IPP

OMEPRAZOLE ZENTIVA CONSEIL is indicated in the treatment of reflux symptoms (for example, heartburn, acid regurgitation) in adults.

Pregnancy

Results from three prospective epidemiological studies (more than 1 000 exposed outcomes) indicate no adverse effects of omeprazole on pregnancy or on the health of the foetus/newborn child. Omeprazole can be used during pregnancy.

Breastfeeding

Omeprazole is excreted in breast milk but is not likely to influence the child when therapeutic doses are used.

Fertility

Animal studies with the racemic mixture of omeprazole, administered by oral route, do not indicate any effects with respect to fertility.

Omeprazole has no effect or a negligible effect on the ability to drive vehicles and use machines. However, adverse effects such as sensations of dizziness and vision disturbances may occur (see section 4.8). In this case, patients must not drive vehicles or use machines.

Summary of the safety profile

The most frequent adverse effects (1– 10 % of patients) are headache, abdominal pain, constipation, diarrhoea, flatulence and nausea/vomiting.

Severe cutaneous adverse effects (SCAR), notably Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS syndrome) and acute generalized exanthematous pustulosis (AGEP), have been reported in association with omeprazole treatment (see section 4.4).

Table listing adverse effects

The following adverse effects have been reported or suspected during clinical trials of omeprazole and since its marketing. None of the effects were dose-dependent. Adverse effects are classified by frequency and by system organ class (SOC). Frequency is defined according to the following convention: very frequent (≥ 1/10), frequent (≥ 1/100, < 1/10), uncommon (≥ 1/1 000, < 1/100), rare (≥ 1/10 000, < 1/1 000), very rare (< 1/10 000), unknown frequency (cannot be estimated on the basis of available data).

Reporting of suspected adverse reactions

Reporting of suspected adverse reactions after authorisation of the medicinal product is important. It allows continuous monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals report any suspected adverse reaction 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/ .