País: Singapur
Idioma: inglés
Fuente: HSA (Health Sciences Authority)
Exemestane
ACCORD HEALTHCARE PRIVATE LIMITED
L02BG06
TABLET, FILM COATED
Exemestane 25 mg
ORAL
Prescription Only
Intas Pharmaceuticals Limited
ACTIVE
2020-12-18
PACKAGE INSERT (For the use of a Registered Medical Practitioner or a Hospital) 1. NAME OF THE MEDICINAL PRODUCT EXACCORD 25 (Exemestane Tablets 25 mg) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film coated tablet contains Exemestane 25 mg For a full list of excipients, see Section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet White to off-white, round, biconvex film coated tablets debossed with ‘E25’ on one side and plain on the other. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC 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. Efficacy has not been demonstrated in patients with oestrogen receptor negative status. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Adult and elderly patients The recommended dose of Exemestane is one 25 mg tablet to be taken once a 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 5.2). Paediatric population Not recommended for use in children 4.3 CONTRA-INDICATIONS Exemestane tablets are contraindicated in patients with a known hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Exemestane should not be administered to women with pre-menopausal endocrine status. Therefore, whenever clinically appropriate, the post-menopausal st Leer el documento completo