País: Malta
Idioma: inglés
Fuente: Medicines Authority
RALOXIFENE HYDROCHLORIDE
Aurobindo Pharma (Malta) Limited Vault 14, Level 2, Valletta Waterfront, Floriana FRN 1913, Malta
G03XC01
RALOXIFENE HYDROCHLORIDE 60 mg
FILM-COATED TABLET
RALOXIFENE HYDROCHLORIDE 60 mg
POM
SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
Withdrawn
2013-08-07
1 PACKAGE LEAFLET: INFORMATION FOR THE USER RALOXIFENE AUROBINDO 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 Aurobindo is and what it is used for 2 What you need to know before you take Raloxifene Aurobindo 3 How to take Raloxifene Aurobindo 4 Possible side effects 5 How to store Raloxifene Aurobindo 6 Contents of the pack and other information 1. WHAT RALOXIFENE AUROBINDO IS AND WHAT IT IS USED FOR Raloxifene Aurobindo contains the active substance raloxifene hydrochloride. Raloxifene Aurobindo is used to treat and prevent osteoporosis in postmenopausal women. Raloxifene Aurobindo 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 Aurobindo works Raloxifene 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 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 AUROBINDO DO NOT Leer el documento completo
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Raloxifene Aurobindo 60 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 60 mg of 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, elliptical, film-coated tablets debossed with 'X' on one side and '57' on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Raloxifene Aurobindo 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 Aurobindo 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 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 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. _Hepatic impairment: _ Raloxifene should not be used in patients with hepatic impairment (see section 4.3). _Paediatric Population _ Raloxifene should not be used in children of any age. There is no relevant use of Raloxifene 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 b Leer el documento completo