- Approval Id
- 802e4ead39d3299a
- Drug Name
- EXEDRAL 25 FILM-COATED TABLET 25MG
- Product Name
- EXEDRAL 25 FILM-COATED TABLET 25MG
- Approval Number
- SIN16646P
- Approval Date
- 2022-11-22
- Registrant
- GOLDPLUS UNIVERSAL PTE LTD
- Licence Holder
- GOLDPLUS UNIVERSAL PTE LTD
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- TABLET, FILM COATED
- Dosage
- <p><strong>6. Recommended Dosage</strong></p>
<p><u>Posology</u></p>
<p><em>Adults and elderly patients</em><br>
The recommended dose of exemestane is one 25 mg tablet to be taken orally once daily, preferably after a meal.</p>
<p>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.</p>
<p>In patients with advanced breast cancer, treatment with exemestane should continue until tumour progression is evident.</p>
<p>No dose adjustments are required for patients with hepatic or renal insufficiency (see section 4 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p><em>Paediatric population</em><br>
Not recommended for use in children.</p>
- Route Of Administration
- ORAL
- Indication Info
- <p><strong>5. Indications</strong></p>
<p>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.</p>
<p>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.</p>
- Contraindications
- <p><strong>8. Contraindications</strong></p>
<p>Hypersensitivity to the active substance or to any of the excipients listed in section 3 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>. In premenopausal women and in pregnant or breastfeeding women.</p>
- Atc Code
- L02BG06
- Atc Item Name
- exemestane
- Pharma Manufacturer Name
- GOLDPLUS UNIVERSAL PTE LTD
