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EXACCORD 25 FILM COATED TABLET 25 MG [SIN16062P]
Active ingredients: EXACCORD 25 FILM COATED TABLET 25 MG
Last updated 26 October 2025
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Product Info
EXACCORD 25 FILM COATED TABLET 25 MG
[SIN16062P]
Product information
Active Ingredient and Strength | EXEMESTANE - 25 MG |
Dosage Form | TABLET, FILM COATED |
Manufacturer and Country | INTAS PHARMACEUTICALS LIMITED - INDIA |
Registration Number | SIN16062P |
Licence Holder | ACCORD HEALTHCARE PRIVATE LIMITED |
Forensic Classification | PRESCRIPTION ONLY MEDICINES |
Anatomical Therapeutic Chemical (ATC) code | L02BG06 |
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 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
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 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.