AMOROLFINE TEVA 5 % medicated nail lacquer medicated nail lacquer 1 bottle lacquer/2,5ml+spatula

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

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

For 100 mL.

Excipient with known effect: Each mL of lacquer contains 480 mg of ethanol.

First-line treatment of onychomycosis without matrix involvement.

Dosage

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

Method of administration

To apply the lacquer, carefully follow the recommendations below:

a) Before the first application of AMOROLFINE TEVA, carefully clean the nails and file the affected area of the nail (in particular the nail surface) with a nail file as completely as possible.

Take care not to file the periungual skin.

b) Clean the nail surface and degrease it using a compress or a cloth soaked in solvent, in order to remove any residual lacquer.

c) Apply the lacquer using one of the reusable spatulas over the entire affected nail. Clean the reusable spatula between each nail to avoid contaminating the lacquer. Do not wipe the spatula on the rim of the bottle.

d) It is important to thoroughly clean the spatula using a cleansing wipe or a compress or a cloth soaked in solvent after each application, before reusing it for another nail, in order 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 cleansing wipe or a compress or a cloth soaked in solvent in order to avoid applying this lacquer to the skin.

f) Reseal the bottle tightly.

Repeat all of the above steps for each affected nail.

Cosmetic nail lacquers may be applied at least 10 minutes after application of AMOROLFINE TEVA lacquer.

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).

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 using nail polish remover to remove residual lacquer.

• When handling organic solvents (white spirit, thinners…), it is necessary to wear waterproof gloves in order to protect the AMOROLFINE TEVA nail lacquer layer on the nails.

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

Special warnings:

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

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

Do not use artificial nails during the use of AMOROLFINE TEVA.

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

After application of AMOROLFINE TEVA lacquer, a period of at least 10 minutes must be observed before applying a cosmetic nail varnish. Before repeating the application of AMOROLFINE TEVA lacquer, the cosmetic nail varnish must be carefully removed.

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 TEVA is not recommended in patients under 18 years of age.

Excipient

Ethanol

This medicine contains 480 mg of alcohol (ethanol) per mL. This may cause a burning sensation on damaged skin.

Ethanol is a flammable substance and must not be used near a flame, a lit cigarette or certain appliances (for example hair dryers).

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 breast-feeding 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 TEVA 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: https://signalement.social-sante.gouv.fr/

No systemic signs of overdose are expected after topical application of AMOROLFINE TEVA.

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

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

AMOROLFINE TEVA 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 antimycotic spectrum. It is very effective against the usual or occasional agents of onychomycosis:

• Yeasts:

• Candida albicans and other Candida species.

• Dermatophytes:

• Trichophyton rubrum, Trichophyton interdigitale and Trichophyton mentagrophytes, other Trichophyton species,
• Epidermophyton floccosum,
• Microsporum.

• Moulds:

• Scopulariopsis.

• The dematiaceous (black fungi):

• Hendersonula, Alternaria, Cladosporium.

• Species with low sensitivity:

• 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.

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