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AMOROLFINE 5% W/V MEDICATED NAIL LACQUER

Active substance(s): AMOROLFINE HYDROCHLORIDE / AMOROLFINE HYDROCHLORIDE / AMOROLFINE HYDROCHLORIDE

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TEVA UK Ref:

231-30-18604-D LEA AMOROLFINE 5% W/V MEDICATED NAIL LACQUER TUK XCHA

Children and adolescents
There are no specific dosage
recommendations for children
owing to the lack of clinical
Amorolfine
experience available to date.
PACKAGE LEAFLET: INFORMATION
FOR THE USER
Other medicines and Amorolfine
5% w/v Medicated Nail Lacquer
Read all of this leaflet carefully
You can use the nail lacquer whilst
before you start using this
you are taking other medicines.
medicine because it contains
important information for you.
Other nail products and Amorolfine
• Keep this leaflet. You may need
5% w/v Medicated Nail Lacquer
to read it again.
Nail varnish or artificial nails
• If you have any further
should not be used while using
questions, ask your doctor or
Amorolfine 5% w/v Medicated Nail
pharmacist.
Lacquer.
• This medicine has been
When organic solvents are used
prescribed for you only. Do not impermeable gloves should be
pass it on to others. It may harm used otherwise amorolfine nail
them, even if their signs of
lacquer will be removed.
illness are the same as yours.
• If you get any side effects talk to Pregnancy and breast-feeding
your doctor or your pharmacist. Amorolfine should not be used
during pregnancy and/or lactation
This includes any possible side
unless clearly necessary.
effects not listed in this leaflet.
If you are pregnant or
See section 4.
breast-feeding, think you may be
In this leaflet:
pregnant or are planning to have a
1. What Amorolfine 5% w/v
baby, ask your doctor or
Medicated Nail Lacquer is and
pharmacist for advice before taking
what it is used for
this medicine.
2. What you need to know before
you use Amorolfine 5% w/v
3 How to use Amorolfine
Medicated Nail Lacquer
5% w/v Medicated Nail
3. How to use Amorolfine 5% w/v
Lacquer
Medicated Nail Lacquer
4. Possible side effects
Always use Amorolfine 5% w/v
5. How to store Amorolfine 5% w/v Medicated Nail Lacquer exactly as
Medicated Nail Lacquer
your doctor has told you. You
6. Contents of the pack and other
should check with your doctor or
information
pharmacist if you are not sure.
Amorolfine 5% w/v Medicated Nail
1 What Amorolfine 5% w/v Lacquer should be applied to the
Medicated Nail Lacquer is affected finger or toe nails once or
and what it is used for
twice a week exactly as directed by
your doctor.
• Amorolfine 5% w/v Medicated
Instructions for use:
Nail Lacquer is used to treat
fungal infections of the nails
Step 1: File the nail
• Amorolfine 5% w/v Medicated
Before the first
Nail Lacquer contains the active application, file
ingredient amorolfine (as the
down the infected
hydrochloride) which belongs to areas of nail,
a group of medicines known as including the nail
antifungals.
surface, as much
• It kills a wide variety of fungi
as possible using the nail file
that can cause nail infections.
provided.
CAUTION: Do not use nail files
2 What you need to know
used for infected nails on healthy
before you use Amorolfine nails, otherwise you may spread
5% w/v Medicated Nail
the infection. To prevent the spread
Lacquer
of infection take care that no one
else uses the files from your kit.
Do not use Amorolfine 5% w/v
Medicated Nail Lacquer if you are: Step 2: Clean the
nail
• allergic (hypersensitive) to
Use one of the
amorolfine or any of the other
swabs provided (or
ingredients of Amorolfine 5 %
nail varnish
w/v Nail Lacquer (see section 6
remover) to clean the nail surface.
for other ingredients).
Repeat steps 1 and 2 for each
Warnings and precautions
affected nail.
Talk to your doctor before using
Amorolfine 5% w/v Medicated Nail Step 3: Take some
lacquer from the
Lacquer:
bottle
• if you suffer from diabetes.
• if you are being treated because Dip one of the
re-usable
you have a weak immune
applicators into the
system.
bottle of nail lacquer. The lacquer
• if you have poor circulation in
must not be wiped off the edge of
your hands and feet.
• if your nail is severely damaged the bottle before it is applied.
Step 4: Apply the
or infected.
Your doctor can advise you on how lacquer
Apply the lacquer
to use Amorolfine 5% w/v
Medicated Nail Lacquer when you evenly over the
entire surface of
have one of the above conditions
the nail.
Repeat this step for each affected
If you get Amorolfine 5% w/v
nail.
Medicated Nail Lacquer in your
eyes or ears wash it out with water Let the treated nail(s) dry for
approximately 3 minutes.
immediately and contact your
doctor, pharmacist or nearest
Step 5: Clean the applicator
hospital straight away.
The applicators provided are
re-usable. However, it is important
Avoid the lacquer coming into
to clean them thoroughly after
contact with mucous membranes
completing each treatment
(e.g. mouth and nostrils). Do not
procedure, using the same swab
breathe it in.

Amorolfine 5% w/v
Medicated Nail Lacquer

Version:

4

22 March 2016

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
previously described.
• When dry, the nail lacquer is
unaffected by soap and water,
so you may 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
Amorolfine 5% w/v Medicated
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.

5 How to store Amorolfine
5% w/v Medicated Nail
Lacquer

• Keep this medicine out of the
sight and reach of children.
• Do not use Amorolfine 5% w/v
Medicated Nail Lacquer 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!
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 Amorolfine 5% w/v
Medicated Nail Lacquer contains:
Amorolfine 5% w/v Medicated Nail
Lacquer contains 50 mg/ml of the
active substance amorolfine
(equivalent to 55.74 mg/ml
Your doctor will probably check
how your treatment is progressing amorolfine hydrochloride). The
other ingredients are Eudragit RL
every 3 months or so.
100 (ammonio methacrylate
If you accidentally swallow
copolymer A), triacetin, butyl
Amorolfine 5% w/v Medicated Nail acetate, ethyl acetate and ethanol
Lacquer
(anhydrous).
If you, or anyone else, accidentally
swallows the lacquer contact your What Amorolfine 5% w/v
Medicated Nail Lacquer looks like
doctor, pharmacist or nearest
and contents of the pack
hospital straight away.
Amorolfine 5% w/v Medicated Nail
If you forget to use Amorolfine 5% Lacquer is a clear, colourless to
w/v Medicated Nail Lacquer
pale yellow solution. It is available
Do not worry if you forget to use
in 2.5 ml, 3 ml and 5 ml packs; 1
the lacquer at the right time. When bottle packed with cleaning wipes,
you remember, start using the
nail files and spatulas.
product again, in the same way as
Not all pack sizes may be
before.
marketed.
If you stop using Amorolfine 5%
Marketing Authorisation Holder
w/v Medicated Nail Lacquer
and Manufacturer
Do not stop using Amorolfine 5%
w/v Medicated Nail Lacquer before Marketing Authorisation holder:
TEVA UK Limited, Eastbourne,
your doctor tells you to or your
BN22 9AG.
infection could come back. If you
have any further questions on the
Manufacturer:
use of this product, ask your doctor Chanelle Medical
or pharmacist.
Loughrea
Co. Galway
Possible
side
effects
4
Ireland
Like all medicines, Amorolfine 5% This leaflet was last amended in:
w/v Medicated Nail Lacquer can
03/2016
cause side effects, although not
PL 00289/1681
everybody gets them.
Rare side effects (may affect up to
1 in 1,000 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 nail.
Not known (frequency cannot be
estimated from the available data)
Skin redness, itching, hives, blister.
Reporting of side effects
If you get 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.

18604-D

Expand Transcript

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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