Riik: Suurbritannia
keel: inglise
Allikas: MHRA (Medicines & Healthcare Products Regulatory Agency)
Raloxifene hydrochloride
Lupin Healthcare (UK) Ltd
G03XC01
Raloxifene hydrochloride
60mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 06040101; GTIN: 8901107024109
1 PACKAGE LEAFLET 2 PACKAGE LEAFLET: INFORMATION FOR THE USER OSTIRAL 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 Ostiral is and what it is used for 2. What you need to know before you take Ostiral 3. How to take Ostiral 4. Possible side effects 5. How to store Ostiral 6. Contents of the pack and other information 1. WHAT OSTIRAL IS AND WHAT IT IS USED FOR Ostiral contains the active substance raloxifene hydrochloride. Ostiral is used to treat and prevent osteoporosis in postmenopausal women. Ostiral reduces the risk of vertebral fractures in women with postmenopausal osteoporosis. A reduction in the risk of hip fractures has not been shown. How Ostiral works Ostiral 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. Ostiral 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 OSTIRAL DO NOT TAKE OSTIRAL: • If you are being treated or have been treated for blood clots in the legs (deep vein thrombosis), i Lugege kogu dokumenti
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Ostiral 60 mg film-coated tablets Raloxifene hydrochloride 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. Excipients with known effect: Each tablet contains lactose monohydrate (1.5 mg). Each tablet contains less than 1 mmol (23 mg) sodium. 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 Ostiral 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 Ostiral 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, Ostiral 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:_ Ostiral should not be used in patients with severe renal impairment (see section 4.3). In patients with moderate and mild renal impairment, Ostiral should be used with caution. _Hepatic impairment:_ Ostiral should not be used in patients with hepatic impairment (see section 4.3 and 4.4). _Paediatric population: _ Ostiral should not be used in children of any age. There is no relevant use of Ostiral in the paediatric population. 4.3 CONTRAINDICATIONS • Hypersensitivity to the active substance or to any of the excipi Lugege kogu dokumenti