Skip to Content

DICLOFENAC SODIUM MULTIDOSE 0.1% EYE DROPS

Active substance: DICLOFENAC SODIUM

View full screen / Print PDF » Download PDF ⇩
Transcript
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.
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 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 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 start to use Voltarol
Ophtha
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.)
 You are more than 6 months pregnant.
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.
Are you taking other medicines?
Voltarol 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 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
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.
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?
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.
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.
Very common (may affect more than 1 in 10 people):
 Eye pain.
The following side effects have also been reported:
 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.
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. Website:
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 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.

6. Further information
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.
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

POM

Voltarol is a registered trademark of Novartis Pharmaceuticals UK
Limited.
Leaflet date: 27.04.2015
How to use Voltarol Ophtha






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 anti-inflammatory 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 start to use 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?
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.
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.
Very common (may affect more than 1 in 10 people):
 Eye pain.
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.

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. Website:
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 Diclofenac sodium Ophtha
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.

6. Further information
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.
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

POM

Leaflet date: 27.04.2015
How to use Diclofenac sodium Ophtha






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.

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