AMOROLFINE 5% W/V MEDICATED NAIL LACQUER

Active substance: AMOROLFINE HYDROCHLORIDE

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AMOROLFINE 5 % w/v
MEDICATED NAIL LACQUER
Amorolfine
PACKAGE LEAFLET: INFORMATION
FOR THE USER

Read all of this leaflet carefully
before you start using this
medicine.
• Keep this leaflet. You may need
to read it again.
• If you have any further
questions, ask your doctor or
pharmacist.
• This medicine has been
prescribed for you. Do not pass
it on to others, it may harm
them, even if their symptoms
are the same as yours.
• If any of the side effects gets
serious, or if you notice any
side effects not listed in this
leaflet, please tell your doctor
or your pharmacist.
IN THIS LEAFLET:

1. What Amorolfine 5% w/v
Medicated Nail Lacquer is and
what it is used for
2. Before you use Amorolfine
5% w/v Medicated Nail Lacquer
3. How to use Amorolfine 5% w/v
Medicated Nail Lacquer
4. Possible side effects
5. How to store Amorolfine
5% w/v Medicated Nail Lacquer
6. Further information

Using other medicines
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 5% w/v Medicated
Nail Lacquer.
Pregnancy and breast-feeding
Tell your doctor if you are
pregnant, planning to become
pregnant or are breast-feeding.
Your doctor will then decide
whether you should use
Amorolfine 5% w/v Medicated
Nail Lacquer.
Ask your doctor or pharmacist for
advice before taking any
medicine.

3 HOW TO USE

AMOROLFINE 5% w/v
MEDICATED NAIL
LACQUER

Always use Amorolfine 5% w/v
Medicated Nail Lacquer exactly
as your doctor has told you. You
should check with your doctor or
pharmacist if you are not sure.
Amorolfine 5% w/v Medicated
Nail Lacquer should be applied to
the affected finger or toe nails
once or twice a week exactly as
directed by your doctor.

1 WHAT AMOROLFINE
5% w/v MEDICATED NAIL
LACQUER IS AND WHAT IT Instructions for use:
IS USED FOR
• Amorolfine 5% w/v Medicated
Nail Lacquer is used to treat
fungal infections of the nails
• Amorolfine 5% w/v Medicated
Nail Lacquer contains the
active ingredient amorolfine
(as the hydrochloride) which
belongs to a group of medicines
known as antifungals
• It kills a wide variety of fungi
that can cause nail infections.

2 BEFORE YOU USE
AMOROLFINE 5% w/v
MEDICATED NAIL
LACQUER
Do not use Amorolfine 5% w/v
Medicated Nail Lacquer if you
are:
• allergic (hypersensitive) to
amorolfine or any of the other
ingredients of Amorolfine
5% w/v Medicated Nail Lacquer
(see section 6 for other
ingredients).
Take special care with Amorolfine
5% w/v Medicated Nail Lacquer:
• 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 Amorolfine 5% w/v
Medicated Nail Lacquer 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.

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: Take some lacquer from
the bottle
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.

Step 4: Apply the lacquer
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 5: 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.








Rare side effects (occurring in
less than 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 (occurring
in less than 1 in 10,000 people)
A burning sensation or allergic
skin reaction (contact dermatitis)
may occur in the area around the
nail.
If any of the side effects gets
serious, or if you notice any side
effects not listed in this leaflet,
please tell your doctor or
pharmacist.

5 HOW TO STORE

AMOROLFINE 5% w/v
MEDICATED NAIL
LACQUER

• Keep out of the reach and sight
of children.
• Do not use Amorolfine 5% w/v
Medicated Nail Lacquer after
the expiry date which is stated
Before using the nail lacquer
on the pack. The expiry date
again, first remove the old
refers to the last day of that
lacquer from your nails using a
month.
swab, then file down the nails
• Store below 30ºC. Protect from
again if necessary.
heat. Keep the bottle tightly
Re-apply the lacquer as
closed and upright.
previously described.
When dry, the nail lacquer is
This product is flammable! Keep
unaffected by soap and water, the solution away from fire and
so you may wash your hands
flames!
and feet as normal. If you need
to use chemicals such as paint Medicines should not be
thinners or white spirit, rubber disposed of via wastewater or
or other impermeable
household waste. Ask your
(waterproof) gloves should be pharmacist how to dispose of
worn to protect the lacquer on medicines no longer required.
your fingernails.
These measures will help to
It is important to carry on using protect the environment.
Amorolfine 5% w/v Medicated
Nail Lacquer until the infection
6 FURTHER INFORMATION
has cleared and healthy nails
have grown back. This usually
What Amorolfine 5% w/v
takes 6 months for fingernails
Medicated Nail Lacquer contains:
and 9 to 12 months for toenails. Amorolfine 5% w/v Medicated

Your doctor will probably check
how your treatment is
progressing every 3 months or
so.

Nail Lacquer 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).

If you accidentally swallow
Amorolfine 5% w/v Medicated
Nail Lacquer
If you, or anyone else,
accidentally swallows the lacquer
contact your doctor, pharmacist
What Amorolfine 5% w/v
or nearest hospital straight away.
Medicated Nail Lacquer looks like
and contents of the pack
If you forget to use Amorolfine
Amorolfine 5% w/v Medicated
5% w/v Medicated Nail Lacquer
Nail Lacquer is a clear, colourless
Do not worry if you forget to use
to pale yellow solution. It is
the lacquer at the right time.
available in 2.5 ml, 3 ml and 5 ml
When you remember, start using
packs; 1 bottle packed with
the product again, in the same
cleaning wipes, nail files and
way as before.
spatulas.
Not all pack sizes may be
If you stop using Amorolfine
marketed.
5% w/v Medicated Nail Lacquer
Do not stop using Amorolfine
Marketing Authorisation Holder
5% w/v Medicated Nail Lacquer
before your doctor tells you to or TEVA UK Limited,
your infection could come back. If Eastbourne, BN22 9AG.
you have any further questions
Manufacturer
on the use of this product, ask
Chanelle Medical, Loughrea,
your doctor or pharmacist.
Co.Galway, Ireland.

4 POSSIBLE SIDE EFFECTS
Like all medicines, Amorolfine
5% w/v Medicated Nail Lacquer
can cause side effects, although
not everybody gets them.

This leaflet was last amended in:
08/2011
PL 00289/1681
18604-B

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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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