text: Summary of Product Characteristics last updated on medicines.ie: 3/11/2016
  Terbinafine hydrochloride 1.0% w/w.
  Excipients: Each gram of cream contains 40 mg cetyl alcohol and 40 mg stearyl alcohol.
  White, smooth or almost smooth, glossy cream.
  Fungal infections of the skin caused by Trichophyton (eg. T. rubrum, T. mentagrophytes, T. verrucosum, T. violaceum), Microsporum canis and Epidermophyton floccosum.
  Yeast infections of the skin, principally those caused by the genus Candida (e.g. C. albicans).
  Lamisil can be applied once or twice daily depending on the indication.
  The likely duration of treatment are as follows:
  Once a day for 1 week
  Once or twice a day for 1 to 2 weeks
  Once or twice a day for 2 weeks
  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.
  There is no evidence to suggest that elderly patients require different dosages or experience side effects different to those of younger patients.
  Lamisil cream is for external use only.
  Contact with the eyes should be avoided. May be irritating to the eyes. In case of accidental contact with the eyes, rinse eyes thoroughly with running water.
  There is no clinical experience with Lamisil Cream in pregnant women, therefore unless the potential benefits outweigh any possible risks, Lamisil Cream should not be administered during pregnancy, unless clearly necessary.
  Terbinafine is excreted in breast milk. Therefore mothers should not use Lamisil Cream whilst breast feeding.
  Infants should not be allowed to come into contact with any treated skin, including the breast.
  No effect of terbinafine on fertility have been seen in animal studies (see section 5.3).
  Uncommon: Pain, application site pain, irritation
  Accidental ingestion of one 30 g tube of Lamisil cream, which contains 300 mg terbinafine hydrochloride, is comparable to ingestion of one Lamisil 250 mg tablet (adult oral unit dose).
  Antifungal for topical use, ATC code: D01A E15.
  Terbinafine is an allylamine which has a broad spectrum of antifungal activity in fungal infections of the skin caused by dermatophytes such as Trichophyton (e.g. T. rubrum, T. mentagrophytes, T. verrucosum, T. violaceum), Microsporum canis and Epidermophyton floccosum.. At low concentrations terbinafine is fungicidal against dermatophytes, moulds and certain dimorphic fungi.
  The activity against yeasts is fungicidal (e.g. Pityrosporum orbiculare or Malassezia furfur) or fungistatic, depending on the species.
  Terbinafine has long lasting action, fewer than 10% of athlete's foot sufferers treated with terbinafine 1% Cream for one week show relapse or re-infection by 3 months after start of treatment.
  Terbinafine interferes specifically with fungal sterol biosynthesis at an early step. This leads to a deficiency in ergosterol and to an intracellular accumulation of squalene, resulting in fungal cell death. Terbinafine acts by inhibition of squalene epoxidase in the fungal cell membrane. The enzyme squalene epoxidase is not linked to the cytochrome P-450 system. Terbinafine does not influence the metabolism of hormones or other drugs.
  Less than 5% of the dose is absorbed after topical application to humans; systemic exposure is therefore very low.
  Following 7 days usage of Lamisil Cream, concentrations of terbinafine in excess of those required for fungicidal activity are available in the affected stratum corneum for at least 7 days after treatment cessation.
  In a two-year oral carcinogenicity study in mice, no neoplastic or other abnormal findings attributable to treatment were made up to doses of 130 (males) and 156 (females) mg/kg a day. In a two-year oral carcinogenicity study in rats at the highest dose level, 69 mg/kg a day, an increased incidence of liver tumors was observed in males. The changes, which may be associated with peroxisome proliferation, have been shown to be species-specific since they were not seen in the carcinogenicity study in mice or in other studies in mice, dogs or monkeys.
  3 years: Aluminium tube and laminated tube
  3 years: Polypropylene dispenser tube
  Aluminium tube with a polypropylene screw-cap closure or laminated tube (low density polyethylene, aluminium, low density polyethylene) with a high density polyethylene shoulder, sealed with an aluminium/ethylene multilayer copolymer peel-off and closed with a polypropylene cap with built-in point to pierce the peel off, in pack sizes of 15 g and 30 g.