AMOROLFINE TEVA 50mg/ml MEDICINAL NAIL POLISH

Introduction

Package Leaflet: Information for the User

Amorolfine Teva 50 mg/ml Medicinal Nail Varnish

Read the package leaflet carefully before starting to use this medicine because it contains important information for you.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

1. What is Amorolfine Teva and what is it used for
2. What you need to know before you start using Amorolfine Teva
3. How to use Amorolfine Teva
4. Possible side effects
5. Storing Amorolfine Teva
6. Contents of the pack and further information

1. What is Amorolfine Teva and what is it used for

• Amorolfine Teva contains the active substance amorolfine (as hydrochloride), which belongs to a group of medicines known as antifungals.
• Amorolfine is used to treat fungal infections of the nails.

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

2. What you need to know before you start using Amorolfine Teva

Do not use Amorolfine Teva

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

Warnings and precautions

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

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

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

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

Children and adolescents

So far, there are no specific dosage recommendations for children due to the lack of clinical experience.

Using Amorolfine Teva with other medicines

You can use the nail varnish while taking other medicines.

Using Amorolfine Teva with other nail productsYou must not use nail varnish or artificial nails during the use of Amorolfine Teva.

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

Pregnancy, breastfeeding, and fertility

Amorolfine must not be used during pregnancy and/or breastfeeding unless clearly necessary.

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Amorolfine 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!

3. How to use Amorolfine Teva

Follow exactly the instructions for administration of this medicine given by your doctor or pharmacist. Ask your doctor or pharmacist if you have any questions.

Amorolfine Teva should be applied once or twice a week to the affected nail of the hand or foot, exactly as indicated by your doctor.

Instructions for use:

• Before reusing the nail varnish, first remove the previous varnish from the nails with a wipe, and then file the nails if necessary.
• Reapply the varnish as described above.
• Once dry, the nail varnish is not affected by water and soap, so you can wash your hands and feet as usual. If you need to use chemical products such as paint thinners or turpentine, you must wear rubber or impermeable gloves (resistant to water) to protect the nail varnish.
• It is essential to continue using Amorolfine Teva until the infection has disappeared and healthy nails have regrown. This usually takes between 6 months for fingernails and 9 to 12 months for toenails.

Probably, your doctor will check how your treatment is progressing every 3 months or so.

If you accidentally ingest Amorolfine Teva

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

If you forget to use Amorolfine Teva

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 stop using Amorolfine Teva

Do not stop using Amorolfine Teva before your doctor tells you to, as the infection could come back.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

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

These reactions may also be related to the onychomycosis itself.

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

Burning sensation on the skin.

Frequency not known (cannot be estimated from the available data)

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

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

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Website: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Amorolfine Teva

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the packaging and label after EXP. The expiry date is the last day of the month stated.
• 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 via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and further information

Composition of Amorolfine Teva

The active substance is amorolfine. Amorolfine Teva contains 50 mg/ml of the active substance amorolfine (equivalent to 55.74 mg/ml of amorolfine hydrochloride), the other ingredients are Eudragit RL 100 (ammonio methacrylate copolymer type A), triacetin, butyl acetate, ethyl acetate, anhydrous ethanol.

Appearance and packaging of the product

Amorolfine is a clear, 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.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Teva Pharma S.L.U.

c/ Anabel Segura 11,

Edificio Albatros B 1ª planta,

Alcobendas 28108 Madrid (Spain)

Manufacturer

Chanelle Medical Unlimited Company

Dublin Road, Loughrea

H62 FH90

Ireland

Date of last revision of this leaflet:June 2023

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

You can access detailed and updated information about this medicine by scanning the QR code included in the packaging with your mobile phone (smartphone). 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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