Pays: Malte
Langue: anglais
Source: Medicines Authority
GLIMEPIRIDE
Actavis Group PTC ehf Revkjavikurvegi 76-78, 220 Hafnarfjordur, Iceland
A10BB12
GLIMEPIRIDE 3 mg
TABLET
GLIMEPIRIDE 3 mg
POM
DRUGS USED IN DIABETES
Withdrawn
2005-12-20
Page 1 of 7 PACKAGE LEAFLET: INFORMATION FOR THE USER GLIMERYL 1 MG, 2 MG, 3 MG AND 4 MG TABLETS Glimepiride 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 signs of illness 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. WHAT IS IN THIS LEAFLET 1. What Glimeryl is and what it is used for 2. What you need to know before you take Glimeryl 3. How to take Glimeryl 4. Possible side effects 5. How to store Glimeryl 6. Contents of the pack and other information 1. WHAT GLIMERYL IS AND WHAT IT IS USED FOR Glimeryl is a medicine taken by mouth to help lower blood sugar. It belongs to a group of medicines called sulfonylureas. Glimeryl works by increasing the amount of insulin released from your pancreas. The insulin then lowers your blood sugar levels. What Glimeryl is used for: Glimeryl is used to treat a certain form of diabetes (type 2 diabetes mellitus) when diet, physical exercise and weight loss alone have not been able to control your blood sugar levels. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE GLIMERYL DO NOT TAKE GLIMERYL IF - you are allergic to glimepiride, to other sulfonylureas (medicines used to lower your blood sugar such as glibenclamide) or sulfonamides (medicines for bacterial infections such as sulfamethoxazole) or to 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 symptoms: tiredness, feeling sick (nausea), frequent urination and muscular stiffness) - you have a severe Lire le document complet
PAGE 1 OF 11 1. NAME OF THE MEDICINAL PRODUCT Glimeryl 1 mg tablets Glimeryl 2 mg tablets Glimeryl 3 mg tablets Glimeryl 4 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 1 mg glimepiride. Excipient with known effect: Each tablet contains 70.81 mg lactose monohydrate (see section 4.4). Each tablet contains 2 mg glimepiride. Excipients with known effect: Each tablet contains 141.08 mg lactose monohydrate, 0.11 mg Sunset Yellow FCF (E110) and 0.14 mg tartrazine (E102) (see section 4.4). Each tablet contains 3 mg glimepiride. Excipient with known effect: Each tablet contains 140.71 mg lactose monohydrate (see section 4.4). Each tablet contains 4 mg glimepiride. Excipient with known effect: Each tablet contains 139.60 mg lactose monohydrate (see section 4.4). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet. The tablet is pink, flat, oblong, 8 mm x 4.1 mm in size, with bevelled edges and a score on one side and marked with “G” on the other side. The tablet is green, flat, oblong, 10.1 mm x 5.1 mm in size, with bevelled edges and a score on one side and marked with “G” on the other side. The tablet is yellow, flat, oblong, 10.1 mm x 5.1 mm in size, with bevelled edges and a score on one side and marked with “G” on the other side. The tablet is blue, flat, oblong, 10.1 mm x 5.1 mm in size, with bevelled edges and a score on one side and marked with “G” on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Glimeryl is indicated for the treatment of type 2 diabetes mellitus, when diet, physical exercise and weight reduction alone are not adequate. PAGE 2 OF 11 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 can not compensate if the patient does not keep to the recommended diet. Dosage is determined by the results of blood and urinary glucose determinations. T Lire le document complet