Therapeutic indications
Sildenafil is indicated in adult men with erectile dysfunction, which is the inability to achieve or maintain a penile erection sufficient for satisfactory sexual performance.
In order for Sildenafil to be effective, sexual stimulation is required.
Posology and method of administration
Posology
Use in adults
The recommended dose is 50mg taken as needed approximately one hour before sexual activity. Based on efficacy and tolerability, the dose may be increased to 100mg or decreased to 25mg. The maximum recommended dose is 100 mg. The maximum recommended dosing frequency is once per day. If Sildenafil is taken with food, the onset of activity may be delayed compared to the fasted state (see Section 5.2).
Special populations
Elderly
Dosage adjustments are not required in elderly patients (= 65 years old).
Renal impairment 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 25mg dose should be considered. Based on efficacy and tolerability, the dose may be increased step-wise to 50mg and 100mg as necessary.
Hepatic impairment Since sildenafil clearance is reduced in patients with hepatic impairment (e.g. cirrhosis) a 25mg dose should be considered. Based on efficacy and tolerability, the dose may be increased step-wise to 50mg and 100mg as necessary.
Paediatric population
Sildenafil is not indicated for individuals below 18 years of age.
Use in patients taking other medicinal products With the exception of ritonavir for which co-administration with sildenafil is not advised a starting dose of 25mg should be considered in patients receiving concomitant treatment with CYP3A4 inhibitors.
In order to minimise the potential of developing postural hypotension in patients receiving alpha-blocker treatment, patients should be stabilised on alpha-blocker therapy prior to initiating sildenafil treatment. In addition, initiation of sildenafil at a dose of 25 mg should be considered.
Method of administration
For oral use.
For full data sheet go to: https://www.medicines.org.uk/emc/product/7124/smpc
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