Krajina: Európska únia
Jazyk: angličtina
Zdroj: EMA (European Medicines Agency)
raloxifene hydrochloride
Substipharm
G03XC01
raloxifene
Sex hormones and modulators of the genital system,
Osteoporosis, Postmenopausal
Evista is indicated for the treatment and prevention of osteoporosis in post-menopausal women. A significant reduction in the incidence of vertebral, but not hip fractures has been demonstrated. When determining the choice of Evista 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: 30
Authorised
1998-08-05
23 B. PACKAGE LEAFLET 24 PACKAGE LEAFLET: INFORMATION FOR THE USER Evista 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 Evista is and what it is used for 2. What you need to know before you take Evista 3. How to take Evista 4. Possible side effects 5. How to store Evista 6. Contents of the pack and other information 1. WHAT EVISTA IS AND WHAT IT IS USED FOR Evista contains the active substance raloxifene hydrochloride. Evista is used to treat and prevent osteoporosis in postmenopausal women. Evista reduces the risk of vertebral fractures in women with postmenopausal osteoporosis. A reduction in the risk of hip fractures has not been shown. How Evista works: Evista 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. Evista 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 EVISTA DO NOT TAKE EVISTA: • If you are being treated or have been treated for blood clots in the legs (deep vein thrombosis), in the lun Prečítajte si celý dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Evista 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. Excipient with known effect: Each tablet contains lactose (149.40 mg). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film coated tablet. Elliptically shaped, white tablets. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Evista 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 Evista 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 by oral administration, which may be taken at any time of the day without regard to meals. Due to the nature of this disease process, Evista 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. _Renal impairment: _ Evista should not be used in patients with severe renal impairment (see section 4.3). In patients with moderate and mild renal impairment, Evista should be used with caution. _ _ _Hepatic impairment: _ Evista should not be used in patients with hepatic impairment (see section 4.3 and 4.4). 3 _Paediatric population: _ Evista should not be used in children of any age. There is no relevant use of Evista in the paediatric population. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Must not be used in women with child bearing potential (see section 4.6). Active o Prečítajte si celý dokument