AMOROLFINE BIOGARAN CONSEIL 5 % medicated nail lacquer bottle/2,5ml+30 spatula

Medicated nail lacquer.

Amorolfine hydrochloride ..................................................................................................................................... 5,574 g

Quantity corresponding to amorolfine base ........................................................................................... 5,000 g

For 100 ml.

Excipients:

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 BIOGARAN CONSEIL to the affected nails at a dosage of once a week.

Method of administration

To apply the lacquer, carefully follow the recommendations below:

For packs without accessories :

A. Before the first application of AMOROLFINE BIOGARAN CONSEIL, carefully groom the nails. Remove any residual lacquer with a nail polish remover, 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 cloth soaked in nail polish remover, in order to avoid contamination of the lacquer. Do not wipe the spatula on the edge of the bottle.

D. It is important to thoroughly clean the spatula with a compress or cloth soaked in nail polish remover 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 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 BIOGARAN CONSEIL, 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 and the affected areas are completely healed.

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, the growth rate of the nail and the height 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, remove residual lacquer, file the affected nails if necessary, and in all cases clean them using a compress or cloth soaked in nail polish remover.

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

For packs with accessories :

A. Before the first application of AMOROLFINE BIOGARAN CONSEIL, carefully groom the nails. Remove any residual lacquer with a nail polish remover, 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 one of the cleaning wipes provided.

C. Apply the varnish using one of the reusable spatulas to the entire affected nail. Clean the reusable spatula between each nail with one of the cleaning wipes provided, to avoid contamination of the varnish. Do not wipe the spatula on the rim of the bottle.

D. It is important to thoroughly clean the spatula with one of the cleaning wipes provided after each application, before reusing it on another nail, to avoid contamination of the varnish.

E. If varnish has been deposited on the outside of the cap during handling, it is important to clean it off using one of the cleaning wipes provided, to avoid applying this varnish to the skin.

F. Seal the bottle tightly.

Repeat all of the above steps for each affected nail.

After each use of AMOROLFINE BIOGARAN CONSEIL, 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 and the affected areas are completely healed.

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, the growth rate of the nail and the height 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, remove residual varnish, file the affected nails if necessary and, in all cases, clean them using one of the cleaning wipes.

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

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

AMOROLFINE BIOGARAN CONSEIL must not be applied to the skin around the nail.

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

In the absence of clinical data, children should not be treated with amorolfine.

Treatment should be determined by a physician in the following cases: patients with peripheral circulatory disorders, diabetes, diseases of the immune system, as well as those 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.

Patients should seek medical advice before starting treatment if they have a history of injury, skin conditions such as psoriasis or other chronic skin condition, oedema, respiratory disorder (yellow nail syndrome), nail pain, deformed/damaged nails or other symptoms.

Do not use cosmetic nail varnish or artificial nails during use of AMOROLFINE BIOGARAN CONSEIL. If organic solvents are handled, waterproof gloves must be worn, otherwise the varnish will be dissolved.

A systemic or local allergic reaction may occur after use of this product. If this happens, the product must be stopped immediately and medical advice must be sought. Gently remove the product using a nail polish remover solution. The product must not be reapplied.

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

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 BIOGARAN CONSEIL must not be used during pregnancy and breastfeeding, except in cases of real necessity.

 

System Organ Class	Frequency	Adverse effects
Immune system disorders	Frequency not known (cannot be estimated from the available data)*	Hypersensitivity (systemic allergic reaction)*
Skin and subcutaneous tissue disorders	Rare (≥ 1/10 000, < 1/1 000)	Nail disorder, nail discolouration, brittle nails (onychoclasis), fragile nails (onychorrhexis)
	Very rare (< 1/10 000)	Sensation of skin burning
	Frequency not known (cannot be estimated from the available data)*	Erythema*, pruritus*, contact dermatitis*, urticaria*, blister*

* Data collected after marketing authorisation.

Reporting of suspected adverse reactions

The reporting of suspected adverse effects after marketing authorisation of the medicine is important. It enables continuous monitoring of the medicine's benefit/risk balance. Healthcare professionals report any suspected adverse effect via the national reporting system: the 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/.

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

In case of accidental ingestion, appropriate symptomatic measures must be taken

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

AMOROLFINE BIOGARAN CONSEIL 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 directed mainly at 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 species of Trichophyton,
• Epidermophyton floccosum,
•  Microsporum.

• Moulds:

• Scopulariopsis.

• 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.

Oral studies have been carried out in rats and dogs, up to 60 mg/kg/day for a duration of 13 weeks and up to 40 mg/kg/day for a duration of 26 weeks. Skin lesions of the keratosis and dermatitis type, hyperkeratoses of the mucous membrane and of the transition between skin and mucous membrane were observed.

Reproductive toxicology studies carried out in laboratory animals have provided evidence of teratogenicity, embryotoxicity and foetotoxicity, but these effects were observed at an exposure far exceeding human exposure; this indicates that no risk is expected for pregnant women. The genotoxic potential of amorolfine has been evaluated in vitro and in vivo. No genotoxic potential was observed.

No carcinogenicity study has been conducted.

Topical administration of amorolfine as a nail lacquer to animals showed skin toxicity under occlusive conditions. Amorolfine in the form of a nail lacquer did not induce sensitisation.

3 years.

This medicine does not require any particular storage precautions.

No special requirements.

Marketing authorisation (AMM)

CIP 3400930007211 (Fl/2,5ml+30spat).

Not reimbursed by Social Security.