País: Irlanda
Língua: inglês
Origem: HPRA (Health Products Regulatory Authority)
EXEMESTANE
Pharmacia Ireland
25mg Milligram
Tablets
2005-02-04
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Aromasin ® 25 mg coated tablets. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Active Substance: exemestane Each coated tablet contains 25 mg exemestane. Each tablet contains 30.2mg of sucrose and 0.003mg of methyl parahydroxybenzoate (E218). For a full list of Excipients, see section 6.1 3 PHARMACEUTICAL FORM Coated tablet. Round, biconvex, off-white coated tablet marked 7663 on one side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Aromasin ® is indicated for the adjuvant treatment of postmenopausal women with oestrogen receptor positive invasive early breast cancer, following 2 – 3 years of initial adjuvant tamoxifen therapy. Aromasin ® 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. Efficacy has not been demonstrated in patients with oestrogen receptor negative status. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adult and elderly patients The recommended dose of Aromasin ® is one 25 mg tablet to be taken once daily, preferably after a meal. In patients with early breast cancer, treatment with Aromasin ® should continue until completion of five years of combined sequential adjuvant hormonal therapy (tamoxifen followed by Aromasin ® ), or earlier if tumour relapse occurs. In patients with advanced breast cancer, treatment with Aromasin ® should continue until tumour progression is evident. No dose adjustments are required for patients with hepatic or renal insufficiency _(see section 5.2, Pharmacokinetic_ _Properties)._ Children Not recommended for use in children. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date P Leia o documento completo