LAMISIL 1% Cutaneous powder spray bottle/15mL

Cutaneous spray solution (clear, colourless to slightly yellow).
Bottle of 15 ml, with spray device.

For 1 g of cutaneous spray solution (i.e. 1 % m/m):

Terbinafine hydrochloride: 10 mg

Excipient(s) with known effect: propylene glycol (E1520) (50 mg/g) and ethanol at 96 % (250 mg/g).

LAMISIL 1 %, solution is indicated in the treatment of cutaneous dermatophytoses and of the Pityriasis versicolor in adults (see section Warnings and precautions).

Cutaneous use only.

Dosage

This medicine is intended for adults only.

Depending on the indication, apply LAMISIL 1 %, solution 1 to 2 times a day.

• Dermatophytoses of hairless skin: 1 application per day for 1 week.
• Genito-crural intertrigo: 1 application/day for 1 week.
• Interdigital-plantar intertrigo: 1 application/day for 1 week.
• Pityriasis versicolor : 2 applications/day for 1 week.

Clinical symptoms usually begin to improve after a few days of treatment. Irregular use or premature discontinuation of treatment may lead to a risk of relapse.

If no sign of improvement appears 1 week after the end of the applications, the patient is advised to ask a pharmacist to check that the product is being applied correctly or a doctor to check the diagnosis.

Paediatric population

The use of LAMISIL 1 %, solution is not recommended in children, as safety and efficacy data are insufficient.

Elderly

There is no data or experience suggesting any difference in dosages or in undesirable effects in elderly subjects compared with younger patients.

Method of administration

CUTANEOUS ROUTE

The affected area must be carefully cleaned and dried before applying LAMISIL 1 %, solution. Apply a sufficient quantity of product so that all the damaged skin and the surrounding area are covered and treated.

In case of intertriginous infection (submammary, interdigital, interglueal, inguinal), the application may be covered with a compress, particularly at night.

Hypersensitivity to the active substance or to any of the excipients listed in section Composition.

LAMISIL 1 %, solution is limited to external use.

LAMISIL 1 %, solution should be used with caution on lesions that could be irritated by alcohol. Do not apply to the face.

This product may be irritating to the eyes. In case of accidental contact with the eyes, rinse the eyes thoroughly with running water.

LAMISIL 1 %, solution must be kept out of sight and out of reach of children.

In case of accidental inhalation, consult your doctor if symptoms develop and persist.

Information on excipients

This medicine contains 250 mg/g of ethanol at 96 %. Ethanol may cause burning sensations on damaged skin.

This medicine contains 50 mg/g of propylene glycol.

No interaction studies have been performed.

Pregnancy

There are no data available on the use of terbinafine in pregnant women.

Animal studies have not shown any harmful effect on pregnancy or on the health of the foetus (see section Preclinical safety). The use of LAMISIL 1 %, solution should be considered during pregnancy only if necessary.

Breast-feeding

Terbinafine is excreted in breast milk. After topical use only, low systemic exposure is expected. LAMISIL 1 %, solution should be used in breastfeeding women only if the expected benefits justify the risk to the infant. In addition, infants must under no circumstances be brought into contact with treated areas of skin, in particular the breasts.

Fertility

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

LAMISIL 1 %, solution has no or negligible effect on the ability to drive vehicles and use machines.

Local symptoms such as pruritus, desquamation, pain, irritation, pigmentation disorder, burning sensation of the skin, erythema, crusting… may occur at the site of application.

These mild symptoms should be differentiated from hypersensitivity reactions including skin rash, reported sporadically and requiring discontinuation of treatment.

In case of accidental contact with the eyes, terbinafine hydrochloride may be irritating to the eyes. In rare cases, the underlying fungal infection may worsen.

Undesirable effects are listed by system organ class, according to their incidence using the following classification:

• 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 determinable (cannot be estimated from the available data).

Within each frequency group, undesirable effects are presented in order of decreasing seriousness.

Undesirable effects identified after marketing are reported voluntarily from a population of uncertain size. The frequency of these undesirable effects is "not known" but may be rare or very rare.

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: www.signalement.social-sante.gouv.fr

Due to the low systemic exposure to LAMISIL 1 %, solution, overdose is unlikely. Accidental ingestion of 30 mL of LAMISIL 1 %, solution containing 300 mg of terbinafine is comparable to that of a 250 mg LAMISIL tablet (adult daily dosage).

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

In case of accidental ingestion, take into account the presence of ethanol (28,87 % v/v).

Treatment of overdose

In case of accidental ingestion, the recommended treatment of overdose consists essentially of eliminating the absorbed terbinafine by administration of activated charcoal, and implementing symptomatic treatment if necessary.

Pharmacotherapeutic class: TOPICAL ANTIFUNGALS, ATC code: D01AE15

Terbinafine is a broad-spectrum antifungal agent belonging to the allylamine class.

Terbinafine is active against cutaneous fungal infections due to dermatophytes such as Trichophyton (T. rubrum, T. mentagrophytes, T. verrucosum, T. violaceum), Microsporum canis and Epidermophyton floccosum. At low concentration, terbinafine is fungicidal against dermatophytes and moulds. The fungicidal activity (e.g., Pityrosporum orbiculare or Malassezia furfur) or fungistatic activity against certain yeasts depends on the species.

Terbinafine interferes specifically and early on with the biosynthesis of ergosterol (an essential component of the fungal cell membrane), which results in an ergosterol deficit and intracellular accumulation of squalene responsible for its fungicidal action.

Terbinafine acts by inhibiting squalene epoxidase in the fungal cell membrane, the squalene epoxidase enzyme not being linked to the cytochrome P-450 system. Terbinafine does not modify the metabolism of hormones or other substances.

Absorption

Less than 5% of the dose is absorbed after topical application in humans, so systemic exposure is very low.

No significant toxic effect was observed in rats and dogs after long-term oral administration (up to one year) of oral doses reaching 100 mg/kg/day. At high oral doses, the liver and, to a lesser degree, the kidneys were identified as potential target organs.

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

In a 2^th carcinogenesis study conducted in rats over 2 years, after oral intake of terbinafine, males treated at the highest dose (i.e., 69 mg/kg/day) showed an increased incidence of liver tumours. It was shown that these observations, which could be linked 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.

During high oral dose studies of terbinafine in monkeys, refractive irregularities at the level of the retina were noted at the highest dosages (no toxic effect dose: 50 mg/kg). These irregularities, not accompanied by histological changes, were associated with the presence of a metabolite of terbinafine in ocular tissue and disappeared after treatment was stopped.

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

No adverse effects relating to fertility or other reproductive parameters were observed in studies in rats and rabbits.

3 years.

12 weeks after first opening.

Store at a temperature not exceeding 30 °C.

Do not refrigerate. Do not freeze.

The LAMISIL 1% solution bottle may be used "head up" or "head down".

Before first use, press the diffuser several times (generally 3 times) to prime the pump.