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AMOROLFINE 5% MEDICATED NAIL LACQUER

Active substance(s): AMOROLFINE HYDROCHLORIDE

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022016

PACKAGE LEAFLET: INFORMATION FOR THE USER
Amorolfine 5% Medicated nail lacquer
Amorolfine

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 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.

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

1.

What Amorolfine is and what it is used for

Amorolfine 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 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:

2.

What you need to know before you use Amorolfine

Do not use Amorolfine

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 Amorolfine,
− if you suffer from diabetes.
− if you are being treated because you have a weak immune system.
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if you have poor circulation in your hands and feet.
if your nail is severely damaged or infected.

If you get Amorolfine 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.
Wear impermeable gloves when using organic solvents to stop the nail lacquer from being removed.
Do not use cosmetic nail lacquer or artificial nails during treatment with amorolfine.
Other medicines and Amorolfine
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 Amorolfine.
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
Pregnancy and breast-feeding
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.
Your doctor will then decide whether you can use Amorolfine.

3.

How to use Amorolfine

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.

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.

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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
provided. Protect any healthy nail while you are doing this so that
you don’t spread the infection. 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. Do not throw the swab away as you will need it
later to clean the applicator. 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 (can be used more than once).
However, it is important to clean them thoroughly after completing
each treatment procedure so you don’t spread the infection. Use 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 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 accidentally swallow Amorolfine

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If you, or anyone else, accidentally swallows the lacquer contact your doctor, pharmacist or nearest
hospital straight away.
If you forget to use Amorolfine
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 Amorolfine
Do not stop using Amorolfine 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.
Frequency not known (cannot be estimated from the available data): redness, itching, hives,
blisters and allergic skin reaction (contact dermatitis).or 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 the Yellow Card Scheme at:
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 Amorolfine

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 bottle. 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.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to
throw away medicines you no longer use. Waste material contaminated with medicines should also
not be disposed of via wastewater. These measures will help protect the environment.

6.

Contents of the pack and other information

What Amorolfine contains
The active substance is amorolfine. 1 ml solution contains 55.74 mg amorolfine hydrochloride
(equivalent to 50 mg amorolfine).
The other ingredients are Eudragit RL 100, triacetin, butyl acetate, ethyl acetate and ethanol.
What Amorolfine looks like and contents of the pack

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The lacquer is a clear, colourless to pale yellow solution, available in a glass bottle of 2.5 ml. The
bottle is made of amber glass (type I or type III) bottle with a HDPE cap, PTFE liner and tamper
evident ring.
Each pack consists of 1 bottle and cleansing swabs, spatulas and nail files.
Marketing Authorisation Holder and Manufacturer
The marketing authorisation holder is Oystershell nv, Booiebos 24, 9031 Drongen, Belgium.
The manufacturer is Chanelle Medical, Dublin Road, Loughrea, Co. Galway, Ireland.
This medicinal product is authorised in the Member States of the EEA under the following
names:

UK:
BE:
LU:
DE:

Amorolfine 5% medicated nail lacquer
Amorolfine Oystershell 50 mg/ml nagellak
Amorolfine Oystershell 50 mg/ml vernis à ongles médicamenteux
Amorolfin Oystershell 50 mg/ml wirkstoffhaltiger Nagellack

This leaflet was last revised in 03/2016.

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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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