Exclude obstruction due to trilobular growth pattern of the prostate before starting treatment. Carefully monitor for obstruction uropathy in patients w/ large residual urine &/or severely diminished urinary flow. Risk of erectile dysfunction &/or decreased libido continuing after treatment discontinuation; male infertility &/or poor seminal quality. Perform digital rectal exam, as well as other evaluations for prostate cancer, prior to initiating therapy & periodically thereafter. Associated w/ decreases in serum PSA conc (approx 50%). May increase the risk of high-grade prostate cancer. Not approved for the prevention of prostate cancer. Reports of breast cancer in men. Reports of mood alterations, including depressed mood, depression &, less frequently, suicidal ideation. Galactose intolerance, total lactase deficiency or glucose-galactose malabsorption. Patients w/ hepatic impairment. Women should not handle crushed or broken tab when they are or may potentially be pregnant due to potential risk to a male foetus (external genitalia abnormalities). Minimise exposure of patient's partner to semen when his sexual partner is or may potentially be pregnant. Slightly decreased elimination rate in elderly >70 yr.
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