Sildenafil 50 mg

Use in adults:

The recommended dose is 50 mg taken as needed approximately one hour before sexual activity. Based on efficacy and toleration, the dose may be increased to 100 mg or decreased to 25 mg. The maximum recommended dose is 100 mg. The maximum recommended dosing frequency is once per day. If Sildenafil 50 mg is taken with food, the onset of activity may be delayed compared to the fasted state (see section 5.2).

Use in the elderly:

Dosage adjustments are not required in elderly patients.

Use in patients with impaired renal function:

The dosing recommendations described in 'Use in adults' apply to patients with mild to moderate renal impairment (creatinine clearance = 30 - 80 ml/min).

Since sildenafil clearance is reduced in patients with severe renal impairment (creatinine clearance <30 ml/min) a 25 mg dose should be considered. Based on efficacy and toleration, the dose may be increased to 50 mg and 100 mg.

Use in patients with impaired hepatic function:

Since Sildenafil 50 mg clearance is reduced in patients with hepatic impairment (e.g. cirrhosis) a 25 mg dose should be considered. Based on efficacy and toleration, the dose may be increased to 50 mg and 100 mg.

Use in children and adolescents:

Sildenafil is not indicated for individuals below 18 years of age.

Use in patients using other medicines:

With the exception of ritonavir for which co-administration with sildenafil is not advised (see section 4.4) a starting dose of 25 mg should be considered in patients receiving concomitant treatment with CYP3A4 inhibitors (see section 4.5).

In order to minimise the potential for developing postural hypotension, patients should be stable on alpha-blocker therapy prior to initiating sildenafil treatment. In addition, initiation of sildenafil at a dose of 25 mg should be considered