Šalis: Airija
kalba: anglų
Šaltinis: HPRA (Health Products Regulatory Authority)
RALOXIFENE HYDROCHLORIDE
Actavis Group PTC ehf
G03XC01
RALOXIFENE HYDROCHLORIDE
60 Milligram
Film Coated Tablet
Product subject to prescription which may be renewed (B)
raloxifene
Marketed
2015-01-30
1 PACKAGE LEAFLET: INFORMATION FOR THE USER RALOXIFENE HYDROCHLORIDE ACTAVIS 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 Hydrochloride Actavis is and what it is used for 2. What you need to know before you take Raloxifene Hydrochloride Actavis 3. How to take Raloxifene Hydrochloride Actavis 4. Possible side effects 5. How to store Raloxifene Hydrochloride Actavis 6. Contents of the pack and other information 1. WHAT RALOXIFENE HYDROCHLORIDE ACTAVIS IS AND WHAT IT IS USED FOR Raloxifene Hydrochloride Actavis contains the active substance raloxifene hydrochloride. Raloxifene Hydrochloride Actavis is used to treat and prevent osteoporosis in postmenopausal women. Raloxifene Hydrochloride Actavis 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 Hydrochloride Actavis works Raloxifene Hydrochloride Actavis 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 Hydrochloride Actavis 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, Perskaitykite visą dokumentą
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Raloxifene Hydrochloride Actavis 60mg 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(s) with known effect: Each tablet contains lactose monohydrate (1.5 mg). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. Elliptically shaped (12.6 mm x 6.6 mm), white film-coated tablets. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Raloxifene Hydrochloride Actavis 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 Hydrochloride Actavis 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, Raloxifene Hydrochloride Actavis 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:_ Raloxifene Hydrochloride Actavis should not be used in patients with severe renal impairment (see section 4.3). In patients with moderate and mild renal impairment, Raloxifene Hydrochloride Actavis should be used with caution. _Hepatic impairment:_ Raloxifene Hydrochloride Actavis should not be used in patients with hepatic impairment (see section 4.3 and 4.4). _Paediatric population_ Raloxifene Hydrochloride Actavis should not be used in children of any age. There is no relevant use of Raloxifene Perskaitykite visą dokumentą