Amorolfine Teva 50 mg/ml medicated nail lacquer
Spain
Table of Contents
- Package leaflet: Information for the user
- Introduction
- 1. What Amorolfina Teva is and what it is used for
- 2. What you need to know before starting to use Amorolfine Teva
- 3. How to use Amorolfina Teva
- 4. Possible adverse effects
- 5. Storage of Amorolfina Teva
- 6. Contents of the pack and other information
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Amorolfina Teva 50 mg/ml medicated nail lacquer
Read all of 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, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
- If you experience any adverse reactions, talk to your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.
Contents of the leaflet
- What Amorolfina Teva is and what it is used for
- What you need to know before using Amorolfina Teva
- How to use Amorolfina Teva
- Possible adverse effects
- How to store Amorolfina Teva
- Contents of the pack and other information
1. What Amorolfina Teva is and what it is used for
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Amorolfina Teva contains the active substance amorolfine (in the form of hydrochloride), which belongs to a group of medicines known as antifungals.
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Amorolfina is used to treat fungal infections of the nails.
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It eliminates a wide range of fungi that can cause infections in the nails.
2. What you need to know before starting to use Amorolfine Teva
Do not use amorolfine Teva
- if you are allergic to amorolfine or to any of the other ingredients of this medicine (listed in section 6)
Warnings and precautions
Talk to your doctor or pharmacist before starting to use Amorolfine Teva:
- if you are diabetic.
- if you are receiving treatment because you have a weakened immune system.
- if you have poor circulation in your hands and feet.
- if the nail is severely damaged or infected.
- Your doctor may advise you on how to use Amorolfine if you have any of the conditions listed above.
If Amorolfine Teva comes into contact with your eyes or ears, rinse immediately with water and contact your doctor, pharmacist, or nearest hospital.
Avoid contact of the nail lacquer with mucous membranes (e.g. mouth and nasal passages). Do not inhale.
Children and adolescents
To date, no specific dosage recommendations can be given for children due to lack of clinical experience.
Using Amorolfine Teva with other medicines
You may use the nail lacquer while taking other medicines.
Using Amorolfine Teva with other nail products
Do not use nail polish or artificial nails during treatment with Amorolfine Teva.
When using organic solvents, protect yourself with waterproof gloves, as otherwise amorolfine nail lacquer will be removed.
Pregnancy, breast-feeding and fertility:
Amorolfine should not be used during pregnancy and/or breast-feeding unless clearly necessary.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Amorolfine 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 Amorolfina Teva
Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. Consult your doctor or pharmacist if you have any doubts. Amorolfina Teva should be applied once or twice a week to the affected fingernail or toenail exactly as directed by your physician.
Instructions for use:
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. WARNING: Healthy nails should never be filed with the file used for infected nails, as this may spread the infection. To prevent spreading the infection, do not allow anyone else to use the files from your package. |
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Step 2: Clean the nail Use one of the cleansing wipes provided (or nail polish remover) to clean the nail surface. Repeat steps 1 and 2 for each affected nail. |
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Step 3: Extract some nail polish from the bottle Insert one of the reusable spatulas into the nail polish bottle. The solution must not touch the neck of the container before application. |
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Step 4: Apply the nail polish Apply the nail polish evenly over the entire nail surface. Repeat this step for each affected nail. Allow the treated nail(s) to dry for about 3 minutes. |
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Step 5: Clean the applicator The spatulas can be reused. However, thorough cleaning after each treatment is important, using the same wipe used to clean the nails. Avoid touching the freshly treated nails with the wipe. Close the nail polish bottle tightly. Dispose of the wipe carefully as it is flammable. |
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- Before reapplying the nail lacquer, first remove the previous coat from the nails using a wipe, and then file the nails if necessary.
- Reapply the lacquer as described above.
- Once dry, the nail lacquer is not affected by water and soap, so you may wash your hands and feet as usual. If you need to use chemicals such as paint thinners, turpentine, or others, you should wear rubber or waterproof (water-resistant) gloves to protect the nail lacquer.
- It is important to continue using Amorolfina Teva until the infection has cleared and healthy nails have completely regrown. This usually takes about 6 months for fingernails and 9 to 12 months for toenails.
Your doctor will likely review your treatment progress approximately every 3 months.
If you accidentally ingest Amorolfina Teva
If you or anyone else accidentally ingests the nail lacquer, contact your doctor, pharmacist, or nearest hospital immediately, or call the Toxicology Information Service at 91 562 04 20, stating the name of the medicine and the amount ingested.
If you forget to use Amorolfina Teva
Do not worry if you forget to apply the lacquer at the scheduled time. When you remember, resume using the product in the same manner as before.
If you interrupt treatment with Amorolfina Teva
Do not stop using Amorolfina Teva before your doctor advises you to do so, as the infection may return.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Rare adverse effects (may affect up to 1 in 1,000 people)
Discoloration of the nail, nail breakage, or separation of the nail from the nail bed.
These reactions may also be related to the underlying onychomycosis itself.
Very rare adverse effects (may affect up to 1 in 10,000 people)
Sensation of burning on the skin.
Frequency not known (cannot be estimated from available data)
Systemic allergic reaction (a serious allergic reaction which may involve swelling of the face, lips, tongue or throat, difficulty breathing, and/or severe skin rash).
Redness of the skin, itching, urticaria, blisters, allergic skin reaction (contact dermatitis: inflammation of the skin caused by contact with the medicine).
Reporting of 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 leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines website: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Amorolfina Teva
- Keep this medicine out of the sight and reach of children.
- Do not use this medicine after the expiry date stated on the container and label after EXP. The expiry date refers to 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 must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of unused containers and medicines. This will help protect the environment.
6. Contents of the pack and other information
Composition of Amorolfina Teva
The active substance is amorolfine. Amorolfina Teva contains 50 mg/ml of the active substance amorolfine (equivalent to 55.74 mg/ml of amorolfine hydrochloride). The other components are Eudragit RL 100 (Ammonio methacrylate copolymer type A), triacetin, butyl acetate, ethyl acetate, and anhydrous ethanol.
Appearance of the medicine and contents of the pack
Amorolfina is a clear, colourless to pale yellow solution and is available in:
2.5 ml, 3 ml and 5 ml; packed in 1 bottle with or without cleaning wipes, spatulas and/or nail files.
Only certain pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Teva Pharma S.L.U.
c/ Anabel Segura 11,
Edificio Albatros B, 1st floor,
Alcobendas 28108 Madrid (Spain)
Manufacturer
Chanelle Medical Unlimited Company
Dublin Road, Loughrea
H62 FH90
Ireland
Date of the most recent revision of this leaflet: June 2023
“Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es”
You can access detailed and up-to-date information about this medicine by scanning the QR code included on the packaging with your mobile phone (smartphone). 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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