FUCITHALMIC VISCOUS EYE DROPS

Active substance: FUSIDIC ACID

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THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

FUCITHALMIC® VISCOUS EYE DROPS
(fusidic acid)
Patient Information Leaflet

This medicine is known by the above name but will be referred to as Fucithalmic throughout this leaflet.

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.

WARNING!

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.

DATE:

CUSTOMER
APPROVED:

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.

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.

DATE:

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.

06/03/13

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.

UK PIL DATED AUGUST 2011

6464/0624A

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.

CODE:

DT

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.

DATE OF PROOF:

ARTWORKER:

CUSTOMER: Waymade
PRODUCT: Fucithalmic eye drops

PRE-PRESS NO.:

05-0440

Q.A.
APPROVED:

Please ask your doctor if you are worried about any of the ingredients in this medicine.

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.

Colour
Swatch

Black

WARNING!

ARIAL REGULAR FONT SIZE 8
ARIAL REGULAR BOLD FONT SIZE 8
BRIDGED TO
SERETIDE 6464/2342 6464/2343

Notes:

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

PROOF HISTORY:
v.1 - waymade - 06/03/13

Leaflet Flat Size = 148 x 317

27mm

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

000-0000A

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

Adults, the elderly and children:
The usual dose is one drop twice each day, in the morning and in the evening.

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:

WARNING!

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

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

06/03/13

DT

DATE:

5. HOW TO STORE FUCITHALMIC
• Do not use after the expiry date printed on the tube or carton label. The expiry date refers to the last day of
that month.
• Fucithalmic viscous eye drops should not be stored above 25°C. Keep the cap tightly closed. The tube
should be discarded one month after opening.
• Keep all medicines out of the sight and reach of children.
• If your doctor tells you to stop using the drops, please take them back to the pharmacist for safe disposal.
Only keep the medicine if your doctor tells you to.
• If the drops become discoloured or show any other signs of deterioration, you should seek the advice of
your 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
Your medicine is called Fucithalmic viscous eye drops. It contains the active ingredient Fusidic Acid 1% w/w,
in a white to off-white gel.

DATE OF PROOF:

ARTWORKER:

PRE-PRESS NO.:

05-0440

Q.A.
APPROVED:

If any of the side effects become serious or you notice any side effects not listed in this leaflet, tell your doctor
or pharmacist.

Fucithalmic viscous eye drops also contain the following:
Benzalkonium chloride, disodium edetate, mannitol, carbomer, sodium hydroxide and water for injection.

UK PIL DATED AUGUST 2011

6464/0624A
CODE:

CUSTOMER: Waymade
PRODUCT: Fucithalmic eye drops

Fucithalmic viscous eye drops are available as tubes of 5g.
POM

PL No: 6464/0624

This product is manufactured by LEO Laboratories Ltd., Cashel Road, Dublin, Ireland and is procured from
within the EU and repackaged by the Product Licence holder:
Waymade plc, Miles Gray Road, Basildon, Essex SS14 3FR
Leaflet revision and issue date (Ref.) 6.3.2013
Fucithalmic is a registered trademark of LEO PHARMA A/S

Colour
Swatch

Black

WARNING!

DATE:

CUSTOMER
APPROVED:

Uncommon side effects (probably affect less than 1 in 100 people)
• Watery eyes or crying on application

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

Leaflet Flat Size = 148 x 317

ARIAL REGULAR FONT SIZE 8
ARIAL REGULAR BOLD FONT SIZE 8
BRIDGED TO
SERETIDE 6464/2342 6464/2343

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.

PROOF HISTORY:
v.1 - waymade - 06/03/13

Notes:

27mm

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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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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