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VOLTAROL OPHTHA MULTIDOSE 0.1% EYE DROPS

Active substance(s): 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.
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 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 label. Check the label carefully.
If you are not sure, ask your doctor or pharmacist.

UK

23299300

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 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 Spectrum 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/1014

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

UK

23299300

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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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