ONILAQ 5% MEDICATED NAIL POLISH, 1 2.5 ML GLASS BOTTLE WITH APPLICATOR CAP AND ACCESSORIES (NAIL FILES, CLEANSING PADS)

Name
ONILAQ 5% medicated nail polish
Amorolfine


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

ONILAQ 5% is used to treat nail fungus ( fungal infections ) in adults involving no more than two nails. Fungal infections generally cause discoloration 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 to any of the other ingredients of ONILAQ;
- if you are under 18 years old.


Warnings and precautions
• Do not apply Onilaq 5% medicated nail polish 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 polish.
• *Consult your doctor:
- if you suffer from diabetes,
- if you are being treated for immune system disorders ( a 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 damage, skin conditions such as psoriasis, or other chronic skin conditions, swelling, yellow nails associated with breathing problems, painful nails, distorted/deformed nails, or any other disorder in the nail area.
- if the nail is severely damaged (with lesions covering more than two-thirds of the nail plate) or infected. In these cases, your doctor may prescribe oral therapy in combination with medicated nail polish.
• During treatment with amorolfine, the use of cosmetic nail polish or artificial nails should be avoided. If using organic solvents, it is advisable to wear waterproof gloves to avoid removing the layer of amorolfine medicated nail polish.
• This product contains ethanol (alcohol). Using the product too often or applying it improperly may cause irritation or dryness of the surrounding skin.
• All medicines can cause allergic reactions; although most are mild, some can be serious. If this occurs, stop using the product, remove it immediately with nail polish remover or the cleansing pads provided, and consult a doctor. The product should not be reapplied.

If you experience any of the following symptoms, contact your doctor urgently:
– has difficulty breathing
– his face, lips, tongue, or throat swells
– his skin shows a severe rash



Possible side effects
Like all medicines, ONILAQ 5% medicated nail polish can cause side effects, although not everybody gets them.
Some nail abnormalities (nail discoloration, brittle or crumbly nails), burning sensations, 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 1,000 people
Nail damage, nail discoloration, 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 serious allergic reaction that may be associated with swelling of the face, lips, tongue or throat, difficulty breathing and/or a severe skin rash).
Redness, itching, hives, blisters and allergic skin reactions.

Reporting of side effects
If you experience 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.