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

Apply AMOROLFINE SANDOZ on nails at dosage once a week.
To apply the varnish, follow carefully the following recommendations

A. Before the first application of AMOROLFINE SANDOZ, make a toilet, careful nails. Remove all traces of residual varnish with a solvent, file with a file the surface of the nail (especially the affected area), as completely as possible. Take the precaution of not filing peri-nail skin.

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

C. Apply the varnish using one of the reusable spatulas on the entire nail. Clean the spatula, reusable between each passage from one nail to the other with a compress or fabric impregnated with a solvent, in order 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 varnish has been deposited on the outside of the stopper during handling, it is important to clean it with a compress or a fabric soaked in solvent in order to Avoid applying this varnish to the skin

F.; Re-seal the bottle tightly.

Repeat all of the above operations for each nail reached.

After each use of AMOROLFINE SANDOZ, it is important to wash your hands, but when applied to the nails of the hands it is necessary to wait until the varnish has completely dried 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 a tissue impregnated with a solvent. >

· When handling organic solvents (white spirit, diluents, etc.), it is necessary to wear gloves, impermeable to protect the layer of varnish, AMOROLFINE SANDOZ on the nails. >

No information in the marketing authorization.

OTHER ANTIFUNGALS FOR USE, TOPICAL, ATC Code: D01AE16.

AMOROLFINE SANDOZ 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 Candida species.

· 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

Not applicable.

Precautions for use

In the absence of data, the use of AMOROLFINE SANDOZ is not recommended in patients