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SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lanafine AFR 1% (w/w) Cream
Terbinafine hydrochloride
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
10 mg terbinafine hydrochloride (equivalent to 8.89 mg terbinafine) in 1 g cream.
Excipients: Also contains cetyl alcohol (0.04g in 1g cream) and cetostearyl alcohol (0.04g in 1g cream).
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Cream.
White or almost white cream, with slight almond odour.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
The treatment of tinea pedis (athlete's foot) and tinea cruris (dhobie itch/jock itch) caused by _Trichophyton (e.g. T._
_rubrum, T. mentagrophytes, T. verrucosum, T. violaceum) and Epidermophyton floccosum_
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Method of administration
Topical administration.
Lanafine AFR Cream is applied once or twice daily.
The affected area should be cleaned and dried thoroughly before application of Lanafine AFR Cream. The cream
should be applied to the affected skin and surrounding area in a thin layer and rubbed in lightly. In the case of
intertriginous infections (interdigital, intergluteal, inguinal) the application may be covered with a gauze strip,
especially at night.
Duration of treatment is one week for tinea pedis and one to two weeks for tinea cruris. Relief of clinical symptoms
usually occurs within a few days. Irregular use or premature discontinuation of treatment carries the risk of recurrence.
If there are no signs of improvement after two weeks, the diagnosis should be verified by a physician.
Children
The experience with topical Lanafine AFR Cream in children is still limited and its use in children under 16 years
cannot therefore be recommended.
Use in the elderly
There is no evidence to suggest that eld
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