Package Leaflet: Information for the Patient

Amorolfina Viatris 50 mg/ml Medicinal Nail Lacquer

amorolfina

Read this leaflet carefully before you start using this medicine because it contains important information for you.

-Keep this leaflet, as 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 others even if they have the same symptoms as you, as it may harm them.

-If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What Amorolfina Viatris is and what it is used for

2. What you need to know before using Amorolfina Viatris

3. How to use Amorolfina Viatris

4. Possible side effects

5. Storage of Amorolfina Viatris

6. Contents of the pack and additional information

Amorolfina Viatris contains the active ingredient amorolfina (as hydrochloride), which belongs to a group of medicines called antifungals. It is used to eliminate a wide variety of fungi causing nail infections.

Amorolfina is used to treat fungal infections of the nails.

No use AmorolfinaViatris

• 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, remove it immediately with nail polish remover or the wipes provided in the package, and consult a doctor. The product should not be reapplied.

Seek urgent medical assistance 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

- Do not apply the lacquer to the skin around the nail.

-Avoid contact with the lacquer on the eyes, ears, and mucous membranes (e.g., the mouth or nasal passages).

-Do not inhale.

-Use impermeable gloves (water-resistant) when using organic solvents, such as paint thinner or acetone, to avoid removing the nail lacquer.

Children and Adolescents

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

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Use of AmorolfinaViatriswith Other Medications

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

Use of Other Nail Products

You can use cosmetic nail polish, but you must wait at least 10 minutes after applying amorolfina to be able to paint your nails.

Nail polish should be carefully removed before repeating the application of amorolfina.

AmorolfinaViatriscontains ethanol

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

Pregnancy and Breastfeeding

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

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

Always use this medication exactly as indicated in this leaflet or as your doctor or pharmacist has instructed 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, make sure no one else uses your kit.

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

-Before reusing amorolfina, remove the old polish from your nails or any nail polish using a cleaning wipe and, subsequently, file the nails if necessary.

-Reapply the polish as described above.

-Once dry, the polish does not change with soap and water, so you can wash your hands and feet normally.If you need to use chemicals like paint thinner or acetone, you must use rubber or impermeable gloves (water-resistant) to protect the nail polish.

-It is essential to continue using amorolfina until the infection has cleared up and healthy nails have grown back. The treatment duration is usually 6 months for hand nails and 9 to 12 months for foot nails.

Your doctor will likely check on your treatment progress 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 immediately 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 Toxicological 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 right time. When you remember, start using the product again exactly as before.

If you interrupt the treatment with Amorolfina Viatris

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

If you have any other doubts about using this medication, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

Immediately contact your doctor if you develop any of the following adverse effects:

Unknown frequency (cannot be estimated from available data)

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

Other possible adverse 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.

Unknown frequency (cannot be estimated from available data):

• Skin redness (erythema).
• Itching on the skin (pruritus).
• Contact dermatitis (skin allergy).
• Rash (urticaria) or blisters.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaram.es.By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

Do not use this medication after the expiration date that appears on the box after "CAD". 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 drains or trash. Dispose of containers and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Amorolfina Viatris

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

Appearance of Amorolfina Viatris and contents of the package

Amber glass bottle with a plastic tamper-evident cap containing a transparent colorless solution.

Package sizes:

2.5 ml, 3 ml, and 5 ml

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

Only some package sizes may be commercially available.

Marketing Authorization Holder

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Manufacturer(s) responsible:

Farmaclair

440, avenue du Général de Gaulle,

14200 Herouville Saint Clair

France

or

Creapharm Industry

29 Rue Leon Faucher

51100 Reims

France

For more information about this medication, please contact 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) with the following names:

SpainAmorolfina Viatris 50 mg/ml nail varnish medicamentoso EFG

ItalyAmorolfina Mylan Generics 5% Smalto medicato per unghie

PortugalAmorolfina Mylan

United Kingdom (Northern Ireland)Clavusimyl5% w/v medicated nail lacquer

SwedenAmorolfin Mylan 5% medicinskt nagellack

Last review date of this leaflet:April 2023.

More detailed information about this medication is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)https://www.aemps.gob.es/