HYPERIUM

Arterial hypertension.

Pregnancy

There are no data or there is limited data (less than 300 pregnancies) on the use of rilménidine in pregnant women.

Studies conducted in animals have not shown direct or indirect deleterious effects on reproduction (see section 5.3).

As a precautionary measure, it is preferable to avoid the use of rilménidine during pregnancy.

Breastfeeding

It is unknown if rilménidine/metabolites are excreted in human breast milk.

Available pharmacodynamic/toxicological data in animals have shown the excretion of rilménidine/metabolites in milk.

A risk to newborns/infants cannot be excluded.

Rilménidine must not be used during breastfeeding.

Fertility

Reproduction studies in rats have shown that rilménidine had no effect on fertility (see section 5.3).

No specific study on the ability to drive vehicles and use machines has been carried out.

However, as drowsiness is a frequent adverse effect, patients should be cautioned regarding their ability to drive vehicles and use machines.

Summary of the safety profile

At a dose of 1 mg in a single daily dose, during controlled studies, the incidence of adverse effects was comparable to that observed under placebo.

At a dose of 2 mg per day of rilménidine, controlled comparative studies versus clonidine at a dose of 0,15 to 0,30 mg/jour or alphaméthyldopa at a dose of 500 to 1000 mg/jour showed that the incidence of adverse effects was significantly lower than that observed under clonidine or alphaméthyldopa.

Table of adverse effects

The following adverse effects or events have been reported and are listed according to the following frequencies: Very frequent: (≥1/10), Frequent (≥1/100, <1/10), Uncommon (≥1/1 000, <1/100), Rare (≥1/10 000, <1/1 000), Very Rare: (< 1/10 0000), undetermined frequency (cannot be estimated on the basis of available data).

Reporting of suspected adverse effects

Reporting of suspected adverse effects after authorization 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: www.ansm.sante.fr .