Voltarol Ophtha
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.
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.