NAUSELIUM

DOMPERIDONE BIOGARAN is indicated for the relief of symptoms such as nausea and vomiting.

Drowsiness and dizzy sensations have been observed following the use of dompéridone (see section 4.8). Consequently, patients must be informed that they must not drive or use machines, nor engage in other activities requiring alertness and coordination, before knowing the effect that DOMPERIDONE BIOGARAN produces on them.

The safety of domperidone was evaluated during clinical trials and during post-marketing experience. Clinical trials (31 double-blind, placebo-controlled studies) included 1275 patients presenting with dyspepsia, gastro-oesophageal reflux (RGO), irritable bowel syndrome, nausea and vomiting or other similar pathologies.

All patients were at least 15 years old and received at least one dose of domperidone base. The median total daily dose was 30 mg (range 10 to 80 mg). The median duration of exposure was 28 days (range 1 to 28 days).

Studies conducted in patients presenting with diabetic gastroparesis, symptoms secondary to chemotherapies or Parkinson's disease were excluded.

Adverse effects are classified according to their frequency, according to the following convention: very frequent (≥1/10), frequent (≥1/100 to <1/10), uncommon (≥1/1 000 to <1/100), rare (≥1/10 000 to <1/1 000) and very rare (<1/10 000). When the frequency could not be estimated on the basis of clinical data, it is indicated as "undetermined".

* exacerbation of restless legs syndrome in patients with Parkinson's disease

Domperidone has been used at higher doses in 45 longer-term clinical studies and in indications such as diabetic gastroparesis. In these studies, the frequency of adverse events (except dry mouth) was considerably higher, particularly the known pharmacological effects related to the increase in prolactin. In addition to the effects listed above, the following effects were also observed: akathisia, nipple discharge, increase in breast volume, breast swelling, depression, hypersensitivity, lactation disorders and irregular periods.

Reporting of suspected adverse effects

Reporting suspected adverse effects after medicinal product authorization 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/