Χώρα: Μάλτα
Γλώσσα: Αγγλικά
Πηγή: Medicines Authority
RALOXIFENE HYDROCHLORIDE
Bristol Laboratories Limited
G03XC01
RALOXIFENE HYDROCHLORIDE
FILM-COATED TABLET
RALOXIFENE HYDROCHLORIDE 60 milligram(s)
POM
SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
Authorised
2014-11-11
Page 1 of 6 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT Raloxifene hydrochloride 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 this medicine is and what it is used for 2. What you need to know before you take this medicine 3. How to take this medicine 4. Possible side effects 5. How to store this medicine 6. Contents of the pack and other information 1. WHAT THIS MEDICINE IS AND WHAT IT IS USED FOR The name of your medicine is Raloxifene hydrochloride 60 mg film-coated tablets and contains the active ingredient raloxifene hydrochloride. Raloxifene hydrochloride 60 mg film-coated tablet 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 60 mg film-coated tablets mimics some of the helpful effects of oestrogen after the menopause. Page 2 of 6 This medicine is used to treat and prevent osteoporosis in postmenopausal women. It reduces the risk of vertebral fractures in women with postmenopausal osteoporosis. A Διαβάστε το πλήρες έγγραφο
Page 1 of 17 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Raloxifene hydrochloride 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. For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Film-coated tablet (tablet) White to off-white, oval biconvex film-coated tablets embossed with 'C' on one side and '12'on other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Raloxifene hydrochloride 60 mg film-coated tablets 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 60 mg film-coated tablets 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 _ Page 2 of 17 Adults and the elderly: The recommended dose is one tablet daily by oral administration, which may be taken at any time of the day without regard to meals. No dose adjustment is necessary for the elderly. Due to the nature of this disease process, Raloxifene hydrochloride 60 mg film-coated tablets is intended for long term use. Generally calcium and vitamin D supplements are advised in women with a low dietary intake. Use in renal impairment: Raloxifene hydrochloride 60 mg film-coated tablets should not be used in patients with severe renal impairment (see section 4.3). In patients with moderate and mild renal impairment, Raloxifene hydrochloride 60 mg film-coated tablets should be used with caution. Use in hepatic impairment: Raloxifene hydrochloride 60 mg film-coated tablets should not be used in patients with hepatic impairment (see section 4.3 and section 4.4). Paediatric populatio Διαβάστε το πλήρες έγγραφο