Package Leaflet: Information for the User

Amorolfina Teva 50 mg/ml Nail Lacquer

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, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

• Amorolfina Teva contains the active ingredient amorolfina (in the form of chlorhydrate), which belongs to a group of medicines known as antifungals.
• Amorolfina is used to treat fungal infections of the nails.

• It eliminates a wide variety of fungi that can cause infections in the nails.

Do not use Amorolfina Teva

- if you are allergic to amorolfina or to any of the other ingredients of this medicine (listed in section 6)

Warnings and precautions

Consult your doctor or pharmacist before starting to use Amorolfina Teva:

• if you are diabetic.
• if you are being treated because you have a weakened immune system.
• if you have poor circulation in your hands and feet.
• if your nail is severely damaged or infected.
• Your doctor may advise you on how to use Amorolfina when you have any of the following conditions.

If Amorolfina Teva comes into contact with your eyes or ears, wash them immediately with water and contact your doctor, pharmacist, or nearest hospital.

Avoid letting the varnish come into contact with mucous membranes (e.g. mouth and nasal passages). Do not inhale.

Children and adolescents

There are currently no specific dosage recommendations for children due to a lack of clinical experience.

Using Amorolfina Teva with other medicines

You can use the nail varnish while taking other medicines.

Using Amorolfina Teva with other nail products

You should not use nail polish or artificial nails while using Amorolfina Teva.

When using organic solvents, you should protect yourself with impermeable gloves, as otherwise the amorolfina nail varnish will be removed.

Pregnancy, breastfeeding, and fertility:

Amorolfina should not be used during pregnancy and/or breastfeeding unless it is clearly necessary.

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

Amorolfina Teva contains ethanol

This medicine contains 482.53 mg of alcohol (ethanol) per ml. This may cause a burning sensation on damaged skin.

This product is flammable! Keep the solution away from fire or flames!

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. Consult your doctor or pharmacist if you have doubts.
Teva Amorolfina should be applied once or twice a week to the affected nail of the hand or foot exactly as indicated by your doctor.

Usage Instructions:

• Before reusing the nail polish, first remove the previous varnish from the nails with a wipe, and then file the nails if necessary.
• Apply the varnish as described above.
• Once dry, the nail varnish does not change with water and soap, so you can wash your hands and feet as usual. If you need to use chemicals such as paint thinners or nail polish remover, you should use rubber or waterproof gloves to protect the varnish from the nails.
• It is essential to continue using Teva Amorolfina until the infection has cleared up and healthy nails have grown back. This usually takes between 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 or so.

If you accidentally ingest Teva Amorolfina

If you, or anyone else, accidentally ingest the varnish, contact your doctor, pharmacist, or nearest hospital immediatelyor call the Toxicology Information Service, phone 91 562 04 20 indicating the medication and the amount ingested.

If you forget to use Teva Amorolfina

Don't 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 treatment with Teva Amorolfina

Do not stop using Teva Amorolfina before your doctor tells you to, as the infection may return.

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.

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

Fingernail discoloration, nail breakage, or separation of the nail bed.

These reactions may also be related to the onychomycosis itself.

Very Rare Adverse Effects (may affect up to 1 in 10,000 people)

Burning sensation on the skin.

Unknown Frequency (cannot be estimated from available data)

Systemic allergic reaction (a serious allergic reaction that may be associated with facial swelling, lip, tongue, or throat swelling, difficulty breathing, and/or intense skin rash).

Redness of the skin, itching, urticaria, blisters, skin allergic reaction (contact dermatitis: skin inflammation caused by contact with the medication).

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish Medication Use Human Website: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 packaging and label after CAD. The expiration date is the last day of the month indicated.
• Store below 30 °C. Protect from heat. Keep the container tightly closed and in an upright position.

This product is flammable! Keep the solution away from fire and flames!

Medicines should not be disposed of through drains or in the trash. Deposit the containers and medicines you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Amorolfina Teva

The active substance is amorolfina. Amorolfina Teva contains 50 mg/ml of the active substance amorolfina (equivalent to 55.74 mg/ml of chlorhydrate of amorolfina), the other components areEudragit RL100 (Copolímero of metacrilato of amonio type A), triacetina, acetate of butilo, acetate of etilo, anhydrous ethanol.

Appearance of the product and content of the container

Amorolfina is a transparent, colorless to pale yellow solution and is available in

2.5 ml, 3 ml and 5 ml;packaged in 1 bottle with or without cleaning wipes, spatulas and/or nail files

Some container sizes may only be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Teva Pharma S.L.U.

c/ Anabel Segura 11,

Edificio Albatros B 1st floor,

Alcobendas28108 Madrid (Spain)

Responsible for manufacturing

Chanelle Medical Unlimited Company

Dublin Road, Loughrea

H62 FH90

Ireland

Date of the last review of this leaflet:June 2023

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

You can access detailed and updated information on this medicine by scanning with your mobile phone (smartphone) the QR code included in the packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/74631/P_74631.html

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