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CASODEX TABLET 50 MG [SIN09772P]
Active ingredients: CASODEX TABLET 50 MG
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Product Info
CASODEX TABLET 50 MG
[SIN09772P]
Product information
Active Ingredient and Strength | BICALUTAMIDE - 50 MG |
Dosage Form | TABLET, FILM COATED |
Manufacturer and Country | CORDEN PHARMA GMBH - GERMANY |
Registration Number | SIN09772P |
Licence Holder | ASTRAZENECA SINGAPORE PTE LTD |
Forensic Classification | PRESCRIPTION ONLY MEDICINES |
Anatomical Therapeutic Chemical (ATC) code | L02BB03 |
4.1 Therapeutic indications
Treatment of advanced prostate cancer in combination with luteinizing hormone-releasing hormone (LHRH) analogue therapy or surgical castration.
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).
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.
