CICLOPIROX VIATRIS 8 % nail medicinal lacquer Bottle/3ml

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

For 100 g of medicated nail lacquer.

CICLOPIROX VIATRIS 8 %, medicated nail lacquer is indicated in adults for the first-line treatment of onychomycosis without matrix involvement due to dermatophytes and/or other fungi sensitive to ciclopirox.

Dosage

CICLOPIROX VIATRIS 8 %, medicated nail lacquer is indicated in adults.

CICLOPIROX VIATRIS 8 %, medicated nail lacquer is generally applied as a thin layer to all infected nails, once daily, preferably in the evening.

Paediatric population

The safety and efficacy of CICLOPIROX VIATRIS 8 %, medicated nail lacquer in newborns, infants and children have not been established. No data are available.

Cutaneous use.

Method of administration

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

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

• Once a week, throughout the duration of treatment, use of a cosmetic dissolving solution makes it possible to remove the film-forming layer on the surface of the nail, which could, over time, impair penetration of the active ingredient. At the same time, it is recommended to remove the free portions of the diseased nails.

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

Fungal culture control must be performed 4 weeks after the end of treatment to avoid any interference with culture results by possible residues of active substance.

As this is a topical treatment, no dose adjustment is necessary for particular population groups.

If the condition is refractory to treatment with medicated nail lacquer and/or if one or more fingernails and toenails are extensively affected, additional oral treatment should be considered.

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 VIATRIS 8 %, medicated nail lacquer is for external use only.

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.

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

No interaction studies have been performed.

Pregnancy

No embryotoxic or teratogenic effects were 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 may 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 VIATRIS 8 %, medicated nail lacquer should not be used during breast-feeding.

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 VIATRIS 8 %, medicated nail lacquer has no effect on the ability to drive vehicles or use machines.

Adverse reactions are listed below by system organ class and 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 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 reaction via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Centres of Pharmacovigilance - Website: https://signalement.social-sante.gouv.fr/.

No cases of overdose have been reported with this product.

Pharmacotherapeutic group: other antifungals for topical use, ATC code: D01AE14.

The active substance of CICLOPIROX VIATRIS 8 %, medicated nail lacquer 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 genera mentioned above must be the subject of an in vitro study to determine its degree of susceptibility.

CICLOPIROX VIATRIS 8 %, medicated nail lacquer is a formulation containing 8 percent 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 the adhesion of 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 was 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 indicate saturation of the nail plate: they appear between:

• day 14th and day 30th day of application for fingernails,
• day 30th and day 45th of application for toenails.

After treatment is stopped, the persistence of ciclopirox is manifested by active concentrations lasting 7 and 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) of 10 mg/kg/day in rats and dogs.

A set of genotoxicity studies did not demonstrate any 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 (Unscheduled DNA Synthesis) test, but without any genotoxic effect in this test. However, it is hypothesised that the in vitro clastogenic activity of ciclopirox olamine observed is directly related to its potential to chelate calcium present in the culture medium.

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

Ciclopiroxolamine administered orally to rats up to 5 mg/kg/day (i.e. 3,85 mg/kg/day of ciclopirox) induces no adverse effect on male or female fertility.

No embryotoxic or teratogenic effect was observed after oral, topical or subcutaneous administration of ciclopiroxolamine. The studies were conducted in several animal species: mice, rats, rabbits and monkeys.

Ciclopiroxolamine administered orally to female rats up to 5 mg/kg/day (i.e. 3,85 mg/kg/day of ciclopirox) from the 15th day of gestation until weaning of the pups induces no adverse effect on peri- or postnatal development.

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

3 years

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

No special requirements.