Država: Irska
Jezik: engleski
Izvor: HPRA (Health Products Regulatory Authority)
Glimepiride
Sanofi-Aventis Ireland Limited T/A SANOFI
A10BB; A10BB12
Glimepiride
1.0 milligram(s)
Tablet
Product subject to prescription which may be renewed (B)
Sulfonamides, urea derivatives; glimepiride
Marketed
1996-11-29
PACKAGE LEAFLET: INFORMATION FOR THE USER AMARYL 1MG TABLETS AMARYL 3MG TABLETS _GLIMEPIRIDE _ IS THIS LEAFLET HARD TO SEE OR READ? PHONE 01 403 5600 FOR HELP READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. 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 only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. IN THIS LEAFLET: 1. What Amaryl is and what it is used for 2. What you need to know before you take Amaryl 3. How to take Amaryl 4. Possible side effects 5. How to store Amaryl Contents of the pack and other information 1. WHAT AMARYL IS AND WHAT IT IS USED FOR Amaryl is an orally active blood sugar lowering medicine. This medicine 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. WHAT YOU NEED TO KNOW BEFORE YOU TAKE AMARYL DO NOT TAKE AMARYL AND TELL YOUR DOCTOR IF: . You are allergic 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 this medicine (listed in section 6) . 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 Pročitajte cijeli dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Amaryl 1 mg tablet 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 1 mg glimepiride. Excipients: also contains 69.0 mg lactose monohydrate per tablet. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet The tablets are pink, oblong and scored on both sides. The tablet can be divided into equal doses. 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. Posology Dose 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 dose should be used for maintenance therapy. For the different dose regimens appropriate strengths are available. If control is unsatisfactory the dose 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 dose 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. H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _ Pročitajte cijeli dokument