Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: Upjohn EESV, Rivium Westlaan 142, 2909 LD Capelle aan den IJssel, Netherlands
VIAGRA 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 VIAGRA to be effective, sexual stimulation is required.
The recommended dose is 50 mg taken as needed approximately one hour before sexual activity.
Based on efficacy and tolerability, 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 VIAGRA is taken with food, the onset of activity may be delayed compared to the fasted state (see section 5.2).
Dosage adjustments are not required in elderly patients (≥65 years old).
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 tolerability, the dose may be increased step-wise to 50 mg up to 100 mg as necessary.
Since sildenafil clearance is reduced in patients with hepatic impairment (e.g. cirrhosis) a 25 mg dose should be considered. Based on efficacy and tolerability, the dose may be increased step-wise to 50 mg up to 100 mg as necessary.
VIAGRA is not indicated for individuals below 18 years of age.
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 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 (see sections 4.4 and 4.5).
For oral use.
In single dose volunteer studies of doses up to 800 mg, adverse reactions were similar to those seen at lower doses, but the incidence rates and severities were increased. Doses of 200 mg did not result in increased efficacy but the incidence of adverse reactions (headache, flushing, dizziness, dyspepsia, nasal congestion, altered vision) was increased.
In cases of overdose, standard supportive measures should be adopted as required. Renal dialysis is not expected to accelerate clearance as sildenafil is highly bound to plasma proteins and not eliminated in the urine.
5 years.
Do not store above 30°C.
Store in the original package in order to protect from moisture.
VIAGRA 25 mg film-coated tablets: PVC/Aluminium blisters in cartons of 2, 4, 8 or 12 tablets.
VIAGRA 50 mg film-coated tablets: PVC/Aluminium blisters in cartons or secondary heat sealed card packaging of 2, 4, 8, 12 or 24 tablets.
VIAGRA 100 mg film-coated tablets: PVC/Aluminium blisters in cartons of 2, 4, 8, 12 or 24 tablets.
Not all pack sizes may be marketed.
No special requirements.
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