ONYTEC Medicated nail lacquer Ref.[49848] Active ingredients: Ciclopirox olamine

Posology

Paediatric population

The safety and efficacy of Onytec in children and adolescents below 18 years of age have not yet been established. No data are available.

Method of administration

Cutaneous use

For topical use on fingernails, toenails and immediately adjacent skin (perionychium, hyponychium).

Unless otherwise directed, Onytec nail lacquer is applied in a thin layer once a day on the affected nail/s after careful washing and drying. The medicated nail lacquer shall be applied over the entire nail plate, 5 mm of surrounding skin and, if possible under the free edge of the nail. Onytec nail lacquer needs about 30 seconds for drying. The treated nails should not be washed for at least six hours, therefore, application in the evening before going to bed is recommended. After that time, normal hygienic practices could be followed.

Onytec nail lacquer does not need to be removed by any solvent or abrasives (i.e. nail filing), it is sufficient to wash the nails. In case of unintentional removal by washing, Onytec nail lacquer can be applied again.

Regular removal of the nail free edge and any onycholitic material by nail clipping, is recommended.

Treatment should be continued until complete mycological and clinical cure is achieved and healthy nail has grown again. Normally, treatment duration of fingernails is for about 6 months while for toenails it is about 9 to 12 months.

The control of fungal culture should be done 4 weeks after the end of the treatment to avoid interference with culture results by possible residues of active substance.

Being a topical treatment, no different posology is necessary for special population groups.

If the condition is refractory to therapy with Onytec nail lacquer and/or there is extensive involvement of one or several fingerand toenails, additional oral therapy shall be considered.

Onytec is for topical use. No overdose has been reported with the use of this product. In the event of accidental oral ingestion, an appropriate method of gastric emptying may be used.

3 years.

After first opening the bottle: 6 months.

Keep the bottle in the outer carton, in order to protect from light. Do not refrigerate or freeze.

After first opening the container: Keep the bottle tightly closed to avoid evaporation of the content.

For storage conditions after first opening of the medicinal product, see section 6.3

This product is flammable. Keep away from heat and open flame.

At temperature below 15°C the medicated nail lacquer may gel. Light flocculation or formation of a light sediment may also occur which can be reversed by warming up to room temperature (25°C) through rubbing the bottle between hands till the solution is clear again (about one minute). This has no impact on product quality or performance.

Clear glass bottles with polypropylene screw caps which are fitted with a brush.

Pack sizes: 3.3 ml, 6.6 ml.

Not all pack sizes may be marketed.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.