What you need to know before you take it

e

6. Contents of the pack and

this medicine

'4. Possible side effects

'other information 7. General advice for people with fungal nail infections

1. What this medicine is

'and what it is used for The active ingredient of this

medicine is amorolfine which

belongs to a group of medicines known as antifungals. This medicine is used to treat mild nail infections in adults aged 18 years and over. 'Amorolfine kills a wide variety of fungi that can cause nail infections. Fungal nail infections can look very different, your nails

Do not use this medicine if:

• your nail does not look similar to picture I.

• 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).
• 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 this medicine.

once a week until the infection has

Pregnancy and breast-feeding

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. e After every 3 months of

3. How to use this

treatment:

You should not use this medicine if you are pregnant, planning to ecome pregnant or are breast-feeding. If you are pregnant, 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.

medicine

Warnings and precautions

Always use this medicine exactly as described in this leaflet. Check with your doctor or pharmacist if

reactions, some can be serious,

you are not sure.

You must get urgent medical help if you have any of the

Keeping a record Before you startusing this 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.

This medicine can cause allergic 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 re-applied.

following symptoms: ¢ you have difficulty breathing.

• your face, lips, tongue or throat swell. e your skin develops a severe rash. Do not apply this medicine on the skin around the nail.

Using other medicines

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.

Using other nail products

How long to use

• You need to use this medicine

Before treatment

Three months

• If the infection is the same or worse talk to your doctor or pharmacist. Take this leaflet with yOu. The images below show examples of a nail at different time points during the course of treatment.

Wy

Before treatment

3 Months

6 Months

Safe use of this medicine

• If you get the medicine in your eyes or ears wash it out with water and talk to your doctor or harmacist or go to the nearest

1

ospital straight away.

• Do not let the medicine come into contact with your mouth or

| ame Six months

• If the infection has improved,

continue the treatment.

nostrils (or other 'mucous membranes').

• Do not inhale the medicine.

Nine months

Artificial nails should not be used while using this 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.

Cosmetic nail varnish can be used,

but you should wait at least 10 minutes after applying this medicine before painting your nails. The nail varnish should be carefully

300 mm

How to use -first use Step 1: Prepare your nail e Protect your healthy nails so that you don't spread the infection. ¢ Use a new file. ° Gently file down the infected reas 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 the nail =

e Use one of the

swabs provided.

• Clean the nail <= _J|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 SS

212 mm

=

nail

lacquer.

jeDo not wipe the lacquer off on the ledge of the bottle before it is 'applied. i¢ Apply the nail lacquer evenly 'over the entire surface of the nail.

'¢ Allow it to dry – let the treated inail(s) dry for about 3 minutes.

When the lacquer is dry it is not 'affected by soap and water. You ican 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 provided more than once. tis important to clean it after each use – so you do not spread the infection.

'e Use the same swab you used for cleaning your nails. 'e 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

this medicine 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.

How to take it

–after first use 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. v the | °

Ke-a

tne lacquer as

described in Ste 3 above.

• Clean the applicator as described in Step 4 above. If you accidentally swallow this medicine If you, or anyone else, accidentally swallows the lacquer talk to your doctor or pharmacist

or go to the nearest

ospital straight away. If you forget to use this medicine 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. If you stop using this medicine Do not stop using this medicine until your nail improves. The images in 'How long to use' can help you understand what you are looking for. If you have any further questions on the use of this product, ask your doctor or pharmacist.

Possible side effects

Like all medicines, this medicine

can cause side effects, although not everybody gets them. The following side effects may happen with this medicine: Rare (may affect up to] in 1,000 people): Nail damage, nail discoloured, fragile or brittle nails. Very rare (may affect up to1 in 10,000 people): Skin burning sensation. Not known (frequency cannot be estimated from the available data):

Systemic allergic reaction (a serious allergic reaction that can be associated with swelling of the face, lips, tongue or throat, difficulty breathing and/or a severe skin rash).

Redness, itching, hives, blister, allergic skin reaction. 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 the Yellow Card Scheme website: www.mhra.gov.uk/yellowcard or

search for MHRA Yellow Card in

the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

How to store it

this medicine Keep this medicine 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 keep the bottle tightly closed after use. 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 protect the environment.

Contents of the pack and other information

What this medicine contains

The active substance is amorolfine (as hydrochloride).

Iml of nail lacquer contains 99./4mg amorolfine bya rochloride (equivalent to 90mg of amorolfine). The other ingredients are ammonio methacrylate copolymer A, triacetin, butyl acetate, ethyl acetate and ethanol.

What this medicine 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 Marketing Authorisation Holder Aspire Pharma Limited, Unit 4, Rotherbrook Court, Bedford Road, Petersfield, Hampshire, GU32 30G, United Kingdom. Manufacturer

PW. Beyvers GmbH, Schaffhausener Str. 26-34, D12099, Berlin, Germany. Distributor

The Boots Company PLC, Nottingham, NG2 3AA, UK.

7. General advice for

people with fungal nail infections

You can reduce your risk of developing a fungal nail infection by:

• 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 athelete'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 sterilised between: uses. This leaflet was last revised in _| 02/2022

wl!