Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
LETROZOLE
PCO Manufacturing
2.5 Milligram
Film Coated Tablet
2009-12-11
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Femara 2.5mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Active substance: letrozole Each film-coated tablet contains 2.5mg letrozole. Excipients: contains lactose. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet _Product imported from the UK:_ Film-coated tablet, dark yellow, round, slightly biconvex with beveled edge. One side bears the imprint “FV”, the other “CG”. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Adjuvant treatment of postmenopausal women with hormone receptor positive early breast cancer. Extended adjuvant treatment of hormone-dependent early breast cancer in postmenopausal women who have received prior standard adjuvant tamoxifen therapy for 5 years. First-line treatment in postmenopausal women with hormone_-_dependent advanced breast cancer. Advanced breast cancer in women with natural or artificially induced postmenopausal status after relapse or disease progression, who have previously been treated with anti-oestrogens. Efficacy has not been demonstrated in patients with hormone receptor negative breast cancer. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adult and elderly patients The recommended dose of Femara is 2.5 mg once daily. No dose adjustment is required for elderly patients. In the adjuvant setting, it is recommended to treat for 5 years or until tumour relapse occurs. In the adjuvant setting, clinical experience is available for 2 years (median duration of treatment was 25 months). In the extended adjuvant setting, clinical experience is available for 4 years (median duration of treatment). In patients with advanced or metastatic disease, treatment with Femara should continue until tumour progression is evident. Children No Read the complete document