LENIRIT NAIL*2.5ML 5% NAIL POLISH

LENIRIT UNGUEALE 5% medicated nail lacquer
Amorolfine

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

• LENIRIT UNGUEALE 5% is used for the treatment of nail mycoses (fungal infections) in adults affecting no more than 2 nails. Mycosis generally causes nail discoloration (white, yellow, or brown) and thickening, although the appearance can vary considerably.
If the infection is limited to the upper part of the nail as shown in photo no. 1 below, follow the pharmacist's instructions. If the infection looks more like photo no. 2 or 3, consult your doctor.

What you need to know before taking the medicine
Do not use LENIRIT UNGUEALE
• if you are allergic (hypersensitive) to the active substance (amorolfine) or any of the other ingredients of this medicine (listed in section 6);
• if you are under 18 years of age.

Warnings and precautions
• Do not apply LENIRIT UNGUEALE 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 LENIRIT UNGUEALE 5% medicated nail lacquer.
• Consult your doctor:
- 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 previous history of nail injury, skin conditions such as psoriasis, or other chronic skin conditions, swelling, yellow nails associated with respiratory disorders, painful nails, distorted/deformed nails, or any other disorder in the nail area;
- if the nail is severely damaged (with lesions exceeding 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. When using organic solvents, it is advisable to wear impermeable gloves to avoid removing the layer of amorolfine medicated nail lacquer.
• This product contains ethanol (alcohol). Using the product too often or applying it improperly can lead to irritation or dryness of the surrounding skin.
• All medicines can cause allergic reactions; although most are mild, some can be severe. 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 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.

Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Some nail abnormalities (nail discoloration, brittle or crumbling nails), skin burning sensation, 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 crumbling nails.

Very rare: may affect up to 1 in 10,000 people
Skin burning sensation.

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, tell 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.