AMOROLFINE VIATRIS 5 % medicated nail lacquer bottle/2,5ml+20 spatulas

Amorolfine hydrochloride...............................................................................................................................5,57 g

Quantity corresponding to amorolfine base..................................................................................................5,00 g

For 100 ml.

Excipient with known effect: ethanol.

100 mL of solution contains 48,23 g of ethanol.

First-line treatment of onychomycosis without matrix involvement.

Dosage

Apply AMOROLFINE VIATRIS to the affected nails at a dosage of once to twice a week.

Method of administration

Cutaneous use.

To apply the lacquer, carefully follow the recommendations below:

Repeat all of the above steps for each affected nail.

Treatment must be continued without interruption until complete regeneration of the nail and clinical and mycological cure of the affected areas.

The duration of treatment is generally 6 months for fingernails and 9 months for toenails (it depends essentially on the severity and location of the infection and the extent of nail involvement).

After 3 months of use without improvement, a doctor must be consulted.

Special instructions:

• Do not reuse nail files on healthy nails.
• Before each new application, file the affected nails if necessary and in all cases clean them with nail polish remover to remove residual varnish.
• When handling organic solvents (white spirit, thinners…), it is necessary to wear impermeable gloves in order to protect the AMOROLFINE VIATRIS varnish layer on the nails.

Paediatric population

Not applicable.

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

Special warnings

Avoid any contact of AMOROLFINE VIATRIS with the eyes, ears or mucous membranes.

AMOROLFINE VIATRIS must be used with caution in patients with conditions predisposing to nail disorders (peripheral circulatory disorders, diabetes, immune system diseases) as well as in patients presenting with nail dystrophy or severely damaged nails (more than two-thirds of the nail plate is affected). In these cases a systemic treatment should be considered.

Do not use cosmetic nail varnish or artificial nails during the use of AMOROLFINE VIATRIS.

If organic solvents are handled, waterproof gloves must be worn, otherwise the varnish will be dissolved.

This product contains ethanol (alcohol). Too frequent use or incorrect application may cause irritation and dryness of the skin surrounding the nail.

A systemic or local allergic reaction could possibly occur after use of this medicine. If this occurs, the medicine must be stopped immediately and a doctor must be consulted. Carefully remove the product using nail polish remover. The medicine must not be reused.

Precautions for use

In the absence of data, the use of AMOROLFINE VIATRIS is not recommended in patients aged less than 18 years.

Excipient

This medicine contains 1,20 g of alcohol (ethanol) per 2,5 ml bottle. This may cause a burning sensation on damaged skin.

The data available to date do not suggest the existence of clinically significant interactions.

There are limited data on the use of amorolfine in pregnant and breastfeeding women. Only a small number of pregnancies exposed to topical amorolfine have been reported after marketing, so the potential risk is unknown.

Studies performed in animals have shown reproductive toxicity at high oral doses (see section Preclinical safety).

It is not known whether amorolfine is excreted in human milk.

AMOROLFINE VIATRIS must not be used during pregnancy and breast-feeding, unless absolutely necessary.

* Adverse effects reported since marketing.

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: www.signalement-sante.gouv.fr.

No systemic signs of overdose are expected following topical application of AMOROLFINE VIATRIS.

In case of accidental ingestion, appropriate symptomatic measures should be taken.

Pharmacotherapeutic class: OTHER ANTIFUNGALS FOR TOPICAL USE, ATC code: D01AE16.

AMOROLFINE VIATRIS is a topical antimycotic. The active ingredient, amorolfine, derived from morpholine, belongs to a new chemical class of antimycotics.

Its fungistatic and fungicidal effect is based on an alteration of the fungal cell membrane mainly targeting sterol biosynthesis.

The ergosterol content is reduced. An accumulation of atypical sterols leads to morphological changes in cell membranes and organelles that cause the death of the fungal cell.

Amorolfine has a broad antifungal spectrum. It is highly effective against the usual or occasional agents of onychomycoses:

• Yeasts:
  • Candida albicans and other Candida species.
• Dermatophytes:
  • Trichophyton rubrum, Trichophyton interdigitale and Trichophyton mentagrophytes, other species of Trichophyton,
  • Epidermophyton floccosum,
  • Mycrosporum.
• Moulds:
  • Scopulariopsis.
• Dematiaceous fungi (black fungi):
  • Hendersonula, Alternaria, Cladosporium.
• Less sensitive species:
  • Aspergillus, Fusarium, Mucorales.

Amorolfine in the form of a nail lacquer penetrates and diffuses through the nail plate and is able to eradicate fungi that are poorly accessible in the nail bed.

The general absorption of the active ingredient is negligible, with the plasma concentration remaining below the sensitivity threshold, even after one year of use.

In rats, amorolfine is not teratogenic and is not embryotoxic at the maximum oral dose tested of 40 and 80 mg/kg/day. However, signs of maternal toxicity (weight loss) were observed at doses of 40 and 80 mg/kg/day.

In rabbits, amorolfine is not teratogenic but has an embryotoxic effect at the maximum oral dose tested of 10 mg/kg/day. Maternal weight loss, reflecting maternal toxicity, was also observed at the dose of 10 mg/kg/day.

Due to the very low systemic absorption of amorolfine following application to the nail or skin, the potential risk of toxicity to the human fetus is negligible.

3 years

No special precautions for storage.

No special requirements.