Regulatory Information
LOTUS INTERNATIONAL PTE. LTD.
LOTUS INTERNATIONAL PTE. LTD.
Therapeutic
Prescription Only
Formulation Information
TABLET, FILM COATED
**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. Due to the nature of this disease process, EVISTA 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 EVISTA should not be used in patients with severe renal impairment (see section 4.3). In patients with moderate and mild renal impairment, EVISTA should be used with caution. Hepatic impairment EVISTA should not be used in patients with hepatic impairment (see section 4.3 and 4.4 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Paediatric population EVISTA should not be used in children of any age. There is no relevant use of EVISTA in the paediatric population.
ORAL
Medical Information
**4.1. Therapeutic indications** EVISTA 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 EVISTA for osteoporosis treatment, EVISTA has been to shown to reduce the risk of invasive breast cancer. When determining the choice of EVISTA 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 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).
**4.3. Contraindications** Hypersensitivity to the active substance or to any of the excipients. Must not be used in women with childbearing potential. EVISTA therapy during pregnancy may be associated with an increased risk of congenital defects in the fetus. 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. EVISTA should not be used in patients with signs or symptoms of endometrial cancer as safety in this patient group has not been adequately studied.
G03XC01
raloxifene
Manufacturer Information
LOTUS INTERNATIONAL PTE. LTD.
LILLY SA
Bushu Pharmaceuticals Ltd., Kawagoe Factory