Curanail 5% w/v Medicated Nail Lacquer

Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.

• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information or advice.
• 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.
• You must talk to a doctor if you do not feel better (or if you feel worse) after 3 months.

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
7. General advice for people with fungal nail infections

• your nail does not look similar to picture 1 above
• you are allergic to amorolfine or any of the other ingredients of this medicine (listed in section 6)
• you are pregnant, might become pregnant or are breast-feeding
• your nail is moderately or severely damaged or infected (see pictures 2 and 3 above)
• you have poor blood circulation in your hands or feet
• you have pain or swelling around the nail
• you have more than 2 infected nails in total
• you have a weak immune system
• you are under the age of 18
• you have diabetes
• you have dark stripes running down the nail

Do not use this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before using Curanail.

This medicine can cause allergic reactions, some can be serious, if this happens, stop applying the product, immediately remove the product with a nail varnish remover or the cleaning swabs provided with the package and seek medical advice. The product must not be reapplied. You must get urgent medical help if you have any of the following symptoms:

• you have difficulty breathing
• your face, lips, tongue or throat swell
• your skin develops a severe rash.

Do not apply Curanail on the skin around the nail.

Tell your doctor or pharmacist if you are using or have recently used or might use any other medicines. This includes medicines obtained without a prescription, and herbal medicines. You can normally use this medicine when you are taking other medicines.

Artificial nails should not be used while using Curanail. Cosmetic nail varnish can be used, but you should wait at least 10 minutes after applying Curanail before painting your nails. The nail varnish should be carefully removed before repeat application of Curanail.

Do not use Curanail if you are pregnant, might become pregnant or are breast-feeding.

If you are pregnant or breast-feeding, think you might be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

One gram of Curanail contains 552 mg of alcohol (ethanol), which is equivalent to 55.2 % w/w. It may cause a burning sensation on damaged skin. Ethanol is a flammable substance and should not be used near an open flame, a lit cigarette or some devices (e.g. hair dryers).

Before you start using the medicine you should keep a record of how your nail looks:

• Shade the area affected by the infection in the ‘Before Treatment' diagram below.
• If you have 2 nails affected, just do this for your worst nail.
• Every 3 months, shade the area affected in the next diagram.
• Do this until the infected nail has completely grown out.

This will help you remember how your nail looked so you can see your progress.

• You need to use the medicine once a week 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 infected nail grows out.
• Nails grow slowly so it may take 2 or 3 months before you start to see an improvement.
• After every 3 months of treatment:
  • If the infection has improved, continue the treatment.
  • If the infection is the same or worse talk to your doctor or pharmacist.
  Take this leaflet with you.

• If you get the medicine in your eyes or ears wash it out with water and talk to your doctor or pharmacist or go to the nearest hospital straight away.
• Do not let the medicine come into contact with your mouth or nostrils (or other ‘mucous membranes’).
• Do not inhale the medicine.
• Do not let anyone else use the files from your kit – this will stop the spread of infection.
• If you need to use chemicals such as paint thinners or white spirit when you have applied the medicine to your fingernails, wear rubber or other waterproof (impermeable) gloves. This will protect the medicine on your nails.

Step 1: Prepare your nail

• Protect your healthy nails so that you don’t spread the infection.
• Use a new file.
• Gently file down the infected areas of your nail - including the nail surface.
• Do not use the same nail file for infected nails and healthy nails - this could spread the infection.

Step 2: Clean your nail

• Use one of the swabs provided.
• Clean the nail surface.
• Do not throw the swab away - you will need it later to clean the applicator.

Step 3: Treat the nail

• Dip the applicator into the bottle of nail lacquer.
• Do not wipe the lacquer off on the edge of the bottle before it is applied.
• Apply the lacquer evenly over the entire surface of the nail.
• Allow it to dry - let the treated nail(s) dry for about 3 minutes. When the lacquer is dry it is not affected by soap and water. You can wash your hands or feet as normal. Wait at least 10 minutes before applying cosmetic nail varnish.

Step 4: Clean the applicator

• You can use the applicator more than once.
• It is important to clean it after each use - so you do not spread the infection.
• Use the same swab you used for cleaning your nails.
• Do not touch the newly treated nails with the swab.
• Close the nail lacquer bottle tightly.
• Throw the swab away carefully as it will set on fire easily.
• It is important to carry on using the nail lacquer every week 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. If the nail is still infected after this time you should see a doctor.
• If you do not continue using the nail lacquer every week the treatment may not work as expected and the fungus could also become resistant to the nail lacquer.

Each infected nail should be treated once a week.

• Before using the lacquer again, remove the old lacquer and any nail varnish from your nails using a swab.
• File down the nails again if needed.
• Re-apply the lacquer as described in Step 3 above.
• Clean the applicator as described in Step 4 above.

If you, or anyone else, accidentally swallows the medicine talk to your doctor or pharmacist or go to the nearest hospital straight away.

Do not worry if you forget to use the lacquer exactly a week after the last time.

When you remember, use the medicine again, in the same way as before.

You could use a diary to remind you.

Do not stop using the medicine until your nail improves. The images in ‘How long to use’ can help you and your family member, friend or carer understand what you are looking for.

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.

• 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.

• Each pack consists of 1 bottle filled with 3ml of Curanail nail lacquer together with cleansing swabs and nail files.

Marketing Authorisation Holder:

(PL 10590/0049)

Manufacturer:

• keeping your hands and feet clean and dry
• wearing well-fitting shoes made of natural materials and clean cotton socks – these will allow your feet to ‘breathe’
• clipping your nails to keep them short – don’t share clippers or scissors with other people
• not sharing towels and socks with other people - ensure you wash your towels regularly
• not walking around barefoot in public pools, showers, or locker rooms – special shower shoes are available to protect your feet.
• replacing old footwear that could be contaminated with fungi
• treating athlete’s foot as soon as possible to stop the infection spreading to your nails.

Nail salon equipment can sometimes be the source of fungal nail infections. If you regularly visit a salon, make sure any equipment used is properly sterilized between uses.