MICETAL DERMAL

Adult MICETAL Dermal Cream is applied topically once or twice daily. The cream should be applied sparingly and rubbed gently into the cleansed, affected skin and surrounding area. Application to intertriginous lesions should be performed with small quantities to avoid skin maceration.

The recommended duration of therapy is four weeks, with the exception of pityriasis for which 1 to 3 weeks may suffice. Patients should be advised to continue applications should there be early resolution of lesions (unless otherwise instructed).

Failure to respond after four weeks of therapy should prompt a re-evaluation of the diagnosis. Children The safety and efficacy of MICETAL Dermal Cream has not been established in children under the age of 10. Elderly Same posology and method of administration as for adults.

The incidence of adverse reactions associated with the administration of MICETAL Dermal Cream was 8% in clinicals trials, the most common ones being slight burning, irritation, itching and erythema in the application area. Hypersensitivity reactions are possible and may occur as a worsening of the rash in the first instance.

4. Special Warnings and Special Precautions for Use MICETAL Dermal Cream is for external use only. 5 cm). The possible systemic absorption and local toxicity of MICETAL Dermal Cream following application to exposed subepidermal layers has not been studied.

Therefore, the product should not be applied to lesions where disruption of the epidermal layer is evident (eg. as in ulcerated areas). MICETAL Dermal Cream must not be applied to the eyes, to skin in close proximity to the eyes, to any mucous membranes or to skin adjacent to mucous membranes.

If irritation or sensitivity develop during the use of MICETAL Dermal Cream, treatment should be discontinued and appropriate therapy instituted.

3. 1. List of excipients).