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Package leaflet: Information for the user
< Invented Name > < 5% > < w/v > < Medicated > < Nail Lacquer >
< Amorolfine hydrochloride >
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 doctor or pharmacist have told
- 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
What is in this leaflet
1. What < Invented Name > is and what it is used for
2. What you need to know before you use < Invented Name >
3. How to use < Invented Name >
4. Possible side effects
5. How to store < Invented Name >
6. Contents of the pack and other information


What is and what it is used for

The active substance in < Invented Name > is amorolfine (as the hydrochloride) which belongs
to a group of medicines known as antifungals.
< Invented Name > 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.
< Invented Name > 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:

What you need to know before you use

Do not use < Invented Name >:

if you are allergic to amorolfine or any of the other ingredients of this medicine (listed in
section 6).

if you are under the age of 18.
Warnings and precautions
Talk to your doctor or pharmacist before using < Invented Name >:

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 < Invented Name > in your eyes or ears wash it out with water immediately and
contact your doctor, pharmacist or nearest hospital straight away.


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avoid the lacquer coming into contact with mucous membranes (e.g. mouth and nostrils). Do
not breathe it in.

Children and adolescents
There are no specific dosage recommendations for children owing to the lack of clinical experience
available to date.
Other medicines and < Invented Name >
You can use the nail lacquer whilst you are taking other medicines.
Other nail products and < Invented Name >
Nail varnish or artificial nails should not be used while using < Invented Name >.
When organic solvents are used impermeable gloves should be used otherwise amorolfine nail
lacquer will be removed.
Pregnancy,breast-feeding and fertility
Amorolfine should not be used during pregnancy and/or lactation unless clearly necessary.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask
your doctor or pharmacist for advice before using this medicine.

How to use

Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told
you. Check with your doctor or pharmacist if you are not sure.
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

Three Months

Six Months

Nine Months

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: 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


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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: Apply the lacquer
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
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 4: 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.

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
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 accidentally swallow < Invented Name >
If you, or anyone else, accidentally swallows the lacquer contact your doctor, pharmacist or nearest
hospital straight away.
If you forget to use < Invented Name >
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 < Invented Name >
Do not stop using < Invented Name > 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.


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Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Rare side effects: may affect up to 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: may affect up to 1 in 10,000 people
A burning sensation or allergic skin reaction (contact dermatitis) may occur in the area around the
Not known: frequency cannot be estimated from the available data
Skin redness, itching, hives, blister
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 national reporting system listed
in Appendix V*. By reporting side effects you can help provide more information on the safety of this

How to store

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 carton and label. The
expiry date refers to the last day of that month.
Store below 30ºC. Protect from heat. Keep the bottle tightly closed and upright.

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 to protect the environment.
6. Contents of the pack and other information

What < Invented Name > contains

The active substance is amorolfine. < Invented Name > contains 50 mg/ml 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 < Invented Name > looks like and contents of the pack
< Invented Name > is a clear, colourless to pale yellow solution. It is available in
2.5 ml, 3 ml and 5 ml packs; 1 bottle 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 <[To be completed nationally]>
The manufacturer is <[To be completed nationally}>


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This medicinal product is authorised in the Member States of the EEA under the following
<[To be completed nationally]>
This leaflet was last revised in
<[To be completed nationally]>


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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.