Quốc gia: Singapore
Ngôn ngữ: Tiếng Anh
Nguồn: HSA (Health Sciences Authority)
Raloxifene hydrochloride (eqv. to raloxifene free base 56 mg)
NOVEM PHARMA PRIVATE LIMITED
G03XC01
60.0 mg
TABLET, FILM COATED
Raloxifene hydrochloride (eqv. to raloxifene free base 56 mg) 60.0 mg
ORAL
Prescription Only
Pharmathen S.A.
ACTIVE
2011-09-16
RALOXON ® 60 MG FILM-COATED TABLETS RALOXIFENE HYDROCHLORIDE 1. NAME OF THE MEDICINAL PRODUCT RALOXON 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 excipients, see Section 6.1. 3. PHARMACEUTICAL FORM White elliptical film-coated tablets. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Raloxifene 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. For those postmenopausal women taking raloxifene for osteoporosis treatment, Raloxifene has been to shown to reduce the risk of invasive breast cancer. When determining the choice of raloxifene 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 The recommended posology 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 is intended for long term use. Generally calcium and vitamin D supplements are advised in women with a low dietary intake. 4.3. CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients. Must not be used in women with child bearing potential. Active or past history of venous thromboembolic events (VTE), including deep vein thrombosis, pulmonary embolism and retinal vein thrombosis. Hepatic impairment including cholestasis. Severe renal impairment. Unexplained uterine bleeding. Raloxifene should not be used in patients with signs or symptoms of endometrial cancer as safety in this patient group has not been adequately studied. 4.4. SPECIAL WARNINGS AND PRECAUTIONS FOR USE Raloxi Đọc toàn bộ tài liệu