Ocufen

PACKAGE LEAFLET: INFORMATION FOR THE USER

OCUFEN 0,3 mg/ml eye drops, solution

Sodium Flurbiprofen Dihydrate
Read this leaflet carefully before using this medicine.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not give it to others. Even if their symptoms are the same as yours, it could be harmful.
• If any of the side effects worsens, or if you notice any side effect not listed in this leaflet, inform your doctor or pharmacist. Contents of 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 belongs to a group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs).
OCUFEN is used to treat painful and non-infectious inflammatory conditions of the anterior segment of the eye, particularly following cataract surgery.

2. BEFORE USING OCUFEN

Do not use OCUFEN:

• If you are allergic (hypersensitive) to flurbiprofen or to any of the excipients in OCUFEN.

Take special care with OCUFEN:

Due to cross-sensitivity to acetylsalicylic acid and other non-steroidal anti-inflammatory drugs (NSAIDs), OCUFEN should be administered with caution in patients who have experienced allergic reactions to these medications.
It is well documented in medical literature that non-steroidal anti-inflammatory drugs may increase bleeding time by interfering with platelet aggregation. It has been observed that using the drug during ocular surgery may lead to increased bleeding of ocular tissues (including hyphema).
Therefore, OCUFEN should be used with caution in patients with blood coagulation disorders or who are receiving treatment with medications that prolong clotting time.
Healing of corneal ulcers may be delayed with the use of OCUFEN.
Patients with a history of herpes simplex keratitis should be closely monitored.

Use of OCUFEN with other medicines
Interactions between OCUFEN and other topical ophthalmic medications have not been fully evaluated.
Although preclinical studies with carbacol and preclinical and clinical studies with acetylcholine chloride have not shown interactions with OCUFEN, reduced efficacy of both drugs has been reported when administered concomitantly with OCUFEN in patients receiving OCUFEN ophthalmically.
It is well documented in medical literature that non-steroidal anti-inflammatory drugs may increase bleeding time by interfering with platelet aggregation. It has been observed that using the drug during ocular surgery may lead to increased bleeding of ocular tissues (including hyphema).
If you are using OCUFEN with other eye drops, wait at least 5 minutes between instilling OCUFEN and the other eye drops.
Inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including those not requiring a prescription.

Pregnancy and breastfeeding
Consult your doctor or pharmacist before taking any medicine.
There is limited data on the use of flurbiprofen during pregnancy. Animal studies have shown reproductive toxicity.
OCUFEN is not recommended during pregnancy.
It is not known whether flurbiprofen or its metabolites are excreted in human milk. A decision should be made whether to discontinue breastfeeding or to discontinue treatment with OCUFEN, taking into account the benefits of breastfeeding for the child and the benefits of therapy for the mother.

Driving and using machines
OCUFEN has a minor influence on the ability to drive or use machinery.
Patients may experience transient blurred vision immediately after using OCUFEN. In this case, patients should not drive or operate machinery until vision has cleared.

3. HOW TO USE OCUFEN

As prescribed by your doctor.
Always use OCUFEN exactly as instructed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
Use in children: the safety and efficacy of Ocufen in pediatric patients have not been established.
Instructions for use
Do not use the bottle if the security seal on the neck of the bottle is broken before first use.
Apply the eye drops as follows:

1. Wash your hands. Tilt your head back and look upward.
2. Gently pull down the lower eyelid to form a small "pocket".
3. Invert the bottle and press it to instill one drop of eye drops into each eye requiring treatment.
4. Release the lower eyelid and keep the eye closed for 30 seconds. If the drop did not enter the eye, repeat the procedure.

To avoid contamination, the tip of the bottle must not touch the eye or any other surface.
Discard the bottle immediately after use.
After use, store any remaining bottles in the pouch and fold it closed.
Proper application of the eye drops is very important. If you have any doubts, consult your
doctor or pharmacist.
If you use more OCUFEN than you should
Accidental overdose of OCUFEN is unlikely to cause acute toxic effects.
In case of accidental ingestion of the eye drops, it is sufficient to drink fluids to dilute it.
If you forget to use OCUFEN
If you forget a dose, instill the eye drops as soon as you remember, unless it is almost time for the next dose. In that case, skip the missed dose.
Then take the next dose at the usual time and continue with your regular dosing schedule.
Do not use a double dose to make up for the forgotten dose.
If you stop using OCUFEN
OCUFEN must be used exactly as instructed by your doctor.
If you have any doubts about using OCUFEN, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, OCUFEN may cause adverse reactions, although not everyone experiences them.
The frequency of the possible adverse reactions listed below is defined according to the following convention:

When using Ocufen, the following adverse effects may occur:
Eye disorders:
Very common: bleeding in the front part of the eye, eye irritation (burning, itching, sensation of a foreign body in the eye, increased tearing, sensation of dry eyes, light sensitivity), eye pain.
Not known: bleeding inside the eye, enlarged pupil (sometimes prolonged), eye redness.

Reporting of adverse effects
If you experience any adverse effect, including those not listed in this leaflet, please inform your doctor or pharmacist. You may also report adverse effects directly through the national reporting system at the following website:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting adverse effects, you can help provide further information on the safety of this medicine.

5. HOW TO STORE OCUFEN

Expiry date: see the expiry date stated on the packaging.
The expiry date refers to the product in its original, unopened packaging, correctly stored.
Warning: do not use the medicine after the expiry date stated on the packaging.
Store below 25°C.
Keep unused vials in the original sachet.
Dispose of the single-dose container immediately after each use.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.
KEEP THIS MEDICINE OUT OF SIGHT AND REACH OF CHILDREN.
It is important to always keep the medicine information available; therefore, retain both the carton and the package leaflet.

6. OTHER INFORMATION

What OCUFEN contains
The active substance is flurbiprofen sodium 0.3 mg/ml.
The excipients are Liquifilm (polyvinyl alcohol), sodium chloride, disodium citrate dihydrate, potassium chloride, citric acid monohydrate, sodium hydroxide or hydrochloric acid (to adjust pH), and purified water.

Description of the appearance of OCUFEN and contents of the pack
OCUFEN is a sterile eye drop solution and each plastic dropper bottle contains 0.4 ml of solution.

Marketing Authorization Holder
AbbVie S.r.l.
S.R. 148 Pontina km 52 snc
04011 Campoverde di Aprilia (LT)
Italy

Manufacturer
Allergan Pharmaceuticals Ireland
Castlebar Road
Westport, Co. Mayo, Ireland