FUCITHALMIC VISCOUS EYE DROPS

PACKAGE LEAFLET: INFORMATION FOR THE USER

Fucithalmic® Viscous Eye Drops
Fusidic Acid 1% Viscous Eye Drops
(fusidic acid)

Your medicine is available using one of the above names but
will be referred to as Fucithalmic throughout this leaflet.

Please read all of this leaflet carefully before
you start taking this medicine.

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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.

In this leaflet:
1.
2.
3.
4.
5.
6.

What Fucithalmic is and what it is used for
Before you use Fucithalmic
How to use Fucithalmic
Possible side effects
How to store Fucithalmic
Further information

1. What Fucithalmic is and what it is used for
Fucithalmic belongs to a group of medicines called antiinfectives. 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).

2. Before you use Fucithalmic
Do not use Fucithalmic
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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
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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:
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If you are pregnant, or think you are pregnant.
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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.

Important information about some of the
ingredients of Fucithalmic

Fucithalmic contains:
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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.

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.

Do not wear any type of contact lenses whilst using this
medicine.

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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.

How much Fucithalmic to use

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

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.

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

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Like all medicines, Fucithalmic can cause side effects,
although not everybody gets them.

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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:
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You have difficulty breathing
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Your face, especially around your eyes or your
eyelids, or throat swell
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Your skin develops a severe rash
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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)
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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)
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Watery eyes or crying on application

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

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.

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The eye drops should not be used after the expiry date
printed on both the carton and label on the tube. The
expiry date is the last day of that month.
Any solution remaining 28 days after first opening the
tube should be discarded or taken to your pharmacist for
safe disposal.
If the drops become discoloured or show any other signs
of deterioration, you should seek the advice of a
pharmacist.
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 name of your viscous eye drops is Fucithalmic
Viscous Eye Drops / Fusidic Acid 1% Viscous Eye Drops.
Each gram of eye drop solution contains 10mg of fusidic
acid hemihydrate as the active ingredient.
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Fucithalmic Eye Drops / Fusidic Acid 1% Viscous Eye
Drops also contains the following:
Benzalkonium chloride, disodium edetate, mannitol,
carbomer 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.
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What Fucithalmic looks like and contents of the
pack

Fucithalmic is packaged as a carton containing one 5g tube
and is ONLY for use in the eyes.

Manufacturer

Manufactured by: Leo Laboratories Limited, 285 Cashel Road,
Dublin 12, Ireland.
Procured from within the EU and repackaged by the Licence
Holder: Doncaster Pharmaceuticals Group Limited, Kirk
Sandall Industrial Estate, Kirk Sandall, Doncaster, DN3 1QR.
PL: 04423/0338

POM

Leaflet revision and issue date (Ref): 29.01.16
Fucithalmic® is a registered trademark of LEO Pharma A/S.

5. How to store Fucithalmic
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Keep the tube in a safe place out of the sight and reach
of children.
Store below 25°C.
Sterile only until opened. Discard any unused solution 4
weeks after opening.
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