Discontinue use in case of sudden visual defect; event of sudden decrease or loss of hearing. Not recommended for continuous daily use. Serious CV events eg, MI, sudden cardiac death, unstable angina pectoris, ventricular arrhythmia, stroke, transient ischemic attacks, chest pain, palpitations & tachycardia. Patients w/ anatomical deformation of penis (eg, angulation, cavernosal fibrosis or Peyronie's disease) or conditions which may predispose them to priapism (eg, sickle cell anemia, multiple myeloma or leukemia). Consider CV status of patients prior to initiating treatment. Not recommended in combination w/ doxazosin. Not to be taken w/ other PDE5 inhibitors or other treatments for erectile dysfunction. Concomitant use w/ antihypertensive medicinal products; α1 blockers; potent CYP3A4 inhibitors eg, ritonavir, saquinavir, ketoconazole, itraconazole & erythromycin. Severe hepatic impairment (Child-Pugh class C). Not recommended as once-daily dosing in severe renal impairment. Not indicated for use by women. Avoid use during pregnancy. Not to be used during lactation. No relevant use w/ regard to erectile dysfunction in childn.