Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
Product Classification
Formulation Information
TABLET, FILM COATED
**4.2 Posology and method of administration** **Adult males including the elderly:** one tablet (50 mg) once a day. Treatment with CASODEX should be started at the same time as treatment with an LHRH analogue or surgical castration. **Children:** CASODEX is contraindicated in children. **Renal impairment:** No dosage adjustment is necessary for patients with renal impairment. **Hepatic impairment:** No dosage adjustment is necessary for patients with mild hepatic impairment. Increased accumulation may occur in patients with moderate to severe hepatic impairment (see section 4.4 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).
ORAL
Medical Information
**4.1 Therapeutic indications** Treatment of advanced prostate cancer in combination with luteinizing hormone-releasing hormone (LHRH) analogue therapy or surgical castration.
**4.3 Contraindications** CASODEX is contraindicated in females and children (see section 4.6 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). CASODEX must not be given to any patient who has shown a hypersensitivity reaction to the active substance or to any of the excipients of this product. Co-administration of terfenadine, astemizole or cisapride with CASODEX is contraindicated.
L02BB03
bicalutamide
Manufacturer Information
ASTRAZENECA SINGAPORE PTE LTD
Corden Pharma GmbH
Active Ingredients
Documents
Package Inserts
Casodex 50mg PI.pdf
Approved: August 22, 2022