Amorolfina teva 50mg/ml barniz de uÑas medicamentoso
Introduction
Package Leaflet: Information for the User
Amorolfina Teva 50 mg/ml 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 you, as it may harm them.
- If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
1. What is Amorolfina Teva and what is it used for
- Amorolfina Teva contains the active ingredient amorolfina (in the form of chlorhydrate), which belongs to a group of medicines known as antifungals.
- Amorolfina is used to treat fungal infections of the nails.
- It eliminates a wide variety of fungi that can cause infections in the nails.
2. What you need to know before starting to use Amorolfina Teva
Do not use Amorolfina Teva
- if you are allergic to amorolfina 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 Amorolfina Teva:
- if you are diabetic.
- if you are being treated because you have a weakened immune system.
- if you have poor circulation in your hands and feet.
- if your nail is severely damaged or infected.
- Your doctor may advise you on how to use Amorolfina when you have any of the following conditions.
If Amorolfina Teva comes into contact with your eyes or ears, wash them immediately with water and contact your doctor, pharmacist, or nearest hospital.
Avoid letting the varnish come into contact with mucous membranes (e.g. mouth and nasal passages). Do not inhale.
Children and adolescents
There are currently no specific dosage recommendations for children due to a lack of clinical experience.
Using Amorolfina Teva with other medicines
You can use the nail varnish while taking other medicines.
Using Amorolfina Teva with other nail products
You should not use nail polish or artificial nails while using Amorolfina Teva.
When using organic solvents, you should protect yourself with impermeable gloves, as otherwise the amorolfina nail varnish will be removed.
Pregnancy, breastfeeding, and fertility:
Amorolfina should not be used during pregnancy and/or breastfeeding unless it is clearly necessary.
If you are pregnant or breastfeeding, or think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Amorolfina Teva contains ethanol
This medicine contains 482.53 mg of alcohol (ethanol) per ml. This may cause a burning sensation on damaged skin.
This product is flammable! Keep the solution away from fire or flames!
3. How to use Amorolfine Teva
Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. Consult your doctor or pharmacist if you have doubts.
Teva Amorolfina should be applied once or twice a week to the affected nail of the hand or foot exactly as indicated by your doctor.
Usage Instructions:
Step 1: File the nail Before the first application, file as deeply as possible the affected parts of the nail including the surface, using one of the files provided in the package. ATTENTION: Healthy nails should never be filed with the file used for the diseased nails, it may spread the infection. To prevent spreading the infection, avoid having someone else use the files from your package. | |
Step 2: Clean the nail Use one of the cleansing wipes provided (or nail removers) to clean the surface of the nail. Repeat steps 1 and 2 for each affected nail. | |
Step 3. Extract a little varnish from the bottle Insert one of the reusable spatulas into the varnish bottle. The solution should not touch the neck of the container before application. | |
Step 4: Apply the varnish Apply the varnish uniformly over the entire surface of the nail. | |
Step 5: Clean the applicator The spatulas can be reused. However, it is essential to thoroughly clean after each treatment, using the same wipe used to clean the nails. Avoid touching the recently treated nails with the wipe. Close the varnish bottle tightly. Dispose of the wipe carefully as it is flammable. |
- Before reusing the nail polish, first remove the previous varnish from the nails with a wipe, and then file the nails if necessary.
- Apply the varnish as described above.
- Once dry, the nail varnish does not change with water and soap, so you can wash your hands and feet as usual. If you need to use chemicals such as paint thinners or nail polish remover, you should use rubber or waterproof gloves to protect the varnish from the nails.
- It is essential to continue using Teva Amorolfina until the infection has cleared up and healthy nails have grown back. This usually takes between 6 months for hand nails and 9 to 12 months for foot nails.
Your doctor will likely check on your treatment progress every 3 months or so.
If you accidentally ingest Teva Amorolfina
If you, or anyone else, accidentally ingest the varnish, contact your doctor, pharmacist, or nearest hospital immediatelyor call the Toxicology Information Service, phone 91 562 04 20 indicating the medication and the amount ingested.
If you forget to use Teva Amorolfina
Don't worry if you forget to use the varnish at the right time. When you remember, start using the product again in the same way as before.
If you interrupt treatment with Teva Amorolfina
Do not stop using Teva Amorolfina before your doctor tells you to, as the infection may return.
If you have any other doubts about using this medication, ask your doctor or pharmacist.
4. Possible Adverse Effects
Like all medications, this medication may produce adverse effects, although not all people will experience them.
Rare Adverse Effects (may affect up to 1 in 1,000 people)
Fingernail discoloration, nail breakage, or separation of the nail bed.
These reactions may also be related to the onychomycosis itself.
Very Rare Adverse Effects (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).
Redness of the skin, itching, urticaria, blisters, skin allergic reaction (contact dermatitis: skin inflammation caused by contact with the medication).
Reporting Adverse Effects
If you experience any type of adverse effect, consult your doctor, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish Medication Use Human Website:www.notificaram.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.
5. Conservation of Amorolfine Teva
- Keep this medication out of the sight and reach of children.
- Do not use this medication after the expiration date that appears on the packaging and label after CAD. The expiration date is the last day of the month indicated.
- Store below 30 °C. Protect from heat. Keep the container tightly closed and in an upright position.
This product is flammable! Keep the solution away from fire and flames!
Medicines should not be disposed of through drains or in the trash. Deposit the containers and medicines you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. By doing so, you will help protect the environment.
6. Content of the container and additional information
Composition of Amorolfina Teva
The active substance is amorolfina. Amorolfina Teva contains 50 mg/ml of the active substance amorolfina (equivalent to 55.74 mg/ml of chlorhydrate of amorolfina), the other components areEudragit RL100 (Copolímero of metacrilato of amonio type A), triacetina, acetate of butilo, acetate of etilo, anhydrous ethanol.
Appearance of the product and content of the container
Amorolfina is a transparent, colorless to pale yellow solution and is available in
2.5 ml, 3 ml and 5 ml;packaged in 1 bottle with or without cleaning wipes, spatulas and/or nail files
Some container sizes may only be commercially marketed.
Holder of the marketing authorization and responsible for manufacturing
Holder of the marketing authorization
Teva Pharma S.L.U.
c/ Anabel Segura 11,
Edificio Albatros B 1st floor,
Alcobendas28108 Madrid (Spain)
Responsible for manufacturing
Chanelle Medical Unlimited Company
Dublin Road, Loughrea
H62 FH90
Ireland
Date of the last review of this leaflet:June 2023
“Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es”
You can access detailed and updated information on this medicine by scanning with your mobile phone (smartphone) the QR code included in the packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/74631/P_74631.html
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