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FUCITHALMIC1 % W/W VISCOUS EYE DROPS

Active substance(s): FUSIDIC ACID MICRONISED STERILE / FUSIDIC ACID MICRONISED STERILE / FUSIDIC ACID MICRONISED STERILE

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PATIENT INFORMATION LEAFLET

2961
25.07.16[1]

Fucithalmic® 1% w/w Viscous Eye Drops
(fusidic acid)
Your medicine is available using the above name but will be referred to as
Fucithalmic throughout this leaflet.
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.
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
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).
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.
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.

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.
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.
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
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
Side effects where the number of people affected is not known:
 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.
5. How to store Fucithalmic
 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.
 Do not store above 25°C. Keep the tube tightly closed.
Medicines should not be disposed of via drains or household waste. Ask
your pharmacist how to dispose of medicines no longer required. These
measures will help to protect the environment.

6. Further Information
What Fucithalmic contains
 The active ingredient is fusidic acid.
Each gram contains 10mg fusidic acid (as hemihydrate).
 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, viscous liquid.
Fucithalmic comes in plastic tubes of 5g.
Manufacturer and Product Licence holder
Manufactured by LEO Laboratories Limited, 285 Cashel Road, Dublin 12,
Ireland.
Procured from within the EU by Product Licence holder:
Star Pharmaceuticals Ltd., 5 Sandridge Close, Harrow, Middlesex, HA1
1XD. Repackaged by Servipharm Ltd.
POM

PL 20636/2961

Leaflet revision and issue date (Ref.) 25.07.16[1]
Fucithalmic is a trademark of Amdipharm Mercury International Limited.

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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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