Pays: Union européenne
Langue: anglais
Source: EMA (European Medicines Agency)
strontium ranelate
Les Laboratoires Servier
M05BX03
strontium ranelate
Drugs for treatment of bone diseases
Osteoporosis, Postmenopausal
Treatment of severe osteoporosis in postmenopausal women at high risk for fracture to reduce the risk of vertebral and hip fractures.Treatment of severe osteoporosis in adult men at increased risk of fracture.The decision to prescribe strontium ranelate should be based on an assessment of the individual patient's overall risks.
Revision: 19
Withdrawn
2004-09-20
33 B. PACKAGE LEAFLET 34 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT OSSEOR 2 G GRANULES FOR ORAL SUSPENSION Strontium ranelate 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 your 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. See section 4. WHAT IS IN THIS LEAFLET: 1. What OSSEOR is and what it is used for 2. What you need to know before you take OSSEOR 3. How to take OSSEOR 4. Possible side effects 5. How to store OSSEOR 6. Contents of the pack and other information 1. WHAT OSSEOR IS AND WHAT IT IS USED FOR OSSEOR is a medicine used to treat severe osteoporosis: - in postmenopausal women, - in adult men, at high risk of fracture, for whom other alternative treatments are not possible. In postmenopausal women, strontium ranelate reduces the risk of fracture at the spine and at the hip. About osteoporosis Your body is constantly breaking down old bone and making new bone tissue. If you have osteoporosis, your body breaks down more bone than it forms so that gradually bone loss occurs and your bones become thinner and fragile. This is especially common in women after the menopause. Many people with osteoporosis have no symptoms and you may not even know that you have it. However, osteoporosis makes you more likely to have fractures (break bones), especially in your spine, hips and wrists. How OSSEOR works OSSEOR, which contains the substance strontium ranelate, belongs to a group of medicines used to treat bone diseases. OSSEOR works by reducing bone breakdown and stimulating rebuilding of bone and therefore reduces the risk of fracture. The newly formed bone is of normal quality. 2. WHA Lire le document complet
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT OSSEOR 2 g granules for oral suspension 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each sachet contains 2 g of strontium ranelate. Excipient with known effect: Each sachet also contains 20 mg of aspartame (E951). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Granules for oral suspension Yellow granules 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of severe osteoporosis: - in postmenopausal women, - in adult men, at high risk of fracture, for whom treatment with other medicinal products approved for the treatment of osteoporosis is not possible due to, for example, contraindications or intolerance. In postmenopausal women, strontium ranelate reduces the risk of vertebral and hip fractures (see section 5.1). The decision to prescribe strontium ranelate should be based on an assessment of the individual patient's overall risks (see sections 4.3 and 4.4). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment should only be initiated by a physician with experience in the treatment of osteoporosis. Posology The recommended dose is one 2 g sachet once daily by oral administration. Due to the nature of the treated disease, strontium ranelate is intended for long-term use. The absorption of strontium ranelate is reduced by food, milk and derivative products and therefore, OSSEOR should be administered in-between meals. Given the slow absorption, OSSEOR should be taken at bedtime, preferably at least two hours after eating (see sections 4.5 and 5.2). _ _ _ _ Patients treated with strontium ranelate should receive vitamin D and calcium supplements if dietary intake is inadequate. _ _ _Elderly _ 3 The efficacy and safety of strontium ranelate have been established in a broad age range (up to 100 years at inclusion) of adult men and postmenopausal women with osteoporosis. No dose adjustment is required in relation to age. _Renal impairment _ Strontium ranelate is not recommended for patients with severe r Lire le document complet