SULIAT /

Treatment of essential arterial hypertension.

AMLODIPINE/VALSARTAN KRKA is indicated in adult patients whose blood pressure is not sufficiently controlled under amlodipine or valsartan monotherapy.

Patients receiving amlodipine/valsartan who drive motor vehicles or use machines must be informed that they may occasionally be subject to sensations of dizziness or fatigue.

amlodipine may have a minor or moderate influence on the ability to drive vehicles and use machines. If patients treated with amlodipine experience sensations of dizziness, headache, fatigue or nausea, their ability to react may be impaired.

Summary of the safety profile

The safety of amlodipine/valsartan was evaluated in five controlled clinical studies in 5 175 patients, of whom 2 613 received valsartan in combination with amlodipine. The following adverse reactions occurred most frequently or were the most significant or severe: nasopharyngitis, influenza, hypersensitivity, headache, syncope, orthostatic hypotension, oedema, pitting oedema, facial oedema, peripheral oedema, fatigue, flushing, asthenia and hot flush.

Tabulated list of adverse reactions

Adverse reactions are ranked by frequency, using the following convention: very common (≥ 1/10); common (≥ 1/100, < 1/10); uncommon (≥ 1/1 000, < 1/100); rare (≥ 1/10 000, < 1/1 000); very rare (< 1/10 000); not known (cannot be estimated from the available data).

* Usually suggestive of cholestasis

Additional information on the combination

Peripheral oedema, a known adverse effect of amlodipine, was generally observed at a lower incidence in patients who received the amlodipine/valsartan combination than in those who received amlodipine alone. In double-blind, controlled clinical trials, the incidence of peripheral oedema according to dose was as follows:

The mean incidence of peripheral oedema, calculated from the data obtained with each dose, was 5,1 % with the amlodipine/valsartan combination.

Additional information on the individual components

Adverse reactions previously reported with one of the individual components (amlodipine or valsartan) may also be potential adverse reactions with amlodipine/valsartan, even if they were not observed in clinical trials or during marketing.

Amlodipine

* usually suggestive of cholestasis

Valsartan

Reporting of suspected adverse reactions

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