MEDIBRONC ENFANT

Treatment of bronchial secretion disorders, notably during acute bronchial conditions: acute bronchitis and acute episode of chronic bronchopneumopathies

· History of hypersensitivity to one of the constituents (notably to methyl parahydroxybenzoate and other parahydroxybenzoate salts) mentioned in section 6.1,

· In case of active gastroduodenal ulcer,

· Infant (less than 2 years) (see section 4.4).

Not applicable.

Pregnancy

Animal studies have not shown any teratogenic effect. There are no available data on the use of carbocistéine in pregnant women.

Consequently, the use of carbocistéine in pregnant women is not recommended.

Breastfeeding

There are no available data on the passage of carbocistéine into breast milk.

Consequently, the use of carbocistéine in breastfeeding women is not recommended.

Not applicable.

· Risk of bronchial congestion in infants (see sections 4.3 and 4.4).

· Gastrointestinal disorders (gastralgia, nausea, vomiting, diarrhea). It is then advised to reduce the dose.

· Gastrointestinal bleeding. It is recommended to stop the treatment.

· Allergic skin rash and anaphylactic reactions such as pruritus, erythematous rash, urticaria and angioedema.

· Some cases of fixed pigment erythema have been reported.

· Isolated cases of bullous dermatoses such as Stevens-Johnson syndrome and erythema multiforme.

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.signalmeent-sante.gouv.fr .