Pays: Union européenne
Langue: anglais
Source: EMA (European Medicines Agency)
rosiglitazone
SmithKline Beecham Plc
A10BG02
rosiglitazone
Drugs used in diabetes
Diabetes Mellitus, Type 2
Rosiglitazone is indicated in the treatment of type 2 diabetes mellitus:as monotherapy-in patients (particularly overweight patients) inadequately controlled by diet and exercise for whom metformin is inappropriate because of contraindications or intoleranceas dual oral therapy in combination with-metformin, in patients (particularly overweight patients) with insufficient glycaemic control despite maximal tolerated dose of monotherapy with metformin-a sulphonylurea, only in patients who show intolerance to metformin or for whom metformin is contraindicated, with insufficient glycaemic control despite monotherapy with a sulphonylureaas triple oral therapy in combination with-metformin and a sulphonylurea, in patients (particularly overweight patients) with insufficient glycaemic control despite dual oral therapy (see section 4.4).
Revision: 23
Withdrawn
2000-07-11
52 B. PACKAGE LEAFLET Medicinal product no longer authorised 53 PACKAGE LEAFLET: INFORMATION FOR THE USER AVANDIA 2 MG FILM-COATED TABLETS AVANDIA 4 MG FILM-COATED TABLETS AVANDIA 8 MG FILM-COATED TABLETS rosiglitazone _ _ 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 AVANDIA IS AND WHAT IT IS USED FOR 2. BEFORE YOU TAKE AVANDIA 3. HOW TO TAKE AVANDIA 4. POSSIBLE SIDE EFFECTS 5 HOW TO STORE AVANDIA 6. FURTHER INFORMATION 1. WHAT AVANDIA IS AND WHAT IT IS USED FOR AVANDIA IS 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. Avandia helps to reduce your blood sugar towards a normal level, by helping your body make better use of the insulin it produces. Avandia can be used alone or in combination with other medicines to treat diabetes (such as metformin or a sulphonylurea). 2. BEFORE YOU TAKE AVANDIA To help manage your diabetes, it is important that you follow any diet and lifestyle advice from your doctor as well as taking Avandia. DON’T TAKE AVANDIA: • IF YOU ARE ALLERGIC ( _hypersensitive_ ) to rosiglitazone or any of the other ingredients of Avandia ( _listed in Section 6)_ • 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 HAVE HAD DIABETIC KETOACIDOSIS (a complication of diabetes causing rapid weight loss, nausea or vomiting) CHECK WITH YOUR DOCTOR if you think any of these Lire le document complet
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Medicinal product no longer authorised 2 1. NAME OF THE MEDICINAL PRODUCT AVANDIA 2 mg film-coated tablets. _ _ 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains rosiglitazone maleate corresponding to 2 mg rosiglitazone. Excipient Contains lactose (approximately 108 mg). For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. Pink film-coated tablets debossed with “GSK” on one side and "2" on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Rosiglitazone is indicated in the treatment of type 2 diabetes mellitus: as MONOTHERAPY – in patients (particularly overweight patients) inadequately controlled by diet and exercise for whom metformin is inappropriate because of contraindications or intolerance as DUAL ORAL THERAPY in combination with – metformin, in patients (particularly overweight patients) with insufficient glycaemic control despite maximal tolerated dose of monotherapy with metformin – a sulphonylurea, only in patients who show intolerance to metformin or for whom metformin is contraindicated, with insufficient glycaemic control despite monotherapy with a sulphonylurea as TRIPLE ORAL THERAPY in combination with – metformin and a sulphonylurea, in patients (particularly overweight patients) with insufficient glycaemic control despite dual oral therapy (see section 4.4). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Rosiglitazone therapy is usually initiated at 4 mg/day. This dose can _ _ be increased to 8 mg/day after eight _ _ weeks if greater glycaemic control is required. In patients administered rosiglitazone in combination with a sulphonylurea, an increase in rosiglitazone to 8 mg/day should be undertaken cautiously following appropriate clinical evaluation to assess the patient's risk of developing adverse reactions relating to fluid retention (see 4.4 and 4.8). Rosiglitazone may be given once or twice a day. Rosiglitazone may be taken with or without food. Elderly (see section 4. Lire le document complet