What is a Patient Information Leaflet and why is it useful?

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

Below is a text only representation of the Patient Information Leaflet, the original can be viewed in PDF format using the link above.

The text only version may be available from RNIB in large print, Braille or audio CD. For further information call RNIB Medicine Leaflet Line on 0800 198 5000. The product code(s) for this leaflet is: PL 00426/0069.

Ocufen

Package leaflet: Information for the user

OCUFEN® 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

1. What OCUFEN is and what it is used for

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.

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.

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.

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:

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.

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.

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 routine.

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
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 OCUFEN

Keep out of the reach and sight of children.

Discard each vial immediately after use, even if there is some solution remaining.

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.

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
Marlow
Bucks
SL7 1YL
UK
Tel:01628 494026
Fax:01628 494057

Manufacturer

Allergan Pharmaceuticals Ireland
Westport
Co. Mayo
Ireland

This leaflet was last revised in April 2014. Version 3.

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.