Package Leaflet: Information for the User

Amorolfina Desgen 50 mg/ml Medicinal 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 it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Amorolfina is used to treat fungal infections. It belongs to a group of medications known as antifungals. This medication is used for fungal infections of the fingernails and toenails.

No use Amorolfina Desgen

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

Warnings and Precautions

Consult your doctor or pharmacist before starting to use this medication.

During treatment, do not use artificial nails.

After applying amorolfina, a gap of at least 10 minutes should be respected before applying any cosmetic nail polish.

Before repeating the application of amorolfina, the cosmetic nail polish must be carefully removed.

This medication is only for external use. DO NOT INGEST.

Avoid contact with eyes and mucous membranes. If accidental contact with the eyes occurs, rinse with abundant water and consult an ophthalmologist if necessary.

Healthy nails should not be filed with the same file used on diseased nails.

This medication may cause allergic reactions, some of which may be serious. If this occurs, discontinue treatment, immediately remove the medication with a nail polish remover, and seek medical advice. The medication should not be reapplied.

You must seek urgent medical help if you experience any of the following symptoms:

• Difficulty breathing.
• Your face, lips, tongue, or throat are swollen.
• Your skin has developed a severe rash.

Children and Adolescents

This medication is not recommended for use in children due to insufficient clinical experience. The medication should be kept out of the sight and reach of children.

Other Medications and Amorolfina Desgen

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Pregnancy and Breastfeeding

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

Pregnancy

The safety of using this medication in pregnant women is unknown, so your doctor will evaluate the benefits of treatment for the mother and the risk to the child.

Breastfeeding

The safety of applying this medication to breastfeeding women is unknown.

Driving and Operating Machines

The influence of this medication on the ability to drive or operate machines is negligible or insignificant.

Follow exactly the administration instructions for this nail medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Administration form: topical use (only for use on nails, do not apply to the skin around the nails).

Apply the solution 1 or 2 times a week, only on the affected nails of the hands or feet. Try to associate the use of the medicated varnish with a hygiene habit, on 1 day of the week that you choose and maintain this routine while the treatment lasts.

The required duration of the treatment will depend basically on the severity and location of the infection. Generally, it will be 6 months on the hands and 9 to 12 months on the feet. A treatment review is recommended every 3 months.

Mode of application:

Attention:

Healthy nails should never be filed with the file used for diseased nails. Fungal infections are contagious. To prevent infection, avoid having someone else use that file.

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The treatment must be continued without interruption until the parts of the nail destroyed by the fungus are replaced by new and healthy layers. Remember that the success of this treatment depends on your perseverance, and you should follow each of the steps indicated above.

If you use more Amorolfina Desgen than you should

This medication should not be ingested. IT IS ONLY FOR EXTERNAL USE.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, or go to a medical center, or call the Toxicological Information Service, phone: 915620420, indicating the medication and the amount ingested.

If you forgot to use Amorolfina Desgen

Do not apply a double dose to compensate for the missed doses.

If you interrupt the treatment with Amorolfina Desgen

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

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

Adverse reactions are rare. They may cause nail changes (e.g., nail discoloration, nail breakage, and brittle nails). These reactions may also be related to the onychomycosis itself.

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

• Nail alteration,
• Nail discoloration,
• Onycholysis (nail breakage)
• Onychorrhexis (brittle nails).

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

• Burning sensation on the skin

Frequency not known (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).
• Erythema, pruritus, contact dermatitis, urticaria, and blisters.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed 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 indicated on the packaging after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

This medication should be used within 9 months after opening.

Medications should not be disposed of through drains or in the trash. Dispose of 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 packaging and medications you no longer need.This will help protect the environment.

Composition Amorolfina Desgen

• The active ingredient is amorolfina. Each milliliter of solution contains 50 mg of amorolfina (as chlorhydrate).
• The other excipients are cpolymethacrylic acid type A, triacetin, butyl acetate, ethyl acetate, and anhydrous ethanol.

Appearance of the product and contents of the packaging

Amorolfina Desgen is a clear, colorless, or almost colorless solution.

Amorolfina Desgen is available in glass vials containing 5 ml of solution.

The packaging also includes 30 cleansing wipes, in individual sachets, as well as 10 disposable spatulas and 30 files.

Holder of the marketing authorization

Generfarma S.L.

Isaac Peral 6, Technological Park

Paterna 46980

Valencia - Spain

Responsible for manufacturing

Farmaclair

440 Avenue du Général de Gaulle

14200 Hérouville Saint Clair - France

or

Creapharm Industry

29 rue Léon Faucher

51100 Reims - France

Last review date of this leaflet: November 2021

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