FUNGILAK 50 MG/ML MEDICATED NAIL POLISH 1 3 ML GLASS BOTTLE WITH 10 REUSABLE SPATULAS 1 SPATULA HOLDER 30 CLEANSING WIPES AND 30 FILES

Name
FUNGILAK 50 mg/ml medicated nail polish
amorolfine


What it is and what it is used for
FUNGILAK is a medicine (broad-spectrum antifungal agent) for the local treatment of fungal infections (mycoses) of the nails (not involving the nail matrix e.g. superficial white fungus, fungus under the nail, involving less than 50% of the nail surface and less than three nails).
FUNGILAK contains the active substance amorolfine, an antifungal that kills a wide range of fungi responsible for nail infections.
Amorolfine medicated nail polish 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 substance amorolfine or 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 on infected nails should not be used on healthy nails.
FUNGILAK should not be applied to the skin around the infected nail.
Avoid any contact of the medicated nail polish with eyes, ears and mucous membranes.
The use of artificial nails should be avoided during treatment.
Users working with organic solvents (thinners, petroleum ether, etc.) must wear waterproof gloves to protect the FUNGILAK layer on the fingernails. Otherwise, FUNGILAK will be removed.
All medicines can cause allergic reactions and although these are usually mild, in some cases they can be serious. If this happens, stop using the product immediately, remove the product with nail polish remover or the cleaning wipes provided and contact your doctor. The product should not be reapplied. If you experience any of the following symptoms, contact your doctor urgently:
- respiratory difficulties
- swelling of the face, lips, tongue or throat
- severe skin rashes

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

Paediatric population
No information is yet available in 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 air surrounding the treated nail (periungual burning)

Not known (frequency cannot be estimated from the available data):
Severe 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 in the post-marketing period.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. 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.