Raloxon Film-coated Tablets 60 mg

**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 – _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 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.

NOVEM PHARMA PRIVATE LIMITED

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