Discontinue use if sudden loss of or decreased vision & hearing occur. Not to be used in men for whom sexual activity is inadvisable. Anatomical penis deformation eg, angulation, cavernosal fibrosis or Peyronie's disease; conditions predisposing to priapism eg, sickle cell anaemia, multiple myeloma or leukaemia. Serious CV events eg, MI, sudden cardiac death, ventricular arrhythmia, cerebrovascular hemorrhage & transient ischaemic attack; pre-existing CV risk factors; left ventricular outflow obstruction (eg, aortic stenosis, hypertrophic obstructive cardiomyopathy) or rare multiple system atrophy syndrome; risk factors eg, low cup to disc ratio, age >50 yr, diabetes, HTN, CAD, hyperlipidemia, smoking; retinitis pigmentosa; bleeding disorders, active peptic ulceration. Consider CV status, certain underlying conditions adversely affected by vasodilatory effects & hemodynamically stable α-blocker therapy prior to initiation. Not recommended in combination w/ other PDE5 inhibitors or pulmonary arterial HTN treatments. Co-administration w/ α-blockers. May affect ability to drive & use machines. Not to be used in women & childn <18 yr.
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