Amorolfine ViatriS 50 mg/ml medicated nail lacquer

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the patient

Amorolfina Viatris 50 mg/ml medicated nail lacquer

amorolfine

Read all of 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 and must not be given to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of this leaflet

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. How to store Amorolfina Viatris
6. Contents of the pack and other information

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

Amorolfina Viatris contains the active substance amorolfine (as hydrochloride), which belongs to a group of medicines called antifungals. It is used to eliminate a wide range of fungi that cause nail infections.

Amorolfine is used to treat fungal infections of the nails.

2. What you need to know before starting to use Amorolfina Viatris

Do not use Amorolfina Viatris

• 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, some of which may be severe. If this occurs, stop applying the product, immediately remove it with nail polish remover or with the wipes provided in the package, and consult a doctor. The product must not be reapplied.

Seek urgent 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 amorolfine:

• Nail polish must not be applied to the skin surrounding the nail.
• Avoid contact of the nail lacquer with eyes, ears, and mucous membranes (e.g., mouth or nostrils).
• Do not inhale.
• Wear waterproof (water-resistant) gloves when using organic solvents, such as paint thinners or turpentine, to avoid removing the nail lacquer.

Children and adolescents

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

Use of Amorolfina Viatris with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Use of other nail products

Cosmetic nail polish may be used, but you must wait at least 10 minutes after applying amorolfine before painting the nails.

The nail polish must be carefully removed before reapplying amorolfine.

Amorolfina Viatris contains ethanol

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

Pregnancy and breastfeeding

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

3. How to use Amorolfina Viatris

Follow exactly the instructions for use of this medicine provided by your doctor or pharmacist. If in doubt, please consult your doctor or pharmacist again.

Always use this medicine exactly as stated in this leaflet or as your doctor or pharmacist has instructed you. Consult your doctor or pharmacist if you are unsure.

Amorolfine should be applied to the affected fingernails or toenails once or twice a week, precisely as directed by your doctor.

Instructions for use

Do not use the nail files intended for infected nails on healthy nails, otherwise you could spread the infection. To prevent spreading the infection, make sure that no one else uses the nail files from your kit.

The spatulas provided are reusable. However, it is important to thoroughly clean them with the same wipe used to clean your nails, after completing the treatment steps. Avoid touching the freshly treated nails with the cleaning wipe. Close the nail lacquer bottle tightly. Dispose of the wipe carefully, as it is flammable.

• Before reapplying amorolfine, first remove the previous nail lacquer or any other nail polish using a cleaning wipe, and then file the nails if necessary.
• Reapply the nail lacquer as described above.
• Once dry, the nail lacquer is not affected by soap and water, so you may wash your hands and feet normally. If you need to use chemicals such as paint solvents or turpentine, you must wear rubber or other waterproof (water-resistant) gloves to protect the nail lacquer.
• It is important that you continue using amorolfine until the infection has cleared and healthy nails have regrown completely. The usual duration of treatment is 6 months for fingernails and 9 to 12 months for toenails.

Your doctor will likely check your treatment progress every 3 months.

If Amorolfina Viatris comes into contact with your eyes or ears

If amorolfine 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, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 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 amorolfine at the scheduled time. When you remember, resume using the product exactly as before.

If you interrupt treatment with Amorolfina Viatris

Do not stop treatment with amorolfine before your doctor tells you to do so, otherwise the infection may return.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

Contact your doctor immediately if you develop any of the following adverse 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, which may cause difficulty breathing or swallowing.

Other possible adverse effects:

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

Discolored, cracked, 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 of 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 leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Amorolfina Viatris

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging following "EXP". The expiry date refers to the last day of the month indicated.

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

Medicines must not be disposed of via wastewater drains or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the container and other information

Composition of Amorolfina Viatris

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

Appearance of Amorolfina Viatris and contents of the container

Amber glass bottle with a tamper-proof plastic cap containing a clear, colourless solution.

Pack sizes:

2.5 ml, 3 ml and 5 ml

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

Only certain pack sizes may be commercially available.

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

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Viatris Pharmaceuticals, S.L.
C/ General Aranaz, 86
28027 - Madrid
Spain

This medicinal product is authorized in the European Economic Area countries and in the United Kingdom (Northern Ireland) under the following names:

Spain: Amorolfina Viatris 50 mg/ml medicated nail lacquer 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 most recent revision of this leaflet: April 2023.

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