LAMISIL 1% Cream tube (LDPE/alu)/15g

Cream.
Tube of 15 g.

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.

1. Dermatophytoses:

Treatment:

• dermatophytoses of glabrous skin,
• genital and crural intertrigo,
• intertrigo of the toes.

2. Candidiasis:

Cutaneous candidiasis encountered in human clinical practice is usually due to Candida albicans. However, the detection of Candida on the skin cannot in itself constitute an indication.

Treatment:

• intertrigo, particularly genito-crural, anal and perianal,
• perleche,
• vulvitis, balanitis.

In some cases, it is recommended to simultaneously treat the digestive tract.

Adjunctive treatment of onychia and perionychia.

3. Pityriasis versicolor

Dosage and duration of treatment

• Interdigital intertrigo due to dermatophytes: one application per day for one week;
• Plantar intertrigo: two applications per day for two weeks;
• Dermatophytoses of glabrous skin and crural intertrigo: one application per day for one week;
• Cutaneous candidiasis: one or two applications per day for one to two weeks;
• Pityriasis versicolor: one or two applications per day for two weeks.

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 must be applied in a thin layer to the affected skin area and its surroundings, followed by gentle massage after cleansing and drying the area concerned.

Wash hands so as not to contaminate other areas of the body.

In the case of intertrigo-type infections (submammary, interdigital, perianal, inguinal), the treated area may be covered with gauze, particularly at night.

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

If no sign of improvement appears 1 week after the end of the applications, the patient must consult a doctor again.

Assessment of the therapeutic effect will be made 4 to 6 weeks after the end of treatment.

Special populations

Elderly:

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

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

Warnings

Due to the low absorption rate of terbinafine (< 5 %), the risk of systemic effects can practically be excluded.

However, on damaged skin, over a large surface area and in infants (due to the surface/weight ratio and the occlusive effect of nappies), attention should be paid to this possibility.

Precautions for use

Use is limited to external use.

• Candidiasis: the use of a soap with an acidic pH (a pH favouring the multiplication of Candida) is not recommended,
• Avoid contact with the eyes when applying to the face. This medicine may be irritating to the eyes. In case of accidental contact with the eyes, rinse the eyes thoroughly with running water.
• Newborns/infants must not come into contact with the treated skin area, including the breasts.
• In rare cases, the underlying fungal infection may worsen.
• Terbinafine, the active substance of this medicine for cutaneous application, is not suitable for the treatment of onychomycosis.

Keep out of sight and reach of children.

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

This medicine contains 150 mg of benzyl alcohol in a 15 g tube. Benzyl alcohol may cause allergic reactions. On cutaneous application, benzyl alcohol may cause slight local irritation.

No drug interactions are known with topical forms of terbinafine.

Pregnancy

Animal studies have not shown any teratogenic effect. In view of the low systemic exposure resulting from the low absorption of terbinafine (< 5 %) after cutaneous application, no malformative or toxic effect on the foetus or newborn is expected.

However, there are no data on the use of terbinafine in pregnant women.

Consequently, and as a precautionary measure (see section Warnings and precautions), it is preferable to avoid using terbinafine during pregnancy.

Breast-feeding

Given the low systemic exposure after cutaneous application, no effect in the breastfed infant/newborn is expected. However, given that terbinafine is excreted in milk and as a precaution (see section Warnings and precautions), it is preferable to avoid its use during breastfeeding.

Furthermore, the newborn/infant 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).

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

Within each class, adverse reactions are presented in order of decreasing seriousness. Adverse reactions are ranked according to the MedDRA system organ classification and by decreasing frequency, according to the following conventions: 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).

* 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.

Accidental ingestion of one tube of 30 g LAMISIL cream, containing 300 mg of terbinafine hydrochloride, is comparable to that of one 250 mg LAMISIL tablet (adult daily dose).

In the event of accidental ingestion of Lamisil 1% cream in a quantity greater than 30 g, adverse effects similar to those observed with an overdose of LAMISIL 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, so systemic exposure is very low.

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.