LEAFLET? 1. What Glimaryl Tablet 2 mg is used for 2. How Glimaryl Tablet 2 mg works 3. Before you take Glimaryl Tablet 2 mg 4. How to take Glimaryl Tablet 2 mg 5. While you are taking Glimaryl Tablet 2 mg 6. Side effects 7. Storage and disposal of Glimaryl Tablet 2 mg 8. Product description 9. Manufacturer and Product Registration Holder 10. Date of revision 11. Serial number WHAT GLIMARYL TABLET 2 MG IS USED FOR Used to treat type 2 diabetes or non- insulin dependent diabetes mellitus (NIDDM) in adults whose high blood sugar levels cannot be lowered through exercising or monitoring food intake. It is also used in combination with insulin. HOW GLIMARYL TABLET 2 MG WORKS This medicine belongs to a group called sulphonylureas that lowers the high blood sugar levels in the body. It works by increasing the amount of insulin produced by your pancreas. BEFORE YOU USE GLIMARYL TABLET 2 MG _When you must not take it _ _ _ Do not take this medicine if: • you are allergic to glimepiride or any other of excipients • you are taking other anti-diabetics • you have Type 1 diabetes mellitus • you have diabetic ketoacidosis • you have diabetic precoma/coma • you have severe liver or kidney impairment • you are pregnant or breastfeeding. _Before you start to take it_ _ _ Tell your doctor if: • you have allergies to any other medicines, foods, dyes or preservatives • you have liver problems • you have kidney problems • you have unstable diabetes • you have adrenal, pituitary or thyroid problems • you have glucose-6-phosphate dehydrogenase (G6PD) deficiency • you drink alcohol • you do not eat regular meals • you do a lot of exercise or heavy exercise or work • you are ill or feeling unwell. _Taking other medicines _ _ _ Talk to your doctor or pharmacist if you are taking any other medicines in any form including any that you buy or obtained without a prescription. Some medicines i Olvassa el a teljes dokumentumot
DESCRIPTION Oblong, green mottled uncoated tablet, bevel-edged, flat faces, break-bar on one face and "hovid" embossed on the other face. COMPOSITION Each tablet contains: Glimepiride Tablet 2 mg. PHARMACODYNAMICS Glimepiride is a sulfonylurea antidiabetic agent that is used to reduce blood glucose in type 2 diabetes patients by directly stimulating release of insulin from functioning beta cells of pancreatic islet tissue. In addition, glimepiride has extrapancreatic effects that increase the insulin sensitivity in target tissues. However, as with other sulfonylurea, the mechanism by which glimepiride lowers blood sugar during long term administration has not been clearly established. Good metabolic control over 24 hours can be achieved with single dose of Glimaryl. In patients with insufficient response to the maximum dose, combination therapy with oral antidiabetic containing metformin or with insulin improves metabolic control. PHARMACOKINETICS ABSORPTION: After oral administration, glimepiride is rapidly and well absorbed from GI tract. Peak drug levels (C max ) are achieved between 2 to 3 hours. When glimepiride was given with meals, the mean T max (time to reach C max ) was slightly elevated and mean C max and area under the curve (AUC) were slightly decreased (by 8% and 9%, respectively). DISTRIBUTION: After intravenous (IV) dosing in normal subjects, the volume of distribution (Vd) was 8.8L (113mL/kg), and total body clearance (CL) was 47.8mL/min. Protein binding was greater than 99.5%. METABOLISM: Glimepiride is completely metabolised by oxidative biotransformation after either an IV or oral dose. The major metabolites are the cyclohexyl hydroxy methyl derivative (M1) and the carboxyl derivative (M2). Cytochrome P450 II C9 has been shown to be involved in the biotransformation of glimepiride to M1. M1 is further metabolised to M2 by one or several cytosolic enzymes. M1, but not M2, possess 1 / 3 of the pharmacological activity as compared to its parent in the animal model; however, whether the sugar lowe Olvassa el a teljes dokumentumot