Skip to Content

FUCIDIC ACID 1% W/W VISCOUS EYE DROPS

Active substance(s): FUSIDIC ACID

View full screen / Print PDF » Download PDF ⇩
Transcript
PACKAGE LEAFLET: INFORMATION FOR THE USER

Fucithalmic® 1% w/w Viscous Eye Drops
(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.
The name of your medicine is Fucithalmic 1% w/w Viscous Eye Drops but it will
be referred to as Fucithalmic throughout this leaflet.
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 Fucithalmic after the expiry
date which is stated on the tube and
the carton label after ‘Exp’. The expiry
date refers to the last day of that
month.
Do not store above 25°C.
Keep the tube tightly closed.
If your medicine become discoloured or
show any signs of deterioration, seek
the advice of your pharmacist.
Discard one month after first opening.
Medicines should not be disposed of
via wastewater 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 substance is fusidic acid.
Each gram contains 10mg fusidic acid
(as hemihydrate).
The other ingredients are:
benzalkonium chloride, disodium
edetate, mannitol, sodium hydroxide,
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.
What Fucithalmic looks like and
contents of the pack
Fucithalmic is a white to off white
viscous sterile suspension contained
within a 5g tube, which is sealed with a
tamper-evident screw cap.
Manufactured by: LEO Laboratories
Limited, 285 Cashel Road, Dublin 12,
Ireland.
Procured from within the EU and
repackaged by the Product Licence
holder: B&S Healthcare, Unit 4,
Bradfield Road, Ruislip, Middlesex,
HA4 0NU, UK.
Fucithalmic® 1% w/w Viscous Eye
Drops,
POM
PL 18799/2483
Leaflet date: 21.10.2015

PACKAGE LEAFLET: INFORMATION FOR THE USER

Fusidic acid 1% w/w Viscous Eye Drops
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.
The name of your medicine is Fusidic acid 1% w/w Viscous Eye Drops but it will
be referred to as Fusidic acid throughout this leaflet.
In this leaflet:
1. What Fusidic acid is and what it is
used for
2. Before you use Fusidic acid
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.
Fusidic acid is an eye drop medicine
used to treat infections of the eyes
caused by germs (bacterial
conjunctivitis).
2. BEFORE YOU USE FUSIDIC ACID
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.
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.

Important information about some
of the ingredients of Fusidic acid
Fusidic acid 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 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.
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 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:
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
Like all medicines, Fusidic acid 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 FUSIDIC ACID
Keep out of the sight and reach of
children.
Do not use Fusidic acid after the expiry
date which is stated on the tube and
the carton label after ‘Exp’. The expiry
date refers to the last day of that
month.
Do not store above 25°C.
Keep the tube tightly closed.
If your medicine become discoloured or
show any signs of deterioration, seek
the advice of your pharmacist.
Discard one month after first opening.
Medicines should not be disposed of
via wastewater 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 Fusidic acid contains
The active substance is fusidic acid.
Each gram contains 10mg fusidic acid
(as hemihydrate).
The other ingredients are:
benzalkonium chloride, disodium
edetate, mannitol, sodium hydroxide,
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.
What Fusidic acid looks like and
contents of the pack
Fucithalmic is a white to off white
viscous sterile suspension contained
within a 5g tube, which is sealed with a
tamper-evident screw cap.
Manufactured by: LEO Laboratories
Limited, 285 Cashel Road, Dublin 12,
Ireland.
Procured from within the EU and
repackaged by the Product Licence
holder: B&S Healthcare, Unit 4,
Bradfield Road, Ruislip, Middlesex,
HA4 0NU, UK.
Fusidic acid 1%w/w Viscous Eye
Drops,
POM
PL 18799/2483
Leaflet date: 21.10.2015

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