50 mgTreatment of advanced prostate cancer in combination w/ LHRH analogue or surgical castration 1 tab once daily, started at least 3 days before commencing treatment w/ an LHRH analogue, or at the same time as surgical castration. 150 mgTreatment of locally advanced prostate cancer at high risk for disease progression, either alone or as adjuvant to radical prostatectomy or radiotherapy. Management of patients w/ locally advanced, non-metastatic prostate cancer for whom surgical castration or other medical intervention is not considered appropriate or acceptable 1 tab once daily continually for at least 2 yr or until disease progression.
Moderate to severe hepatic impairment. Reduction in glucose tolerance has been observed. May prolong QT interval. May cause morphological changes in spermatozoa. Concomitant use w/ drugs metabolised predominantly by CYP3A4; coumarin anticoagulant. Galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
Potential increase in exposure of terfenadine, astemizole, cisapride; ciclosporin, Ca-channel blockers. Increased conc w/ cimetidine, ketoconazole. Increased effect of warfarin & other coumarin anticoagulants. Potential additive effect on QT interval w/ medicinal products known to prolong the QT interval or medicinal products able to induce Torsade de pointes.
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