ONYTEC

The medicated nail lacquer is intended for topical use on fingernails, toenails and immediately adjacent skin (perionychium, hyponychium). Unless otherwise directed, Onytec nail lacquer is applied once a day in a thin layer to the affected nail/s after careful washing and drying.

The medicated nail lacquer should 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. 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.

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 finger- and toenails, additional oral therapy should be considered.

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.

According to clinical and post-marketing data, the most commonly reported adverse reactions during treatment are application site reactions, most of them mild and transient. Given the low amount of ciclopirox absorbed, no systemic adverse reactions are expected.

Tabulated list of adverse drug reactions The adverse reactions reported are listed below using the following frequency categories: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).

System Organ Class (SOC) Frequency Adverse reaction (PT) Very rare Erythema, skin exfoliation, skin burning sensation, pruritus Skin and subcutaneous tissue disorders Not known Nail discolouration*, nail disorder, dermatitis contact**, rash, eczema General disorders and administration site conditions Not known Application site pain, application site paraesthesia * This reaction can also be attributed to the onychomycosis itself.

** Also beyond the application site. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

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Mild to moderate onychomycosis is defined as fungal infection affecting up to 75 % of the nail surface, involvement of up to 5 nails, without involvement of nail matrix/lunula. In case of severe onychomycosis and of predisposing factors, such as diabetes and immune disorders, alternative systemic therapy should be considered.

Duration of disease, extent of infection (involvement of the nail plate) and nail thickness (>2mm may indicate matrix involvement, and keratinaceous debris) may influence results of therapy. Sampling of nails for fungal culture should be done 4 weeks after stopping the treatment to avoid interference with culture results by possible residues of active substance.

In case of sensitisation, treatment should be discontinued and appropriate therapy instituted. Consideration of alternative treatment may be needed in patients with a history of diabetes, immune disorders, peripheral vascular disease, injury, painful or seriously damaged nails, skin conditions such as psoriasis or any other chronic skin condition, oedema, breathing disorders (Yellow nail syndrome).

The risk of removal of the unattached, infected nail, by the health care professional or during cleaning by the patient should be carefully considered for patients with a history of insulin dependent diabetes mellitus or diabetic neuropathy.

Contact with the eyes and mucous membranes should be avoided. Avoid biting or sucking nails during the treatment period with Onytec. The medicated nail lacquer is for external use only. Nail polish or other nail cosmetic products should be removed before application of Onytec and should not be used on the treated nails.

contact dermatitis). This medicine contains 730 mg alcohol (ethanol) in each g of solution. It may cause a burning sensation on damaged skin. The bottle should be capped when not in use. This product is flammable. Keep away from heat and open flame.

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