AMOROLFINA SAN 50 MG/ML MEDICATED NAIL POLISH 1 GLASS BOTTLE OF 2.5 ML

Name
Amorolfine Sandoz 50 mg/ml medicated nail polish
Equivalent medicine


What is it and what is it used for?
Amorolfine Sandoz is used to treat fungal nail infections in adults.
It should only be used if the top half or sides of the nail are affected.
The active ingredient amorolfine prevents the growth of fungi and kills them.

Amorolfine Sandoz is effective against a wide variety of fungi susceptible to amorolfine, such as yeasts, skin fungi, and molds. However, bacteria are not susceptible to amorolfine.
Contact your doctor if you notice no improvement or if you notice worsening of symptoms after 3 months.


What you need to know before taking the medicine
Do not use Amorolfina Sandoz:
• if you are allergic to 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 Amorolfina Sandoz if you suffer from:
• diabetes;
• a weakened immune system or is undergoing treatment to reduce its activity;
• circulatory problems in the hands and feet;
• a severely damaged or infected nail;
• if you have a history of nail injury, skin conditions such as psoriasis, or other chronic skin condition, swelling, yellow nails associated with breathing problems, painful nails, distorted/deformed nails or any other disorder in the nail area.

This medicine can cause allergic reactions, some of which can be serious. If this happens, stop using this medicine and remove it immediately with nail polish remover (or the alcohol swabs provided) and consult a doctor.
If you experience any of the following symptoms, contact your doctor immediately:
- if you have difficulty breathing;
- if you notice swelling of your face, lips, tongue or throat;
- if you develop a severe skin rash.

Amorolfina Sandoz should not be applied to the skin around the nail.
Avoid using artificial nails during treatment with Amorolfina Sandoz.

There is no experience in patients with inflammatory changes surrounding the nail, diabetes, poor circulation, malnutrition, alcohol abuse, or in children and infants. Wear waterproof gloves when using organic solvents, otherwise the Amorolfine Sandoz coating on the nails will be removed.

Avoid contact of the nail polish with your eyes, ears, or mucous membranes. If Amorolfine Sandoz comes into contact with your eyes or ears, rinse immediately with water and contact your doctor or pharmacist.

Children and adolescents
Due to lack of experience, treatment of children and adolescents is not recommended.


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

Side effects may occur with the following frequencies:

Rare , may affect up to 1 in 1,000 people:
• damaged nails;
• alteration of nail color;
• weak or brittle nails (onychorrhexis);
• broken nails (onychoclasis).

Very rare , may affect up to 1 in 10,000 people:
• burning of the skin.

Not known , frequency cannot be estimated from the available data:
• systemic allergic reaction (a serious allergic reaction that may be associated with swelling of the face, lips, tongue or throat, difficulty breathing and/or a severe skin rash);
• redness of the skin, itching;
• allergic skin reactions;
• 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.