Package Leaflet: Information for the User

Odenil 50 mg/ml Medicinal Nail Lacquer

Amorolfine

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 similar 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.

1. What Odenil Medicinal Nail Lacquer is and what it is used for

2.What you need to know before you start using Odenil Medicinal Nail Lacquer

3. How to use Odenil Medicinal Nail Lacquer

4. Possible side effects

5. Storage of Odenil Medicinal Nail Lacquer

6. Contents of the pack and additional information

Amorolfine is used to treat fungal infections. It belongs to a group of medicines called antifungals.

This medicine is used for fungal infections of the fingernails and toenails.

Do not use Odenil nail polish medicamentoso

If you are allergic to amorolfine 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.

Do not use artificial nails during treatment.

After applying Odenil, wait at least 10 minutes before applying any cosmetic nail polish.

Before repeating the application of Odenil, 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 severe. 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 must be kept out of the sight and reach of children.

Use of Odenil nail polish medicamentoso with other medications

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 if you 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 benefit 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 machinery

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

Odenil contains alcohol (ethanol)

This medication contains 481.3 mg of alcohol (ethanol) in each ml of solution. It may cause a burning sensation on damaged skin.

Odenil contains ethanol, which is flammable and should not be used near an open flame, lit cigarettes, or certain devices (e.g., hair dryers).

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 nail polish with a hygiene habit, on 1 day of the week that you choose and maintain this routine while the treatment lasts.

The required treatment duration will depend basically on the severity and location of the infection. Generally, it will be six months for hand nails and nine to twelve months for foot nails. It is recommended to review the treatment every three months.

Application mode:

1.Before the first application of Odenil, it is essential to file as deeply as possible the affected parts of the nail (especially the surface), with one of the files included in the package.

Attention:

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

2.Clean and degrease the nail surface with one of the impregnated wipes contained in the package. Before each new application, file the infected nails and degrease them again, in order to eliminate the remaining Odenil, including cosmetic nail polish.

3.Insert one of the included spatulas into the solution. The spatula should not touch the neck of the container when being removed before application. Ensure that the solution does not drip from the outside of the container neck.

7.The spatulas can be reused, although it is essential to clean them after each treatment, using the same wipe used to clean the nails. Avoid touching the treated nails with the wipe. Dispose of the used wipe.

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 must follow each of the steps indicated above.

If you use more Odenilmedicated nail polishthan 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: 91 5620420, indicating the medication and the amount ingested.

If you forgot to useOdenilmedicated nail polish

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

If you interrupt the treatment withOdenilmedicated nail polish

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

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

Adverse reactions are rare. They may cause nail changes (e.g. nail discoloration, nail breakage, 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

Unknown frequency(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.

No special storage conditions are required.

Store in the original packaging

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.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medicines at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. By doing so, you will help protect the environment.

Odenil CompositionMedicated Nail Lacquer

• The active ingredient is amorolfine. Each milliliter of solution contains 50 milligrams of amorolfine.

• The other excipients are methacrylic acid copolymer, triacetin, butyl acetate, ethyl acetate, and ethanol at 96%.

Appearance of the product and contents of the packaging

Odenil is a clear, colorless, or almost colorless solution.

Odenil isavailable in:

Glass bottles containing 5 milliliters of solution.

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

Glass bottles containing 5 milliliters of solution and a built-in spatula in the cap

The packaging also includes 30 cleansing wipes, in individual sachets, and 30 files.

Only one of the packaging options may be commercially available.

Marketing Authorization Holder

Laboratorios Galderma, S.A.

Serrano Galvache, 56

28033 Madrid

Spain

Responsible for Manufacturing

Laboratoires Galderma

Alby sur Chéran (France)

Last review date of this leaflet:October 2017

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