AMOROLFINE MY*NAIL LACQUER 2.5ML 5%

Amorolfine Mylan Generics 5% medicated nail lacquer
amorolfine

What it is and what it is used for
Amorolfine Mylan Generics contains the active substance amorolfine (as amorolfine hydrochloride) which belongs to a group of medicines known as antifungals. It kills a wide variety of fungi that can cause nail infections.

Amorolfine Mylan Generics is used to treat fungal nail infections.

What you need to know before taking the medicine
Do not use Amorolfine Mylan Generics:
• if you are allergic to amorolfine or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
This medicine can cause allergic reactions, including severe ones. If this occurs, stop applying the product, immediately remove the product with nail polish remover or with the cleaning swabs provided in the package, and consult a doctor. The product must no longer be applied.
You should seek urgent medical attention if you experience any of the following symptoms:
• difficulty breathing
• swelling of the face, lips, tongue or throat
• if you develop a severe skin rash

Talk to your doctor or pharmacist before using Amorolfine Mylan Generics
• The medicated nail lacquer must not be applied to the skin around the nail.
• Avoid contact of the nail lacquer with eyes, ears or mucous membranes (e.g. mouth or nostrils).
• Do not inhale.
• Wear impermeable gloves when using organic solvents, e.g. paint removers, thinners, to prevent the layer of lacquer applied to the nails from being removed.

Children and adolescents
Due to the current lack of clinical experience, children should not be treated with Amorolfine Mylan Generics.

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

Contact a doctor immediately if any of the following side effects occur:

Not known (frequency cannot be estimated from the available data):
• severe allergic reaction with symptoms including dizziness or fainting, rash, itchy skin and swelling of the face, lips, tongue or throat which may cause difficulty breathing or swallowing

Other possible side effects

Rare (may affect up to 1 in 1,000 people):
• discolouration, breaking or fragility of the nails.

Very rare (may affect up to 1 in 10,000 people):
• a burning sensation may appear in the area around the nail.

Not known (frequency cannot be estimated from the available data):
• skin redness (erythema)
• skin itching
• allergic skin reaction (contact dermatitis)
• hives or blisters.

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.