ODENIL 50 mg/ml MEDICINAL NAIL POLISH

Introduction

Package Leaflet: Information for the User

Odenil 50 mg/ml Medicinal Nail Varnish

Amorolfine

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

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

Contents of the Package Leaflet:

1. What Odenil Medicinal Nail Varnish is and what it is used for
2. What you need to know before using Odenil Medicinal Nail Varnish
3. How to use Odenil Medicinal Nail Varnish
4. Possible side effects
5. Storage of Odenil Medicinal Nail Varnish
6. Package Contents and Additional Information

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

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

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

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

Do not use Odenil Medicinal Nail Varnish

If you are allergic to amorolfine or any of the other ingredients 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 Odenil, wait at least 10 minutes before applying any cosmetic nail polish.

Before reapplying Odenil, carefully remove any cosmetic nail polish.

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

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

Healthy nails should not be filed with the same file used for infected nails.

This medication may cause allergic reactions, some of which can 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 should seek urgent medical attention 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

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

Using Odenil Medicinal Nail Varnish with Other Medications

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

Pregnancy and Breastfeeding

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

Pregnancy

It is unknown whether the use of this medication is safe in pregnant women; therefore, your doctor will assess the benefit of treatment for the mother and the risk to the child.

Breastfeeding

It is unknown whether the application of this medication is safe in breastfeeding women.

Driving and Using Machines

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

Odenil contains alcohol (ethanol)

This medication contains 481.3 mg of alcohol (ethanol) per milliliter 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).

3. How to use Odenil Medicinal Nail Varnish

Follow your doctor's instructions for using this medication exactly. If you are unsure, consult your doctor or pharmacist again.

Method of administration: cutaneous use (only for use on nails, not to be applied to the surrounding skin).

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

The required duration of treatment will depend mainly on the severity and location of the infection. It is usually 6 months for fingernails and 9 to 12 months for toenails. A review of the treatment is recommended every 3 months.

Method of Application:

1. Before the first application of Odenil, it is essential to file the affected parts of the nail (especially the surface) as deeply as possible, using 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 letting another person use the file.

1. Clean and degrease the nail surface with one of the impregnated wipes contained in the package. Before each new application, refile the infected nails and degrease them, in order to remove any remaining Odenil, including cosmetic nail polish.

1. The spatulas can be reused, although it is important to clean them after each treatment, using the same wipe used to clean the nails. Avoid touching the nails treated with Odenil with the wipe. Discard the used wipe.

The treatment should 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 Odenil Medicinal Nail Varnish than you should

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, or go to a medical center, or call the Toxicology Information Service, phone: 91 5620420, indicating the medication and the amount ingested.

If you forget to use Odenil Medicinal Nail Varnish

Do not apply a double dose to make up for forgotten doses.

If you interrupt treatment with Odenil Medicinal Nail Varnish

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

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Adverse reactions are rare. They may include alterations to the nail (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,
• Onychoclasis (nail breakage)
• Onychorexis (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 swelling of the face, lips, tongue, or throat, difficulty breathing, and/or severe skin rash).
• Erythema, itching, contact dermatitis, urticaria, and blisters.

Reporting Side Effects

If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this package leaflet. You can also report them directly through the Spanish Medication Monitoring System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Odenil Medicinal Nail Varnish

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 package after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medication in the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package Contents and Additional Information

Odenil Medicinal Nail Varnish Composition

• 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 96% ethanol.

Appearance of the Product and Package Contents

Odenil is a clear, colorless or almost colorless solution.

Odenil is available in:

Glass bottles containing 5 milliliters of solution.

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

In glass bottles containing 5 milliliters of solution and a spatula integrated into the cap

The package also includes 30 cleaning wipes, in individual sachets, and 30 files.

Only some of the packaging options may be marketed.

Marketing Authorization Holder

Laboratorios Galderma, S.A.

Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Laboratoires Galderma

Alby sur Chéran (France)

Date of Last Revision of this Package Leaflet:October 2017

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.es/