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RALOXON FILM-COATED TABLETS 60 MG [SIN14013P]
Active ingredients: RALOXON FILM-COATED TABLETS 60 MG
Last updated 26 October 2025
Product Info
RALOXON FILM-COATED TABLETS 60 MG
[SIN14013P]
Product information
Active Ingredient and Strength | RALOXIFENE HYDROCHLORIDE (EQV. TO RALOXIFENE FREE BASE 56 MG) - 60 MG |
Dosage Form | TABLET, FILM COATED |
Manufacturer and Country | PHARMATHEN S.A. - GREECE |
Registration Number | SIN14013P |
Licence Holder | NOVEM PHARMA PRIVATE LIMITED |
Forensic Classification | PRESCRIPTION ONLY MEDICINES |
Anatomical Therapeutic Chemical (ATC) code | G03XC01 |
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).
4.2. 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.