AMOROLFINA MY 5% MEDICATED NAIL POLISH 1 GLASS BOTTLE OF 2.5 ML

Name
Amorolfina Mylan Generics 5% medicated nail polish
amorolfine


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

Amorolfina Mylan Generics is used to treat fungal nail infections.


What you need to know before taking the medicine
Do not use Amorolfina 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, even serious ones. If this occurs, stop using the product, remove it immediately with nail polish remover or the cleaning pads provided, and consult a doctor. The product should not be used again.
You should seek urgent medical help 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 Amorolfina Mylan Generics
• Medicated nail polish should not be applied to the skin around the nail.
• Avoid contact of nail polish with eyes, ears or mucous membranes (e.g. mouth or nostrils).
• Do not inhale.
• Wear waterproof gloves when using organic solvents such as paint strippers and thinners to prevent the layer of nail polish applied to the nails from being removed.

Children and adolescents
Due to the current lack of clinical experience, children should not be treated with Amorolfina 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, itching of the skin and swelling of the face, lips, tongue or throat which may cause difficulty in breathing or swallowing

Other possible side effects

Rare (may affect up to 1 in 1,000 people):
• discoloration, breakage, or brittleness 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):
• redness of the skin (erythema)
• itchy skin
• allergic skin reaction (contact dermatitis)
• hives or blisters.

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.