OFTALMOLOSA CUSI ANTIEDEMA 50 mg/g OPHTHALMIC OINTMENT

Introduction

Leaflet: information for the user

OFTALMOLOSA CUSÍ ANTIEDEMA 50 mg/g ophthalmic ointment

sodium chloride

Read the entire leaflet carefully before starting to use this medication, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others

even if they have the same symptoms as you, as it may harm them.

• If you experience side effects, consult your doctor or pharmacist, even if it is

about side effects that are not listed in this leaflet. See section 4.

Contents of the leaflet

1. What OFTALMOLOSA CUSÍ ANTIEDEMA is and what it is used for
2. What you need to know before starting to use OFTALMOLOSA CUSÍ ANTIEDEMA
3. How to use OFTALMOLOSA CUSÍ ANTIEDEMA
4. Possible side effects
5. Storage of OFTALMOLOSA CUSÍ ANTIEDEMA
6. Package contents and additional information

1. What OFTALMOLOSA CUSÍ ANTIEDEMA is and what it is used for

It is an ointment for the eyes that contains sodium chloride as the active ingredient. Sodium chloride is found in a hypertonic concentration, so that when it comes into contact with the corneal epithelium, it extracts water from the cornea. This helps to keep the cornea free of inflammation.

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

2. What you need to know before starting to use OFTALMOLOSA CUSÍ ANTIEDEMA Do not use OFTALMOLOSA CUSÍ ANTIEDEMA

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

Warnings and precautions

Consult your doctor or pharmacist before starting to use Oftalmolosa Cusí Antiedema. Only use this medication in your eye(s).

Children

The use of this medication is not recommended in children because there is currently no data available.

Other medications and Oftalmolosa Cusí Antiedema

Tell your doctor or pharmacist if you are using, have recently used, 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 can be used during pregnancy and breastfeeding.

Driving and using machines

You may notice that your vision becomes blurry for a while after applying this ointment. Do not drive or use machines until this effect has disappeared.

OFTALMOLOSA CUSÍ ANTIEDEMA containsmethylparaben (E-218) and propylparaben (E-216)

This medication may cause allergic reactions (possibly delayed) because it contains methylparaben (E-218) and propylparaben (E-216).

3. How to use OFTALMOLOSA CUSÍ ANTIEDEMA

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

The recommended dose is:

Adults (including elderly patients):

Generally, apply approximately 1 cm of ointment to the affected eye(s) 1 or 2 times a day.

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

Usage recommendations:

• Wash your hands and stand in front of a mirror.
• Take the tube.
• The ointment should be applied inside the eye.
• Bring the tip of the tube close to the eyes. Use the mirror if needed.
• Pull down the lower eyelid with a clean finger.
• Apply the ointment to the pouch that forms between the eyelid and the eye.
• Avoid touching the eyes, eyelids, surrounding areas, or other surfaces with the tip of the tube.
• Gently press the tube to release the ointment.
• It is sufficient to apply approximately 1 cm of ointment to the conjunctival sac.
• Close the eye(s) for a few seconds after applying the ointment.
• Close the tube tightly after use.

If you are using other ophthalmic medications, wait at least 5 minutes between the administration of this ointment and the other ophthalmic medications. Ophthalmic ointments should be administered last.

If you use more OFTALMOLOSA CUSÍ ANTIEDEMA than you should

An overdose in the eyes can be eliminated by rinsing the eyes with lukewarm water. Do not apply more ointment until it is time for your next dose.

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

No toxic effects are expected with the ophthalmic use of this medication or in the event of accidental ingestion of the contents of a tube.

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

If you forget to use OFTALMOLOSA CUSÍ ANTIEDEMA

Do not apply a double dose to make up for forgotten doses.

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

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

The following side effects have been observed with this medication, but their frequency is not known (cannot be estimated from the available data):

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

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that is not listed in this leaflet. You can also report them directly through the Spanish Medicines Monitoring System: https://www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of OFTALMOLOSA CUSÍ ANTIEDEMA

Keep this medication out of the sight and reach of children. No special storage conditions are required.

Do not use this medication after the expiration date stated on the tube and carton after EXP. The expiration date is the last day of the month indicated.

To avoid infections, the tube should be discarded 4 weeks after it was first opened.

Write the opening date of the tube in the space provided for this purpose on the carton.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and unused medications at the SIGRE collection point in the pharmacy. If you have any questions, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of OFTALMOLOSA CUSÍ ANTIEDEMA

• The active ingredient is sodium chloride. One gram of ophthalmic ointment contains 50 mg of sodium chloride (5%).
• The other ingredients are methylparaben (E-218), propylparaben (E-216), lanolin, liquid paraffin, white petrolatum, and purified water.

Appearance and package contents

Oftalmolosa Cusí Antiedema is a homogeneous and yellowish ophthalmic ointment. It is available in a 5g aluminum tube.

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

Pl: 6 Pt: 2

08034 Barcelona

Spain

Date of the last revision of this leaflet:June 2019.

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