Amorolfine ISDIN 50 mg/ml medicated nail lacquer
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Amorolfina Isdin 50 mg/ml medicated nail lacquer
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 Amorolfina Isdin is and what it is used for
- What you need to know before using Amorolfina Isdin
- How to use Amorolfina Isdin
- Possible adverse effects
- How to store Amorolfina Isdin
- Contents of the pack and other information
1. What Amorolfina Isdin is and what it is used for
- Amorolfina Isdin is used to treat fungal infections of the nails.
- Amorolfina Isdin contains amorolfine (as hydrochloride) as the active substance, which belongs to a group of medicines known as antifungals.
- It eliminates a wide range of fungi that can cause nail infections.
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2. What you need to know before using Amorolfina Isdin
Do not use Amorolfina Isdin if:
- you are allergic (hypersensitive) to amorolfine or to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
This medicine may cause allergic reactions, some of which may be serious. If this occurs, stop treatment immediately, remove the product promptly using nail polish remover or the cleansing wipes provided in the package, 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 the face, lips, tongue, or throat
- severe skin rash
Consult your doctor or pharmacist before starting to use Amorolfina Isdin:
- the nail lacquer must not be applied to the skin around the nails
- if you have diabetes
- if you are receiving treatment for a weakened immune system
- if you have poor circulation in the hands and feet
- if your nails are severely damaged or infected
- if Amorolfina Isdin gets into your eyes or ears, rinse immediately with water and contact your doctor, pharmacist, or nearest hospital right away
- avoid contact of the lacquer with mucous membranes (e.g. mouth and nasal passages)
- do not inhale the product
Use of Amorolfina Isdin with other medicines
You may use the nail lacquer while taking other medicines.
Use of other nail products
Do not use artificial nails while using Amorolfina Isdin.
You may use cosmetic nail polish or nail lacquer, but you must wait at least 10 minutes after applying Amorolfina Isdin before painting your nails.
Cosmetic nail polish or lacquer must be carefully removed before reapplying Amorolfina Isdin.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
3. How to use Amorolfina Isdin
Follow exactly the administration instructions for this medicine as indicated by your doctor.<0> If in doubt, consult your doctor or pharmacist<0>.
Amorolfina Isdin should be applied to the fingernails or toenails once or twice a week, exactly as directed by your doctor.<0>
Instructions for use: <0>
{>Step 1 File the nail <0} {>Before the first application, file as much as possible the affected nail areas, including the nail surfaces, using the nail file provided.<0} CAUTION:<0} {0> Do not use nail files that have been used on infected nails on healthy nails, as this may spread the infection.<0} {0> To prevent spreading the infection, ensure that no one else uses the files from your package.<0} |
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Step 2: <0} {0> Clean the nail <0} Use one of the wipes provided (or a nail polish remover) to clean the nail surface.<0} Repeat steps 1 and 2 for each affected nail.<0} |
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Step 3: <0} {0{>Take some varnish from the bottle <0} {00{>Dip the spatula into the nail lacquer bottle.<0} {0>.<}0{>Do not wipe off the lacquer from the rim of the bottle before application.<0} |
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Step 4: <0} {0> Apply the varnish <0} Apply the varnish evenly over the entire surface of the nail. <0} Repeat this step for each affected nail.<0} Allow the treated nail(s) to dry for approximately 3 minutes.<0} Wait at least 10 minutes before applying cosmetic nail polish or lacquer. |
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Step 5: <0} {0> Clean the spatula <0} {0> {>The spatulas provided are reusable.<0} {0> However, it is important to clean them as thoroughly as possible after each treatment, using the same wipe used to clean the nails.<0} {0> {>Avoid touching newly treated nails with the wipe.<0} {0> Close the varnish bottle tightly.<0} {0> Dispose of the wipe carefully as it is flammable.<0} |
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- {>Before reapplying the nail polish, first remove any residue of the previous polish and any cosmetic nail varnish or lacquer from your nails using a wipe, then file the nails again if necessary.<0}
- Reapply the nail polish as described above.<0}
- {Once dry, the nail polish will not be affected by soap or water, so you can wash your hands and feet as usual.<0} {0> If you need to handle chemicals, such as paint thinners or turpentine, you should wear rubber or other waterproof (water-resistant) gloves to protect the nail polish on your hands.<0}
- {0> It is important to continue using Amorolfina Isdin until the infection has cleared and healthy nails have regrown.<0} {0> Treatment usually lasts 6 months for fingernails and 9 to 12 months for toenails.<0}
{0> Your doctor will likely check your treatment progress approximately every 3 months.<0}
{0> If Amorolfina Isdin is accidentally ingested <0}
{If accidentally swallowed, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medication and the amount ingested.<0}
If you forget to use Amorolfina Isdin <0}
Do not worry if you forget to apply the nail polish at the scheduled time.<0} {When you remember, resume using the product as before.<0}
If you stop using Amorolfina Isdin <0}
{>Do not discontinue using Amorolfina Isdin before your doctor advises you to do so, as the infection may return.<0} {0If you have any further questions about using this product, consult your doctor or pharmacist.<0}
4. Possible adverse effects
Like all medicines, Amorolfina Isdin may cause adverse effects, although not everyone will experience them.
Stop using the product and seek immediate medical attention if you experience any of the following:
- Systemic allergic reaction (a severe allergic reaction which may involve swelling of the face, lips, tongue or throat, difficulty breathing and/or a severe skin rash <0>
Rare (may affect up to 1 in 1,000 people) <0>
Nail injury, nail discoloration, brittle or fragile nails.
Very rare (may affect up to 1 in 10,000 people) <0>
Burning sensation.<0>
Frequency not known: frequency cannot be estimated from available data
Redness, itching, hives, blisters, and allergic skin reactions.
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 Amorolfina ISDIN
- Keep this medicine out of sight and reach of children.<0}
- Do not use this medicine after the expiry date stated on the container. <0} {The expiry date refers to the last day of the month indicated.<0}
- Store below 30 °C.<0} {Protect from heat.<0} {0> Keep the bottle tightly closed and in an upright position.<0}
{0> This product is flammable! <0} {0Keep the solution away from fire and flames! <0}
Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point located at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and packaging. This will help protect the environment.
6. Contents of the pack and other information
What Amorolfina Isdin contains
The active substance is amorolfine. Each ml of Amorolfina Isdin contains 50 mg of amorolfine (equivalent to 55.74 mg per ml of amorolfine hydrochloride).
The other components are Eudragit RL 100 (ammonio methacrylate copolymer type A), triacetin, butyl acetate, ethyl acetate, ethanol (anhydrous).
Appearance of Amorolfina Isdin and contents of the pack
Amorolfina Isdin is a clear, colourless to pale yellow solution.
It is available in packs containing 1 bottle of 2.5 ml, 3 ml and 5 ml; also includes cleaning wipes, spatulas and nail files.
Amorolfina Isdin is also available in packs of 7.5 ml (1 bottle of 5 ml and 1 bottle of 2.5 ml) and 10 ml (2 bottles of 5 ml); also includes cleaning wipes, spatulas and nail files.
Only certain pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
The Marketing Authorization Holder is Isdin SA, Provençals 33, 08019 Barcelona, Spain.
The manufacturer is Chanelle Medical Unlimited Company, Loughrea, Co. Galway, Ireland.
This medicinal product is authorized in the EEA Member States under the following names:
Hungary | Amorolfine 5% medicinal nail lacquer |
Poland | Myconolak |
Portugal | Amorolfine Bluepharma |
Spain | Amorolfine Isdin 50 mg/ml medicated nail polish |
This patient information leaflet was approved in 12/2018
Detailed and up-to-date information on this medication is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS):
http://www.aemps.gob.es