Package Leaflet: Information for the User

COLIRCUSÍ ANTIEDEMA 50 mg/ml eye drops solution

Sodium chloride

Read this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

It is an eye drop that contains sodium chloride as its active ingredient. Sodium chloride is present in the form of a hypertonic solution, which, upon contact with the corneal epithelium, causes the extraction of water from the cornea. In this way, it helps to maintain the cornea without inflammation.

Colircusí Antiedema is indicated to reduce corneal edema (accumulation of fluid in the cornea) that may be caused by various factors such as bullous keratopathy (small blisters that form on the cornea), eye surgery (especially of the cornea), and hereditary corneal dystrophy or Fuchs' dystrophy (disorders in which abnormal material accumulates in the cornea).

Do not use COLIRCUSÍ ANTIEDEMA:

• If you are allergic to sodium chloride or to any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to use Colircusí Antiedema.

Only use this medication in your eye(s).

Children

This medication is not recommended for use in children because there is currently no data available.

Other medications and Colircusí Antiedema

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

No interactions with this medication are known.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

In necessary cases, this medication may be used during pregnancy and breastfeeding.

Driving and operating machinery

You may notice that your vision becomes blurry for a while after applying this eye drop. Do not drive or operate machinery until this effect has disappeared.

COLIRCUSÍ ANTIEDEMA contains sodium methoxybenzoate (E-219) and sodium propylparaben (E-217)

It may cause allergic reactions (possibly delayed) because it contains sodium methoxybenzoate (E-219) and sodium propylparaben (E-217).

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is:

Adults (including elderly patients):

Generally, 1 or 2 drops will be instilled in the affected eye every 3 or 4 hours.

The number of daily applications and the duration of treatment may be modified according to medical criteria.

Usage recommendations:

• Wash your hands.
• Take the bottle (or dropper).
• After opening the bottle for the first time, remove the plastic ring from the cap if it is loose.
• Hold the bottle, upside down, between your fingers.
• Tilt your head back. Gently separate your eyelid from your eye with a finger until a pouch forms between your eyelid and your eye, where the drop should fall (figure 1).
• Bring the tip of the bottle close to your eye. It may be helpful to use a mirror.
• Do not touch your eye or eyelid, nearby areas, or other surfaces with the dropper. The drops may become contaminated.
• Press gently on the base of the bottle with your index finger to allow one drop to fall at a time (figure 2).
• If drops are applied to both eyes, repeat all previous steps for the other eye.
• Close the bottle tightly immediately after using the product.

If a drop falls outside the eye, try again.

If you are using other eye medications, wait at least 5 minutes between administering this eye drop and the other eye medications. Eye ointments should be administered last.

If you use more COLIRCUSÍ ANTIEDEMA than you should

A drop overdose in the eye can be eliminated by rinsing the eyes with warm water. Do not apply more drops until it is safe to do so.

In the event of eye drop overdose side effects, symptoms may be similar to local reactions reported with the use of the medication (see section 4).

Systemic toxicity is not expected with the use of this medication as eye drops or in the event of accidental ingestion of the contents of a bottle.

In the event of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service. Phone 91 562 04 20 indicating the medication and the amount used.

If you forgot to use COLIRCUSÍ ANTIEDEMA

Do not apply a double dose to compensate for the missed dose.

Apply a single dose as soon as you remember and continue with the next dose that was scheduled. If it is almost time for the next dose, do not apply the missed dose and continue with the next dose in your regular regimen.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

The following adverse effects have been observed with this medication, but their frequency is unknown (cannot be estimated from available data):

• Eye effects: eye pain, eye irritation, transient burning sensation.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaRAM.es.Reporting adverse effects can help provide more information about the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not store at a temperature above 25°C.

Do not use this medication after the expiration date that appears on the bottle and on the box after CAD. The expiration date is the last day of the month indicated.

To prevent infections, discard the bottle 4 weeks after first opening it.

Record the date of opening the bottle in the reserved box on the box.

Medications should not be disposed of through drains or in the trash. Deposit containers and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of COLIRCUSÍ ANTIEDEMA

• The active principle is sodium chloride. One ml of eye drop contains 50 mg of sodium chloride (5%).
• The other components are: methyl parahydroxybenzoate (E-219), propyl parahydroxybenzoate (E-217), hypromellose and purified water.

Appearance of the product and contents of the packaging

Colircusí Antiedema is an colourless solution.

It is presented in a box containing a dropper bottle (plastic bottle) with a screw cap. Each bottle contains 10 ml of eye drops.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

OmniVision GmbH

Lindberghstrasse 9

82178 Puchheim

Germany

Responsible for manufacturing

Siegfried El Masnou, S.A

C/ Camil Fabra, 58

08320 El Masnou – Barcelona, Spain

Local representative

OmniVision Farma España S.L.

C/ Josep Irla i Bosch, 1-3

Pl: 6 Pt: 2

08034 Barcelona

Spain

Last review date of this leaflet:January 2019.

The detailed information of this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es