GRISOL Cutaneous spray, solution Ref.[8524] Active ingredients: Griseofulvin

Grisol is for external use only and should only be applied to the feet. Do not spray onto any other parts of the body. Avoid spraying Grisol into the eyes. The solution should not be allowed to come into contact with mucous membranes.

Caution should be exercised when using Grisol on broken skin as the solution may cause stinging.

The adverse reactions associated with oral griseofulvin therapy have not been reported in association with topical administration.

None known.

Systemic treatment with griseofulvin should be avoided in pregnancy and although human studies have not shown any significant absorption into the systemic circulation following topical administration of Grisol, safety in human pregnancy or lactation has not been established, and therefore it should not be used unless the practitioner considers that the benefit of treatment outweighs the risk.

None known.

Grisol may cause skin irritation, i.e. slight stinging or burning on application, although this is unlikely to necessitate discontinuation of treatment.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system in the United Kingdom: Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard.

None known.