Special Precautions:
Liver disease; cardiac failure. Perform digital rectal exam & other prostate cancer evaluations on BPH patients prior to therapy & periodically thereafter. Establish new prostate specific antigen (PSA) baseline after 6 mth of treatment. Regularly monitor & carefully evaluate any sustained increase of PSA values. Risk of prostate cancer & high grade tumor; orthostatic hypotension; intraoperative floppy iris syndrome. Discontinue therapy 1-2 wk prior to cataract surgery. Concomitant use w/ CYP3A4 & CYP2D6 inhibitors. Possible breast cancer in men. May affect ability to drive or operate machinery. Women & childn should avoid contact w/ leaking caps.
Side Effects / Adverse Reactions:
Abdominal pain & diarrhoea. Anaphylactic reactions, angioedema, hypersensitivity; dehydration; dizziness, syncope; abdominal cramps, nausea, haematochezia, vomiting, abdominal & anorectal discomfort, colitis eg, ischaemic colitis.
Dosage / Direction for Use:
Adult males (including elderly) 1 cap once daily.