AMOROLFINE ISDIN 50mg/ml MEDICINAL NAIL POLISH

2. What you need to know before using Amorolfina Isdin

Do not use Amorolfina Isdin if you are

• allergic (hypersensitive) 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 occurs, discontinue treatment, immediately remove the product with nail polish remover or the cleaning wipes included in the package, and seek medical advice. The medication should not be reapplied.

You should seek urgent medical attention if you experience any of the following symptoms:

• difficulty breathing
• your face, lips, tongue, or throat are swollen
• you have a severe skin rash.

Consult your doctor or pharmacist before starting to use Amorolfina Isdin

• The varnish should not be applied to the skin around the nails.

• avoid getting the varnish into contact with mucous membranes (e.g., mouth and nasal openings). Do not inhale.

Using Amorolfina Isdin with other medications

You can use the nail varnish while taking other medications.

Using other nail products

Do not use false nails while using Amorolfina Isdin.

You can use a cosmetic nail polish or varnish, but you should wait at least 10 minutes after applying Amorolfina Isdin before painting your nails.

The nail polish or varnish should be carefully removed before reapplying Amorolfina Isdin.

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.

3. How to use Amorolfina Isdin

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

Amorolfina Isdin should be applied to the nails of the hand or foot once or twice a week, exactly as indicated by your doctor.

Instructions for use:

• Before using the nail varnish again, first remove any remaining varnish and cosmetic nail polish or varnish from your nails using a wipe, then file your nails again if necessary.
• Reapply the varnish as described above.
• When dry, the nail varnish will not be affected by soap or water, so you can wash your hands and feet as usual. If you need to use chemicals, such as paint thinners or solvents, you should wear rubber or other waterproof gloves to protect the nail varnish from the hands.
• It is essential to continue using Amorolfina Isdin until the infection has disappeared and healthy nails have grown back. This usually takes 6 months for fingernails and 9 to 12 months for toenails.

Your doctor will probably check on your treatment progress every 3 months or so.

If you accidentally ingest Amorolfina Isdin

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

If you forget to use Amorolfina Isdin

Do not worry if you forget to use the varnish at the right time. When you remember, start using the product again, in the same way as before.

If you interrupt the use of Amorolfina Isdin

Do not interrupt the use of Amorolfina Isdin before your doctor indicates it or the infection may return. If you have any other doubts about using this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, Amorolfina Isdin can cause side effects, although not everyone will experience them.

Stop using and seek immediate medical attention if you experience any of the following:

• Systemic allergic reaction (a severe allergic reaction that may be associated with swelling of the face, lips, tongue, or throat, difficulty breathing, and/or a severe skin rash).

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

Nail injury, changes in nail color, fragile or brittle nails.

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

Burning sensation.

Frequency not known: frequency that cannot be estimated from the available data

Redness, itching, hives, blisters, and skin allergic reaction.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this prospectus. You can also report them directly through the Spanish Medicines Surveillance System for Human Use: https://www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Amorolfina ISDIN

• Keep this medication out of the sight and reach of children.
• Do not use this medication after the expiration date stated on the package. The expiration date is the last day of the month indicated.
• Store below 30°C. Protect from heat. Keep the bottle tightly closed and in a vertical position.

This product is flammable!

Keep the solution away from fire and flames!

Medications should not be disposed of through wastewater or household waste. Deposit the packages and medications you no longer need at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packages and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

What Amorolfina Isdin contains

The active ingredient is amorolfina. Each ml of Amorolfina Isdin contains 50 mg of amorolfina (equivalent to 55.74 mg/ml of amorolfina hydrochloride).

The other components are Eudragit RL 100 (ammonio methacrylate copolymer A), triacetin, butyl acetate, ethyl acetate, anhydrous ethanol.

Appearance of Amorolfina Isdin and package contents

Amorolfina Isdin is a clear, colorless to pale yellow solution.

It is available in packages with 1 bottle of 2.5 ml, 3 ml, and 5 ml; it also contains cleaning wipes, spatulas, and nail files.

Amorolfina Isdin is also available in packages of 7.5 ml (1 bottle of 5 ml and 1 bottle of 2.5 ml) and 10 ml (2 bottles of 5 ml); it also contains cleaning wipes, spatulas, and nail files.

Not all package sizes may be marketed.

Marketing authorization holder and manufacturer

The marketing authorization holder is Isdin SA, Provençals 33, 08019 Barcelona, Spain.

The manufacturer is Chanelle Medical Unlimited Company, Loughrea, Co. Galway, Ireland.

This medication is authorized in the EEA member states under the following names:

This prospectus was approved in12/2018.

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS).

http://www.aemps.gob.es.