CICLOPIROX BIOGARAN 8 % nail medicinal lacquer Bottle/3ml

Ciclopirox................................................................................................................................................................ 8 g

For 100 g of medicated nail lacquer.

For the full list of excipients, see section Composition.

First-line treatment of onychomycosis without matrix involvement due to dermatophytes and/or other fungi sensitive to ciclopirox.

Dosage

CICLOPIROX BIOGARAN is indicated in adults.

Paediatric population

The safety and efficacy of CICLOPIROX BIOGARAN in newborns, infants and children have not been established. No data are available.

Method of administration

Cutaneous use.

Unless otherwise stated, CICLOPIROX BIOGARAN is applied as a thin layer to all infected nails, once a day, preferably in the evening.

The medicated lacquer must be applied over the entire nail plate. Close the bottle securely after each use.

Before starting treatment, it is recommended to remove the free parts of the diseased nails using nail clippers, a nail file or scissors.

Once a week, throughout the duration of treatment, the use of a cosmetic nail polish remover makes it possible to remove the film-forming layer on the surface of the nail, which could, in the long run, impair penetration of the active ingredient. At the same time, it is recommended to remove the free parts of the diseased nails.

Treatment must continue until complete clinical and mycological cure and regrowth of healthy nail.

Treatment usually lasts between 3 (fingernail onychomycosis) and 6 months (toenail onychomycosis).

However, the duration of treatment must not exceed 6 months.

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

Avoid contact with the eyes or mucous membranes.

CICLOPIROX BIOGARAN nail lacquer is for external use only.

Do not apply ordinary nail polish or other cosmetic products to the treated nails.

In case of local or systemic sensitisation, treatment must be stopped immediately and the lacquer layer must be carefully removed with nail polish remover. Appropriate treatment must be initiated.

As with all topical treatments for onychomycosis, in case of involvement of several nails (> 5 nails), where more than two thirds of the nail plate is affected, and in the presence of predisposing factors such as diabetes and immune disorders, the addition of systemic treatment should be considered.

In patients with a history of insulin-dependent diabetes or diabetic neuropathy, the risk of detachment of a loosened or infected nail by the healthcare professional or during cleaning by the patient must be taken into account.

No interaction studies have been performed.

Pregnancy

No embryotoxic or teratogenic effects have been observed after oral, topical or subcutaneous administration of ciclopirox olamine in animals (see section Preclinical safety).

No effect of ciclopirox is expected during pregnancy due to negligible systemic exposure. CICLOPIROX BIOGARAN can be used during pregnancy.

Breast-feeding

There is not enough data on the excretion of ciclopirox and its potential metabolites in breast milk. A risk to the newborn/infant cannot be excluded.

CICLOPIROX BIOGARAN should not be used during breastfeeding.

Fertility

No effect on male or female fertility has been demonstrated in rats after oral administration of ciclopirox olamine up to 5 mg/kg/day (see section Preclinical safety).

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

Adverse effects are listed below by system organ class and by frequency. Frequencies are defined as follows: very common (≥ 1/10), common (≥ 1/100, < 1/10), uncommon (≥ 1/1000, < 1/100), rare (≥ 1/10 000, < 1/1000), very rare (< 1/10 000), and not known (cannot be estimated from the available data).

* Generalised allergic reaction (oedema, pruritus, rash, urticaria, dyspnoea), requires discontinuation of treatment

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorization of the medicinal product is important. It allows continuous monitoring of the benefit/risk balance of the medicinal product. Health professionals should report any suspected adverse reaction via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Centres for Pharmacovigilance - Website: www.signalement-sante.gouv.fr.

No cases of overdose have been reported with this product.

Pharmacotherapeutic class: OTHER ANTIFUNGALS FOR TOPICAL USE, ATC code: D01AE14.

The active ingredient of CICLOPIROX BIOGARAN is ciclopirox, an antifungal of the pyridone family.

Ciclopirox is a broad-spectrum antimycotic agent with activity against dermatophytes (Trichophytons, Microsporum canis, Epidermophytons), yeasts (Candida, Torulopsis, Trichosporum, Geotrichum), moulds (Scopulariopsis, Aspergillus) and actinomycetes, as well as some gram-positive and gram-negative bacteria.

Any fungal species not belonging to one of the above-mentioned genera should be the subject of a study in vitro allowing determination of its degree of sensitivity.

CICLOPIROX BIOGARAN is a 8 percent formulation of ciclopirox in a lacquer base. The solvents (ethyl acetate and isopropanol) and the film-forming agent (Gantrez ES-435), once applied to the nail, evaporate and ensure adhesion of the ciclopirox to the nail.

The fungicidal activity of ciclopirox is based on the inhibition of the uptake by fungal cells of certain substances (metal ions, phosphate and potassium ions).

Ciclopirox accumulates in the fungal cell, where it binds irreversibly to certain structures such as the cell membrane, mitochondria, ribosomes or microsomes.

The fate of the drug has been studied in situ in healthy humans (healthy nail).

Ciclopirox distributes into the nail plate very rapidly:

• fungicidal concentrations are detected from 7 days of daily application;
• the maximum concentrations detected in the distal part of the nail are indicative of saturation of the nail plate: they appear between:
  • day 14th and day 30th of application for fingernails;
  • day 30th and day 45th of application for toenails.

Upon therapeutic discontinuation, the persistence of ciclopirox is manifested by active concentrations lasting 7 to 14 days.

Systemic absorption of the active ingredient is negligible.

Acute toxicity studies performed with ciclopirox and/or ciclopirox olamine in rats and mice after oral or subcutaneous administration show similar and moderate toxicities (LD50 between 1740 mg/kg and 2500 mg/kg).

Repeated-dose toxicity studies with ciclopirox olamine demonstrated good systemic tolerance with a chronic oral NOAEL (No Observable Adverse Effect Level : No Observable Adverse Effect Level) of 10 mg/kg/day in rats and dogs.

A set of genotoxicity studies did not demonstrate genotoxic potential of ciclopirox olamine. An equivocal clastogenic activity was observed in the HPRT/V79 test with a significant increase in mutations preferentially affecting small colonies. Ciclopirox olamine also significantly inhibited DNA repair activity in the UDS test (Unscheduled DNA Synthesis), but without any genotoxic effect in this test. However, the hypothesis is that the clastogenic activity in vitro of ciclopirox olamine observed is directly related to its potential for chelating calcium present in the culture medium.

No carcinogenicity study has been performed with ciclopirox and/or ciclopirox olamine.

Ciclopirox olamine administered orally to rats up to 5 mg/kg/day (i.e. 3,85 mg/kg/day of ciclopirox) does not induce any adverse effect on male or female fertility.

No embryotoxic or teratogenic effect has been observed after oral, topical or subcutaneous administration of ciclopirox olamine. Studies were conducted in several animal species: mice, rats, rabbits and monkeys.

Ciclopirox olamine administered orally to female rats at up to 5 mg/kg/day (equivalent to 3,85 mg/kg/day of ciclopirox) from the 15th day of gestation until weaning of the pups did not induce any adverse effects on peri- or postnatal development.

Local tolerance studies conducted in rabbits showed that the varnish was irritating to the skin. It furthermore has a low sensitising potential.

3 years.

To be stored at a temperature not exceeding 30°C.

No special requirements.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.