AMOROLFINE VIATRIS 50 mg/ml NAIL LACQUER

2. What you need to know before using Amorolfina Viatris

Do not use Amorolfina Viatris

• If you are allergic to amorolfina or any of the other components of this medication (listed in section 6).

Warnings and Precautions

This medication may cause allergic reactions, some of which can be severe. If this happens, stop applying the product, immediately remove it with a nail polish remover or the wipes provided in the package, and consult a doctor. The product should not be reapplied.

Seek immediate medical attention if you experience any of the following symptoms:

• Difficulty breathing
• Swelling of the face, lips, tongue, or throat
• Severe skin rash

Consult your doctor or pharmacist before starting to use amorolfina

• The nail varnish should not be applied to the skin surrounding the nail.
• Avoid contact of the varnish with the eyes, ears, and mucous membranes (e.g., mouth or nostrils).
• Do not inhale it.
• Wear impermeable gloves (resistant to water) when using organic solvents, such as paint thinners or turpentine, to prevent removal of the nail varnish.

Children and Adolescents

Due to the lack of available clinical experience to date, children should not be treated with amorolfina.

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Using Amorolfina Viatris with Other Medications

Tell your doctor or pharmacist if you are using, have recently used, or may need to use any other medication.

Using Other Nail Products

Cosmetic nail varnish can be used, but you should wait at least 10 minutes after applying amorolfina before painting your nails.

The nail varnish should be carefully removed before reapplying amorolfina.

Amorolfina Viatris Contains Ethanol

This medication contains 482.3 mg of alcohol (ethanol) per mL. It may cause a burning sensation on damaged skin. Do not use it near an open flame, a lit cigarette, or some devices (e.g., hair dryers), as it is flammable.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication. Your doctor will decide whether you can use amorolfina.

3. How to Use Amorolfina Viatris

Follow the instructions for administration of this medication exactly as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Always use this medication exactly as described in this package leaflet or as your doctor or pharmacist has told you. Consult your doctor or pharmacist if you are unsure.

Amorolfina should be applied to the affected nails of the hands or feet once or twice a week, exactly as instructed by your doctor.

Instructions for Use

Do not use the nail files for affected nails on healthy nails, as this could spread the infection. To prevent the infection from spreading, ensure that no one else uses the files from your kit.

The provided spatulas are reusable. However, it is essential to wash them thoroughly with the same wipe you used to clean your nails, once you have finished the treatment steps. Avoid touching the newly treated nails with the cleaning wipe. Close the nail varnish bottle perfectly. Dispose of the wipe carefully, as it is flammable.

• Before reusing amorolfina, first remove any previous nail varnish or nail polish from your nails using a cleaning wipe, and then file your nails if necessary.
• Reapply the varnish as described above.
• Once dry, the varnish is not affected by soap and water, so you can wash your hands and feet normally. If you need to use chemical products such as paint thinners or turpentine, you should wear impermeable gloves (resistant to water) to protect the nail varnish.
• It is essential that you continue using amorolfina until the infection has disappeared and healthy nails have grown back. The duration of treatment is usually 6 months for fingernails and 9 to 12 months for toenails.

Your doctor will probably check how your treatment is progressing every 3 months.

If Amorolfina Viatris Comes into Contact with Your Eyes or Ears

If amorolfina comes into contact with your eyes or ears, rinse them immediately with water and contact your doctor or pharmacist, or go to the nearest hospital.

If You Accidentally Ingest Amorolfina Viatris

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If You Forget to Use Amorolfina Viatris

Do not worry if you forget to use amorolfina at the scheduled time. When you remember, start using the product again, exactly as before.

If You Interrupt Treatment with Amorolfina Viatris

Do not interrupt treatment with amorolfina before your doctor tells you to, as the infection may recur.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Contact your doctor immediately if you develop any of the following side effects:

Frequency not known (cannot be estimated from available data)

• Severe allergic reaction with symptoms such as dizziness or fainting, skin rash, itching, and swelling of the face, lips, tongue, or throat that can cause difficulty breathing or swallowing.

Other Possible Side Effects:

Rare (may affect up to 1 in 1,000 people):

Discolored, broken, or brittle nails.

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

Burning sensation around the nail.

Frequency Not Known (cannot be estimated from available data):

• Redness of the skin (erythema).
• Itching of the skin (pruritus).
• Allergic skin reaction (contact dermatitis).
• Rash (urticaria) or blisters.

Reporting Side Effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medication Monitoring System: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Amorolfina Viatris

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date stated on the carton after "EXP". The expiration date is the last day of the month indicated.

Protect from heat. Keep the bottle tightly closed after use.

Medications should not be disposed of through wastewater or household waste. Dispose of the packaging and any unused medication in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Amorolfina Viatris

• The active ingredient is amorolfina hydrochloride. 1 ml of Amorolfina Viatris contains 55.70 mg of amorolfina hydrochloride, equivalent to 50 mg of amorolfina.
• The other components are: anhydrous ethanol, ammonio methacrylate copolymer, ethyl acetate, butyl acetate, and triacetin.

Appearance of Amorolfina Viatris and Package Contents

Ambber glass bottle with a tamper-evident plastic cap containing a clear, colorless solution.

Package sizes:

2.5 ml, 3 ml, and 5 ml

All packages contain 30 cleaning wipes, 10 spatulas, and 30 nail files.

Not all package sizes may be marketed.

Marketing Authorization Holder

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Manufacturer(s):

Farmaclair

440, avenue du Général de Gaulle,

14200 Herouville Saint Clair

France

or

Creapharm Industry

29 Rue Leon Faucher

51100 Reims

France

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

This medication is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Spain Amorolfina Viatris 50 mg/ml Medicinal Nail Varnish EFG

Italy Amorolfina Mylan Generics 5% Smalto medicato per unghie

Portugal Amorolfina Mylan

United Kingdom (Northern Ireland) Clavusimyl 5% w/v Medicated Nail Lacquer

Sweden Amorolfin Mylan 5% Medicinskt nagellack

Date of the Last Revision of this Package Leaflet:April 2023.

Detailed information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) https://www.aemps.gob.es/