Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
EXEMESTANE
Helm Pharmaceuticals GmbH
25 Milligram
Coated Tablets
2011-02-11
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Exemestane Helm 25mg Coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each coated tablet contains 25 mg exemestane. Excipients: Each coated tablet contains 31.63 mg of Sucrose. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Coated tablet White to off white, round, biconvex, coated tablets. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Exemestan HELM 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. Exemestan HELM 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 Exemestan HELM is one 25 mg tablet to be taken once daily, after a meal. In patients with early breast cancer, treatment with Exemestan HELM should continue until completion of five years of combined sequential adjuvant hormonal therapy (tamoxifen followed by Exemestan HELM), or earlier if tumour relapse occurs. In patients with advanced breast cancer, treatment with Exemestan HELM should continue until tumour progression is evident. Hepatic or renal impairment No dose adjustments are required for patients with hepatic or renal impairment (see section 5.2). Paediatric population There is no relevant indication for use of Exemestan Helm in children. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 25/ Read the complete document