Amorolfina desgen 50 mg/ml barniz de uÑas medicamentoso
Introduction
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.
1. What is Amorolfina Desgen and what is it used for
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.
2. What you need to know before using Amorolfine Desogen
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.
3. How to Use Amorolfine Desgen
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:
- Before the first application of amorolfina, 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 diseased nails. Fungal infections are contagious. To prevent infection, avoid having someone else use that file.
- Clean and degrease the surface of the nail with one of the impregnated wipes contained in the package. Before each new application, re-file the diseased nails and degrease them, in order to eliminate the amorolfina residue, including cosmetic nail polish.
- Insert one of the spatulas provided 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 neck of the container.
- Apply amorolfina uniformly over the entire surface of the nail. Repeat steps 3 and 4 for each diseased nail. Cosmetic nail polish can be applied 10 minutes after amorolfina application.
- Clean the exterior of the container neck using the same wipe used to clean the nails.Close the container tightly immediately after use.
- Allow the solution to dry on the nails for approximately 3 minutes.
- The spatulas can be reused, but 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.
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- Water and soap do not affect the amorolfina solution. You can wash your hands and feet normally. To protect the amorolfina solution applied to the nails, you should use impermeable gloves when working with organic solvents (diluents, synthetic turpentine, petroleum, paraffin, etc.).
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.
4. Possible Adverse Effects
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.
5. Conservation of Amorolfine Desgen
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.
6. Contents of the packaging and additional information
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/
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