MEDIBRONC ADULTE

This medicine is indicated in adults and adolescents over 15 years of age in case of recent respiratory disease with difficulty in expectoration (difficulty in coughing up bronchial secretions).

Not applicable.

Pregnancy

Animal studies have not shown any teratogenic effect. In the absence of a teratogenic effect in animals, a malformative effect in the human species is not expected. Indeed, to date, substances responsible for malformations in the human species have proven to be teratogenic in animals during well-conducted studies on two species.

In clinical practice, no particular malformative or foetotoxic effect has appeared to date. However, monitoring of pregnancies exposed to carbocistéine is insufficient to exclude any risk.

Consequently, the use of carbocistéine should only be considered during pregnancy if necessary.

Breastfeeding

There is no data concerning the passage of carbocistéine into breast milk. However, given its low toxicity, the potential risks to the child appear negligible in case of treatment with this medicine. Consequently, breastfeeding is possible.

Not applicable.

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

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

· Possibility of allergic skin reactions such as urticaria, angioedema, pruritus, erythematous eruption.

· 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 medicine is important. It allows continuous monitoring of the benefit/risk ratio of the medicine. 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.signalement-sante.gouv.fr .