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

Apply AMOROLFINE BIOGARAN TIP on nails at dosage once a week.

To apply the varnish, follow carefully the following recommendations

For packaging without accessories

A. Before the first application of AMOROLFINE BIOGARAN TIP, make a careful nail care. 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 a 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 reuse for another nail in order to avoid contamination of the varnish

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

F. Re-seal the bottle.

Repeat all of the above operations for each nail reached.

After each use of AMOROLFINE BIOGARAN TIP, it is important to wash your hands. However, when applied to the nails of the hands, it is necessary to wait for the complete drying of the front varnish.
The treatment must be carried out without interruption until regeneration, complete the nail.

The duration of the 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 ...), it is necessary to wear gloves, waterproof to protect the layer of varnish, AMOROLFINE BIOGARAN CONSEIL on the nails
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For packaging with accessories

A. Before the first application of AMOROLFINE BIOGARAN TIP, make a careful nail care. 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 using one of the cleaning wipes provided.

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 one of the cleaning wipes provided, 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 one of the cleaning wipes provided after each application before re-using it for another nail to avoid contamination of the varnish. >

E. If varnish has been applied to the exterior of the stopper during handling, it is important to clean it with one of the cleaning wipes provided to avoid Varnish on the skin

F. Re-seal the bottle.

Repeat all of the above operations for each nail reached.

After each use of AMOROLFINE BIOGARAN TIP, it is important to wash your hands. However, when applied to the nails of the hands, it is necessary to wait for the complete drying of the front varnish.
The treatment must be carried out without interruption until regeneration, complete the nail.

The duration of the 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 one of the cleaning wipes

· When handling organic solvents (white spirit, diluents ...), it is necessary to wear gloves, waterproof to protect the layer of varnish, AMOROLFINE BIOGARAN CONSEIL on the nails
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OTHER ANTIFUNGALS FOR USE, TOPICAL, ATC Code: D01AE16.

AMOROLFINE BIOGARAN COUNCIL is a topical antimycotic. The active ingredient, amorolfin, derived from morpholine, belongs to a new chemical class of antimycotics. Its fungistatic and fungicidal action is based on an alteration of the fungal cell membrane directed mainly to the biosynthesis of 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 with AMOROLFINE BIOGARAN; CONSULT with eyes, ears or mucous membranes

AMOROLFINE BIOGARAN CONSEIL should be used with caution in patients with pathologies predisposing to onychopathies (peripheral circulatory disorders, diabetes, diseases of the immune system) as well as in patients with nail dystrophy or severe nails (More than two-thirds of the nail plate is affected). In these cases, systemic treatment should be considered.
Do not apply ordinary nail varnish or other cosmetic products to nails, treated

Precautions for use

In the absence of data, the use of AMOROLFINE BIOGARAN CONSEIL 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, BIOGARAN CONSEIL.

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

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