DICLOFENAC SODIUM MULTIDOSE 0.1% EYE DROPS

Active substance: DICLOFENAC SODIUM

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Voltarol® Ophtha Multidose
0.1% Eye Drops
(diclofenac sodium)
Patient Information Leaflet
Your doctor has decided that you need these eye drops
to help treat your condition.
Please read this leaflet carefully before you start to
use the eye drops. It contains important information.
Keep the leaflet in a safe place because you may want
to read it again.

You should also ask yourself these questions before
you have Voltarol Ophtha:
 Do you have an eye infection?
 Are you using any other eye drops?
 Do you have any bleeding disorders?
 Do you wear soft contact lenses?
 Are you pregnant or breast feeding?
If the answer to any of these questions is YES, tell your
doctor or pharmacist because Voltarol Ophtha might not
be the right medicine for you.

If you have any other questions, or if there is something
you don’t understand, please ask your doctor or
pharmacist.

Are you taking other medicines?

This medicine has been prescribed for you. Never give it
to someone else. It may not be the right medicine for
them even if their symptoms seem to be the same as
yours.

 Medicines to prevent your blood clotting.

If any of the side effects gets serious, or if you notice
any side effects not listed in this leaflet, please tell your
doctor or pharmacist.
The eye drops will be referred to as Voltarol Ophtha in
this leaflet.
In this leaflet:
1. What Voltarol Ophtha are and what they are used for
2. Things to consider before you start to use Voltarol
Ophtha
3. How to use Voltarol Ophtha
4. Possible side effects
5. How to store Voltarol Ophtha
6. Further information

1. What Voltarol Ophtha are and what they are
used for
Voltarol Ophtha contain 0.1% of the active ingredient
diclofenac sodium. Diclofenac sodium is one of a group
of medicines called non-steroidal anti-inflammatory
drugs (NSAIDs). NSAIDs reduce pain and inflammation.

Voltarol Ophtha may interfere with other drugs you might
be taking or using.
Tell your Doctor if you are taking or using:
 Eye drops or ointment containing steroids such as
hydrocortisone or betamethasone.
Always tell your doctor or pharmacist about all the
medicines you are taking. This means medicines you
have bought yourself as well as medicines on
prescription from your doctor.
Will there be any problems with driving or using
machinery?
Some people may have problems with their eyes such
as blurred vision, while they are being treated with
Voltarol Ophtha. If you are affected, you should not drive
or use machinery.
Other special warnings
 The eye drops contain benzalkonium chloride as a
preservative. This can sometimes irritate the eyes. If
you wear contact lenses, remove them before you
use the eye drops and do not put them back in for at
least 15 minutes. Soft contact lenses must not come
into contact with benzalkonium chloride. They may
become discoloured.
 If you are using more than one sort of eye drops
leave five minutes between applications.

3. How Voltarol Ophtha is used
Voltarol Ophtha are used
 before eye surgery, to help keep the pupil open
during surgery, or
 after eye surgery or injury, to control pain and/or
inflammation,
 to reduce the symptoms, such as red, runny or itchy
eyes associated with seasonal allergic conjunctivitis
(hayfever).

When Voltarol Ophtha is being used during eye surgery
the doctor will work out the correct dose.
If you have been prescribed the drops to use at home
the doctor will tell you how and when to use them.
Always follow the doctor’s instructions carefully.
The usual dose is 1 drop in the affected eye 4 times
a day.

2. Things to consider before you have Voltarol
Ophtha

How often you use the drops, and how long you use
them for, will be different depending on your condition.

Some people MUST NOT have Voltarol Ophtha. Talk
to your doctor if:

you think you may be allergic to diclofenac sodium,
aspirin or any other NSAIDs, or to any of the other
ingredients of the eye drops. (These are listed at
the end of the leaflet.)

The dose will be on the pharmacist’s label. Check the
label carefully. If you are not sure, ask your doctor or
pharmacist.



These drops should not be used in children under 18
years old.

You are more than 6 months pregnant.

Instructions for using the eye drops are given at the end
of this leaflet.

What if you forget to use the drops?

6. Further information

If you miss a dose continue with the next dose as normal.
Do not double the dose to make up for the one you
missed.

Each ml of eye drops solution contains 1mg diclofenac
sodium. It also contains the inactive ingredients
benzalkonium chloride (a preservative) and disodium
edetate, hydroxypropyl g-cyclodextrin, hydrochloric acid,
propylene glycol, trometamol, tyloxapol and water for
injection.

What if you use too much?
If you use too much or if you accidentally swallow the
eye drops, see your doctor at once or go to your nearest
hospital casualty department. Take your medicine with
you.

4. Possible side effects
Voltarol Ophtha are suitable for most people, but, like all
medicines, they can sometimes cause side effects.
Stop using Voltarol Ophtha and tell your doctor
straight away if you notice:
 Allergic reactions in your eyes such as red, itching
and swollen eyes and eyelids.
 Other general allergic reaction symptoms such as
rash, redness, itching, cough and runny or stuffy
nose.

Voltarol Ophtha Multidose 0.1% Eye Drops solution is a
5ml white LDPE bottle with LDPE dropper and HDPE
closure containing a clear, colourless, odourless solution.
Manufactured by: Excelvision S.A.S., Rue de la
Lombardiere, Annonay, F-07100, France.
Procured from within the EU & repackaged by
Product Licence holder: Kosei Pharma UK Ltd.,
956 Buckingham Avenue, Slough Trading Estate,
SL1 4NL.
®

Voltarol Ophtha Multidose 0.1% Eye Drops,
PL 39352/0063
Voltarol is a registered trademark of Novartis
Pharmaceuticals UK Limited.

The following side effects have also been reported:
 Eye pain.

Leaflet date: 27.06.2013

 A mild or moderate burning sensation and/or redness
in the eyes.

POM

How to use Voltarol Ophtha

 Blurred vision immediately after using the eye drops.
 Breathlessness and wheezing or other symptoms of
asthma.
 Unusual sensitivity to light.
 Damage to cells on the surface of the cornea (the
membrane covering the front of the eye), corneal
thinning or ulcers that might result in loss of sight.
If any of these symptoms become troublesome, or if
you notice anything else not mentioned here, please
go and see your doctor. He/she may want to give
you a different medicine.

5. How to store Voltarol Ophtha
Keep all medicines out of the sight and reach of children.
Do not use the drops after the expiry date which is
printed on the outside of the pack.
Discard 4 weeks after opening.
If your doctor tells you to stop using Voltarol Ophtha,
please take any left back to your pharmacist to be
destroyed. Only keep the drops if the doctor tells you to.
Do not throw them away with your normal household
water or waste. This will help to protect the environment.
If your medicine gets discoloured or shows any other
signs of deterioration, seek the advice of your
pharmacist.

 Wash your hands before using the drops
 Remove the cap from the dropper bottle
 Make sure that the tip of the bottle does not touch
anything
 Hold the bottle in one hand between the thumb and
forefinger
 Tilt your head back, and use your other forefinger to
pull down the lower eyelid
 Place the dropper tip close to your eye, but not
touching the eye or lid, and gently squeeze the bottle
to release one drop into your eye
 Close your eyelid and gently press the corner of your
eye with your forefinger for three minutes
 Replace the cap and wash your hands.
Follow these instructions carefully. Consult your doctor
or pharmacist if there is anything you do not understand.

Diclofenac sodium Multidose
0.1% Eye Drops
Patient Information Leaflet
Your doctor has decided that you need these eye drops
to help treat your condition.
Please read this leaflet carefully before you start to
use the eye drops. It contains important information.
Keep the leaflet in a safe place because you may want
to read it again.
If you have any other questions, or if there is something
you don’t understand, please ask your doctor or
pharmacist.
This medicine has been prescribed for you. Never give it
to someone else. It may not be the right medicine for
them even if their symptoms seem to be the same as
yours.
If any of the side effects gets serious, or if you notice
any side effects not listed in this leaflet, please tell your
doctor or pharmacist.
The eye drops will be referred to as Diclofenac sodium
Ophtha in this leaflet.
In this leaflet:
1. What Diclofenac sodium Ophtha are and what they
are used for
2. Things to consider before you start to use Diclofenac
sodium Ophtha
3. How to use Diclofenac sodium Ophtha
4. Possible side effects
5. How to store Diclofenac sodium Ophtha
6. Further information

1. What Diclofenac sodium Ophtha are and
what they are used for
Diclofenac sodium Ophtha contain 0.1% of the active
ingredient diclofenac sodium. Diclofenac sodium is one
of a group of medicines called non-steroidal antiinflammatory drugs (NSAIDs). NSAIDs reduce pain and
inflammation.
Diclofenac sodium Ophtha are used
 before eye surgery, to help keep the pupil open
during surgery, or
 after eye surgery or injury, to control pain and/or
inflammation,
 to reduce the symptoms, such as red, runny or itchy
eyes associated with seasonal allergic conjunctivitis
(hayfever).

2. Things to consider before you have
Diclofenac sodium Ophtha
Some people MUST NOT have Diclofenac sodium
Ophtha. Talk to your doctor if:

you think you may be allergic to diclofenac sodium,
aspirin or any other NSAIDs, or to any of the other
ingredients of the eye drops. (These are listed at
the end of the leaflet.)


You are more than 6 months pregnant.

You should also ask yourself these questions before
you have Diclofenac sodium Ophtha:
 Do you have an eye infection?
 Are you using any other eye drops?
 Do you have any bleeding disorders?
 Do you wear soft contact lenses?
 Are you pregnant or breast feeding?
If the answer to any of these questions is YES, tell your
doctor or pharmacist because Diclofenac sodium
Ophtha might not be the right medicine for you.
Are you taking other medicines?
Diclofenac sodium Ophtha may interfere with other
drugs you might be taking or using.
Tell your Doctor if you are taking or using:
 Medicines to prevent your blood clotting.
 Eye drops or ointment containing steroids such as
hydrocortisone or betamethasone.
Always tell your doctor or pharmacist about all the
medicines you are taking. This means medicines you
have bought yourself as well as medicines on
prescription from your doctor.
Will there be any problems with driving or using
machinery?
Some people may have problems with their eyes such
as blurred vision, while they are being treated with
Diclofenac sodium Ophtha. If you are affected, you
should not drive or use machinery.
Other special warnings
 The eye drops contain benzalkonium chloride as a
preservative. This can sometimes irritate the eyes. If
you wear contact lenses, remove them before you
use the eye drops and do not put them back in for at
least 15 minutes. Soft contact lenses must not come
into contact with benzalkonium chloride. They may
become discoloured.
 If you are using more than one sort of eye drops
leave five minutes between applications.

3. How Diclofenac sodium Ophtha is used
When Diclofenac sodium Ophtha is being used during
eye surgery the doctor will work out the correct dose.
If you have been prescribed the drops to use at home
the doctor will tell you how and when to use them.
Always follow the doctor’s instructions carefully.
The usual dose is 1 drop in the affected eye 4 times
a day.
How often you use the drops, and how long you use
them for, will be different depending on your condition.
The dose will be on the pharmacist’s label. Check the
label carefully. If you are not sure, ask your doctor or
pharmacist.
Instructions for using the eye drops are given at the end
of this leaflet.
These drops should not be used in children under 18
years old.

What if you forget to use the drops?

6. Further information

If you miss a dose continue with the next dose as normal.
Do not double the dose to make up for the one you
missed.

Each ml of eye drops solution conatins 1 mg diclofenac
sodium. It also contains the inactive ingredients
benzalkonium chloride (a preservative) and disodium
edetate, hydroxypropyl g-cyclodextrin, hydrochloric acid,
propylene glycol, trometamol, tyloxapol and water for
injection.

What if you use too much?
If you use too much or if you accidentally swallow the
eye drops, see your doctor at once or go to your nearest
hospital casualty department. Take your medicine with
you.

4. Possible side effects
Diclofenac sodium Ophtha are suitable for most people,
but, like all medicines, they can sometimes cause side
effects.
Stop using Diclofenac sodium Ophtha and tell your
doctor straight away if you notice:
 Allergic reactions in your eyes such as red, itching
and swollen eyes and eyelids.
 Other general allergic reaction symptoms such as
rash, redness, itching, cough and runny or stuffy
nose.

Voltarol Ophtha Multidose 0.1% Eye Drops solution is a
5ml white LDPE bottle with LDPE dropper and HDPE
closure containing a clear, colourless, odourless solution
Manufactured by: Excelvision S.A.S., Rue de la
Lombardiere, Annonay, F-07100, France.
Procured from within the EU & repackaged by
Product licence holder: Kosei Pharma UK Ltd.,
956 Buckingham Avenue, Slough Trading Estate,
SL1 4NL.
Diclofenac sodium Multidose 0.1% Eye Drops,
PL 39352/0063
Leaflet date: 27.06.2013

POM

How to use Diclofenac sodium Ophtha
The following side effects have also been reported:
 Eye pain.
 A mild or moderate burning sensation and/or redness
in the eyes.
 Blurred vision immediately after using the eye drops.
 Breathlessness and wheezing or other symptoms of
asthma.
 Unusual sensitivity to light.
 Damage to cells on the surface of the cornea (the
membrane covering the front of the eye), corneal
thinning or ulcers that might result in loss of sight.

 Wash your hands before using the drops
 Remove the cap from the dropper bottle
 Make sure that the tip of the bottle does not touch
anything
 Hold the bottle in one hand between the thumb and
forefinger
 Tilt your head back, and use your other forefinger to
pull down the lower eyelid
 Place the dropper tip close to your eye, but not
touching the eye or lid, and gently squeeze the bottle
to release one drop into your eye

If any of these symptoms become troublesome, or if
you notice anything else not mentioned here, please
go and see your doctor. He/she may want to give
you a different medicine.

 Close your eyelid and gently press the corner of your
eye with your forefinger for three minutes

5. How to store Diclofenac sodium Ophtha

Follow these instructions carefully. Consult your doctor
or pharmacist if there is anything you do not understand.

Keep all medicines out of the reach and sight of children.
Do not use the drops after the expiry date which is
printed on the outside of the pack.
Discard 4 weeks after opening.
If your doctor tells you to stop using Diclofenac sodium
Ophtha, please take any left back to your pharmacist to
be destroyed. Only keep the drops if the doctor tells you
to. Do not throw them away with your normal household
water or waste. This will help to protect the environment.
If your medicine gets discoloured or shows any other
signs of deterioration, seek the advice of your
pharmacist.

 Replace the cap and wash your hands.

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.

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