Colircusi Antiedema 50 mg/ml eye drops solution

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

COLIRCUSÍ ANTIEDEMA 50 mg/ml eye drops solution

Sodium chloride

Read this entire 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, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What COLIRCUSÍ ANTIEDEMA is and what it is used for
2. What you need to know before using COLIRCUSÍ ANTIEDEMA
3. How to use COLIRCUSÍ ANTIEDEMA
4. Possible adverse effects
5. How to store COLIRCUSÍ ANTIEDEMA
6. Contents of the pack and other information

1. What COLIRCUSÍ ANTIEDEMA is and what it is used for

It is an eye drop that contains sodium chloride as the active substance. Sodium chloride is present in the form of a hypertonic solution, so that, upon contact with the corneal epithelium, it draws water out of the cornea. In this way, it helps maintain the cornea free of swelling.

Colircusí Antiedema is indicated to reduce corneal edema (fluid accumulation in the cornea) that may be caused by various conditions 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).

2. What you need to know before using COLIRCUSÍ ANTIEDEMA

Do not use COLIRCUSÍ ANTIEDEMA:

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

Warnings and precautions

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

Use this medicine only in your eye(s).

Children

The use of this medicine is not recommended in children, as data are currently unavailable.

Other medicines and Colircusí Antiedema

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

No interactions with this medicine are known.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

This medicine may be used during pregnancy and breast-feeding if necessary.

Driving and using machines

You may notice blurred vision for a short time after instilling this eye drop. Do not drive or operate machinery until this effect has disappeared.

COLIRCUSÍ ANTIEDEMA contains sodium methyl parahydroxybenzoate (E-219) and sodium propyl parahydroxybenzoate (E-217)

It may cause allergic reactions (possibly delayed) because it contains sodium methyl parahydroxybenzoate (E-219) and sodium propyl parahydroxybenzoate (E-217).

3. How to use COLIRCUSÍ ANTIEDEMA

Follow exactly the instructions for administering this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose is:

Adults (including elderly patients):

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

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

Instructions for use:

• Wash your hands.
• Take the bottle (or dropper container).
• After opening the bottle for the first time, remove the loose plastic ring from the seal.
• Hold the bottle upside down between your fingers.
• Tilt your head backwards. Gently pull down the eyelid to form a pouch between the eyelid and your eye, into which the drop should fall (figure 1).
• Bring the tip of the bottle close to the eye. A mirror may be helpful.
• Do not touch the eye, eyelid, surrounding areas, or any other surfaces with the dropper tip. The drops could become contaminated.
• Gently squeeze the base of the bottle with your index finger to release one drop at a time (figure 2).
• If applying drops to both eyes, repeat all the previous steps for the other eye.
• Close the bottle tightly immediately after using the product.

If a drop misses the eye, try again.

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

If you use more COLIRCUSÍ ANTIEDEMA than you should

An overdose in the eyes can be removed by rinsing the eyes with lukewarm water. Do not apply further drops until the next scheduled dose.

In case of adverse effects due to ocular overdose, symptoms may be similar to the local reactions reported with the use of this medicine (see section 4).

Toxic effects are not expected with ophthalmic use of this medicine, nor in the case of accidental ingestion of the contents of a bottle.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount used.

If you forget to use COLIRCUSÍ ANTIEDEMA

Do not apply a double dose to make up for a missed dose.

Apply a single dose as soon as you remember, and then continue with the next dose as scheduled. If it is almost time for your next dose, do not apply the missed dose and continue with your next scheduled dose as usual.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

The following adverse effects have been observed with this medicine, whose frequency is unknown (cannot be estimated from the available data):

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

Reporting of 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 leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of COLIRCUSÍ ANTIEDEMA

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

Do not store above 25°C.

Do not use this medicine after the expiry date stated on the bottle and the outer packaging after EXP. The expiry date refers to the last day of the month indicated.

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

Record the date of opening the bottle in the space provided for this purpose on the carton.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point at your pharmacy. If you are unsure, please ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of COLIRCUSÍ ANTIEDEMA

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

Appearance of the medicine and contents of the pack

Colircusí Antiedema is an eye drop solution that is colourless.

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

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

OmniVision GmbH

Lindberghstrasse 9

82178 Puchheim

Germany

Manufacturer

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

Floor: 6, Door: 2

08034 Barcelona

Spain

Date of the most recent revision of this leaflet: January 2019.

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es