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Active substance(s): FLURBIPROFEN SODIUM

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Insert - Ocufen® - UK - MoH Submission

Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required.
These measures will help to protect the environment.
6. Further Information
What OCUFEN contains
• The active substance is Flurbiprofen sodium 0.03% w/v
• The other ingredients are LIQUIFILM® (polyvinyl alcohol), potassium
chloride, sodium chloride, sodium citrate dihydrate, citric acid
monohydrate, hydrochloric acid or sodium hydroxide (for pH-adjustment)
and purified water.
What OCUFEN looks like and contents of the pack
OCUFEN is a sterile eye drop and each clear plastic vial contains 0.4 ml of
the medicine.
Marketing Authorisation Holder
Allergan Limited
Marlow International
The Parkway

Package leaflet:
Information for the user

Eye drops, solution

Flurbiprofen sodium 0.03% w/v
Read all of this leaflet carefully before you start using this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others.
It may harm them, even if their symptoms are 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.
In this leaflet:
1. What OCUFEN is and what it is used for
2. Before you use OCUFEN
3. How to use OCUFEN
4. Possible side effects
5. How to store OCUFEN
6. Further information

Tel: 01628 494026
Fax: 01628 494057

1. What OCUFEN is and what it is used for

Allergan Pharmaceuticals Ireland
Co. Mayo

OCUFEN is used for two different purposes:
• Given before and after eye surgery and laser surgery, to control eye
inflammation in patients who have been recommended not to use steroids.
• Given before an operation to help prevent the pupil becoming smaller
during surgery.

This leaflet was last revised in April 2014.

To listen to or request a copy of this leaflet in
Braille, large print or audio please call, free of
charge: 0800 198 5000 (UK only).
Please be ready to give the following information:
Flurbiprofen sodium 0.03% reference number
PL 00426/0069.
This is a service provided by the Royal National
Institute of Blind People.

OCUFEN belongs to a group of medicines known as non-steroidal
anti-inflammatory drugs (NSAIDs).
2. Before you use OCUFEN
Do not use OCUFEN
• If you are allergic (hypersensitive) to flurbiprofen (or other similar
medicines), aspirin, or any of the other ingredients in OCUFEN.
• If you have a viral eye infection
• If you have a tendency to bleed easily
• If you are taking medicine that increases the time needed for your blood
to clot
• During surgery
• If you are in the third trimester of pregnancy
Take special care with OCUFEN
Talk to your doctor before using OCUFEN if you suffer from, or have in the
past suffered from:
• Viral infections of the eye
• A tendency to bleed
The use of OCUFEN after surgery may slow down healing.
Using other medicines
Please tell your doctor or pharmacist if you are using or have recently used
any other medicine, including medicines obtained without a prescription.

© 2014 Allergan, Inc., Irvine CA 92612
® Marks owned by Allergan, Inc.

Artwork created at 100%
Drop all keylines and notes before printing
Part Number: 72167MD081F
Drawing Number: 0106901


Other eye medicine should not usually be used with OCUFEN. However,
if your doctor recommends using OCUFEN with another eye medicine, leave
at least 5 minutes between putting in OCUFEN and the other medicine.

Throw away each vial immediately after use.
After use, put the remaining vials back in the pouch and fold over the end.
The proper application of your eye drops is very important. If you have any
questions ask your doctor or pharmacist.

Please tell your doctor or pharmacist if you are taking or have recently
taken any other medicines, including medicines obtained without
a prescription.
Pregnancy and breast-feeding
Tell your doctor before you start using OCUFEN if you are pregnant or if
you are breast-feeding.
Do not use OCUFEN if you are in your third trimester of pregnancy.
Ask your doctor or pharmacist for advice before using any medicine.
Driving and using machines
OCUFEN may cause blurred vision following administration, if this occurs
wait until your vision clears before driving or using machinery.
3. How to use OCUFEN
Always use OCUFEN exactly as your doctor has told you. You should check
with your doctor or pharmacist if you are not sure.
In adults
Dose before surgery
The usual dose is 1 drop in the eye(s) undergoing surgery, every half hour
starting 2 hours before the operation or laser surgery (4 drops in total per
eye being treated).
The final drop should be given at least 30 minutes before surgery.
Dose after surgery
24 hours after laser surgery the usual dose is 1 drop, 4 times a day for
1 week.
24 hours after eye surgery the usual dose is 1 drop, 4 times a day for
2 to 3 weeks.
Instructions for use
You must not use the vial if the seal on the vial neck is broken before you
use it. Apply your eye drops in the following way:




If you use more OCUFEN than you should
Putting too many drops in your eye(s) is unlikely to lead to unwanted
side-effects. If you have placed too many drops in your eye(s), wash your
eye(s) with clean water. Apply your next dose at the normal time.
If, by accident, anyone drinks this medicine, contact your doctor
straight away.
If you forget to use OCUFEN
If you forget a dose apply it as soon as you remember, unless it is almost
time for your next dose, in which case you should miss out the forgotten
dose. Then apply your next dose as usual and continue with your normal
Do not use a double dose to make up for a forgotten dose.
If you stop using OCUFEN
OCUFEN should be used as advised by your doctor. If you have any further
questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, OCUFEN can cause side effects, but not everyone
gets them.
Tell your doctor if the following side effects prove troublesome or if they are
long lasting

Irritation of the eye
Stinging and/or burning in the eye
Bleeding in the eye
Blood in the front area of the eye
Excessive dilatation of the pupil
Redness of the eye.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes
any possible side effects not listed in this leaflet. You can also report side
effects directly via:
Yellow Card Scheme
By reporting side effects you can help provide more information on the
safety of this medicine.
5. How to store OCUFEN

1. Wash your hands. Twist off the tab to open the vial. Tilt your head back
and look at the ceiling.
2. Gently pull the lower eyelid down until there is a small pocket.
3. Turn the vial upside down and squeeze it to release one drop into each
eye that needs treatment.
4. Let go of the lower lid and close your eye for 30 seconds.
If a drop misses your eye, try again.
To avoid contamination, do not let the tip of the dropper touch your eye or
anything else.

Keep out of the reach and sight of children.
Discard each vial immediately after use, even if there is some solution
Do not use OCUFEN after the expiry date which is printed on the vial,
the pouch the vial comes in and on the bottom of the carton after EXP.
The expiry date refers to the last day of that month.
Store unused vials in the original pouch.
Store at or below 25°C.

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Further information

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