Kraj: Unia Europejska
Język: angielski
Źródło: 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Withdrawn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
B. PACKAGE LEAFLET 23 Medicinal product no longer authorised PACKAGE LEAFLET: INFORMATION FOR THE USER ZIMULTI 20 MG FILM-COATED TABLETS (RIMONABANT) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. - Keep this leaf let. 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 s ide effects get 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 ZIMULTI is and what it is used for 2. Before you take ZIMULTI 3. How to take ZIMULTI 4. Possible side effects 5 How to store ZIMULTI 6. Further information 1. WHAT ZIMULTI IS AND WHAT IT IS USED FOR The active ingredient of ZIMULTI is rimonabant. It works by blocking specific receptors in the brain and fat tissues called CB1 receptors. ZIMULTI 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 ZIMULTI DO NOT TAKE ZIMULTI − 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 ZIMULTI − if you are breast-feeding . TAKE SPECIAL CARE WITH ZIMULTI 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 are less than 18 years of age. There is no information Przeczytaj cały dokument
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 Medicinal product no longer authorised 1. NAME OF THE MEDICINAL PRODUCT ZIMULTI 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 AND 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 elderly (see section 5.2). ZIMULTI 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 ild or moderate hepatic impairment_._ ZIMULTI should be used with caution in patients with moderate hepatic impairment. ZIMULTI 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 pairment (see section 5.2). ZIMULTI should not be used in patients with severe renal impairment (see section 4.4 and 5.2). _Paediatrics: _ ZIMULTI 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 any of the excipients Lactation. Ongoing major d Przeczytaj cały dokument