CASODEX TABLET 50 mg

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.

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).