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National Drug Formulary

EXACCORD 25 FILM COATED TABLET 25 MG [SIN16062P]

Active ingredients: EXEMESTANE

View product's general information
Last updated on 9 October 2026

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

Prescription-only Medicines with Exemptions for Supply without Prescription

NA

Indication

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.

Dosing

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

Contraindications

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.