CURANAIL Medicated nail lacquer Ref.[49838] Active ingredients: Amorolfine

Source: Health Products Regulatory Authority (IE)  Revision Year: 2019  Publisher: Galderma International S.A.S., Tour Europlaza, La Dรฉfense 4, 20 Avenue Andrรฉ Prothin, France

4.1. Therapeutic indications

Treatment of mild cases of distal and lateral subungual onychomycoses caused by dermatophytes, yeasts and moulds limited up to 2 nails, in adults.

4.2. Posology and method of administration

Posology

Apply CURANAIL to the affected nails once a week.

Method of administration

To apply the nail lacquer, comply carefully with the following recommendations:

A. Before the first application of CURANAIL, clean the nails thoroughly. Remove any former varnish layers with a nail varnish remover; then using a nail file, file the surface of the nail (particularly the affected nail surface) as thoroughly as possible. Be careful not to file the periungual skin.

B. The surface of the nail should be cleansed and degreased using one of the cleaning swabs (supplied).

C. Apply the nail lacquer to the whole surface of the nail with one of the reusable applicators supplied. Between each nail application, clean the applicator with the cleaning swab supplied, thus avoiding any contamination of the nail lacquer. Do not wipe the applicator off on the edge of the bottle.

D. The applicator must be carefully cleaned with one of the swabs supplied after each application before treating another nail so as to avoid contamination of the lacquer.

E. If some nail lacquer has been put on the exterior of the stopper, please make sure to clean it with one of the cleaning swab supplied to avoid any contact with the skin.

F. Keep the bottle tightly closed.

Repeat the same process for each affected nail.

After each application of CURANAIL, it is important to wash your hands. However, when applying on fingernails, wait till it is completely dry before doing so.

Treatment should be continued without interruption until the nail is regenerated and the affected areas are finally cured. In general, the duration of treatment is 6 months for fingernails and 9 months for toenails (it depends essentially on the intensity, localisation, growth rate of the nail, and extent of the infection).

After a 3-month use without improvement, a doctor should be consulted.

Special instructions:

  • Do not reuse the nail files for healthy nails.
  • Before each new application, remove any remaining lacquer, file the affected nails if required, and then always clean them with one of the cleansing swabs.

4.9. Overdose

No systemic signs of overdose are expected after topical application of CURANAIL.

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

6.3. Shelf life

3 years.

Shelf life after first opening: 6 months.

6.4. Special precautions for storage

Protect from heat.

Keep bottle tightly closed after use.

6.5. Nature and contents of container

Amber glass type I bottle with screw thread and plastic screw closure 2.5 ml-glass bottle with accessories (30 nail files, 30 cleaning swabs, 30 applicators).

or

Amber glass type III bottle with screw thread and plastic screw closure with integretated applicator. 1.25 ml or 2.5 ml – glass bottle with accessories (nail files, cleaning swabs, applicator)

Not all pack sizes may be marketed.

6.6. Special precautions for disposal and other handling

No special requirements.

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