Država: Malta
Jezik: angleščina
Source: Medicines Authority
GLIMEPIRIDE
Sanofi Malta Limited Level2, Fort Business Centre, Mriehel Bypass, Birkirkara, Malta
A10BB12
GLIMEPIRIDE 4 mg
TABLET
GLIMEPIRIDE 4 mg
POM
DRUGS USED IN DIABETES
Withdrawn
2011-11-03
Page 1 of 8 PACKAGE LEAFLET: INFORMATION FOR THE USER AMARYL 1 MG, 2 MG, 3 MG AND 4 MG TABLETS glimepiride READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. • Keep this leaflet. You may need to read it again • If you have any further questions, ask your doctor or pharmacist • This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours • If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist IN THIS LEAFLET: 1. What Amaryl is and what it is used for 2. Before you take Amaryl 3. How to take Amaryl 4. Possible side effects 5. How to store Amaryl 6. Further information 1. WHAT AMARYL IS AND WHAT IT IS USED FOR 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. 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 2. BEFORE YOU TAKE AMARYL 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 (listed in Section 6 What Amaryl conta Preberite celoten dokument
Page 1 of 11 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Amaryl 1 mg, tablet Amaryl 2 mg, tablet Amaryl 3 mg, tablet Amaryl 4 mg, tablet 2. QUALITATIVE AND QUANTITATIVE COMPOSITION [Each tablet contains 1 mg glimepiride.] [Each tablet contains 2 mg glimepiride.] [Each tablet contains 3 mg glimepiride.] [Each tablet contains 4 mg glimepiride.] For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet [Amaryl 1 mg] The tablets are pink, oblong and scored on both sides. [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. [Amaryl 4 mg] The tablets are light blue, oblong and scored on both sides. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Amaryl is indicated for the treatment of type 2 diabetes mellitus, when diet, physical exercise and weight reduction alone are not adequate. 4.2 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. Page 2 of 11 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 week Preberite celoten dokument