EVISTA TABLET 60 MG [SIN10872P]

Product Info

EVISTA TABLET 60 MG

[SIN10872P]

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).

4.2. 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.

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.