Amorolfine Stada 50 mg/ml medicated nail lacquer

Spain
Brand name Amorolfine Stada 50 mg/ml medicated nail lacquer
Form nail polish, medicated
Active substance / Dosage
AMOROLFINE HYDROCHLORIDE · 6,40 Porcentaje peso/peso
Prescription type Prescription Only Medicine
ATC code
D01A D01AE D01AE16
Registration number 75031
Manufacturer Laboratorio Stada S.L.
Amorolfine Stada 50 mg/ml medicated nail lacquer nail polish, medicated

Table of Contents

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Amorolfina Stada 50 mg/ml medicated nail lacquer

Read the entire leaflet carefully before you start using this medicine, as it contains important information for you.

  • Keep this leaflet, as you may need to read it again.
  • If you have any questions, consult your doctor, pharmacist, or nurse.
  • This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, since it could harm them.
  • If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents:

  1. What Amorolfina Stada is and what it is used for
  2. What you need to know before using Amorolfina Stada
  3. How to use Amorolfina Stada
  4. Possible adverse effects
  5. How to store Amorolfina Stada
  6. Contents of the pack and other information
  7. General advice for people with fungal nail infections

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

  • Amorolfina Stada contains the active substance amorolfine. This belongs to a group of medicines called antifungals.
  • Amorolfine is used to treat mild fungal infections of the nails in adults over 18 years of age.

It should only be used if:

  • you have 1 or 2 affected nails
  • the upper half or sides of the nail are affected (see image 1).

Consult your doctor if the infection looks like the ones shown in images 2 or 3.

Three nail details with varying severity of infection: mild with green checkmark, moderate and severe with red crosses

Amorolfine is active against a wide range of fungi that can cause nail infections.

In fungal infections, the appearance of the nails can vary considerably, becoming discolored (white, yellow, or brown), thickened, or brittle.

2. What you need to know before using Amorolfina Stada

DO NOT use Amorolfina Stada

  • if you are allergic to amorolfine or to any of the other ingredients of this medicine (listed in section 6)
  • your nail does not look like image 1 above
  • your nail is damaged or moderately to severely infected (see images 2 and 3 above)
  • you have poor blood circulation in your hands or feet
  • you have pain or swelling around the nail
  • you have more than 2 infected nails in total
  • you have a weakened immune system
  • you are under 18 years of age
  • you have diabetes
  • you have dark streaks running along the nail

Do not use this medicine if any of the above apply to you. If you are unsure, tell your doctor or pharmacist before using amorolfine.

Warnings and precautions

This medicine may cause allergic reactions, some of which may be serious. If this happens, stop applying the product, immediately remove the product with nail polish remover or the cleansing wipes provided in the package, and seek medical attention. The product must not be reapplied. Seek urgent medical help if you experience any of the following symptoms:

  • difficulty breathing
  • swelling of the face, lips, tongue, or throat
  • severe skin rash

Do not apply amorolfine to the skin around the nail.

Other nail products and Amorolfina Stada

Artificial nails should not be used while using amorolfine. Cosmetic nail polish may be used, but you must wait at least 10 minutes after applying amorolfine before applying nail polish. Nail polish must be carefully removed before reapplying amorolfine.

Other medicines and Amorolfina Stada

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. You can normally use this medicine while taking other medicines.

Pregnancy and breastfeeding

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

Amorolfina Stada contains alcohol (ethanol)

This medicine contains 0.61 ml of alcohol (ethanol) in each ml. It may cause a burning sensation on damaged skin.

3. How to use Amorolfina Stada

Follow exactly the instructions for use of this medicine given by your doctor. If in doubt, consult your doctor again.

Keep a record

Before starting treatment, you should keep a record of how your nail looks:

  • Shade the area affected by the infection in 'Before treatment' on the diagram below.
  • If you have 2 affected nails, select your worst nail for this exercise.
  • Every 3 months, shade the affected area on the following diagram.
  • Continue doing this until the infected nail has completely grown out.

This will help you remember how your nail looked so that you can see your progress.

Four identical black-and-white schematic diagrams showing a cross-section of an organ with horizontal and vertical reference lines

Before treatment Three months Six months Nine months

Safe use of Amorolfina Stada

  • If the medicine comes into contact with your eyes or ears, rinse them with water and contact your doctor or pharmacist or go to the nearest hospital immediately.
  • Avoid contact of the medicine with your mouth or nasal passages (or other 'mucous membranes').
  • Do not inhale the medicine.
  • Do not allow anyone else to use the nail files from the package: this will prevent the spread of infection.
  • If you need to use chemicals such as paint thinners or turpentine after applying the medicine to your nails, you must wear rubber or other waterproof gloves. This will protect the nail polish.

How to use – first use

Step 1: Prepare your nail

  • Protect your healthy nails to prevent the infection from spreading.
  • Use a new nail file.
  • Gently file the infected areas of the nail, including the nail surface.
  • Do not use the same nail file for infected and healthy nails; this could spread the infection.

Black-and-white schematic drawing showing a medical device applied to a curved surface or body part with motion lines

Step 2: Clean your nail

  • Use one of the cleansing wipes provided (or nail polish remover).
  • Clean the nail surface.
  • Do not discard the cleansing wipe; you will need it later to clean the spatula.

Black-and-white schematic drawing showing an anatomical section of a limb with detailed internal tissues and structures

Step 3: Treat the nail

  • Dip the spatula into the nail polish bottle.
  • Do not wipe off the polish on the rim of the bottle before application.
  • Apply the polish evenly over the entire nail surface.
  • Allow it to dry: let the treated nails dry for approximately 3 minutes. Once the polish is dry, water and soap will not affect it. You may wash your hands or feet as usual. Wait at least 10 minutes before applying cosmetic nail polish.

Schematic drawing showing a syringe injecting liquid into

Step 4: Clean the spatula

  • You may use the spatula more than once.
  • It is important to clean it after each use to avoid spreading the infection.
  • Use the same cleansing wipe you used to clean your nails.
  • Do not touch the freshly treated nails with the cleansing wipe.
  • Close the nail polish bottle tightly.
  • Dispose of the cleansing wipe carefully, as it is flammable.
  • It is important to continue using the nail polish every week until the infection has cleared and healthy nails have regrown completely. This usually takes about 6 months for fingernails and 9 to 12 months for toenails. If the nail remains infected after this time, consult a doctor.
  • If you do not use the nail polish every week, the treatment may not work as intended and the fungus could become resistant to the medication.

Black-and-white schematic drawing showing the upper part of a human body with the head and shoulders in profile

How to use – after first use

Each infected nail should be treated once a week.

  • Before reapplying the nail polish, remove the old polish and any nail varnish using the cleansing wipe.
  • File the nails again if necessary.
  • Reapply the polish as described in Step 3 above.
  • Clean the spatula as described in Step 4 above.

How long to use

  • You should use the medicine once a week until the infection has cleared and healthy nails have regrown completely.
  • This usually takes about 6 months for fingernails and 9 to 12 months for toenails.
  • As the infected nail grows, you will see healthy nail growing in.
  • Nails grow slowly, so it may take 2 or 3 months before you begin to see any improvement.
  • Every 3 months of treatment:
    • If the infection has improved, continue treatment.
    • If the infection is the same or worse, consult your doctor or pharmacist. Bring this leaflet with you.

The following images show two examples of a nail at different times:

Close-up of a circular skin lesion with irregular borders and a lighter-colored, crusted center on pinkish skinClose-up of a clear skin area with a circular, depressed lesion with a yellowish center and slightly reddened borders

Before treatment After treatment

If Amorolfina Stada is accidentally swallowed

If you or anyone else has accidentally ingested the medicine, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, stating the name of the medicine and the amount ingested.

If you forget to use Amorolfina Stada

Don't worry if you forget to apply the nail polish exactly one week after the last application. When you remember, use the medicine again as before. You may use a diary to help remind you. Do not use a double dose to make up for a missed dose.

If you interrupt treatment with Amorolfina Stada

Do not stop using the medicine until your nail has improved, as the infection could return. This usually requires about 6 months for fingernails and 9 to 12 months for toenails. The images in 'How long to use' will help you understand what to look for.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

The following side effects may occur with this medicine:

Rare: may affect up to 1 in 1,000 people

  • Nail damage, discolored nails, brittle or fragile nails.

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

  • Burning sensation of the skin

Frequency not known: frequency 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)
  • Redness, itching, hives, blisters, allergic skin reaction.

Reporting of adverse effects:

If you experience any adverse effect, consult your doctor, pharmacist or nurse, 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 Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Amorolfina Stada

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

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

Do not store above 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 must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Amorolfina Stada

  • The active substance is amorolfine. Each millilitre contains 55.74 mg of amorolfine hydrochloride (equivalent to 50 mg of amorolfine).
  • The other excipients are Eudragit RL 100 (ammonium methacrylate copolymer type A), triacetin, butyl acetate, ethyl acetate and anhydrous ethanol.

Appearance of the product and contents of the container

Amorolfina Stada is a clear, colourless or pale yellow solution.

It is available in a 5 ml pack; 1 bottle with or without cleansing wipes, spatulas and/or nail files.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Laboratorio STADA, S.L.
Frederic Mompou, 5
08960 Sant Just Desvern (Barcelona)
Spain
[email protected]

Manufacturer

Chanelle Medical Unlimited Company
Dublin Road, Loughrea,
H62 FH90
Ireland

or

STADA Arzneimittel AG
Stadastrasse 2 – 18,
61118 Bad Vilbel
Germany

This medicinal product is authorised in the European Economic Area (EEA) Member States and in the United Kingdom (Northern Ireland) under the following names:

United Kingdom (Northern Ireland): Amorolfine hydrochloride 5% w/v nail lacquer
Portugal: Amorolfina Ciclum
Spain: Amorolfina Stada 50 mg/ml medicated nail lacquer

Date of the most recent revision of this leaflet: November 2020

  1. General advice for people with fungal nail infections.

You can reduce the risk of developing a fungal nail infection by:

  • keeping your hands and feet clean and dry
  • wearing well-fitting shoes made from natural materials and clean cotton socks; this allows your feet to breathe properly
  • keeping your nails short: do not share nail clippers or scissors with other people
  • not sharing towels or socks with other people: make sure you wash your towels regularly
  • not walking barefoot in public pools, showers or changing rooms. Special shower shoes are available to protect your feet
  • replacing old footwear that could be contaminated with fungi
  • treating athlete's foot as soon as possible, which will help prevent the infection spreading to the nails.

Nail salon equipment can sometimes be a source of fungal nail infections. If you regularly visit a salon, ensure that any equipment used is properly sterilised between clients.

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