País: Malásia
Língua: inglês
Origem: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
METFORMIN HYDROCHLORIDE
LABORATORIES TORRENT (MALAYSIA) SDN. BHD.
METFORMIN HYDROCHLORIDE
30Tablet Tablets; 60 Tablet Tablets; 10 Tablet Tablets; 100 Tablet Tablets
TORRENT PHARMACEUTICALS LTD.
METTA SR TABLET _ _ Metformin Hydrochloride (500 mg, 750 mg) _ _ _ _ 1 _ CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ WHAT IS IN THIS LEAFLET 1. What is Metta SR used for 2. How Metta SR works 3. Before you use Metta SR 4. How to use Metta SR 5. While you are using it 6. Side effects 7. Storage and Disposal of Metta SR 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT METTA SR IS USED FOR Metformin is used for the treatment of Type 2 (non-insulin dependent) diabetes mellitus when diet and exercise changes alone have not been enough to control blood glucose (sugar). HOW METTA SR WORKS Metformin is an antihyperglycemic agent (lowering glucose levels in the blood). People with Type 2 diabetes do not make enough insulin in their pancreas or their body does not respond properly to the insulin it does make. This causes a build-up of glucose in the blood which can cause a number of serious long-term problems. Metformin SR makes the body more sensitive to insulin and helps return to normal the way your body uses glucose. BEFORE YOU USE METTA SR - _When you must not use it _ Do not take Metta SR if you: • Have long-term kidney or liver problems. • Have been treated for heart problems or have recently had a heart attack or have severe circulatory problems or breathing difficulties. • Are allergic to metformin or to any of the other ingredients. • Have ketosis (this is a symptom of uncontrolled diabetes in which substances called ‘ketone bodies’ accumulate in the blood – you may notice that your breath has an unusual, fruity odour). • Have lactic acidosis [too much lactic acid in the blood (see “Risk of lactic acidosis” below)] or ketoacidosis. Ketoacidosis is a condition in which substances called ‘ketone bodies’ accumulate in the blood and which can lead to diabetic pre-coma. Symptoms of acidosis may include stomach pain, abnormal breathing and drowsiness (if severe). _Pregnancy and lactation _ _ _ _ _ Do not take Metta SR if you are pregnant, tryi Leia o documento completo
xxxxxxxx-5253 COMPOSITION METTA SR TABLETS 750 MG Each extended release tablet contains Metformin Hydrochloride USP….750mg. Colour: Red oxide of iron METTA SR TABLETS 500 MG Each extended release tablet contains Metformin Hydrochloride USP….500mg. PRODUCT DESCRIPTION: METTA SR TABLETS 500 MG: White to off-white coloured, capsule shaped, biconvex tablets with ‘Torrent logo’ debossed on one side and ‘500’ on the other side. METTA SR TABLETS 750 MG: Pale red colored, capsule shaped, biconvex tablets with ‘Torrent logo’ debossed on one side and ‘750’ on the other side. CLINICAL PHARMACOLOGY _PHARMACODYNAMICS_ Metformin is an antihyperglycemic agent, which improves glucose tolerance in patients with, type II diabetes, lowering both basal and postprandial plasma glucose. Its pharmacologic mechanisms of action are different from other classes of oral antihyperglycemic agents. Metformin decreases hepatic glucose production, decreases intestinal absorption of glucose, and improves insulin sensitivity by increasing the peripheral glucose uptake and utilization. Unlike sulfonylureas, Metformin does not cause hypoglycemia in either with patients with type II diabetes or normal individuals. _PHARMACOKINETICS_ ABSORPTION Metformin is absorbed incompletely after oral administration, about 30% of an oral dose recovered from the faeces. Oral bioavailability is about 50-60%. The drug may undergo some minor degree of first pass metabolism. It also gets concentrated in the walls of oesophagus, stomach and duodenum. Bioavailability is not improved when Metformin is given as an aqueous solution or rapidly dissolving tablets. Extended release formulations give lower bioavailability, as also do higher doses. Mean study state plasma levels of 505mcg/L were reached in 13 patients with doses of 1240 ± 560mg/day. Concominant food intake may slightly impair absorption. Following a single oral dose of Metformin Hydrochloride Cmax is achieved with a median value of 7 hours and a range of 4 to 8 hours. Food did not have any Leia o documento completo