Amorolfine Mylan Generics

Patient Information Leaflet

Amorolfina Mylan Generics 5% medicated nail lacquer

amorolfine
Please read all of this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Amorolfina Mylan Generics is and what it is used for
2. What you need to know before using Amorolfina Mylan Generics
3. How to use Amorolfina Mylan Generics
4. Possible side effects
5. How to store Amorolfina Mylan Generics
6. Contents of the pack and other information

1. What Amorolfina Mylan Generics is and what it is used for

Amorolfina Mylan Generics contains the active substance amorolfine (in the form of amorolfine
hydrochloride), which belongs to a group of medicines known as antifungal agents. It kills
a wide range of fungi that can cause nail infections.
Amorolfina Mylan Generics is used to treat fungal infections of the nails.

2. What you need to know before using Amorolfina Mylan Generics

Do not use Amorolfina Mylan Generics:

• if you are allergic to amorolfine or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
This medicine may cause allergic reactions, even severe ones. If this occurs,
discontinue application of the product immediately, remove the product promptly using a nail polish remover or the cleaning pads supplied in the package, and consult a doctor.
The product must no longer be applied.
Seek urgent medical advice 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

• The medicated nail lacquer must not be applied to the skin around the nail.
• Avoid contact of the lacquer with eyes, ears or mucous membranes (e.g. mouth or nostrils).
• Do not inhale.
• Wear waterproof gloves when handling organic solvents, such as paint removers or thinners, to prevent removal of the applied nail lacquer layer.

Children and adolescents
Due to the current lack of clinical experience, children should not be treated with
Amorolfina Mylan Generics.
Other medicines and Amorolfina Mylan Generics
Inform your doctor or pharmacist if you are currently using, have recently used, or might use any
other medicines.
Use of other nail products
Avoid using artificial nails during treatment.
Cosmetic nail polish may be used, but you must wait at least 10 minutes after applying Amorolfina Mylan Generics before applying the cosmetic polish.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding,
ask your doctor or pharmacist for advice before using this medicine. Your doctor will decide whether you should use Amorolfina Mylan Generics.

3. How to use Amorolfina Mylan Generics

Use this medicine exactly as instructed by your doctor. If you have any doubts,
consult your doctor or pharmacist.
Amorolfina Mylan Generics should be applied to the affected fingernails or toenails once or
twice a week, strictly following your doctor's instructions.
Instructions for use

	1. Before the first application of Amorolfine Mylan Generics, carefully clean the nails: file as deeply as possible the affected area of the nail (especially its surface) using the nail file provided. Be careful not to file the skin around the nail.
	2. Clean the nail surface and remove any fatty residue using the swabs provided.
	3. Apply the nail lacquer to the entire affected nail using one of the reusable spatulas (provided in the package). Clean the reusable spatula before using it on other nails to avoid contaminating the nail lacquer. Do not rub the spatula against the neck of the bottle.
	4. Repeat steps 1 to 3 for each affected nail.
	5. Clean the spatula using the swabs provided.
	6. Close the bottle tightly. Allow the treated nails to dry for about 3 minutes. Wait at least 10 minutes before applying cosmetic nail polish.

Do not use nail files intended for infected nails on healthy nails, as this may spread the infection. To prevent the spread of infection, ensure that no one else uses the nail files provided with the package.
The spatulas provided are reusable. However, it is important to clean them thoroughly after each treatment procedure, using the same pad used to clean the nails. Avoid touching the treated nails with the pad. Close the nail lacquer bottle tightly. Be careful when disposing of the pad, as it is flammable.

• Before reusing Amorolfina Mylan Generics, remove the old medicated nail lacquer and any other nail polish from the nails using the pad; if necessary, file the nails again afterwards.
• Reapply the nail lacquer as described above.
• Once the nail lacquer is dry, it is not damaged by soap or water, so you may wash your hands and feet normally. If you need to use chemical products such as solvents or turpentine, wear rubber or other waterproof gloves to protect the nail lacquer.
• It is important to continue using Amorolfina Mylan Generics until the infection has healed and healthy nails have fully regrown. This usually takes 6 months for fingernails and 9 to 12 months for toenails.

Your doctor will likely monitor the progress of treatment approximately every 3 months.
If Amorolfina Mylan Generics comes into contact with eyes or ears
If Amorolfina Mylan Generics comes into contact with the eyes or ears, rinse immediately with water and contact your doctor, pharmacist, or nearest hospital immediately.
If you accidentally ingest Amorolfina Mylan Generics
If you or someone else accidentally ingests the nail lacquer, contact your doctor, pharmacist, or nearest hospital immediately.
If you forget to use Amorolfina Mylan Generics
Do not worry if you forget to use Amorolfina Mylan Generics. When you remember, simply resume using the product as before.
If you stop treatment with Amorolfina Mylan Generics
Do not stop using Amorolfina Mylan Generics before your doctor tells you to do so, otherwise the infection may return.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Contact a doctor immediately if you experience any of the following side effects:

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 nails

Very rare (may affect up to 1 in 10,000 people):

• a burning sensation in the area around the nail may occur

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 experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at
www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Amorolfina Mylan Generics

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp.".
The expiry date refers to the last day of that month.
Protect from heat. Keep the bottle tightly closed after use.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Amorolfina Mylan Generics contains

• The active substance is amorolfine hydrochloride. 1 ml of Amorolfina Mylan Generics contains amorolfine hydrochloride equivalent to 50 mg of amorolfine.
• The other components are: anhydrous ethyl alcohol, methacrylic acid copolymer ammonium salt, ethyl acetate, butyl acetate, triacetin.

Description of the appearance of Amorolfina Mylan Generics and contents of the pack
Amber glass bottle with a child-resistant plastic closure containing a clear, colourless solution.
Pack sizes: 2.5 ml, 3 ml, 5 ml.
All packs contain 30 swabs for cleaning, 10 spatulas and 30 nail files.
It is possible that not all pack sizes are marketed.

Marketing Authorisation Holder
Mylan S.p.A., Via Vittor Pisani 20, 20124 Milano, Italy

Manufacturer
Farmaclair
440 avenue du General de Gaulle, 14200 Herouville Saint Clair, France
Stradis, 29 rue Léon Faucher, 51100 Reims, France

This medicinal product is authorised in the European Economic Area countries under the following names:
Italy: Amorolfina Mylan Generics 5% Medicated Nail Lacquer
Portugal: Amorolfina Mylan
Spain: Amorolfina Mylan 50 mg/ml barniz de uñas medicamentoso EFG
Sweden: Amorolfin Mylan 5% medicinskt nagellack
United Kingdom: Clavusimyl 5% w/v medicated nail lacquer