Generic drug from Loceryl
Therapeutic class: Dermatology
active ingredients: Amorolfine
laboratory: Zydus France
Medicated nail polish
Bottle (+ 20 spatulas) of 2.5 ml
Treatment of moderate distal and lateral subungual onychomycosis, caused by dermatophytes, yeasts or molds, affecting no more than two nails in adults.
Dosage AMOROLFINE ZYDUS 5% Medicated nail varnish Bottle (+ 20 spatulas) of 2.5 ml
Apply AMOROLFINE ZYDUS to the affected nails at a dosage of once a week.
To apply the varnish, carefully follow the following recommendations:
A. Before the first application of AMOROLFINE ZYDUS, clean the nails thoroughly. 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 the periungual skin.
B. Clean the surface of the nail and degrease it with a compress or cloth impregnated with solvent.
C. Apply the varnish using one of the reusable spatulas on the entire nail reached. Clean the reusable spatula between each pass from one nail to the other with a compress or cloth impregnated with solvent, to prevent 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 cloth soaked in solvent after each application before reuse for another nail to prevent contamination of the varnish.
E. If varnish has been applied to the outside of the cap during handling, it is important to clean it with a compress or cloth soaked in solvent to avoid applying this varnish on the skin.
F. Seal the vial tightly.
Repeat all the above operations for each nail achieved.
After each use of AMOROLFINE ZYDUS, it is important to wash your hands. However, when applying on the nails of the hands, it is necessary to wait for the complete drying of the front varnish.
The treatment must be conducted without interruption until complete regeneration of the nail.
The duration of treatment is generally 6 months for the nails of the hands and 9 months for the nails of the feet (it depends essentially on the intensity, the localization of the infection and the height of the attack of the nail).
After 3 months of use in the absence of improvement, a doctor must be consulted.
· Do not reuse nail files for healthy nails.
· Before each new application, remove the residual varnish, file, if necessary, the affected nails and in any case, clean them with a compress or a cloth impregnated with solvent.
· When handling organic solvents (white spirit, thinners.), It is necessary to wear waterproof gloves to protect the coat of varnish AMOROLFINE MYPLIX on the nails.
History of allergy to one of the components.
Adverse effects Amorolfine Zydus
Reactions to the product are rare.
Skin and subcutaneous tissues:
Since marketing have been reported:
· Ungual anomalies (eg nail dyschromia, 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 benefit / risk ratio of the drug. Health professionals declare 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 Pharmacovigilance Centers - Website: www.ansm.sante.fr.