FUNGILAC*NAIL LACQUER FL 3ML

FUNGILAK 50 mg/ml medicated nail lacquer
amorolfine

What it is and what it is used for
FUNGILAK is a medicinal product (broad-spectrum antifungal agent) for the topical treatment of fungal nail infections (mycoses) (that do not involve the nail matrix, e.g., superficial white fungi, fungi under the nail, affecting less than 50% of the nail surface and fewer than three nails).

FUNGILAK contains the active ingredient amorolfine, an antifungal that kills a wide range of fungi responsible for nail infections.
Amorolfine medicated nail lacquer is used to treat fungal nail infections (caused by dermatophytes and yeasts) when up to 50% of the nail is infected (especially the most exposed area).

What you need to know before taking the medicine
Do not use FUNGILAK
- if you are allergic to the active ingredient amorolfine or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before using FUNGILAK.
Nail files used for infected nails must not be used for healthy nails.
FUNGILAK must not be applied to the skin around the infected nail.
Avoid any contact of the medicated nail lacquer with eyes, ears, and mucous membranes.
The use of artificial nails should be avoided during treatment.
Users who work with organic solvents (thinners, petroleum ether, etc.) must wear impermeable gloves to protect the FUNGILAK layer on their fingernails. Otherwise, FUNGILAK will be removed.
All medicines can trigger allergic reactions, and although they are usually mild, in some cases they can be severe. If this happens, stop applying the product immediately, remove the product with nail polish remover or with the cleaning wipes provided in the package, and consult your doctor. The product should not be reapplied. If any of the following symptoms occur, seek urgent medical attention:
- difficulty breathing
- swelling of the face, lips, tongue, or throat
- severe skin rashes

No information is yet available for patients with inflammatory changes around the nail, diabetes, limited blood circulation, malnutrition, and alcoholism.

Paediatric population
No information is yet available for infants, children, and adolescents. Therefore, patients under 18 years of age should not be treated with FUNGILAK.

Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.

Possible side effects

Rare (may affect up to 1 in 1,000 people):
Nail disorders (e.g., discoloration, brittle or chipped nails)
This reaction could also be due to the fungal infection itself.

Very rare (may affect up to 1 in 10,000 people):
Mild and transient tingling in the area surrounding the treated nail (periungual burning)

Not known (frequency cannot be estimated from the available data):
Serious allergic reactions have been reported, which may be associated with swelling of the face, lips, tongue, or throat, difficulty breathing and/or severe skin rashes, allergic skin reactions (contact dermatitis*, at the application site or extending beyond the application site), itching*, erythema*, urticaria*, vesicles*.

*Information obtained during the post-marketing period.

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.