Amorolfine 5% W/V Medicated Nail Lacquer
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Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects talk to your doctor or your pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
IN THIS LEAFLET:
1. What Amorolfine 5% w/v Medicated Nail Lacquer is and what it is used for
2. What you need to know before you use Amorolfine 5% w/v Medicated Nail Lacquer
3. How to use Amorolfine 5% w/v Medicated Nail Lacquer
4. Possible side effects
5. How to store Amorolfine 5% w/v Medicated Nail Lacquer
6. Contents of the pack and other information
[1 WHAT AMOROLFINE 5% W/V MEDICATED NAIL LACQUER IS AND WHAT IT IS USED FOR
• Amorolfine 5% w/v Medicated Nail Lacquer is used to treat fungal infections of the nails
• Amorolfine 5% w/v Medicated Nail Lacquer contains the active ingredient amorolfine (as the hydrochloride) which belongs to a group of medicines known as antifungals.
• It kills a wide variety of fungi that can cause nail infections.
WHAT YOU NEED TO KNOW BEFORE YOU USE AMOROLFINE 5% W/V MEDICATED NAIL LACQUER
Do not use Amorolfine 5% w/v Medicated Nail Lacquer if you are:
• allergic (hypersensitive) to amorolfine or any of the other ingredients of Amorolfine 5 % w/v Nail Lacquer (see section 6 for other ingredients).
Warnings and precautions
Talk to your doctor before using Amorolfine 5% w/v Medicated Nail Lacquer:
• if you suffer from diabetes.
• if you are being treated because you have a weak immune system.
• if you have poor circulation in your hands and feet.
• if your nail is severely damaged or infected.
• if you get Amorolfine 5% w/v Medicated Nail Lacquer in your eyes or ears wash it out with water immediately and contact your doctor, pharmacist or nearest hospital straight away.
• avoid the lacquer coming into contact with mucous membranes (e.g. mouth and nostrils). Do not breathe it in.
Children and adolescents
There are no specific dosage recommendations for children owing to the lack of clinical experience available to date.
Other medicines and Amorolfine 5% w/v Medicated Nail Lacquer You can use the nail lacquer whilst you are taking other medicines.
Other nail products and Amorolfine 5% w/v Medicated Nail Lacquer Nail varnish or artificial nails should not be used while using Amorolfine 5% w/v Medicated Nail Lacquer.
When organic solvents are used impermeable gloves should be used otherwise amorolfine nail lacquer will be removed.
Pregnancy and breast-feeding
Amorolfine should not be used during pregnancy and/or lactation unless clearly necessary.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
©HOW TO USE AMOROLFINE 5% W/V MEDICATED NAIL LACQUER
Always use Amorolfine 5% w/v Medicated Nail Lacquer exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Amorolfine 5% w/v Medicated Nail Lacquer should be applied to the affected finger or toe nails once or twice a week exactly as directed by your doctor.
Instructions for use:
Step 1: File the nail Before the first application, file down the infected areas of nail, including the nail surface, as much as possible using the nail file provided.
CAUTION: Do not use nail files used for infected nails on healthy nails, otherwise you may spread the infection. To prevent the spread of infection take care that no one else uses the files from your kit.
Step 2: Clean the nail
Use one of the swabs provided (or nail varnish remover) to clean the nail surface. Repeat steps 1 and 2 for each affected nail.
Step 3: Take some lacquer from the bottle
Dip one of the re-usable applicators into the bottle of nail lacquer. The lacquer must not be wiped off the edge of the bottle before it is applied.
Step 4: Apply the lacquer
Apply the lacquer evenly over the entire surface of the nail. Repeat this step for each affected nail.
Let the treated nail(s) dry for approximately 3 minutes.
Step 5: Clean the applicator
The applicators provided are re-usable. However, it is important to clean them thoroughly after completing each treatment procedure, using the same swab you used for nail cleansing. Avoid touching newly treated nails with the swab. Close the nail lacquer bottle tightly. Dispose of the swab carefully as it is inflammable.
• Before using the nail lacquer again, first remove the old lacquer from your nails using a swab, then file down the nails again if necessary.
• Re-apply the lacquer as previously described.
• When dry, the nail lacquer is unaffected by soap and water, so you may wash your hands and feet as normal. If you need to use chemicals such as paint thinners or white spirit, rubber or other impermeable (waterproof) gloves should be worn to protect the lacquer on your fingernails.
• It is important to carry on using Amorolfine 5% w/v Medicated Nail Lacquer until the infection has cleared and healthy nails have grown back. This usually takes 6 months for fingernails and 9 to 12 months for toenails.
Your doctor will probably check how your treatment is progressing every 3 months or so.
If you accidentally swallow Amorolfine 5% w/v Medicated Nail Lacquer
If you, or anyone else, accidentally swallows the lacquer contact your doctor, pharmacist or nearest hospital straight away.
If you forget to use Amorolfine 5% w/v Medicated Nail Lacquer Do not worry if you forget to use the lacquer at the right time. When you remember, start using the product again, in the same way as before.
If you stop using Amorolfine 5% w/v Medicated Nail Lacquer Do not stop using Amorolfine 5% w/v Medicated Nail Lacquer before your doctor tells you to or your infection could come back. If you have any further questions on the use of this product, ask your doctor or pharmacist.
^ POSSIBLE SIDE EFFECTS
Like all medicines, Amorolfine 5% w/v Medicated Nail Lacquer can cause side effects, although not everybody gets them.
Rare side effects (may affect up to 1 in 1,000 people)
Your nail may become discoloured or it may become loose or start to separate from the nail bed.
Very rare side effects (may affect up to 1 in 10,000 people)
A burning sensation or allergic skin reaction (contact dermatitis) may occur in the area around the nail.
Not known (frequency cannot be estimated from the available data)
Skin redness, itching, hives, blister.
Reporting of side effects
If you get side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
You can also report side effects directly via the Yellow Card Scheme at:
By reporting side effects you can help provide more information on the safety of this medicine.
©HOW TO STORE
AMOROLFINE 5% W/V MEDICATED NAIL LACQUER
• Keep this medicine out of the sight and reach of children.
• Do not use Amorolfine 5% w/v Medicated Nail Lacquer after the expiry date which is stated on the pack. The expiry date refers to the last day of that month.
• Store below 3o°C. Protect from heat. Keep the bottle tightly closed and upright.
This product is flammable! Keep the solution away from fire and flames!
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
©CONTENTS OF THE PACK AND OTHER INFORMATION
What Amorolfine 5% w/v Medicated Nail Lacquer contains: Amorolfine 5% w/v Medicated Nail Lacquer contains 50 mg/ml of the active substance amorolfine (equivalent to 55.74 mg/ml amorolfine hydrochloride). The other ingredients are Eudragit RL 100 (ammonio methacrylate copolymer A), triacetin, butyl acetate, ethyl acetate and ethanol (anhydrous).
What Amorolfine 5% w/v Medicated Nail Lacquer looks like and contents of the pack
Amorolfine 5% w/v Medicated Nail Lacquer is a clear, colourless to pale yellow solution. It is available in 2.5 ml, 3 ml and 5 ml packs; 1 bottle packed with cleaning wipes, nail files and spatulas.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation holder:
TEVA UK Limited, Eastbourne, BN22 9AG.
Manufacturer:
Chanelle Medical Loughrea Co. Galway Ireland
This leaflet was last amended in: 11/2013
PL 00289/1681
18604-C