Product Information for the User

Amorolfina Stada 50 mg/ml Nail Lacquer

Read this entire product information carefully before starting to use this medication, as it contains important information for you.

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

1.What is Amorolfina Stada and how is it used

2.What you need to know before starting to use Amorolfina Stada

3.How to use Amorolfina Stada

4.Possible adverse effects

5.Storage of Amorolfina Stada

6.Contents of the package and additional information

7.General advice for people withfungal infectionsof thenails.

•Amorolfina Stada contains the active ingredient amorolfina. This belongs to a group of medicines called antifungals.

•Amorolfina is used to treat mild fungal infections of the nails in adults aged 18 years and above.

It should only be used if:

-you have 1 or 2 affected nails

-the top half or the sides of the nail are affected (see image 1).

Consult your doctor if the infection resembles images 2 or 3.

Amorolfina is activeagainst awiderange of fungi that can cause nail infections.

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

Do not use Amorolfina Stada

•If you are allergic to amorolfina or any of the other components of this medication (including those listed in section 6)

•Your nail does not resemble image 1 above

•Your nail is damaged or infected moderately or severely (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 old

•You have diabetes

•You have dark streaks along the nail

Do not use this medication if any of the above applies to you. If you are unsure, inform your doctor or pharmacist before using amorolfina.

Warnings and precautions

This medication may cause allergic reactions, some of which may be severe, if this happens, stop applying the product, remove the product immediately with a nail polish remover or the cleaning wipes provided in the packaging and seek medical attention. The product should not be reapplied. You should seek urgent medical help if you experience any of the following symptoms:

•You have difficulty breathing

•Your face, lips, tongue, or throat become swollen

•Your skin develops a severe rash

Do not apply amorolfina to the skin around the nail.

Other nail products and Amorolfina Stada

You should not use artificial nails while using amorolfina. You can use cosmetic nail polish, but you should wait at least 10 minutes after applying amorolfina before painting your nails. The nail polish should be carefully removed before repeating the application of amorolfina.

Other medications and Amorolfina Stada

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication. You can use this medication normally when taking other medications.

Pregnancy and breastfeeding.

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

Amorolfina Stada contains alcohol (ethanol)

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

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

Keep a record

Before starting to use the medication, you must keep a record of how your nail looks:

•Shade the affected area 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.

•Do it until the infected nail has grown completely.

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

Before treatmentThree monthsSix monthsNine months

Safe use ofAmorolfina Stada

•If the medication 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 medication coming into contact with your mouth or nasal passages (or other 'mucous membranes').

•Do not inhale the medication.

•Do not allow anyone else to use the file from the packaging: this will stop the spread of the infection.

•If you need to use chemicals such as paint thinner or acetone when the medication has been applied to your nails, you must use rubber gloves or other impermeable material. This will protect the varnish of your nails.

How to use - first use

How to use - after thefirstuse

Each infected nail must be treated once a week.

•Before reusing the varnish, remove the old varnish and any nail polish 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 must use the medication once a week until the infection has disappeared and your healthy nails have grown back.

•This usually takes 6 months for hand nails and 9 to 12 months for foot nails.

•As the infected nail grows, you will see that it is growing 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 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:

Before treatmentAfter treatment

If you accidentally ingest Amorolfina Stada

If you or anyone else has accidentally ingested the medication, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to use Amorolfina Stada

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

If you interrupt the treatment with Amorolfina Stada

Do not stop using the medication until your nail improves, as the infection may reappear. This usually takes 6 months for hand nails and 9 to 12 months for foot nails. The images in 'How long to use' will help you understand what you are looking for.

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

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

The following secondary effects may occur with this medication:

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

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

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

•Burning sensation on the skin

Unknown frequency:the 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, urticaria, blisters, allergic reaction on the skin.

Reporting Adverse Effects:

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect that does not appear 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.

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

Do not store at a temperature above 30 °C. Protect from heat. Keep the packaging perfectly closed and in a vertical position.

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

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

Composition of Amorolfina Stada

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

Appearance of the product and contents of the package

Amorolfina Stada is a transparent, colorless, or pale yellow solution.

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

Only some package sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Responsible for manufacturing

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) with 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 polish

Last review date of this leaflet:November 2020

7. General advice for people with fungal nail infections.

You can reduce the risk of developing a fungal infection of the nails 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 pools, showers, or changing rooms. Special shower shoes are available to protect your feet,

•replace old shoes that may be contaminated with fungi

•treat athlete's foot as soon as possible, which will help stop the spread of the infection to the nails.

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

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