BRUMIXOL

Dermatoses superinfected or not by bacteria:

· dermatophytoses caused by Trichophyton,

· Epidermophyton, Microsporum outside of tinea capitis,

· cutaneous candidiasis,

· pityriasis versicolor,

· Onychomycoses caused by dermatophytes.

Mild to moderate seborrheic dermatitis of the face.

No interaction studies have been conducted.

CICLOPIROX OLAMINE BIOGARAN has no effect on the ability to drive vehicles and use machines.

The following table presents the adverse effects by MedDRA system organ class.

Frequencies are defined as: very frequent (≥ 1/10), frequent (≥ 1/100, < 1/10), uncommon (≥ 1/1000, < 1/100), rare (≥ 1/10 000, < 1/1000), very rare (< 1/10 000), undetermined (cannot be estimated from the available data).

* requires interruption of treatment

** cases of contact dermatitis have been reported since marketing

*** does not require discontinuation of treatment

The possibility of occurrence of systemic effects must be taken into account in case of prolonged treatment over a large area, on damaged skin, a mucosa or under an occlusive dressing.

Reporting of suspected adverse effects

Reporting of suspected adverse effects after authorisation 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: https://signalement.social-sante.gouv.fr/