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VOLTAROL OPHTHA

Active substance(s): DICLOFENAC SODIUM

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This means medicines you
have bought yourself as well as
medicines on prescription from your
doctor.

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VOLTAROL® Ophtha
Multidose
0.1% Eye Drops

Will there be any problems with
driving or using machinery?
Some people may have problems
Patient Information Leaflet
with their eyes such as blurred
Your doctor has decided that you need
vision, while they are being treated
these eye drops to help treat your
with Voltarol Ophtha. If you are
condition.
affected, you should not drive or
Please read this leaflet carefully
use machinery.
before you start to use the eye
Other special warnings
drops. It contains important
information. Keep the leaflet in a safe • The eye drops contain benzalkonium
chloride as a preservative. This can
place because you may want to read
sometimes irritate the eyes. If you
it again.
wear contact lenses, remove them
If you have any other questions,
before you use the eye drops and
or if there is something you don’t
do not put them back in for at least
understand, please ask your doctor or
15 minutes. Soft contact lenses
pharmacist.
must not come into contact with
This medicine has been prescribed for
benzalkonium chloride. They may
you. Never give it to someone else. It
become discoloured.
may not be the right medicine for them • If you are using more than one sort
even if their symptoms seem to be the
of eye drops leave five minutes
same as yours.
between applications.

(diclofenac sodium)

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

3. How to use Voltarol Ophtha

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
1. What Voltarol Ophtha are and label. Check the label carefully. If you
are not sure, ask your doctor or
what they are used for
pharmacist.
Voltarol Ophtha contain 0.1% of the
Instructions for using the eye drops are
active ingredient diclofenac sodium.
given at the end of this leaflet.
Diclofenac sodium is one of a group
These drops should not be used in
of medicines called non-steroidal antichildren under 18 years old.
inflammatory drugs (NSAIDs). NSAIDs
reduce pain and inflammation.
What if you forget to use the
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

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

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?

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
If the answer to any of these questions
sensation and/or redness in the
is YES, tell your doctor or pharmacist
eyes.
because Voltarol Ophtha might not be • Blurred vision immediately after
the right medicine for you.
using the eye drops.
• Breathlessness and wheezing or
Are you taking other medicines?
other symptoms of asthma.
Voltarol Ophtha may interfere with

Unusual
sensitivity to light.
other drugs you might be taking or
• Damage to cells on the surface of
using.
the cornea (the membrane covering
Tell your doctor if you are taking or
the front of the eye), corneal thinning
using:
or ulcers that might result in loss of
• Medicines to prevent your blood
sight.
clotting.
Reporting of side effects
• Eye drops or ointment containing
If you get any side effects, talk to
steroids such as hydrocortisone or
your doctor, pharmacist or nurse.
betamethasone.
This includes any possible side effects
Always tell your doctor or pharmacist
not listed in this leaflet. You can also
about all the medicines you are taking. report side effects directly via the
Yellow Card Scheme.
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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 reach
and sight of children.

Do not use the drops after the expiry
date which is printed on the outside of
the pack.
Do not use for more than 28 days
after opening the bottle.
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.

6. Further information

Voltarol Ophtha contain 0.1%
(1 mg/ml) of the active ingredient,
diclofenac sodium. They also contain
the inactive ingredients benzalkonium
chloride (a preservative) and disodium
edetate, hydroxypropyl γ-cyclodextrin,
hydrochloric acid, propylene glycol,
trometamol, tyloxapol and water.
The bottles contain 5 ml of eye drops.
The product licence/authorisation
holder is Laboratoires THEA
12 rue Louis Blériot,
63017 Clermont-Ferrand Cedex 2,
France.
Voltarol Ophtha are made by
EXCELVISION,
rue de la Lombardière,
07100 Annonay, France.
This leaflet was last approved in
September 2014.
If you would like any more
information, or would like the
leaflet in a different format, please
contact Medical Information
at THEA Pharmaceuticals Ltd,
telephone number 0870 192 3283.
Voltarol is a registered trademark
Copyright Novartis Pharmaceuticals UK Limited

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.

N2950C5ASP/1117

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

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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