Flurekain

Patient Information Leaflet

Flurekain 1.25 mg/ml + 3 mg/ml eye drops, solution

Sodium fluorescein/hydrochloride oxybuprocaine
Please read this leaflet carefully before this medicine is administered to you
because it contains important information for you.
Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
If you experience any side effects, including those not listed in this
leaflet, tell your doctor or pharmacist. See section 4.
Contents of this leaflet:

1. What Flurekain eye drops are and what they are used for
2. What you need to know before Flurekain eye drops are administered to you
3. How Flurekain eye drops are administered
4. Possible side effects
5. How Flurekain eye drops are stored
6. Contents of the pack and other information

1. What Flurekain eye drops is and what it is used for

Flurekain eye drops contain the active substances oxybuprocaine and fluorescein. Oxybuprocaine is a local anaesthetic used to temporarily numb the surface of the eye. Fluorescein is a dye that helps in diagnosing corneal damage. This eye drop is for diagnostic use. It is used during measurements of intraocular pressure and examinations for corneal damage.

2. What you need to know before you are given Flurekain eye drops

Flurekain eye drops must not be administered:

• if you are allergic to oxybuprocaine, fluorescein, or any of the other ingredients of this medicine (listed in section 6).
• if you are allergic to other local anaesthetics belonging to the para-aminobenzoic acid group or if you have an allergy to paraben-based preservatives.

Warnings and precautions

Remove your contact lenses before receiving this eye drop, as the fluorescein contained in this medicine may cause discoloration of soft contact lenses. Contact lenses may be reinserted one hour after administration of this medicine.
Avoid rubbing your eye during the anaesthetic effect.
Contact your doctor immediately if you experience symptoms of a severe anaphylactic/allergic reaction (see section 4).

Other medicines and Flurekain eye drops
Inform your doctor or pharmacist if you are currently using, have recently used, or might use any other medicines. This eye drop may reduce the effect of sulfonamides (medicines used to treat infections).

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before being administered this medicine.

Driving and using machines
This eye drop may cause temporary blurred vision. Do not drive or operate machinery until your vision returns to normal.

3. How Flurekain eye drops are administered

This medicine is for ocular use only. It will be administered by your doctor. The usual dose
for adults and children is 1-2 drops per eye. The surface of the eye will become numb within
one minute, allowing measurement of intraocular pressure.
If different medicines are to be applied to the same eye, wait at least 5 minutes between each
administration.
If you are given more Flurekain eye drops than you should have
Overdose is unlikely, as the drops are used on the surface of the eye (locally).
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact your doctor immediately if you experience any of the following symptoms
(symptoms of a severe anaphylactic/allergic reaction): swelling of the face, rash,
generalised itching, hives, tightness in the chest, difficulty breathing, chills, flushing, headache,
general feeling of being unwell, nausea, restlessness, rapid heartbeat or low blood pressure.

Other possible side effects:
Common: may affect up to 1 in 10 people:

• eye irritation
• sensation of a foreign body in the eye after the anaesthetic effect has worn off
• superficial damage to the cornea (punctate keratitis) with repeated use

Rare: may affect up to 1 in 1,000 people:

• swelling of the eye (cornea)
• change in eye colour (cornea)
• inflammation of the iris
• slow heartbeat
• low blood pressure
• dizziness
• nausea

Frequency not known: frequency cannot be estimated from the available data:

• temporary blurred vision after administration

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Flurekain eye drops

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date (Exp.) stated on the packaging. The expiry date refers to the last day of that month.
• Store in a refrigerator (2 °C - 8 °C).
• The shelf life of an opened bottle is 28 days when stored at a temperature below 25 °C.
• Keep the bottle in the outer packaging to protect the medicine from light.
• Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Flurekain eye drops contains

• The active substances are sodium fluorescein and oxybuprocaine hydrochloride. Each ml of solution contains 1.25 mg of sodium fluorescein and 3 mg of oxybuprocaine hydrochloride.
• The other components are chlorobutanol hemihydrate, sodium chloride, povidone, and water for injections.

Description of the appearance of Flurekain eye drops and package contents
Eye drops, solution. Yellow (fluorescent), clear, practically particle-free solution.
White plastic bottle with a yellow plastic screw cap.
Pack size: 5 ml.

Marketing Authorisation Holder and Manufacturer
Santen Oy
Niittyhaankatu 20
33720 Tampere
Finland

The following information is intended for healthcare professionals only:
INFORMATION FOR HEALTHCARE PROFESSIONALS
Refer to the Summary of Product Characteristics for complete prescribing information.

Presentation
White plastic (PP) bottle with a yellow plastic (HDPE) screw cap.
Pack size: 5 ml.

Dosage and method of administration
Adults and children: 1 to 2 drops in the eye. The ocular surface becomes insensitive within one minute, allowing measurement of intraocular pressure.

Precautions
Contact lenses of any type must be removed before using the eye drops. Contact lenses may be reinserted one hour after using the eye drops.

Application:

1. Open the bottle. Do not touch any surface with the dropper tip, as this could contaminate the contents.
2. Administration is easier when the patient's head is tilted backward or when the patient is lying down.
3. Pull down the patient’s lower eyelid and instruct them to look upward. Gently squeeze the bottle to instill one drop into the pocket formed by the lower eyelid.
4. Immediately after administration, instruct the patient to keep the eye closed and to press with the index finger on the inner corner of the eye for one minute. Close the bottle.

Shelf life
18 months. The shelf life of an opened bottle is 28 days when stored below 25°C.

Special precautions for storage
Store in a refrigerator (2°C – 8°C). Opened bottles may be stored at temperatures below 25°C for 28 days. Keep the bottle in the outer carton to protect the medicine from light.

Special precautions for disposal and handling
Unused medicine and waste material must be disposed of in accordance with local regulations.