Amorolfine 5% W/V Medicated Nail Lacquer
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PACKAGE LEAFLET: INFORMATION FOR THE USER
Amorolfine 5% w/v Medicated nail lacquer
Amorolfine
Read all of this leaflet carefully because it contains important information for you.
This medicine is available without prescription. However, you still need to use Amorolfine 5%w/v Medicated nail lacquer carefully to get the best results from it.
• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information or advice.
• You must contact a doctor if your symptoms worsen or do not improve within 3months.
• If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
In this leaflet:
dWhat Amorolfine 5% w/v Medicated nail lacquer is and what it is used for
dWhat you need to know before you use Amorolfine 5% w/v Medicated nail lacquer
dHow to use Amorolfine 5% w/v Medicated nail lacquer
©Possible side effects (5)How to store Amorolfine 5% w/v Medicated nail lacquer ©Contents of the pack and other information dWhat 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 affecting the upper half or sides of the nail in up to 2 nails.
The active ingredient of Amorolfine 5% w/v Medicated nail lacquer is amorolfine (as the hydrochloride) which belongs to a group of medicines known as antifungals.
It can eradicate a range of different fungi that can cause nail infections, a condition also known as onchomycosis.
(2) 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 Medicated nail lacquer (see Section 6 for other ingredients)
• pregnant, or planning to become pregnant, or are breast-feeding
• under the age of 18.
Warnings and precautions
Take special care with Amorolfine 5% w/v Medicated nail lacquer
• avoid the nail lacquer coming into contact with the eyes, ears or mucous membranes (e.g. mouth and nostrils). If this happens, wash it off immediately and contact your doctor, pharmacist or nearest hospital, straightaway.
• do not inhale
• 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. Using other medicines
There are no known interactions with other medicines.
Using Amorolfine 5% w/v Medicated nail lacquer with other nail products
Do NOT apply nail varnish or use artificial nails when using Amorolfine 5% w/v medicated nail lacquer. Please tell your doctor or pharmacist if you are using or have recently used any other medicines, including medicines obtained without prescription.
Pregnancy and breast-feeding
You should not use Amorolfine 5% w/v Medicated nail lacquer if you are pregnant or planning to be pregnant or are breastfeeding. Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
There are no known effects of the medicine which would affect your ability to drive or operate machinery.
(3) 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.
Instructions for use
Follow the steps as shown below in the correct order to ensure that the lacquer is applied to the nail correctly.
Nails should be treated once a week.
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 to clean the nail surface. Repeat steps 1 and 2 for each affected nail. After using the swab and completing Step 6, dispose of it carefully in the general household waste. Do not incinerate the swab as it is inflammable.
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 on the edge of the bottle before it is applied.
Step 4. Apply the lacquer
Apply the nail lacquer evenly over the entire surface of the nail. Repeat steps 3 and 4 for each affected nail.
Step 5. Allow to dry
Let the treated nail(s) dry for approximately 3 minutes.
Step 6. Clean the applicator
The applicators provided are re-useable. However, it is important to clean them thoroughly after each application to a nail. Use the same swab you used for nail cleansing to clean the applicator each time before you put it back into the nail lacquer. Do not put an unclean applicator into the bottle.
Avoid touching newly treated nails with the swab.
Close the nail lacquer bottle tightly.
• Before using Amorolfine 5% w/v Medicated 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 described above.
Additional information on applying Amorolfine 5% w/v Medicated nail lacquer
• 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 finger nails and 9 to 12 months for toe nails.
If you get Amorolfine 5% w/v Medicated nail lacquer in your eyes or ears
If you get Amorolfine 5% w/v Medicated nail lacquer in your eyes or ears wash out with water immediately and contact your doctor, pharmacist or nearest hospital straight away.
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
Don’t worry if you forget to use Amorolfine 5% w/v Medicated nail 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.
continued overleaf
©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
(occurring in less than 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
(occurring in less than 1 in 10,000 people)
A burning sensation or allergic skin reaction (contact dermatitis) may occur in the area around the nail.
Unknown frequency of occurrence
Redness, itching, hives and blisters Reporting of side effects
If you get any 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 www. m h ra .gov. u k/ye 11 o wca rd.
By reporting side effects you can help provide more information on the safety of this medicine.
©Howto store Amorolfine 5% w/v Medicated nail lacquer
Keep this medicine out of the sight and reach ofchildren.
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.
Keepthe packawayfrom heatand keep the bottle tightly closed after use.
This product is flammable! Keep the solution away from fire and flames!
Medicines should not be disposed of via wastewateror household waste. Askyour pharmacist howto dispose of medicines no longer required. These measures will help to protect the environment.
©Contents of the pack and other information
What Amorolfine 5% w/v Medicated nail lacquer contains
• The active substance is amorolfine (as hydrochloride). 1ml of nail lacquercontains 55.74mgamorolfme hydrochloride (equivalent to 50mg of amorolfine).
• Theotheringredientsareammonio methacrylate copolymer A, triacetin, butyl acetate, ethyl acetate and ethanol.
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 solution.
The pack is available as a 3ml bottle.
Each pack consists of 1 bottle filled with Amorolfine 5% w/v Medicated nail lacquer together with cleansing swabs, spatulas and nail files.
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation Holder is:
Aspire Pharma Limited Bellamy House Winton Road Petersfie Id
Hampshire CU32 3HA United Kingdom.
The Manufacturer is:
P.W.BeyversGmbH Schaffhausener Str. 26-34 D-12099 Berlin Germany.
This leaflet was last revised in
03/2014.
1010095-P3.3
Aspire
Pharma