Regulatory Information
ACCORD HEALTHCARE PRIVATE LIMITED
ACCORD HEALTHCARE PRIVATE LIMITED
Therapeutic
Prescription Only
Formulation Information
TABLET, FILM COATED
**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.
ORAL
Medical Information
**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.
**4.3 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_.
L02BG06
exemestane
Manufacturer Information
ACCORD HEALTHCARE PRIVATE LIMITED
Intas Pharmaceuticals Limited
Active Ingredients
Documents
Package Inserts
Exaccord 25 Film Coated Tablet PI.pdf
Approved: December 18, 2020