TERBINAFINE BIOGARAN 1 % cream tube/15g

Terbinafine hydrochloride.............................................................................................................................. 1 g

For 100 g of cream.

Excipients with known effect: cetyl alcohol, cetostearyl alcohol, benzyl 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 demonstration of a 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

• Interdigital intertrigo due to dermatophytes: 1 application per day for 1 week.
• Plantar intertrigo: 2 applications per day for 2 weeks.
• Dermatophytoses of glabrous skin and crural intertrigo: 1 application per day for 1 week.
• Cutaneous candidiasis: 1 or 2 applications per day for 1 to 2 weeks.
• Pityriasis versicolor : 1 or 2 applications per day for 2 weeks.

Method of administration

Cutaneous use.

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 patients :

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

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

Special 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: use of a soap with an acidic pH (pH favouring the multiplication of Candida).
• 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 treating onychomycosis.

Keep out of sight and reach of children.

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

This medicine contains benzyl alcohol and may cause mild 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 is expected in breastfed infants/newborns. However, since terbinafine is excreted in breast milk and as a precautionary measure (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.

TERBINAFINE BIOGARAN has no effect on the ability to drive vehicles and use machines.

Within each class, adverse reactions are presented in order of decreasing seriousness. Adverse reactions are classified 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 (≥ 1/1000 to < 1/100); rare (≥1/10 000 to <1/1000); 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 of suspected adverse effects after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Health professionals should report any suspected adverse effects via the national reporting system: Agence nationale de sécurité du médicament et des produits de santé (ANSM) and the network of Regional Centres of Pharmacovigilance - Website: www.signalement-sante.gouv.fr.

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

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

In the case of accidental ingestion of TERBINAFINE BIOGARAN in a quantity greater than 30 g, adverse effects similar to those observed with an overdose of TERBINAFINE BIOGARAN 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…), on 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.

Pre-clinical safety data on terbinafine have not revealed 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 carcinogenesis study conducted in rats over two years, following 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 studies in vivo in mice, rats, dogs and monkeys as well as studies in vitro on rat, monkey or 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.

5 years.

This medicine does not require any particular storage precautions.

No special requirements.