ONILAQARE*NAIL LACQUER 2.5ML

Onilaqare 5% medicated nail lacquer
Amorolfine

What it is and what it is used for
ONILAQARE 5% medicated nail lacquer contains amorolfine, an active substance capable of inhibiting the growth of fungi (antifungal).
It is used for the local treatment of onychomycosis (nail infections caused by fungi) in adults affecting no more than two nails and involving the side or upper part of the nail, as shown in photo 1. If the infection looks more like photo no. 2 or 3, you should consult a doctor before using Onilaqare 5% medicated nail lacquer.

A fungal infection generally causes discoloration of the nail (white, yellow, or brown) and its thickening, although the appearance can vary considerably, as shown in the photographs.

What you need to know before taking the medicine
Do not use Onilaqare 5% medicated nail lacquer
- if you are allergic (hypersensitive) to the active substance (amorolfine) or any of the other components of this medicine (listed in paragraph 6).

Warnings and precautions
Talk to your doctor or pharmacist before using Onilaqare 5% medicated nail lacquer:
• if you suffer from diabetes;
• if you are being treated for immune system disorders (disorders that reduce the body's defenses);
• if you suffer from circulatory problems in your hands and feet;
• if you have a history of nail injury, skin conditions such as psoriasis, or other chronic skin conditions, swelling, yellow nails associated with respiratory problems, painful nails, distorted/deformed nails or any other disorder in the nail area;
• if the nail is severely damaged (with lesions affecting more than two-thirds of the nail plate) or infected. In these cases, your doctor might prescribe oral therapy in combination with the medicated nail lacquer.

Do not apply Onilaqare 5% medicated nail lacquer to the skin around the nail.

Avoid contact with mucous membranes (e.g., mouth or nostrils). Do not inhale the lacquer.

If Onilaqare 5% medicated nail lacquer comes into contact with eyes or ears, rinse immediately with water, and contact your doctor, pharmacist, or the nearest hospital immediately.

In case of contact with organic solvents (e.g., nitro thinners, white spirit, etc.) wear impermeable gloves to protect the layer of Onilaqare 5% medicated nail lacquer applied to the nails.

Do not use the nail file used for diseased nails on healthy nails.

During treatment with Onilaqare 5% medicated nail lacquer, do not use artificial nails.

After applying Onilaqare 5% medicated nail lacquer, an interval of at least 10 minutes should be respected before using any cosmetic nail polish.

Before reapplying Onilaqare 5% medicated nail lacquer, the cosmetic nail polish must be carefully removed.

This medicine can cause allergic reactions, some of which can be severe. In this case, stop applying the medicine, remove it immediately with nail polish remover or with the cleansing swabs provided in the package, and consult a doctor. The medicine must not be reapplied.
If any of the following symptoms occur, seek urgent medical attention:
- you have difficulty breathing
- your face, lips, tongue or throat swell;
- your skin develops a severe rash.

Children and adolescents
The use of Onilaqare 5% medicated nail lacquer is not recommended in children and adolescents up to 18 years of age.

Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Reactions to this medicine are rare.
Some nail disorders have been reported (e.g., nail discoloration, nail breakage or brittleness). However, these reactions may be directly related to the nail infection itself.

The following side effects are listed in order of frequency:

Rare: may affect up to 1 in 1,000 people
• Nail disorders, nail discoloration and fragility

Very rare: may affect up to 1 in 10,000 people
• Burning sensation of the skin

Frequency not known: frequency cannot be estimated from the available data
• Systemic allergic reaction (a severe allergic reaction that may be associated with swelling of the face, lips, tongue or throat, difficulty breathing and/or severe rash)
• Redness (erythema)
• Itching
• Inflammatory skin reaction (contact dermatitis)
• Urticaria
• Blisters

Reporting of side effects
If you get any side effects, including any not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazionireazioni-avverse.
By reporting side effects you can help provide more information on the safety of this medicine.