Treatment of onychomycoses, subalucleal distal and lateral, moderate, caused by dermatophytes, yeasts or molds, not touching more than two nails, in adults.

Apply AMOROLFINE ZYDUS to the nails at the dose of once a week.

To apply the varnish, follow carefully the following recommendations

A. Before the first application of AMOROLFINE ZYDUS, thoroughly clean the nails, remove all traces of residual varnish with a solvent, file the surface of the nail with a file Affected area), as completely as possible. Take the precaution not to file the skin, peri-unguéale.

B. Clean the surface of the nail and degrease it with a compress or a cloth, impregnated with a solvent.

C. Apply the varnish using one of the reusable spatulas on the entire nail. Clean the re-usable spatula between each nail-to-nail with a compress or fabric impregnated with solvent to avoid contamination of the varnish. Do not wipe the spatula on the edge of the bottle.

D. It is important to thoroughly clean the spatula with a compress or a cloth, impregnated with a solvent after each application before re-using it for another nail in order to avoid contamination of the varnish.

E. If the varnish has been deposited on the outside of the stopper, it is important to clean it with a compress or fabric impregnated with a solvent, Avoid applying this varnish on the skin.

F. Re-seal the bottle.

Repeat all of the above operations for each nail reached.

After each use of AMOROLFINE ZYDUS, it is important to wash your hands, but when applying to the nails of the hands, it is necessary to wait for the varnish to dry completely before

The treatment must be carried out without interruption until regeneration, complete the nail.

The duration of treatment is generally 6 months for the nails of the hands and 9 months, and for the nails of the feet (it depends mainly on the intensity, the location of the infection and the height of the nail, Affection of the nail).

After 3 months of use in the absence of improvement, a doctor should be consulted.

Special instructions

· Do not reuse nail files for nails, healthy

· Before each new application, remove residual varnish, file, if necessary, the affected nails and, in any case, clean them with a compress or fabric impregnated with solvent. Code>
· When handling organic solvents (white spirit, diluents, etc.), it is necessary to wear gloves that are impermeable to protect the varnish layer: AMOROLFINE MYPLIX on the nails
< Br>

Nail varnish, medicinal.

OTHER ANTIFUNGALS FOR TOPICAL USE, ATC Code: D01AE16.

AMOROLFINE ZYDUS is an antimycotic, topical. 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 cell membrane, fungal directed mainly on biosynthesis, sterols.

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

Amorolphin has a broad antimycotic spectrum. It is very effective against the usual or occasional agents of onychomycoses

· Yeasts

O Candida albicans and other species of Candida

· Dermatophytes

Trichophyton rubrum, Trichophyton interdigitalis and Trichophyton mentagrophytes, other species of Trichophyton

O Epidermophyton floccosum

O Mycrosporum.

· Molds

O; Scopulariopsis.

· The dematies (black mushrooms)

Hendersonula, Alternaria, Cladosporium.

· Not sensitive species

Aspergillus, Fusarium, mucorales.

Not applicable.

History of allergy to any of the components

Special warnings

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

AMOROLFINE ZYDUS should be used with caution in patients with pathologies predisposing to onychopathies (disorders, peripheral circulatory disorders, diabetes, diseases, immune system) as well as in patients with severe nail or nail dystrophy; Damaged (more than two-thirds of the nail plate is reached). In such cases systemic treatment should be considered.


Precautions for use

In the absence of data, the use of AMOROLFINE ZYDUS is not recommended in patients under the age of 18.
The data available to date do not imply the existence of clinically significant interactions.

Not applicable.

No systemic signs of overdose are expected after topical application of AMOROLFINE ZYDUS.
In case of accidental ingestion, appropriate symptomatic measures should be taken.
No effect of amorolfine is expected during pregnancy and lactation due to negligible systemic exposure. Amoroline may be used during pregnancy and lactation

Reactions to the product are rare.

Skin and Tissue Subcutaneous

Since the marketing have been reported

· Nail anomalies (eg dyschromias, nail, brittle nail, fragile nail). However, these reactions may be directly related to onychomycosis.

· Skin burning sensations and contact dermatitis

Reporting of suspected adverse reactions

The reporting of suspected adverse reactions after authorization of the drug is important. It allows continuous monitoring of the ratio, benefit / risk of the drug. Health professionals report any suspected adverse effects via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and network of Regional Centers, Pharmacovigilance - Website: www.ansm .sante.fr.
Treatment of onychomycoses, subalucleal distal and lateral, moderate, caused by dermatophytes, yeasts or molds, not touching more than two nails, in adults.