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AMOROLFINE 5% W/V NAIL LACQUER

Active substance(s): AMOROLFINE HYDROCHLORIDE

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PACKAGE LEAFLET:
INFORMATION FOR THE USER





Amorolfine 5% w/v Nail Lacquer


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 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.

Read all of this leaflet carefully before you start using this medicine.
• 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. Do not pass it on to others, it may harm
them, even if their symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice any side effects not listed in this
leaflet, please tell your doctor or your pharmacist.

Your doctor will probably check how your treatment is progressing every 3 months
or so.

In this leaflet:
1. What Amorolfine 5% w/v is and what it is used for
2. Before you use Amorolfine 5% w/v
3. How to use Amorolfine 5% w/v
4. Possible side effects
5. How to store Amorolfine 5% w/v
6. Further information

If you forget to use Amorolfine 5% w/v
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.

1. What Amorolfine 5% w/v is and what it is
used for




Amorolfine 5% w/v is used to treat fungal infections of the nails.
Amorolfine 5% w/v 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.

2. Before you use Amorolfine 5% w/v
Do not use Amorolfine 5% w/v if you are:
• allergic (hypersensitive) to amorolfine or any of the other ingredients of Amorolfine 5%
nail lacquer (see section 6 for other ingredients).
• pregnant, planning to become pregnant or are breast feeding.
Take special care with Amorolfine 5% w/v:
• 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 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.

If you accidentally swallow Amorolfine 5% w/v
If you, or anyone else, accidentally swallows the lacquer contact your doctor,
pharmacist or nearest hospital straight away.

If you stop using Amorolfine 5% w/v
Do not stop using Amorolfine 5% w/v 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.

4. Possible side effects
Like all medicines, Amorolfine 5% w/v can cause side effects, although not
everybody gets them.
Rare side effects (occurring in less than 1 in 1000 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.
If any of the side effects gets serious, or if you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.

5. How to store Amorolfine 5% w/v




Keep out of the reach and sight of children.
Do not use Amorolfine 5% w/v after the expiry date which is stated on
the pack. The expiry date refers to the last day of that month.
Store below 30°C. Protect from heat. Keep the bottle tightly closed and upright.

Using other medicines
You can use the nail lacquer whilst you are taking other medicines.

This product is flammable! Keep the solution away from fire and flames!

Using other nail products
Nail varnish or artificial nails should not be used while using Amorolfine 5% w/v.

Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. These measures will
help to protect the environment.

Pregnancy and breast-feeding
Tell your doctor if you are pregnant, planning to become pregnant or are breast-feeding.
Your doctor will then decide whether you should use Amorolfine 5% w/v.
Ask your doctor or pharmacist for advice before taking any medicine.

6. Further information

3. How to use Amorolfine 5% w/v
Always use Amorolfine 5% w/v exactly as your doctor has told you. You should check
with your doctor or pharmacist if you are not sure.
Amorolfine 5% w/v 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.

What Amorolfine 5% w/v contains
Amorolfine 5% w/v contains 50 mg/ml (5%) 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 looks like and contents of the pack
Amorolfine 5% w/v is a clear, colourless to pale yellow solution.
It is available in 2.5ml, 3ml and 5ml packs; 1 bottle with or without cleansing swabs,
spatulas and/or nail files. Amorolfine 5% w/v is also available in 7.5ml and 10ml
packs; 2 bottles packed with or without cleansing swabs, spatulas and/or nail files.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
The marketing authorisation holder is Chanelle Medical, Loughrea, Co Galway, Ireland.
The manufacturer is Chanelle Medical, Loughrea, Co. Galway, Ireland.
This leaflet was ast approved in: 06/2011

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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