TINADERM Cream Ref.[50294] Active ingredients: Tolnaftate

Tinaderm Cream 1% is for external use only.

This product should be kept away from the eyes and mucous membranes.

In mixed infections supplementary anti-infective therapy is indicated. If there is no response after 4 weeks, reassessment of diagnosis should be made.

None Known.

There is no evidence of safety of the drug in human pregnancy or during lactation, but it has been in wide use for many years without apparent ill consequence. If drug therapy is needed during pregnancy, this drug can be used if there is no safer alternative.

Compared with control groups, no significant teratogenic effects were seen in rabbits, guinea-pigs, mice and rats following oral, topical or subcutaneous administration of tolnaftate.

Not applicable.

Skin reactions occur rarely with tolnaftate and include irritation and contact dermatitis. If this occurs treatment should be stopped and referral made to GP.

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 HPRA Pharmacovigilance, Earlsfort Terrace, IRL – Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: medsafety@hpra.ie.

Not applicable.