Amorolfine Bluefish 50 mg/ml medicated nail polish

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Amorolfina Bluefish 50 mg/ml medicated nail lacquer

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

Use this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you.

• Keep this leaflet, as you may need to read it again.

If you have any questions, consult your doctor or pharmacist.

• This medicine has been prescribed for you only, and you should not give it 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 adverse effects not listed in this leaflet. See section 4.
  • Consult your doctor if your condition worsens after three months.

Contents of the leaflet

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

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

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

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

Do not use Amorolfina Bluefish

• If you are allergic to amorolfine or to any of the other ingredients of this medicine (listed in section 6).
• If you are under 18 years of age.

This medicine may cause allergic reactions, some of which may be serious. If this occurs, stop treatment immediately, remove the medicine with nail polish remover or the alcohol wipes provided in the package, and seek medical advice. The medicine must not be applied again. If you experience any of the following symptoms, you must seek urgent medical help:

• Difficulty breathing.
• Swelling of your face, lips, tongue, or throat.
• If your skin develops a severe rash.

Warnings and precautions

Talk to your doctor or pharmacist before starting to use Amorolfina Bluefish.

After applying Amorolfina Bluefish, wait at least 10 minutes before applying any cosmetic nail polish. Before reapplying Amorolfina Bluefish, any cosmetic nail polish must be carefully removed.

Given the nature of this medicine (a non-prescription medicine to be dispensed exclusively in pharmacies), the medicine should not be dispensed in the following situations, unless otherwise directed by a doctor:

• if you have diabetes
• if you are being treated for an immune system disorder (a condition that reduces your body's defenses)
• if you have poor circulation in your hands or feet
• if you have a history of nail injuries, skin conditions such as psoriasis, or other chronic skin problems, swelling, yellow nails combined with respiratory problems, nail pain, deformed nails, or other problems around the nail
• if your nail is severely damaged (more than two-thirds of the nail surface affected) or infected. In such cases, your doctor may prescribe an oral medication in addition to the medicated nail lacquer Amorolfina Bluefish.
• if you are pregnant or breastfeeding
• if you have nail dystrophy and/or destruction of the nail plate.

Special recommendations

• Avoid contact of the nail lacquer with eyes, ears, and mucous membranes.
• Amorolfina Bluefish is not recommended for children under 18 years of age.
• Healthy nails should not be filed with the same file used on infected nails.
• Do not use nail polish or artificial nails during treatment with Amorolfina Bluefish.
• Patients who work with organic solvents (thinners, turpentine, etc.) should wear waterproof gloves to protect the Amorolfina Bluefish coating on their nails.
• Amorolfina Bluefish should not be applied to the skin around the nail. There is a possibility of a local or systemic allergic reaction after using this medicine. If this occurs, treatment must be stopped immediately and medical attention sought. The medicine should be removed with a nail polish remover. The medicine must not be reapplied.

Other medicines and Amorolfina Bluefish

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

There are no studies on the interaction of Amorolfina Bluefish with other medicines. Inform your doctor or pharmacist if you notice any adverse effects.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor before using this medicine.

Experience with the use of amorolfine during pregnancy and breastfeeding is limited. Amorolfina Bluefish should not be used during pregnancy or breastfeeding unless clearly necessary.

This medicine contains alcohol (ethanol). Ethanol is flammable, and Amorolfina Bluefish must not be used near open flames, lit cigarettes, or certain devices (e.g., hair dryers).

3. How to use Amorolfine Bluefish

Follow exactly the instructions for using this medicine as given by your doctor. If you are unsure, consult your doctor or pharmacist again.

Before starting treatment:

In the diagram below, shade the area of the nail affected by fungal infection. This will help you remember how the nail originally looked when your treatment is reviewed. Every three months, shade the affected area again until the infected nail has completely grown out. If more than one nail is affected, select the most severely affected nail for this exercise. Bring this leaflet to your doctor or pharmacist when your treatment is reviewed to inform them about the progress of your treatment so far.

Amorolfine Bluefish should be applied to affected fingernails once or twice weekly, or to toenails once a week, exactly as directed by your doctor (normally once weekly application is sufficient).

1. File the nail

File as deeply as possible the affected parts of the nail, including the surface, using one of the files provided in the package.

WARNING: Healthy nails must never be filed with the file used for infected nails, as this may spread the infection. To prevent spreading the infection, do not allow anyone else to use the files from your package.

2. Clean the nail

Use one of the wipes provided to clean the nail surface. Keep the wipe or cotton pad to clean the spatula later. Repeat steps 1 and 2 for each affected nail.

3. Take some of the nail lacquer from the bottle

Dip one of the reusable spatulas into the nail lacquer bottle. Do not wipe the spatula against the rim of the bottle before application.

4. Apply the nail lacquer

Apply the lacquer evenly over the entire nail surface. Clean the reusable spatula between each application from one nail to another to avoid contaminating the lacquer. Repeat steps 3 and 4 for each affected nail. Close the bottle immediately after each application.

5. Let dry

Allow the treated nail(s) to dry for approximately 3 minutes.

6. Clean the spatula

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

Before using Amorolfine Bluefish again, first remove any remaining lacquer from the nails using a wipe, then re-file the nails if necessary. Reapply the lacquer as described above.

Once dry, the nail lacquer will not be affected by soap or water, so you may wash your hands and feet as usual. If you need to use chemicals such as paint thinners or turpentine, you must wear rubber or other waterproof gloves to protect the nail lacquer on your fingernails.

Average duration of treatment

Treatment should be continued without interruption until a healthy nail has completely grown out and the affected areas have healed. The duration of treatment essentially depends on the severity and location of the infection, as well as the nail's growth rate. Generally, this means about 6 months for fingernails and 9 to 12 months for toenails.

If there is no improvement after 3 months of treatment, you should consult your doctor.

Important

• Wait until the medicated nail lacquer has dried completely before washing your hands or feet.
• Do not use artificial nails during treatment with Amorolfine Bluefish.
• If Amorolfine Bluefish gets into your eyes or ears, rinse immediately with water and contact your doctor, pharmacist, or nearest hospital immediately.
• Avoid contact of the lacquer with mucous membranes (e.g., mouth and nostrils). Do not inhale.
• Wear waterproof gloves when using solvents or thinners (e.g., turpentine) to prevent removal of the medicated nail lacquer.
• Do not apply Amorolfine Bluefish to the skin around the nail. This product contains ethanol (alcohol). Incorrect use of Amorolfine Bluefish may cause irritation or dryness of the skin around the nail.
• Do not inhale the medicated nail lacquer.
• If you or anyone else accidentally swallows the nail lacquer, contact your doctor, pharmacist, or nearest hospital immediately.
• Cosmetic nail polishes based on nitrocellulose (cellulose nitrate) may be applied (check the ingredient list; most cosmetic nail polishes contain nitrocellulose). You must wait at least 10 minutes after applying Amorolfine Bluefish before applying cosmetic nail polish. Before reapplying Amorolfine Bluefish, carefully remove the cosmetic nail polish. Until the next application of Amorolfine Bluefish, avoid using cosmetic nail polish removers.

If you stop using Amorolfine Bluefish

It is important to continue using Amorolfine Bluefish until the infection has cleared and healthy nails have fully grown out. This usually takes about 6 months for fingernails and 9 to 12 months for toenails. Your doctor will likely review your treatment progress every 3 months.

If you have any questions about using this product, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

The adverse effects of this medicine are rare or very rare.

Rare adverse effects (may affect up to 1 in 1,000 people): damaged, discolored, fragile or brittle nails.

Very rare adverse effects (may affect up to 1 in 10,000 people): a burning sensation around the nails may occur.

Frequency not known (cannot be estimated from the available data): Systemic allergic reaction (a severe allergic reaction which may be associated with swelling of the face, lips, tongue or throat, difficulty breathing and/or severe skin rash).

Skin redness, itching, contact dermatitis in the area around the nail, hives 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 via 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 Bluefish

Keep this medicine out of sight and reach of children.

Store below 30°C.

Protect from heat. Keep the bottle tightly closed and in an upright position.

Do not use this medicine after the expiry date, which is stated on the packaging and bottle after EXP. The expiry date refers to the last day of the month indicated.

Do not use this medicine if you notice any visible signs of deterioration.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the container and other information

Composition of Amorolfine Bluefish

• The active substance is amorolfine as hydrochloride.
• The other ingredients are: ammonium methacrylate copolymer (type A), triacetin, n-butyl acetate, ethyl acetate, anhydrous ethanol.

Appearance of Amorolfine Bluefish and contents of the container

Amorolfine Bluefish is a clear, colourless to pale yellow solution.

The medicated nail lacquer, Amorolfine Bluefish, is available in 2.5 ml or 5 ml amber glass bottles.

Only some pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Bluefish Pharmaceuticals AB

P.O. Box 49013

100 28 Stockholm

Sweden

Manufacturer:

Chanelle Medical Unlimited Company

Loughrea,

County Galway, Ireland

Further information about this medicinal product can be obtained from the local representative of the Marketing Authorisation Holder:

Bluefish Pharma S.L.U.,

P.O. Box 36007

2832094 Madrid, Branch 36

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

Date of the most recent review of this leaflet: June 2024

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicinal Products and Medical Devices (AEMPS) http://www.aemps.gob.es/