Kraj: Malezja
Język: angielski
Źródło: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
GLIMEPIRIDE
SANOFI-AVENTIS (MALAYSIA) SDN. BHD.
GLIMEPIRIDE
30Tablet Tablets
Sanofi S.p.A.
AMARYL® Glimepride (2mg, 3mg) _ _ _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ WHAT IS IN THIS LEAFLET 1. What Amaryl is used for 2. How Amaryl works 3. Before you use Amaryl 4. How to use Amaryl 5. While you are using it 6. Possible side effects 7. Storage and disposal of Amaryl 8. Product description 9. Manufacturer and Product Registration Holder 10. Date of revision 11. Serial number WHAT AMARYL IS USED FOR Amaryl is used to treat a certain form of diabetes (type 2 diabetes mellitus) when diet, physical exercise and weight reduction alone have not been able to control your blood sugar levels HOW AMARYL WORKS Amaryl is an orally active blood sugar lowering drug. This drug belongs to a blood sugar lowering group of medicines called sulfonylurea. Amaryl works by increasing the amount of insulin released from your pancreas. The insulin then lowers your blood sugar levels. BEFORE YOU USE AMARYL - _ When you must not use it _ DO NOT TAKE AMARYL AND TELL YOUR DOCTOR IF: • You are allergic (hypersensitive) to: Glimepiride or other sulfonylureas (medicines used to lower your blood sugar such as glibenclamide) or sulfonamides (medicines for bacterial infections such as sulfamethoxazole ) or any of the other ingredients of Amaryl • You have insulin dependent diabetes (type 1 diabetes mellitus) • You have diabetic ketoacidosis (a complication of diabetes when your acid level is raised in your body and you may have some of the following signs: fatigue, feeling sick (nausea), frequent urination and muscular stiffness) • You are in a diabetic coma • You have severe kidney disease • You have a severe liver disease Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Amaryl. - _ Before you start to take it _ CHECK WITH YOUR DOCTOR OR PHARMACIST BEFORE TAKING YOUR MEDICINE IF: - You are recovering from an injury, operation, infections with fever, or from other forms of stress, inform your doctor as temporary change of treatment may b Przeczytaj cały dokument
1 This package insert is continually updated: please read carefully before using a new pack! NAME OF THE MEDICINAL PRODUCT AMARYL® 2.0 AMARYL® 3.0 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet AMARYL 2.0 contains, as active ingredient, 2 mg glimepiride. Each tablet AMARYL 3.0 contains, as active ingredient, 3 mg glimepiride. _ _ Excipients: Lactose monohydrate, sodium starch glycolate, povidone 25000, microcrystalline cellulose, magnesium stearate, yellow iron oxide ( AMARYL 2.0 and AMARYL 3.0 ), indigo carmine aluminium lake ( AMARYL 2.0 ). PHARMACEUTICAL FORM Tablet [Amaryl 2 mg] The tablets are green, oblong and scored on both sides. [Amaryl 3 mg] The tablets are pale yellow, oblong and scored on both sides. The tablet can be divided into equal doses. CLINICAL PARTICULARS THERAPEUTIC INDICATIONS As an adjunct to diet and exercise in Non-insulin-dependent (type II) diabetes, whenever blood sugar levels cannot be controlled adequately by diet, physical exercise and weight reduction alone. Amaryl may also be used in combination with an oral antidiabetic containing metformin or with insulin. POSOLOGY AND METHOD OF ADMINISTRATION For oral administration The basis for successful treatment of diabetes is a good diet, regular physical activity, as well as routine checks of blood and urine. Tablets or insulin cannot compensate if the patient does not keep to the recommended diet. Dosage is determined by the results of blood and urinary glucose determinations. The starting dose is 1 mg glimepiride per day. If good control is achieved this dosage should be used for maintenance therapy. For the different dosage regimens appropriate strengths are available. If control is unsatisfactory the dosage should be increased, based on the glycaemic control, in a stepwise manner with an interval of about 1 to 2 weeks between each step, to 2, 3 or 4 mg glimepiride per day. A dosage of more than 4 mg glimepiride per day gives better results only in exceptional cases. The maximum recommended dose is 6 mg glimepiride per day. I Przeczytaj cały dokument