FUCITHALMIC 1% W/W VISCOUS EYE DROPS

Active substance: FUSIDIC ACID MICRONISED STERILE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Fucithalmic 1% w/w Viscous Eye Drops
Fusidic acid

In this leaflet:
1. What Fucithalmic® is and what it is
used for
2. Before you use Fucithalmic®
3. How to use Fucithalmic®
4. Possible side effects
5. How to store Fucithalmic®
6. Further information

1. WHAT FUCITHALMIC IS AND
WHAT IT IS USED FOR

Important information about some of
the ingredients of Fucithalmic®
Fucithalmic® contains:
• Benzalkonium chloride. This is a
preservative. It may cause eye
irritation.
Please ask your doctor if you are
worried about any of the ingredients in
this medicine.

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Fucithalmic® belongs to a group of
medicines called anti-infectives. It is a
type of antibiotic.
Fucithalmic® works by killing germs
(bacteria) that cause infections.
Fucithalmic is an eye drop medicine
used to treat infections of the eyes
caused by germs (bacterial
conjunctivitis).

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2. BEFORE YOU USE FUCITHALMIC®
Do not use Fucithalmic®
• If you are allergic (hypersensitive) to
fusidic acid, or any of the other
ingredients in your medicine. You can
find a list of these ingredients in
section 6 of this leaflet.
Take special care with Fucithalmic
• Do not wear any type of contact
lenses whilst using this medicine.

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Taking other medicines
Please tell your doctor or pharmacist if
you are taking, or have recently taken
any other medicines. This includes any
medicines which you have bought
without a prescription.
Pregnancy and breast-feeding
Please ask your doctor or pharmacist
for advice before using Fucithalmic®:
• If you are pregnant, or think you are
pregnant.
• If you are breast-feeding.
Tell your doctor if you become
pregnant while using this medicine.
Driving and using machines
Following application of your
medicine, a brief blurring of vision may
occur. Do not drive or use machinery
until your vision is clear. Check with
your doctor if you feel any side effect
that may stop you from driving or
using machines.

3. HOW TO USE FUCITHALMIC®
Always use Fucithalmic® exactly as
your doctor has told you. You should
check with your doctor or pharmacist if
you are not sure.
How to use Fucithalmic®
This medicine is only for use in your
eyes. Do not swallow the drops. Do not
put the drops inside your body or in
your ears.
Always wash your hands before using
Fucithalmic®. Do not use if the cap seal
on the tube is broken.
This diagram will help show how to
use your medicine. It may be useful to
look in a mirror.
Only take the
cap off the tube
when you are
ready to use the
medicine. It is
important the tip
of the tube does
not touch your
eye.
Tilt your head back. Pull your lower
eyelid down gently. Hold the tube over
your eye and look up.
Squeeze one drop into your lower
eyelid. The drop will come out as a
thick drop. It will become more liquid
in your eye and you should still see
clearly.
After using your medicine you may see
a white powder around your eye. This
can happen when the drops dry out. It
is quite normal and is nothing to worry
about. You can wipe the powder off
with cotton wool.
If the medicine is for a child, you can
put the drops in their eye while they
are asleep or lying down if it is easier.

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Please read all of this leaflet carefully before you start taking 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 become serious, or you notice any side effects not
listed in this leaflet please tell your doctor or pharmacist.

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Adults, the elderly and children:
The usual dose is one drop twice each
day, in the morning and in the evening.
Taking all the course of Fucithalmic®
It is very important to use all the
medicine that your doctor has told you
to use. You must use your medicine for
at least 48 hours after you feel better
and your eye looks normal. You must
do this because otherwise your eye
infection may come back.

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What to do if you use more
Fucithalmic® than you should
If you accidentally apply too many
drops in the eye(s) or a small quantity
of the drops are accidentally
swallowed, it is unlikely to cause any
harm. If a larger quantity of the drops
are accidentally swallowed or you are
worried contact your doctor,
pharmacist or A+E department for
advice.
If you forget to use Fucithalmic®
If you forget to use your medicine, use
it as soon as you remember. Then next
use your medicine at the usual time.
If you have any further questions about
taking this medicine, please ask your
doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Fucithalmic® can
cause side effects, although not
everybody gets them.
Important side effects to look out for:
You must get urgent medical help
if you have any of the following
symptoms. You may be having an
allergic reaction:
• You have difficulty breathing
• Your face, especially around your
eyes or your eyelids, or throat swell
• Your skin develops a severe rash
• You have burning or stinging in your
eye that does not go away
Other possible side effects:
Common side effects (probably affect
less than 1 in 10 people)
• Burning, stinging, discomfort,
smarting, irritation, itching, soreness
or dryness in the eye being treated.
• Blurring of vision in the eye being
treated.
Uncommon side effects (probably
affect less than 1 in 100 people)
• Watery eyes or crying on application

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If any of the side effects become
serious or you notice any side effects
not listed in this leaflet, tell your doctor
or pharmacist.
Reporting of side effects:
If you get any side effects, talk to your
doctor, pharmacist or nurse. 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 FUCITHALMIC

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• Keep out of the sight and reach of
children.
• Do not use the drops after the expiry
date on the carton. The expiry date is
the last day of that month.
• Do not keep the tube for more than
one month after you first open it.
• Store below 25°C. Keep the tube
tightly closed.
Medicines should not be thrown away
in waste water or in household waste.
Please ask your pharmacist how to
throw away any medicine you do not
need anymore. If you do this you will
help protect the environment.

6. FURTHER INFORMATION
What Fucithalmic® contains
• The active ingredient is fusidic acid.
Fucithalmic® contains 10 milligrams of
fusidic acid in each gram of drops.
• The other ingredients are
benzalkonium chloride, disodium
edetate, mannitol, carbomer, sodium
hydroxide and water for injections.
You can find important information about
some of the ingredients in your medicine
near the end of section 2 of this leaflet.
What Fucithalmic® looks like and
contents of the pack
Fucithalmic® is a white to off-white,
slightly thick liquid. Fucithalmic® comes
in tubes of 5 g.
Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder:
Amdipharm UK Limited,
Capital House,
85 King William Street,
London, EC4N 7BL, UK
Manufacturer:
LEO Laboratories Limited, Dublin 12,
Ireland.
This leaflet was last revised in
February 2014.

Amdipharm is licensed to use the
registered trademark Fucithalmic ®.

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You should use your medicine twice
each day. To remind you to use your
medicine it may help to use it when
you do another regular action, such as
brushing your teeth.

Side effects where the number of
people affected is not known:
• Itching
• Rash
• Hives
• Conjunctivitis may get worse

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How much Fucithalmic® to use
Your doctor will tell you how many
drops to use, or to give to your child.

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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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