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AMOROLFINE 5 % W/V MEDICATED NAIL LACQUER

Active substance(s): AMOROLFINE HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Amorolfine 5 % w/v Medicated Nail Lacquer
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.
This medicine is available without prescription. However, you still need to use Medicated Nail Lacquer>carefully to get the best results from it.
 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 is and what it is used for
2. What you need to know before you use
3. How to use
4. Possible side effects
5. How to store
6. Contents of the pack and other information
1.




2.

What is and what it is used for
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 is amorolfine (as the
hydrochloride) which belongs to a group of medicines known as antifungals.
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 do you need to know before you use Lacquer>nail lacquer

Do not use

If you are allergic (hypersensitive) to the active ingredient (amorolfine) or any of the other
ingredients of (see section 6 for other
ingredients)

If you are under the age of 18
Warnings and precautions
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 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
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Your skin develops a severe rash

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

if you have poor circulation in your hands and feet

if your nail is severely damaged or infected
If you get 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
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 Lacquer>.
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
Pregnancy and breast-feeding
You should not use 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 .
Ask your doctor or pharmacist for advice before taking any medicine.
3.

How to use

Always use exactly 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. A review of the treatment is recommended at intervals of approximately three months.

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:

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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.
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
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
If you, or anyone else, accidentally swallows the lacquer contact your doctor, pharmacist or nearest
hospital straight away.
If you forget to use
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.

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If you stop using
Do not stop using before your doctor tells you to or
your infection could come back. If you have any further questions on the use of this product, ask your
doctor or pharmacist.
4.

Possible side effects

Like all medicines, 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, broken or brittle.
Very rare side effects (may affect up to 1 in 10,000 people)
A burning sensation may occur in the area around the nail.
Frequency not known (frequency cannot be estimated from the available data)
Redness, itching, hives, blisters and allergic skin reaction (contact dermatitis).

Reporting of side effects
If you get any side effects, talk to your health care professional. 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 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.
5.




How to store
Keep out of the reach and sight of children
Do not use after the expiry date which is stated
on the pack. 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!
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. These measures will help to protect the environment.
6.

Contents of the pack and other information

What contains
1 ml of contains 55.74 mg amorolfine hydrochloride
(equivalent to 50mg amorolfine). The other ingredients are Eudragit RL 100 (ammonio methacrylate
copolymer A), triacetin, butyl acetate, ethyl acetate and ethanol (anhydrous).
What looks like and contents of the pack
is a clear, colourless to pale yellow solution. It is
available in 2.5 ml and 3 ml packs; 1 bottle packed with cleansing swabs, spatulas and nail files. Not
all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Reckitt Benckiser Healthcare (UK) Limited,
103-105 Bath Road
Slough, SL1 3UH
United Kingdom

This leaflet was last reviewed in: 01/2018

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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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