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언어: 영어
출처: myHealthbox
raloxifene hydrochloride
Fair-Med Healthcare GmbH
G03XC01.
raloxifene hydrochloride
60mg
Film-coated tablets
Oral use
Blister boxes contain 14, 28, or 84 tablets
POM - Prescription Only Medicine
Pharmadox Healthcare Ltd
Selective Oestrogen Receptor Modulator
It 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.
Authorised
2015-05-21
1 PACKAGE LEAFLET: INFORMATION FOR THE USER RALOXIFENE HYDROCHLORIDE FAIR-MED 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, pharmacist or nurse. • 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Raloxifene Hydrochloride Fair-Med is and what it is used for 2. What you need to know before you take Raloxifene Hydrochloride Fair-Med 3. How to take Raloxifene Hydrochloride Fair-Med 4. Possible side effects 5. How to store Raloxifene Hydrochloride Fair-Med 6. Contents of the pack and other information 1. WHAT RALOXIFENE HYDROCHLORIDE FAIR-MED IS AND WHAT IT IS USED FOR Raloxifene Hydrochloride Fair-Med contains the active substance raloxifene hydrochloride. Raloxifene Hydrochloride Fair-Med is used to treat and prevent osteoporosis in postmenopausal women. Raloxifene Hydrochloride Fair-Med 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 Fair-Med works _ Raloxifene Hydrochloride Fair-Med 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. 전체 문서 읽기
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Raloxifene Hydrochloride Fair-Med 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. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film coated tablet. White to off-white, oval biconvex film-coated tablets with 'C' on one side and '12' on other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Raloxifene Hydrochloride Fair-Med 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 Fair-Med 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 Fair-Med 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 Fair-Med should not be used in patients with severe renal impairment (see section 4.3). In patients with moderate and mild renal impairment, Raloxifene Hydrochloride Fair-Med should be used with caution. _Hepatic impairment:_ Raloxifene Hydrochloride Fair-Med should not be used in p 전체 문서 읽기