CASODEX TABLET 150 mg

4.1 Therapeutic indications

CASODEX 150 mg is indicated either alone or as adjuvant to radical prostatectomy or radiotherapy in patients with locally advanced prostrate cancer at high risk for disease progression (see section 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

CASODEX 150 mg is also indicated for the management of patients with locally advanced, non-metastatic prostate cancer for whom surgical castration or other medical intervention is not considered appropriate or acceptable.

4.3 Contraindications

CASODEX 150 mg 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 150 mg must not be given to any patient who has shown a hypersensitivity to the active substance or to any of the excipients of this product.

Co-administration of terfenadine, astemizole or cisapride with Casodex is contraindicated (see section 4.5 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

4.2 Posology and method of administration

Adult males including the elderly: The dosage is one 150 mg tablet to be taken orally once a day.

CASODEX 150 mg should be taken continuously for at least 2 years or until disease progression.

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).