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

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, the addition of a 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.

In case of sensitisation, treatment should be discontinued and appropriate therapy instituted.

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) should seek medical advice prior to commencing treatment.

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 should be avoided.

The medicated nail lacquer is for external use only.

Nail polish or other nail cosmetic products should not be used on the treated nails.

Onytec contains cetostearyl alcohol which may cause local skin reactions (e.g. contact dermatitis).

The bottle should be capped when not in use. This product is flammable. Keep away from heat and open flame.

No drug interaction studies have been performed. However, after application as recommended, the systemic bioavailability of ciclopirox is below 2%, an amount which is considered as negligible, thus no interactions are foreseen at systemic level.

Pregnancy

There are no clinical data on exposed pregnant women for ciclopirox. Animal studies have shown no direct or indirect harmful effect on pregnancy, embryonic development, development of the foetus and/or the birth. However, there are no adequate data on possible long term effects on postnatal development (see section 5.3). As the systemic exposure to ciclopirox is negligible, the use of Onytec nail lacquer may be considered during pregnancy, if necessary.

Breast feeding

It is unknown whether ciclopirox or its metabolites are excreted in human milk but at therapeutic doses of Onytec nail lacquer no effects to the newborn/infants are anticipated.

Fertility

No fertility studies have been performed in humans. A reduced fertility index in the rat was observed following oral administration (see section 5.3). This animal data are of negligible clinical relevance due to the low systemic exposure to ciclopirox following therapeutic treatment with Onytec.

Onytec has no influence on the ability to drive and use machines.

For the frequency of occurrence of undersirable effects, the following phrases are used: 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).

General disorders and administration site conditions

Very rare: erythema, scales, burning and itching at the application site.

Not known: rash, eczema, allergic dermatitis, also beyond the application site. (Transient) nail discolouration (this reaction can also be attributed to the onychomycosis itself).

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. Healthcare professionals are asked to report any suspected adverse reactions via HPRA Pharmacovigilance, Earlsfort Terrace, IRL – Dublin 2, Tel: +353 1 6764971, Fax: +353 1 6762517, Website: www.hpra.ie, e-mail: medsafety@hpra.ie.

Not applicable.