LAMISILATE 1% Cream tube (LDPE/alu)/7.5g

Cream.
Tube of 7,5 g with aluminium membrane closed by a cap.

For 100 g of cream:

Terbinafine hydrochloride: 1,00 g
Quantity corresponding to terbinafine base: 0,88 g

Excipients with known effect: benzyl alcohol, cetyl alcohol and stearyl alcohol.

Treatment of interdigital-plantar intertrigo or athlete's foot.

Dosage and duration of treatment

Adults and children older than 12 years: 1 application per day for 1 week.

Method of administration

Cutaneous use.

Before first use, the sealing membrane of the tube must be removed or pierced using the tip of the screw cap.

The cream should be applied in a thin layer followed by gentle massage after cleansing and drying the affected area.

The beneficial effect should appear after a few days. Stopping treatment too early or irregular applications may result in treatment failure or relapses.

In case of worsening or in the absence of improvement of symptoms 1 week after the end of applications, the patient must consult a doctor or a pharmacist in order to verify the diagnosis.

In case of multiple lesions or very extensive lesions, medical advice is necessary.

Paediatric population:

The use of LAMISILATE 1 %, cream is not recommended in children under 12 years.

Elderly:

There is no data suggesting the need for dose adjustment in elderly subjects.

Hypersensitivity to terbinafine or to any of the excipients mentioned in section Composition.

LAMISILATE cream is for external use only.

Avoid contact with the eyes. This medicine may be irritating to the eyes. In case of accidental contact with the eyes, rinse the eyes thoroughly with running water. Keep out of sight and reach of children.

Newborns/infants must not come into contact with the treated skin area, including the breasts.

Terbinafine, the active substance of this medicine for cutaneous application, is not suitable for the treatment of onychomycosis.

This medicine contains cetyl and stearyl alcohol and may cause local skin reactions (for example: contact dermatitis).

This medicine contains 75 mg of benzyl alcohol per tube of 7,5 g. Benzyl alcohol may cause allergic reactions. For cutaneous application, benzyl alcohol may cause mild local irritation.

No drug interactions are known with topical forms of terbinafine.

Pregnancy

Animal studies have not shown any teratogenic effect.

Given the low systemic passage resulting from the poor absorption of terbinafine (< 5 %) after cutaneous application, no malformative or toxic effect on the fetus or newborn is expected. However, there are no data on the use of terbinafine in pregnant women.

Consequently, and as a precautionary measure, it is preferable to avoid the use of terbinafine during pregnancy.

Breast-feeding

Given the low systemic passage after cutaneous application, no effect in the breastfed infant/newborn is expected.

However, given that terbinafine is excreted in milk and as a precautionary measure (see section Warnings and precautions), it is preferable to avoid its use during breastfeeding.

In addition, newborns/infants must not come into contact with the treated skin area, including the breasts.

Fertility

Animal studies have not shown an effect of terbinafine on fertility (see section Preclinical safety).

LAMISILATE 1 %, cream has no effect on the ability to drive vehicles and use machines.

Adverse effects are listed by system organ class and by frequency. Frequencies are defined as follows: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1 000 to < 1/100); rare (≥ 1/10 000 to < 1/1 000); very rare (< 1/10 000), frequency not known (cannot be estimated from the available data).

Within each class, adverse effects are presented in order of decreasing seriousness:

* Based on post-marketing experience

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: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centres - Website: https://signalement.social-sante.gouv.fr.

The low systemic absorption of topical terbinafine makes overdose extremely unlikely.

An accidental ingestion of a 30 g tube of LAMISILATE cream, containing 300 mg of terbinafine hydrochloride, is comparable to that of a 250 mg LAMISILATE tablet (daily adult dosage).

In the event of accidental ingestion of LAMISILATE 1 %, cream in a quantity greater than 30 g, adverse effects similar to those observed with an overdose of LAMISILATE tablets could occur. These side effects include headache, nausea, gastric pain and dizziness.

Treatment of overdose

In the event of accidental ingestion, the recommended treatment of overdose consists of eliminating the absorbed terbinafine, essentially by administration of activated charcoal, and treating symptomatically if necessary.

Pharmacotherapeutic class: TOPICAL ANTIFUNGALS, ATC code: D01AE15.

Terbinafine is a broad-spectrum antifungal agent belonging to the new class of allylamines.

Terbinafine is active against dermatophytes (Trichophyton, Microsporum, Epidermophyton), against yeasts (Candida, Pityrosporum orbiculare or Malassezia furfur...), against certain filamentous fungi and certain dimorphic fungi.

Terbinafine prevents the biosynthesis of ergosterol, an essential component of the fungal cell membrane, by specific inhibition of squalene epoxidase. The intracellular accumulation of squalene is thought to be responsible for its fungicidal action.

Terbinafine does not alter the metabolism of hormones or other medicinal products (the enzyme squalene epoxidase is not linked to the cytochrome P-450 system).

Absorption

Less than 5 % of the dose is absorbed after topical application; systemic exposure is therefore very low.

Distribution

After 7 days of use of LAMISILATE 1 % cream, the concentration of terbinafine providing fungicidal activity is available in the stratum corneum for at least 7 days after treatment is stopped.

Preclinical safety data on terbinafine have not revealed any results relevant to the recommended dose and use of the product.

Carcinogenesis and mutagenesis

In a two-year carcinogenicity study in mice, no data on the occurrence of neoplasms or other abnormalities attributable to treatment were revealed after administration of doses up to 130 mg/kg/day (males) and 156 mg/kg/day (females).

In a carcinogenicity study in rats conducted over 2 years, after oral administration of terbinafine, males treated at the highest dose (i.e. 69 mg/kg/day) showed an increased incidence of liver tumours. It has been shown that these observations, which could be related to peroxisome proliferation, are specific to this animal species, as they were not found in the carcinogenicity study in mice or in other studies conducted in mice, dogs or monkeys. A broad range of in vivo studies in mice, rats, dogs and monkeys, as well as in vitro studies on rat, monkey and human hepatocytes, suggest that peroxisome proliferation in the liver is an observation specific to the rat.

A standard battery of genotoxicity tests performed in vitro and in vivo revealed no mutagenic or clastogenic potential of the product.

3 years.

Store at a temperature below 30 °C.

No special requirements.