Země: Evropská unie
Jazyk: angličtina
Zdroj: EMA (European Medicines Agency)
rimonabant
sanofi-aventis
A08AX01
rimonabant
Antiobesity preparations, excl. diet products
Obesity
As an adjunct to diet and exercise for the treatment of obese patients (BMI 30 kg/m2), or overweight patients (BMI 27 kg/m2) with associated risk factor(s), such as type 2 diabetes or dyslipidaemia (see section 5.1).
Revision: 8
Withdrawn
2006-06-19
Medicinal product no longer authorised B. PACKAGE LEAFLET 23 Medicinal product no longer authorised PACKAGE LEAFLET: INFORMATION FOR THE USER ACOMPLIA 20 MG FILM-COATED TABLETS (rimonabant) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. - Keep this leaflet. You m ay 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 s ide effects ge t serious, or if you notice any side effect not listed in this leaflet, please tell your doctor or pharmacist. - You are advised to share the information in this leaflet with relatives or other relevant persons. IN THIS LEAFLET: 1. What ACOMPLIA is and what it is used for 2. Before you take ACOMPLIA 3. How to take ACOMPLIA 4. Possible side effects 5 How to store ACOMPLIA 6. Further information 1. WHAT ACOMPLIA IS AND WHAT IT IS USED FOR The active ingredient of ACOMPLIA is rimonabant. It works by blocking specific receptors i n the brain and fat tissues called CB1 receptors. ACOMPLIA is indicated in the treatment of obese or overweight patients with additional risk factors such as diabetes or high levels of fatty substances in the blood called lipids (dyslipidaemia; mainly cholesterol and triglycerides) as adjunct to diet and exercise. 2. BEFORE YOU TAKE ACOMPLIA DO NOT TAKE ACOMPLIA − if you currently suffer from depression − if you are currently being treated for depression − if you are allergic (hypersensitive) to rimonabant, or any of the other ingredients of ACOMPLIA − if you are breast-feeding . TAKE SPECIAL CARE WITH ACOMPLIA Tell your doctor before you start to take this medicine − if you have previously suffered from depression or have had suicidal thoughts − if you have impaired liver function − if you have severely impaired renal function − if you have diabetes (see section 4) − if you are currently being treated for epilepsy − if you ar Přečtěte si celý dokument
Medicinal product no longer authorised ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 Medicinal product no longer authorised 1. NAME OF THE MEDICINAL PRODUCT ACOMPLIA 20 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 20 mg rimonabant. Excipients: The tablets contain approx. 115 mg lactose. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet Biconvex, teardrop-shaped, white tablets debossed with “20” on one side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS As an adjunct to diet and exercise for the treatment of obese patients (BMI ≥ 30 kg/m 2 ), or overweight patients (BMI > 27 kg/m 2 ) with associated risk factor(s), such as type 2 diabetes or dyslipidaemia (see section 5.1). 4.2 POSOLOGY AN D METHOD OF ADMINISTRATION In adults, the recommended dosage is one 20 mg tablet daily to be taken in the morning before breakfast. The treatment should be introduced with a mildly reduced calorie diet. The safety and efficacy of rimonabant have not been evaluated beyond 2 years. • Special Popul ations _Elderly: _ No dosage adjustment is required in elde rly (see section 5.2). ACOMPLIA should be used with caution in patients over 75 years of age (see section 4.4). _Patients with hepatic insufficiency: _ No dosage adjustment is required for patients with m il d or moderate hepatic impairment_._ ACOMPLIA should be used with caution in patients with moderate hepatic impairment. ACOMPLIA should not be used in patients with severe hepatic impairment (see section 4.4 and 5.2). _Patients with renal impairment: _ No dosage adjustment is required for patients with mild and moderate_ _renal im pairm ent (see section 5.2). ACOMPLIA should not be used in patients with severe renal impairment (see section 4.4 and 5.2). _Paediatrics: _ ACOMPLIA is not recommended for use in children below age 18 due to a lack of data on efficacy and safety. 2 Medicinal product no longer authorised 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or to Přečtěte si celý dokument