Skip to Content

FUCITHALMIC 1% W/W VICOUS EYE DROPS

Active substance(s): FUSIDIC ACID

View full screen / Print PDF » Download PDF ⇩
Transcript
S1794 LEAFLET Fucithalmic 20160516

PACKAGE LEAFLET: INFORMATION FOR THE USER

Important information about some of the ingredients of
Fucithalmic
Fucithalmic contains:

Fucithalmic®

1% w/w Viscous Eye Drops
(fusidic acid)

Your medicine is known as Fucithalmic 1% w/w Viscous Eye Drops
but will be referred to as Fucithalmic throughout the following
patient information 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:



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.

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).

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.

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.

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 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.

Taking all the course of Fucithalmic

Pregnancy and breast-feeding

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.

Please ask your doctor or pharmacist for advice before using
Fucithalmic:

What to do if you use more Fucithalmic than you should



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.

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.

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.

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

5. HOW TO STORE FUCITHALMIC

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



KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Do not store above 25°C. Keep the tube tightly closed.



Do not keep the tube for more than one month after you first
open it.



Do not use the drops after the expiry date which is stated on the
tube and the outer carton after “EXP”. The expiry date refers to
the last day of that month.



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.

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
6. FURTHER INFORMATION

Other possible side effects:

What Fucithalmic contains

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

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, slightly thick liquid.
Fucithalmic comes in tubes of 5 g.
Product Licence holder
Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Ltd, Chemilines House,
Alperton Lane, Wembley, HA0 1DX.

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

Manufacturer

Reporting of side effects

This product is manufactured by LEO Laboratories Limited, Cashel
Road, Dublin12, Ireland.

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.

POM

PL: 19488/1794

Leaflet revision date: 16 May 2016
Fucithalmic is a registered trademark of Amdipharm Mercury
International Limited.
S1794 LEAFLET Fucithalmic 20160516

S1794 LEAFLET Fusidic acid 20160516

PACKAGE LEAFLET: INFORMATION FOR THE USER

Important information about some of the ingredients of Fusidic
acid
Fusidic acid contains:

Fusidic acid 1% w/w Viscous Eye Drops
Your medicine is known as Fusidic acid 1% w/w Viscous Eye Drops
but will be referred to as Fusidic acid throughout the following
patient information leaflet.



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 FUSIDIC ACID

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 Fusidic acid is and what it is used for
2. Before you use Fusidic acid

Always use Fusidic acid exactly as your doctor has told you. You
should check with your doctor or pharmacist if you are not sure.
How to use Fusidic acid
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 Fusidic acid. 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.

3. How to use Fusidic acid
4. Possible side effects
5. How to store Fusidic acid
6. Further information
1. WHAT FUSIDIC ACID IS AND WHAT IT IS USED FOR
Fusidic acid belongs to a group of medicines called anti-infectives.
It is a type of antibiotic.
Fusidic acid works by killing germs (bacteria) that cause infections.

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.

Fusidic acid is an eye drop medicine used to treat infections of the
eyes caused by germs (bacterial conjunctivitis).

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.

2. BEFORE YOU USE FUSIDIC ACID

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.

Do not use Fusidic acid


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 Fusidic acid


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

How much Fusidic acid 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:

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
Fusidic acid:


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.

The usual dose is one drop twice each day, in the morning and in
the evening.
Taking all the course of Fusidic acid
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 Fusidic acid 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 Fusidic acid
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

5. HOW TO STORE FUSIDIC ACID

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



KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Do not store above 25°C. Keep the tube tightly closed.



Do not keep the tube for more than one month after you first
open it.



Do not use the drops after the expiry date which is stated on the
tube and the outer carton after “EXP”. The expiry date refers to
the last day of that month.



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.

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
6. FURTHER INFORMATION

Other possible side effects:

What Fusidic acid contains

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

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 Fusidic acid looks like and contents of the pack
Fusidic acid is a white to off-white, slightly thick liquid.
Fusidic acid comes in tubes of 5 g.
Product Licence holder
Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Ltd, Chemilines House,
Alperton Lane, Wembley, HA0 1DX.

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

Manufacturer

Reporting of side effects

This product is manufactured by LEO Laboratories Limited, Cashel
Road, Dublin12, Ireland.

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.

POM

PL: 19488/1794

Leaflet revision date: 16 May 2016
S1794 LEAFLET Fusidic acid 20160516

Expand view ⇕

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.

Hide