REVATIO

Adults

Treatment of pulmonary arterial hypertension in adult patients in functional classes II and III according to the WHO classification, to improve exercise capacity. Efficacy has been demonstrated in idiopathic pulmonary arterial hypertension and in pulmonary arterial hypertension associated with connective tissue disease.

Pediatric population

Treatment of pulmonary arterial hypertension in pediatric patients aged 1 year to 17 years.

Efficacy in terms of improvement of exercise capacity or pulmonary hemodynamics has been shown in idiopathic pulmonary arterial hypertension and in pulmonary arterial hypertension associated with congenital heart disease (see section 5.1).

Women of childbearing potential and contraception in men and women

Due to a lack of data in pregnant women, sildénafil is not recommended in women of childbearing potential unless appropriate contraceptive measures are used.

Pregnancy

There is no data on the use of sildénafil in pregnant women. Animal studies do not show any direct or indirect harmful effect on gestation and embryofetal development. Animal studies have shown toxicity on post-natal development (see section 5.3).

Due to a lack of data, sildénafil should not be used in pregnant women except in cases of extreme necessity.

Breastfeeding

There are no specific studies in breastfeeding women. Data obtained from a breastfeeding woman revealed excretion of sildénafil and its active metabolite, N-desméthylsildénafil, at very low concentrations in breast milk. No clinical data is available regarding adverse effects in breastfed infants. Nevertheless, the amounts ingested would a priori not be likely to cause adverse effects in the breastfed newborn. Prescribers should assess the clinical benefit of sildénafil for the mother and the potential risk of adverse effects in the breastfed child.

Fertility

Conventional preclinical fertility studies have not revealed any particular risk for Man (see section 5.3).

Sildenafil has a moderate 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 must previously test their individual reaction to sildenafil before driving a vehicle or using machines.