ONILAQ*NAIL POLISH 2.5ML+CAP

ONILAQ 5% medicated nail lacquer
Amorolfine

What it is and what it is used for
ONILAQ 5% medicated nail lacquer is an antifungal (medicine used to treat infections caused by microscopic fungi).

ONILAQ 5% is used for the treatment of nail mycosis (fungal infections) in adults, affecting no more than 2 nails. Mycosis generally causes discolouration of the nail (white, yellow or brown) and thickening, although the appearance can vary considerably.

What you need to know before taking the medicine
Do not use ONILAQ:
- if you are allergic (hypersensitive) to the active substance (amorolfine) or any of the other ingredients of ONILAQ;
- if you are under 18 years of age.

Warnings and precautions
• Do not apply Onilaq 5% medicated nail lacquer to the skin around the nail.
• Avoid contact with eyes, ears or mucous membranes.
• Due to the current lack of clinical experience, children should not be treated with Onilaq 5% medicated nail lacquer.
• *Consult your doctor:
- if you have diabetes,
- if you are being treated for immune system disorders (disorder that reduces 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 disorders, sore 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 may prescribe oral therapy in combination with the medicated nail lacquer.
• During treatment with amorolfine, the use of cosmetic nail polishes or artificial nails should be avoided. If using organic solvents, it is advisable to wear waterproof gloves to avoid removing the amorolfine medicated nail lacquer layer.
• This product contains ethanol (alcohol). Using the product too often or applying it improperly can cause irritation or dryness of the surrounding skin.
• All medicines can cause allergic reactions; although most are mild, some can be serious. In this case, stop applying the product, immediately remove the product with a nail polish remover or with the cleansing pads provided in the package and consult a doctor. The product must not be reapplied.

If you experience any of the following symptoms, seek urgent medical attention:
– you have difficulty breathing
– your face, lips, tongue or throat swell
– your skin develops a severe rash

Possible side effects
Like all medicines, ONILAQ 5% medicated nail lacquer can cause side effects, although not everyone experiences them.
Some nail abnormalities (nail discolouration, brittle or crumbly nails), burning sensation of the skin, redness, itching, hives, blisters and allergic skin reactions have been reported. However, these reactions may be directly related to the nail infection.

Rare: may affect up to 1 in 1000 people
Nail damage, nail discolouration, brittle or crumbly nails.

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

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 a severe rash).
Redness, itching, hives, blisters and allergic skin reactions.

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.