Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
raloxifene hydrochloride
Teva B.V.
G03XC01
raloxifene
Sex hormones and modulators of the genital system,
Osteoporosis, Postmenopausal
Raloxifene is indicated for the treatment and prevention of osteoporosis in postmenopausal women. A significant reduction in the incidence of vertebral, but not hip fractures has been demonstrated.When determining the choice of raloxifene or other therapies, including oestrogens, for an individual postmenopausal woman, consideration should be given to menopausal symptoms, effects on uterine and breast tissues, and cardiovascular risks and benefits.
Revision: 10
Authorised
2010-04-29
20 B. PACKAGE LEAFLET 21 PACKAGE LEAFLET: INFORMATION FOR THE USER RALOXIFENE TEVA 60 MG FILM-COATED TABLETS raloxifene hydrochloride 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 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 Raloxifene Teva is and what it is used for 2. What you need to know before you take Raloxifene Teva 3. How to take Raloxifene Teva 4. Possible side effects 5. How to store Raloxifene Teva 6. Contents of the pack and other information 1. WHAT RALOXIFENE TEVA IS AND WHAT IT IS USED FOR Raloxifene Teva is used to treat and prevent osteoporosis in postmenopausal women. Raloxifene Teva reduces the risk of vertebral fractures in women with postmenopausal osteoporosis. A reduction in the risk of hip fractures has not been shown. How Raloxifene Teva works Raloxifene Teva belongs to a group of non-hormonal medicines called selective oestrogen receptor modulators (SERMs). When a woman reaches the menopause, the level of the female sex hormone oestrogen goes down. Raloxifene Teva mimics some of the helpful effects of oestrogen after the menopause. Osteoporosis is a disease that causes your bones to become thin and fragile - this disease is especially common in women after the menopause. Although it may have no symptoms at first, osteoporosis makes you more likely to break bones, especially in your spine, hips and wrists and may cause back pain, loss of height and a curved back. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE RALOXIFENE TEVA DO NOT TAKE RALOXIFENE TEVA - If you are allergic to raloxifene or any of the other ingredien Przeczytaj cały dokument
1 _ _ _ _ ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Raloxifene Teva 60 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 60 mg raloxifene hydrochloride, equivalent to 56 mg raloxifene free base. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. White to off-white, film coated, oval shaped tablets, embossed with the number “60” on one side and “N” on the other side of the tablet. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Raloxifene is indicated for the treatment and prevention of osteoporosis in postmenopausal women. A significant reduction in the incidence of vertebral, but not hip fractures has been demonstrated. When determining the choice of raloxifene or other therapies, including oestrogens, for an individual postmenopausal woman, consideration should be given to menopausal symptoms, effects on uterine and breast tissues, and cardiovascular risks and benefits (see section 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The recommended dose is one tablet daily.Due to the nature of this disease process, raloxifene is intended for long term use. Generally calcium and vitamin D supplements are advised in women with a low dietary intake. _Elderly: _ No dose adjustment is necessary for the elderly. _Patients with renal impairment: _ Raloxifene should not be used in patients with severe renal impairment (see section 4.3). In patients with moderate and mild renal impairment, raloxifene should be used with caution. _Patients with hepatic impairment_ : Raloxifene should not be used in patients with hepatic impairment (see section 4.3 and 4.4). _Paediatric population: _ Raloxifene should not be used in children of any age. There is no relevant use of Raloxifene in the paediatric population. Method of administration Oral administration. The tablet can be taken at any time of the day without regard to meals. 3 4.3 CONTRAINDICATIONS Hypersensitivity to the active subst Przeczytaj cały dokument