Ország: Írország
Nyelv: angol
Forrás: HPRA (Health Products Regulatory Authority)
EXEMESTANE
Pfizer Healthcare Ireland
EXEMESTANE
25 Milligram
Coated Tablets
Product subject to prescription which may not be renewed (A)
Authorised
0000-00-00
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Exemestane Pfizer 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 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 Exemestane Pfizer 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. Exemestane Pfizer 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 Exemestane Pfizer is one 25 mg tablet to be taken once daily after a meal. In patients with early breast cancer, treatment with Exemestane Pfizer should continue until completion of five years of combined sequential adjuvant hormonal therapy (tamoxifen followed by Exemestane Pfizer), or earlier if tumour relapse occurs. In patients with advanced breast cancer, treatment with Exemestane Pfizer should continue until tumour progression is evident. No dose adjustments are required for patients with hepatic or renal insufficiency (see 5.2). Children Not recommended for use in children 4.3 CONTRAINDICATIONS Exemestane Pfizer tablets are contraindicated in patients with a known hypersensitivity to the active substance or Olvassa el a teljes dokumentumot