AMOROLFINE STADA 50 mg/ml MEDICINAL NAIL POLISH

Introduction

Package Leaflet: Information for the User

Amorolfine Stada 50 mg/ml medicated nail varnish

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

• Keep this 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 symptoms are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

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

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

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

It should only be used if:

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

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

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

In fungal nail infections, the appearance of the nails can vary considerably, and they may become discolored (white, yellow or brown), thickened or brittle.

2. What you need to know before you use Amorolfine Stada

Do not use Amorolfine Stada

• if you are allergic to amorolfine or any of the other ingredients of this medicine (listed in section 6)
• your nail does not look like the one in image 1 above
• your nail is damaged or infected to a moderate or severe degree (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 stripes along the nail

Do not use this medicine if any of the above applies to you. If you are not sure, consult your doctor or pharmacist before using amorolfine.

Warnings and precautions

This medicine can cause allergic reactions, some of which may be serious. If this happens, stop using the product, immediately remove the product with a nail varnish remover or the cleaning wipes provided in the pack, and seek medical attention. The product should not be reapplied. You should get urgent medical help if you have any of the following symptoms:

• difficulty breathing
• your face, lips, tongue or throat become swollen
• your skin develops a severe rash

Do not apply amorolfine to the skin around the nail.

Other nail products and Amorolfine Stada

Do not use artificial nails while using amorolfine. You can use cosmetic nail varnish, but you must wait at least 10 minutes after applying amorolfine before painting your nails. The nail varnish must be carefully removed before reapplying amorolfine.

Other medicines and Amorolfine Stada

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

Pregnancy and breastfeeding

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 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 Amorolfine Stada

Follow the instructions for using this medicine exactly as your doctor has told you. If you are not sure, ask your doctor again.

Keep a record

Before you start using the medicine, you should keep a record of what your nail looks like:

• Shade in the area affected by the infection in 'Before treatment' in the diagram below.
• If you have 2 infected nails, choose the worst one for this exercise.
• Every 3 months, shade in the area affected in the next diagram.
• Do this until the infected nail has grown out completely.

This will help you remember what your nail looked like so you can see your progress.

Before treatment Three months Six months Nine months

Safe use of Amorolfine Stada

• If the medicine comes into contact with your eyes or ears, wash them with water and contact your doctor or pharmacist or go to the nearest hospital immediately.
• Avoid the medicine coming into contact with your mouth or nostrils (or other 'mucous membranes').
• Do not inhale the medicine.
• Do not let anyone else use the nail files in the pack: this will stop the infection spreading.
• If you need to use chemicals such as paint thinners or solvents when you have applied the medicine to your nails, you must wear rubber or other impermeable gloves. This will protect the varnish on your nails.

How to use - first use

How to use - after the first use

Each infected nail should be treated once a week.

• Before reusing the varnish, remove the old varnish and any nail varnish with the cleaning wipe.
• File the nails again if necessary.
• Reapply the varnish 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 gone and your healthy nails have grown out.
• This usually takes 6 months for fingernails and 9 to 12 months for toenails.
• As the infected nail grows out, you will see that it grows out healthy.
• Nails grow slowly, so it may take 2 or 3 months before you start to see any improvement.
• Every 3 months of treatment:
• If the infection has improved, continue the treatment.
• If the infection is the same or worse, consult your doctor or pharmacist. Take this leaflet with you.

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

Before treatment After treatment

If you accidentally swallow Amorolfine Stada

If you or anyone else has accidentally swallowed the medicine, contact your doctor or pharmacist or call the Toxicology Information Service, telephone 91 562 04 20, stating the medicine and the amount swallowed.

If you forget to use Amorolfine Stada

Do not worry if you forget to use the nail varnish exactly one week after the last time. When you remember, use the medicine again as before. You can use a diary to remind you. Do not use a double dose to make up for a forgotten dose.

If you stop using Amorolfine Stada

Do not stop using the medicine until your nail has improved, as the infection may come back. This usually takes 6 months for fingernails and 9 to 12 months for toenails. The images in 'How long to use' will help you understand what you are looking for.

If you have any other questions about using 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.

The following side effects may happen with this medicine:

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

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

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

• Burning sensation on the skin

Frequency not known:frequency cannot be estimated from the available data

• Systemic allergic reaction (a severe allergic reaction that 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 side effects:

If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines Agency's website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Amorolfine Stada

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 pack after EXP. The expiry date is the last day of the month shown.

Do not store above 30°C. Protect from heat. Keep the pack 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. Return any unused medicine to a pharmacy. Ask your pharmacist how to dispose of medicines no longer required. This will help to protect the environment.

6. Contents of the pack and other information

Composition of Amorolfine Stada

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

Appearance and pack size

Amorolfine Stada is a clear, colorless or pale yellow solution.

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

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

info@stada.es

Manufacturer

Chanelle Medical Unlimited Company

Dublin Road, Loughrea,

H62 FH90

Ireland

or

STADA Arzneimittel AG

Stadastrasse 2 – 18,

61118 Bad Vilbel

Germany

This medicine is authorized in the Member States of the European Economic Area 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 varnish

Date of last 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 if:

• you keep your hands and feet clean and dry
• you wear well-fitting shoes made of natural materials and clean cotton socks; this will allow your feet to breathe properly
• you keep your nails short: do not share nail clippers or scissors with others
• you do not share towels or socks with others: make sure to wash your towels regularly
• you do not walk barefoot in public swimming pools, showers or changing rooms. There are special shower shoes available to protect your feet,
• you replace old footwear that may be contaminated with fungi
• you treat athlete's foot as soon as possible, which will help stop the infection spreading to your nails.

The equipment used in nail salons can sometimes be a source of fungal nail infections. If you regularly visit a salon, make sure that any equipment used is properly sterilized between uses.

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