Regulatory Information
GOLDPLUS UNIVERSAL PTE LTD
GOLDPLUS UNIVERSAL PTE LTD
Therapeutic
Prescription Only
Formulation Information
TABLET, FILM COATED
**6\. Recommended Dosage** Posology _Adults and elderly patients_ The recommended dose of exemestane is one 25 mg tablet to be taken orally once 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 section 4 – _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
**5\. 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.
**8\. Contraindications** Hypersensitivity to the active substance or to any of the excipients listed in section 3 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_. In premenopausal women and in pregnant or breastfeeding women.
L02BG06
exemestane
Manufacturer Information
GOLDPLUS UNIVERSAL PTE LTD
Remedica Ltd
Active Ingredients
Documents
Package Inserts
sg-pi-exedral-fc-tabs-a4.pdf
Approved: November 22, 2022