Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
METFORMIN HYDROCHLORIDE; GLIMEPIRIDE
SANOFI-AVENTIS (MALAYSIA) SDN. BHD.
METFORMIN HYDROCHLORIDE; GLIMEPIRIDE
30Tablet Tablets
Handok Inc.
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ AMARYL M SR 2/500MG TABLET Glimepiride/ Metformin Hydrochloride (2mg/500mg) _1 _ _ _ WHAT IS IN THIS LEAFLET 1. What Amaryl M SR is used for 2. How Amaryl M SR works 3. Before you use Amaryl M SR 4. How to use Amaryl M SR 5. While you are using it 6. Side effects 7. Storage and disposal of Amaryl M SR 8. Product description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT AMARYL M SR IS USED FOR Amaryl M SR is used, with diet and physical exercise, to treat a certain form of diabetes (type 2 diabetes mellitus), in patients who are: - unable to achieve sufficient control of blood sugar level with glimepiride or metformin alone, or - already treated with the combination of glimepiride and metformin as separate tablets. HOW AMARYL M SR WORKS Both active substances, glimepiride and metformin, help to control the level of sugar in blood. Glimepiride works by making the pancreas produce more insulin. Metformin works by reducing glucose production by the liver, helping the body to make better use of insulin and delaying glucose absorption in intestines. BEFORE YOU USE AMARYL M SR _- When you must not use it _ Do not take Amaryl M SR: - if you have insulin-dependent diabetes (type 1 diabetes requiring insulin therapy) - if you are allergic (hypersensitive) to glimepiride, metformin, or any of the other ingredients of Amaryl M SR, to sulphonamides (medicines for bacterial infections such as sulfamethoxazole) or other sulfonylureas (medicines used to lower your blood sugar such as glibenclamide) - if you have severely reduced kidney function - if you 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, abdominal breathing and drowsiness (if severe) - if you are pregnant, planning to get pregnant or are Baca dokumen lengkap
1 MY/AMA-M/0220/CCDSV6,7,9,10 AMARYL M SR FILM COATED TABLET GLIMEPIRIDE / METFORMIN 2MG / 500MG DESCRIPTION Prolonged-release tablet. White oblong biconvex film coated tablet, engraved with “SR25” on one side. Each tablet contains 2mg of glimepiride and 500mg of metformin hydrochloride. PHARMACOKINETICS Glimepiride pharmacokinetics (T max and AUC) after meal was similar between a sustained- release formulation of Amaryl-M SR 2/500 mg and an immediate-release formulation of single Amaryl-M 2/500 mg or B.I.D. Amaryl-M 1/250 mg. Meanwhile, metformin t max was delayed in sustained-release formulation compared to immediate-release formulation, but its elimination half-life was not prolonged. The extent of metformin exposure after meal was lower in sustained- release formulation than in immediate-release formulation and its B.I.D. treatment in divided doses by 14% and 23% on average respectively. This effect on exposure is not considered clinically significant as there was no significant difference in safety between treatment groups. _ _ _The following supplementary information is provided: _ An open label, 3-period, 3-treatment, 3-way crossover study was conducted in 12 healthy Korean male subjects to evaluate the pharmacokinetic and safety profiles of Amaryl-M and Amaryl-M SR tablets. Subjects were randomized to one of 3 treatment arms (Group A, B, or C). Subjects in group A received a single Amaryl-M SR 2/500 mg after breakfast. Group B received a single Amaryl-M 2/500 mg after breakfast. Group C received Amaryl-M 1/250 mg after breakfast and 12 hours later after dinner. There was a 7-day washout period between each treatment period. Pharmacokinetic parameters: 2 MY/AMA-M/0220/CCDSV6,7,9,10 Values are presented as mean ± SD except T max : median [min – max] PHARMACODYNAMICS GLIMEPIRIDE Pharmacotherapeutic group: Oral blood glucose lowering drugs: Sulfonamides, urea derivatives. ATC Code: A10B B12. Glimepiride is an orally active hypoglycaemic substance belonging to the sulfonylurea group. It may be used Baca dokumen lengkap