Package Leaflet: Information for the user

Amorolfine Bluefish 50 mg/ml nail lacquer

Read this leaflet carefully before you start taking 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 told 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.
• • Consult your doctor if you get worse after three months.

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

No use Amorolfina Bluefish

• If you are allergic to amorolfina or any of the other components of this medication (listed in section 6).
• You are under 18 years old.

This medication may cause allergic reactions, some of which can be severe. If this occurs, stop treatment, remove the medication immediately with nail polish remover or alcohol wipes included in the packaging, and seek medical advice. The medication should not be reapplied. If you experience any of the following symptoms, seek urgent medical help if you have any of the following symptoms:

- Difficulty breathing.

- Your face, lips, tongue, or throat are swollen.

- If your skin has developed a severe rash.

Warnings and Precautions

Consult your doctor or pharmacist before starting to use Amorolfina Bluefish

After applying Amorolfina Bluefish, a gap of at least 10 minutes should be respected before applying any cosmetic nail polish. Before repeating the application of Amorolfina Bluefish, the nail polish should be carefully removed.

Considering the state of the medication (non-prescription medication to be dispensed exclusively in pharmacies), the medication should not be dispensed in the following situations, unless medical indication:

• If you have diabetes
• If you are being treated for an immune system problem (a problem that makes your body's defenses decrease)
• If you have poor circulation in your hands or feet
• If you have a history of nail injuries, skin problems 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 affected nail surface) or infected. In these cases, your doctor may prescribe an oral medication at the same time as applying the medicated nail polish 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 varnish with the eyes, ears, and mucous membranes.
• Amorolfina Bluefish is not recommended for children under 18 years old.
• Healthy nails should not be filed with the same file used for diseased nails.
• Nail polish or artificial nails should not be used during treatment with Amorolfina Bluefish.
• Patients who work with organic solvents (diluents, turpentine, etc.) should wear impermeable gloves to protect Amorolfina Bluefish on the 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 medication. If this happens, the medication should be stopped immediately and medical attention sought. The medication should be removed with a varnish thinner. The medication should not be reapplied.

Other Medications and Amorolfina Bluefish

Inform your doctor or pharmacist if you are using or have recently used any other medication.

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

Pregnancy, Lactation, and Fertility

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor before using this medication.

The experience with the use of amorolfina during pregnancy and lactation is limited. Amorolfina Bluefish should not be used during pregnancy and lactation unless clearly necessary.

This medication contains alcohol (ethanol). Ethanol is flammable, and Amorolfina Bluefish should not be used near an open flame, lit cigarettes, or certain appliances (e.g., hair dryers).

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

Before starting treatment:

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

Amorolfina Bluefish should be applied to the affected nails of the hands, one or two times a week, or to the nails of the feet once a week exactly as indicated by your doctor (usually one 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.

ATTENTION: Healthy nails should never be filed with the file used for infected nails, as the infection can spread. To prevent the infection from spreading, avoid having someone else use the files from your package.

1. Clean the nail

Use one of the provided wipes to clean the surface of the nail. Save the compress or cotton for cleaning the spatula later. Repeat steps 1 and 2 for each affected nail.

1. Take some varnish from the bottle

Dip one of the reusable spatulas into the varnish bottle. Do not clean the spatula at the edge of the bottle before application.

1. Apply the varnish

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

1. Let it dry

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

1. Clean the spatula

The provided spatulas are reusable. However, it is essential to clean them as thoroughly as possible after each treatment, using the same wipe used for nail cleaning. Avoid touching the recently treated nails with the wipe. Close the varnish bottle tightly. Carefully dispose of the wipe, as it is flammable.

Before using Amorolfina Bluefish again, remove any remaining varnish from the nails using a wipe, then file the nails again if necessary. Apply the varnish as described above.

When dry, the varnish on the nails 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 acetone, you must use rubber or other impermeable gloves to protect the varnish on your nails from the chemicals.

Average duration of treatment

The treatment should be continued without interruption until a healthy nail has grown completely and the affected areas have healed. The duration of treatment depends essentially on the intensity, location of the infection, and nail growth capacity. Generally, this translates to 6 months for hand nails and 9 to 12 months for foot nails.

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

Important

• Wait until the medicinal varnish has dried before washing your hands or feet.
• Do not use artificial nails during treatment with Amorolfina Bluefish.
• If Amorolfina Bluefish enters your eyes or ears, wash them immediately with water and contact your doctor, pharmacist, or the nearest hospital immediately.
• Avoid the varnish coming into contact with mucous membranes (e.g., mouth and nostrils). Do not inhale.
• Use impermeable gloves when using solvents or thinners (e.g., acetone) to prevent the medicinal varnish from being removed.
• Do not apply Amorolfina Bluefish to the skin around the nail. This product contains ethanol (alcohol). Improper use of Amorolfina Bluefish may cause skin irritation or dryness around the nail.
• Do not inhale the medicinal varnish.
• If you, or anyone else, accidentally ingest the varnish, contact your doctor, pharmacist, or the nearest hospital immediately.
• You can apply cosmetic nail polish based on nitrocellulose (cellulose nitrate) (see the ingredient list; most cosmetic nail polishes contain nitrocellulose). You must wait at least 10 minutes after applying Amorolfina Bluefish before painting your nails. Before repeating the application of Amorolfina Bluefish, carefully remove the cosmetic nail polish. Until a new application of Amorolfina Bluefish is made, avoid using cosmetic nail polish removers.

If you interrupt the use of Amorolfina Bluefish

It is essential to continue using Amorolfina Bluefish until the infection has cleared and healthy nails have grown. This generally takes 6 months for hand nails and 9 to 12 months for foot nails. Your doctor may check on the progress of your treatment every 3 months.

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

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

The adverse effects of this medication 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 may occur in the area near the nails.

Unknown Frequency(cannot be calculated with available data): Systemic Allergic Reaction (severe allergic reaction that may be associated with facial swelling, lip, tongue, or throat swelling, difficulty breathing, and/or severe skin rash).

Redness of the skin, itching, contact dermatitis in the area around the nail, 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 on the safety of this medication.

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

Store below 30°C.

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

Do not use this medication after the expiration date, which appears on the packaging and bottle after CAD. The expiration date is the last day of the month indicated.

Do not use this medication if you observe visible signs of deterioration.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Compositionof Amorolfina Bluefish

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

Appearance of Amorolfina Bluefish and content of the container

Amorolfina Bluefish is atransparent, colorless to pale yellow solution.

The medicated nail polish, Amorolfina Bluefish, is available in amber glass bottles of 2.5 ml or 5 ml.

Only some sizes of containers may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Bluefish Pharmaceuticals AB

P.O. Box 49013

100 28 Stockholm

Sweden

Responsible for manufacturing:

Chanelle MedicalUnlimited Company

Loughrea,

County Galway, Ireland

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

Bluefish Pharma S.L.U.,

AP 36007

2832094 Madrid, Branch 36

This medication is authorized in the Member States of the European Economic Area with the following names:

Last review date of this leaflet: June 2024

Detailed and updated information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/