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CURANAIL 5% NAIL LACQUER

Active substance: AMOROLFINE HYDROCHLORIDE

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Transcript
Instructions for use:
• Treat your infected nails as described below. NAILS SHOULD BE TREATED ONCE A WEEK.
• Once weekly application should continue for 6 months for finger nails and 9 to 12 months
for toe nails.
• Nails grow slowly so it may take 2 or 3 months before you start to see an improvement.
It is important to carry on using the nail lacquer until the infection has cleared and healthy
nails have grown back.
• The following steps should be followed carefully for each affected nail:
Step 1: Prepare the Nail
Using a new file, gently file down the infected areas of
nail, including the nail surface. Protect any healthy nails
while you are doing this so that you don't spread the
infection. CAUTION: Do not use the same nail file for
infected nails and healthy nails, as this could spread the
infection as well. 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.
Do not throw the swab away as you will need it later to
clean the applicator.

5% W/V MEDICATED NAIL LACQUER
AMOROLFINE

PACKAGE LEAFLET: INFORMATION FOR THE USER
Curanail 5% w/v Medicated Nail Lacquer
Amorolfine

What is in this leaflet
1. What Curanail is and what it is used for
2. What you need to know before you use Curanail
3. How to use Curanail
4. Possible side effects
5. How to store Curanail
6. Contents of the pack and other information

1. What Curanail is and what it is used for
• Curanail is used to treat fungal infections affecting up to 2 nails and affecting the upper
half or sides of the nail (as shown in the first picture below). If the infection appears to be
more like pictures 2 or 3, you should consult your doctor.
• The active substance in Curanail is amorolfine (as the hydrochloride) which belongs to a
group of medicines known as antifungals.
• Amorolfine kills a wide variety of fungi that can cause nail infections. A fungal nail infection
is likely to result in discoloured (white, yellow or brown), thick or brittle nails, although their
appearance can vary considerably as the following pictures show:
1
2
3

2. What you need to know before you use Curanail
Do not use Curanail if you are:
• Allergic (hypersensitive) to amorolfine or any of the other ingredients of this medicine
(listed in section 6).
• Under the age of 18.
Warnings and precautions
Take special care with Curanail:
• 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 Curanail 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 inhale.
• Wear impermeable gloves when using organic solvents to stop the nail lacquer from being removed.
Using other medicines
You can use the nail lacquer whilst you are taking other medicines.
Using other nail products
Nail varnish or artificial nails should not be used while using Curanail.
Please tell your doctor or pharmacist if you are using or have recently used any other
medicines, including medicines obtained without a prescription.
Pregnancy and breast-feeding
You should not use Curanail and tell your doctor if you are pregnant, planning to become
pregnant or are breast-feeding. Your doctor will then decide whether you should use Curanail.
Ask your doctor or pharmacist for advice before taking any medicine.

3. How to use Curanail
Always use this medicine exactly as your doctor or pharmacist has told you. Check with your
doctor or pharmacist if you are not sure.

Step 3: Treat the nail
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. Apply the lacquer.
Apply the nail lacquer evenly over the entire surface of
the nail. Allow to dry. Let the treated nail(s) dry for
approximately 3 minutes.
Step 4: Clean the applicator
You can use the applicators provided more than once. However, it is important to clean them
thoroughly each time so that you don't spread the infection. Use the same swab you used for
cleaning your nails. Don't touch the 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 described above.
• When dry the nail lacquer is unaffected by soap and water, so you can 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 the 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. You will see a healthy nail growing as the diseased nail grows out.

Before treatment
After treatment
If you accidently swallow Curanail
If you, or anyone else, accidentally swallows the lacquer contact your doctor, pharmacist or
nearest hospital straight away.
If you forget to use Curanail
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 Curanail
Do not stop using Curanail before your doctor tells you to or your infection could come back.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, this medicine 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, broken or brittle.
Very rare side effects (occurring in less than 1 in 10,000 people)
A burning sensation may occur in the area around the nail.
Unknown frequency of occurrence
Redness, itching, hives, blisters and allergic skin reaction (contact dermatitis).
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.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Curanail
• Keep out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the pack. The expiry date
refers to the last day of that month.
• Keep the pack away from heat and do not store above 30ºC. Keep the bottle tightly closed after use.
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 protect the environment.

6. Contents of the pack and other information

Adults and the Elderly
Before Commencing Treatment:
In the diagram below, shade the area affected by the fungal nail infection. This will help you in
remembering how the nail looked originally when your treatment is reviewed. Every three months,
shade the area now affected until the infected nail has completely grown out. If more than one
nail is affected, select the worst affected nail for this exercise. Take this leaflet to the pharmacist or
podiatrist when treatment is being reviewed to inform them of treatment progress to date.

Before Treatment

P2XXXX-X

Read all of this leaflet carefully before you start using this medicine because it contains
important information for you.
Always use this medicine exactly as described in this leaflet or as your pharmacist has told you.
- 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 3 months.
- 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.

Three Months

Six Months

Nine Months

What Curanail contains
The active substance is amorolfine. Curanail contains 50 mg/ml (5%) of amorolfine
(equivalent to 6.4% amorolfine hydrochloride). The other ingredients are ammonio
methacrylate copolymer A, triacetin, butyl acetate, ethyl acetate and ethanol.
What Curanail looks like and contents of the pack
Each pack consists of 1 bottle filled with 3ml of Curanail nail lacquer together with cleansing
swabs, reusable applicators and nail files.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder: Galderma (UK) Ltd, Meridien House, 69-71 Clarendon Road,
Watford, Herts, WD17 1DS, United Kingdom. (PL 10590/0049).
Manufacturer: Laboratoires Galderma,
ZI-Montdésir, 74540 Alby-Sur-Chéran, France.
This leaflet was last revised in 07/2013.

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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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