VIBREX

Sildenafil is indicated in adult men presenting with erectile dysfunction, which corresponds to the inability to achieve or maintain an erection of the penis sufficient for satisfactory sexual activity.

Sexual stimulation is required for sildenafil to be effective.

Sildenafil is not indicated in women.

No appropriate and adequately controlled studies have been conducted in pregnant or breastfeeding women.

During reproduction studies in rats and rabbits, no relevant adverse effects were observed after oral administration of sildenafil.

No effect on sperm motility or morphology appeared after oral administration of a single 100 mg dose of sildenafil in healthy volunteers (see section 5.1).

SILDENAFIL SANDOZ may have a minor influence on the ability to drive vehicles and use machines.

As sensations of dizziness and vision disturbances have been reported in clinical studies with sildenafil, patients should know how they react to sildenafil before driving a vehicle or operating machines.

Summary of the safety profile

The safety profile of sildenafil is based on 9570 patients from 74 double-blind, placebo-controlled clinical trials. The most frequently reported adverse effects during clinical trials among patients treated with sildenafil were headache, congestive flushing, dyspepsia, nasal congestion, dizziness sensations, nausea, hot flashes, visual disturbance, cyanopsia and blurred vision.

The adverse effects reported during post-marketing surveillance concern an estimated period of more than 10 years. The frequencies of these effects cannot be reliably determined because not all adverse effects are reported to the Marketing Authorisation Holder and included in the tolerability database.

Table of adverse effects

In the table below, all clinically important adverse effects, which appeared during clinical trials with an incidence higher than placebo, are listed by organ system classes and by frequency (very frequent (≥ 1/10), frequent (≥ 1/100 and < 1/10), uncommon (≥ 1/1000 and < 1/100), rare (≥ 1/10 000 and < 1/1000).

Within each frequency group, adverse effects must be presented in descending order of severity.

Table 1: clinically important adverse effects reported with an incidence higher than placebo during controlled clinical trials and clinically important adverse effects reported during post-marketing surveillance.

*Only reported during post-marketing surveillance

** Alteration of colour vision: chloropsia, chromatopsia, cyanopsia, erythropsia and xanthopsia

*** Lacrimal disorders: ocular dryness, lacrimal disorder and increase in lacrimal secretion

Reporting of suspected adverse effects

Reporting of suspected adverse effects after authorisation of the medicinal product is important. It allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare professionals report any suspected adverse effect via the national reporting system: French National Agency for Medicines and Health Products Safety (Ansm) and the network of Regional Pharmacovigilance Centres - Website: https://signalement.social-sante.gouv.fr/ .