AMOROLFINE ZENTIVA 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.

Excipients with known effect: not applicable.

Treatment of moderate distal and lateral subungual onychomycosis caused by dermatophytes, yeasts or moulds, not affecting more than two nails in adults.

Dosage

Apply AMOROLFINE ZENTIVA 5% to the affected nails at a dosage of once a week.

To apply the lacquer, carefully follow the recommendations below:

A. Before the first application of AMOROLFINE ZENTIVA 5%, thoroughly clean the nails. Remove any residual lacquer with a solvent, file the surface of the nail (in particular the affected area) as completely as possible with a nail file. Take care not to file the periungual skin.

B. Clean the nail surface and degrease it using a compress or cloth soaked in nail polish remover.

C. Apply the lacquer using one of the reusable spatulas over the entire affected nail. Clean the reusable spatula between each nail with a compress or tissue soaked in solvent, in order to avoid contamination of the lacquer. Do not wipe the spatula on the rim of the bottle.

D. It is important to thoroughly clean the spatula using a compress or cloth soaked in nail polish remover after each application, before reusing it on another nail, to avoid contamination of the lacquer.

E. If lacquer has been deposited on the outside of the cap during handling, it is important to clean it using a compress or cloth soaked in nail polish remover, in order to avoid applying this lacquer to the skin.

F. Seal the bottle tightly.

Repeat all of the above steps for each affected nail.

After each use of AMOROLFINE ZENTIVA 5%, it is important to wash your hands. However, when applying to the nails of the hands, it is necessary to wait for the lacquer to dry completely beforehand.

Treatment must be continued without interruption until the nail has completely regrown.

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

After 3 months of use with no improvement, a doctor must be consulted.

Special instructions :

• Do not reuse nail files on healthy nails.
• Before each new application, remove residual lacquer, file the affected nails if necessary and in all cases clean them with a compress or tissue soaked in solvent.
• When handling organic solvents (white spirit, thinners…), it is necessary to wear impermeable gloves in order to protect the layer of AMOROLFINE ZENTIVA 5% lacquer on the nails.

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

Special warnings

Not applicable.

Precautions for use

In the absence of data, the use of AMOROLFINE ZENTIVA 5% is not recommended in patients aged less than 18 years.

Pregnancy

In animals, amorolfine is not teratogenic, but has an embryotoxic and foetotoxic effect.

In the absence of clinical data in pregnant women, AMOROLFINE ZENTIVA 5% should be avoided during pregnancy.

Breast-feeding

In the absence of data, AMOROLFINE ZENTIVA 5% will be avoided in breast-feeding women.

Fertility

Not applicable.

Reactions to the product are rare.

Skin and subcutaneous tissues

Since marketing, the following have been reported:

• Nail abnormalities (for example nail discolouration, brittle nail, fragile nail). However, these reactions may be directly related to onychomycosis.
• Sensations of skin burning and contact dermatitis.

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/.

Pharmacotherapeutic class: Other antifungals for topical use, ATC code: D01AE16.

AMOROLFINE ZENTIVA 5% is a topical antimycotic. The active substance, 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:

• The yeasts:
  • Candida albicans and other Candida species.
• The dermatophytes:
  • Trichophyton rubrum, Trichophyton interdigitale and Trichophyton mentagrophytes, other species of Trichophyton,
  • Epidermophyton floccosum,
  • Microsporum.
• 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.

Before opening: 3 years.

After first opening: 6 months

No special precautions for storage.

No special requirements.

• Indication(s) appearing in the marketing authorisation at the date of publication of this decree