Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Mylan, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom
The treatment of tinea pedis (athlete’s foot) and tinea cruris (dhobie itch/jock itch).
Fungal infections of the skin caused by dermatophytes such as species of Trichophyton (e.g. T. rubrum, T. mentagrophytes, T. verrucosum, T. violaceum), Microsporum canis and Epidermophyton floccosum.
Infections of the skin caused by Candida (e.g. Candida albicans).
Pityriasis (tinea) versicolor caused by Pityrosporum orbiculare (Malassezia furfur).
Terbinafine can be applied once or twice daily.
The likely duration of each treatment is as follows:
Tinea pedis: 1 week.
Tinea cruris and Tinea corporis: 1 to 2 weeks.
Cutaneous candida: 2 weeks.
Pityriasis versicolor: 2 weeks.
Relief of symptoms is usually obtained within a few days.
Irregular use or an inadequate treatment period increases the risk of the symptoms returning. If no improvement is obtained after 2 weeks, the diagnosis should be re-evaluated.
There has been nothing to indicate that elderly patients require a different dosage or have a side effects profile different from younger patients.
Terbinafine 1% Cream is not recommended for children below 12 years of age due to insufficient data on safety. The experience in children is limited.
For cutaneous use.
The skin should be clean and dry. The cream should be applied in a thin layer on and around the affected skin and rubbed in gently. In cases of reddened and weeping infection (under the breasts, between the fingers, buttocks or in the groin) the skin may be covered with a sterile compress after application of the cream, especially at night.
The low systemic absorption of topical terbinafine renders over dose extremely unlikely.
Accidental ingestion of one 30 g tube of terbinafine cream, which contains 300 mg terbinafine hydrochloride, is comparable to ingestion of one terbinafine 250 mg tablet (adult oral unit dose).
Should a larger amount of terbinafine cream be inadvertently ingested, adverse effects similar to those observed with an over dose of terbinafine tablets are to be expected. These include headache, nausea, epigastric pain and dizziness.
If accidentally ingested, the recommended treatment of over dose consists of eliminating the active substance, primarily by the administration of activated charcoal, and giving symptomatic supportive therapy if needed.
4 years.
Shelf life after opening: 28 days.
Store in original container after first opening.
Do not freeze.
Keep the tube tightly closed.
Collapsible aluminium tube with a polyethylene screw cap in pack sizes of 7.5 g, 15 g or 30 g.
Not all pack sizes may be marketed.
Not applicable.
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