Odenil 50 mg/ml medicated nail lacquer
Spain
Table of Contents
- Package leaflet: Information for the user
- Introduction
- 1. What Odenil medicated nail lacquer is and what it is used for
- 2. What you need to know before using Odenil medicated nail lacquer
- **Pregnancy and breastfeeding**
- **Driving and Use of Machinery**
- 3. How to use Odenil medicated nail lacquer
- 4. Possible adverse effects
- 5. Storage of Odenil medicated nail polish
- 6. Contents of the pack and other information
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Odenil 50 mg/ml medicated nail lacquer
Amorolfine
Read the entire 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, consult your doctor or pharmacist.
- This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms, as it may harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
Contents of the leaflet:
- What Odenil medicated nail lacquer is and what it is used for
- What you need to know before using Odenil medicated nail lacquer
- How to use Odenil medicated nail lacquer
- Possible adverse effects
- How to store Odenil medicated nail lacquer
- Contents of the pack and other information
1. What Odenil medicated nail lacquer is and what it is used for
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.
2. What you need to know before using Odenil medicated nail lacquer
Do not use Odenil medicated nail lacquer
If you are allergic to amorolfine or to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Consult your doctor or pharmacist before starting to use this medicine.
During treatment, do not use artificial nails.
After applying Odenil, wait at least 10 minutes before applying any cosmetic nail polish.
Before reapplying Odenil, any cosmetic nail polish must be carefully removed.
This medicine is for external use only. DO NOT INGEST.
Avoid contact with eyes and mucous membranes. If accidental contact with the eyes occurs, rinse thoroughly with water and consult an ophthalmologist if necessary.
Healthy nails should not be filed with the same file used on infected nails.
This medicine may cause allergic reactions, some of which may be serious. If this occurs, stop treatment immediately, remove the medicine with nail polish remover, and seek medical advice. The medicine must not be applied again.
Seek urgent medical help if you experience any of the following symptoms:
- Difficulty breathing.
- Swelling of your face, lips, tongue, or throat.
- Severe skin rash.
Children and adolescents
Use of this medicine is not recommended in children due to insufficient clinical experience. Keep this medicine out of the sight and reach of children.
Using Odenil medicated nail lacquer with other medicines
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor before using this medicine.
Pregnancy
It is unknown whether the use of this medicine is safe in pregnant women; therefore, your doctor will assess the benefit of treatment for the mother and the risk to the unborn child.
Breastfeeding
It is unknown whether it is safe to administer this medicine to women who are breastfeeding.
Driving and Use of Machinery
The influence of this medication on the ability to drive or use machinery is none or negligible.
Odenil contains alcohol (ethanol)
This medicine 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 must not be used near flames, lit cigarettes, or certain devices (e.g., hair dryers).
3. How to use Odenil medicated nail lacquer
Follow exactly the administration instructions for this nail medication provided by your doctor. If in doubt, consult your doctor or pharmacist again.
Route of administration: Topical use (for nails only; must not be applied to the surrounding skin).
Apply the solution once or twice weekly, only to the affected fingernails or toenails. Try to associate the use of the medicated nail lacquer with a regular hygiene habit, on a specific day of the week of your choice, and maintain this routine throughout the duration of treatment.
The required treatment duration will depend mainly on the severity and location of the infection. Generally, treatment lasts six months for fingernails and nine to twelve months for toenails. A review of the treatment every three months is recommended.
Instructions for application:
- Before the first application of Odenil, it is essential to file as deeply as possible the affected parts of the nail (especially the surface), using one of the files included in the package.
Caution:
Healthy nails must never be filed with the same file used for infected nails. Fungal infections are contagious. To prevent spreading infection, avoid allowing other people to use this file.
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Clean and degrease the nail surface using one of the pre-impregnated wipes provided in the package. Before each new application, re-file the infected nails and degrease them to remove any residual Odenil, including cosmetic nail polish residues.
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Dip one of the provided spatulas into the solution. When removing the spatula, ensure it does not touch the neck of the bottle. Make sure the solution does not drip down the outside of the bottle neck.
- The spatulas may be reused, but they must be cleaned after each use with the same wipe used to clean the nails. Avoid touching the treated nails with the wipe. Dispose of the used wipe.
Treatment must be continued without interruption until the parts of the nail destroyed by fungi have been replaced by new, healthy layers. Remember that the success of this treatment depends on your perseverance; you must follow each of the steps described above.
If you use more Odenil medicated nail lacquer than you should
This medicine must not be ingested. FOR EXTERNAL USE ONLY.
In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, go to a medical center, or call the Toxicology Information Service at 91 5620420, indicating the name of the medicine and the amount ingested.
If you forget to use Odenil medicated nail lacquer
Do not apply a double dose to make up for missed doses.
If you stop treatment with Odenil medicated nail lacquer
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine may produce adverse effects, although not everyone will experience them.
Adverse reactions are rare. Nail disorders may occur (e.g. nail discolouration, 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 disorder
- Nail discolouration
- Onycholysis (nail breakage)
- Onychorrhexis (brittle nails)
Very rare (may affect up to 1 in 10,000 people)
- Burning sensation of the skin
Frequency not known (cannot be estimated from available data):
- Systemic allergic reaction (a serious allergic reaction which 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 of 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 leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Odenil medicated nail polish
Keep this medicine out of the sight and reach of children.
No special storage conditions are required.
Store in the original packaging.
Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of unused medicines and their containers. This will help protect the environment.
6. Contents of the pack and other information
Composition of Odenil Nail Lacquer Medicinal
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The active substance is amorolfine. Each millilitre of solution contains 50 milligrams of amorolfine.
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The other excipients are methacrylic acid copolymer, triacetin, butyl acetate, ethyl acetate and 96% ethanol.
Appearance of the product and contents of the pack
Odenil is a clear, colourless or almost colourless solution.
Odenil is available in:
Glass bottles containing 5 millilitres of solution.
The pack also includes 30 cleansing wipes in individual sachets, as well as 10 disposable spatulas and 30 files.
Glass bottles containing 5 millilitres of solution with an integrated spatula in the cap.
The pack also includes 30 cleansing wipes in individual sachets and 30 files.
Only some of these pack sizes may be marketed.
Marketing Authorisation Holder
Laboratorios Galderma, S.A.
Serrano Galvache, 56
28033 Madrid
Spain
Manufacturer
Laboratoires Galderma
Alby sur Chéran (France)
Date of latest revision of this leaflet: October 2017
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.es/