EXEDRAL 25 FILM-COATED TABLET 25MG [SIN16646P]

Product Info

EXEDRAL 25 FILM-COATED TABLET 25MG

[SIN16646P]

5. Indications

Exemestane is indicated for the adjuvant treatment of postmenopausal women with oestrogen receptor positive invasive early breast cancer (EBC), following 2 – 3 years of initial adjuvant tamoxifen therapy.

Exemestane is indicated for the treatment of advanced breast cancer in women with natural or induced postmenopausal status whose disease has progressed following anti-oestrogen therapy.

6. Recommended Dosage

Posology

Adults and elderly patients
The recommended dose of exemestane is one 25 mg tablet to be taken orally once daily, preferably after a meal.

In patients with early breast cancer, treatment with exemestane should continue until completion of five years of combined sequential adjuvant hormonal therapy (tamoxifen followed by exemestane), or earlier if tumour relapse occurs.

In patients with advanced breast cancer, treatment with exemestane should continue until tumour progression is evident.

No dose adjustments are required for patients with hepatic or renal insufficiency (see section 4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Paediatric population
Not recommended for use in children.

8. Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 3 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information. In premenopausal women and in pregnant or breastfeeding women.