국가: 유럽 연합
언어: 영어
출처: EMA (European Medicines Agency)
rosiglitazone, glimepiride
SmithKline Beecham Ltd
A10BD04
rosiglitazone, glimepiride
Drugs used in diabetes
Diabetes Mellitus, Type 2
AVAGLIM is indicated in the treatment of type 2 diabetes mellitus patients who are unable to achieve sufficient glycaemic control on optimal dosage of sulphonylurea monotherapy, and for whom metformin is inappropriate because of contraindication or intolerance.
Revision: 11
Withdrawn
2006-06-27
Medicinal product no longer authorised 46 B. PACKAGE LEAFLET Medicinal product no longer authorised 47 PACKAGE LEAFLET: INFORMATION FOR THE USER AVAGLIM 4 MG/4 MG FILM-COATED TABLETS AVAGLIM 8 MG/4 MG FILM-COATED TABLETS rosiglitazone/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, TELL YOUR DOCTOR OR PHARMACIST. IN THIS LEAFLET : 1. WHAT AVAGLIM IS AND WHAT IT IS USED FOR 2. BEFORE YOU TAKE AVAGLIM 3. HOW TO TAKE AVAGLIM 4. POSSIBLE SIDE EFFECTS 5 HOW TO STORE AVAGLIM 6. FURTHER INFORMATION 1. WHAT AVAGLIM IS AND WHAT IT IS USED FOR AVAGLIM TABLETS ARE A COMBINATION OF TWO DIFFERENT MEDICINES called _rosiglitazone_ and _glimepiride. _ These two medicines are used to treat TYPE 2 DIABETES. People with type 2 diabetes either don’t make enough insulin (a hormone that controls blood sugar levels), or don’t respond normally to the insulin their body makes. Rosiglitazone and glimepiride work together so your body makes better use of the insulin it produces, and this helps reduce your blood sugar to a normal level. 2. BEFORE YOU TAKE AVAGLIM To help manage your diabetes, it is important that you follow any diet and lifestyle advice from your doctor as well as taking Avaglim. DON’T TAKE AVAGLIM: • IF YOU ARE ALLERGIC ( _hypersensitive_ ) to rosiglitazone, glimepiride, or any of the other ingredients of Avaglim ( _listed in Section 6), _ or to _ _ other medicines called sulphonylureas (like _glibenclamide_ ) or sulphonamides • IF YOU HAVE HAD A HEART ATTACK OR SEVERE ANGINA, that’s being treated in hospital • IF YOU HAVE HEART FAILURE, or have had heart failure in the past • IF YOU HAVE LIVER DISEASE • IF YOU 전체 문서 읽기
Medicinal product no longer authorised 1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Medicinal product no longer authorised 2 1. NAME OF THE MEDICINAL PRODUCT AVAGLIM 4 mg/4 mg film-coated tablets. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION _ _ Each tablet contains rosiglitazone maleate corresponding to 4 mg rosiglitazone and 4 mg glimepiride. Excipient - contains lactose (approximately 104 mg) For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. Pink, rounded triangular tablet with “gsk” debossed on one side and “4/4” on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS AVAGLIM is indicated in the treatment of type 2 diabetes mellitus patients who are unable to achieve sufficient glycaemic control on optimal dosage of sulphonylurea monotherapy, and for whom metformin is inappropriate because of contraindication or intolerance. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION AVAGLIM therapy should be individualised for each patient. Before therapy is initiated with AVAGLIM appropriate clinical evaluation should be made to assess the patient’s risk of developing hypoglycaemia (see section 4.4). AVAGLIM should be taken once daily shortly before or during a meal (usually the first main meal of the day). If a dose is forgotten, the following dose must not be increased. _For patients inadequately controlled on glimepiride monotherapy (typically 4 mg)._ Concomitant administration should be considered before the patient is switched to AVAGLIM. Where clinically appropriate, direct change from glimepiride monotherapy to AVAGLIM may be considered . The starting dose is 4 mg/day rosiglitazone plus 4 mg/day glimepiride (given as one tablet AVAGLIM 4 mg/4 mg). _Patients unable to achieve glycaemic control on at least half-maximum dose of other sulphonylurea _ _monotherapy (except chlorpropamide, see section 4.4)._ Rosiglitazone 4 mg should be administered concomitantly with the dose of sulphonylurea already being taken. Once glycaemic control is stable at these doses 전체 문서 읽기