Oftalmolosa Cusi Antiedema 50 mg/g ophthalmic ointment

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

OFTALMOLOSA CUSÍ ANTIEDEMA 50 mg/g ophthalmic ointment

sodium chloride

Read all of 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, and you should not give it to other people,

even if they have the same symptoms as you, because it may 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 this leaflet

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

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

It is an ophthalmic ointment containing sodium chloride as the active substance. Sodium chloride is present in a hypertonic concentration, 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 inflammation.

OFTALMOLOSA CUSÍ ANTIEDEMA is indicated for reducing corneal edema (fluid accumulation in the cornea) that may be caused by various conditions such as bullous keratopathy (small blisters forming 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 OFTALMOLOSA CUSÍ ANTIEDEMA Do not use OFTALMOLOSA CUSÍ 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 Oftalmolosa Cusí Antiedema. Use this medicine only in your eye(s).

Children

The use of this medicine is not recommended in children, as there are currently no available data.

Other medicines and Oftalmolosa Cusí 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, breastfeeding and fertility

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

If necessary, this medicine may be used during pregnancy and breastfeeding.

Driving and using machines

You may notice blurred vision for a short while after applying this ointment. Do not drive or operate machinery until this effect has passed.

OFTALMOLOSA CUSÍ ANTIEDEMA contains methyl parahydroxybenzoate (E-218) and propyl parahydroxybenzoate (E-216)

This medicine can cause allergic reactions (possibly delayed) because it contains methyl parahydroxybenzoate (E-218) and propyl parahydroxybenzoate (E-216).

3. How to use OFTALMOLOSA CUSÍ ANTIEDEMA

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

Recommended dose:

Adults (including elderly patients):

Generally, apply approximately 1 cm of ointment into the affected eye(s) 1 or 2 times daily.

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

Instructions for use:

• Wash your hands and position yourself 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 eye. Use the mirror if necessary.
• Pull down the lower eyelid with a clean finger.
• Apply the ointment into the pocket formed 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 so that the ointment comes out.
• It is sufficient to apply approximately 1 cm of ointment into 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 medicines, wait at least 5 minutes between the administration of this ointment and other ophthalmic medicines. Ophthalmic ointments should be administered last.

If you use more OFTALMOLOSA CUSÍ ANTIEDEMA than you should

An overdose in the eyes can be removed by rinsing the eyes with lukewarm water. Do not apply more ointment until instructed to do so.

In case of adverse effects due to an ophthalmic 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 tube.

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 OFTALMOLOSA CUSÍ ANTIEDEMA

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

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

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 can cause adverse effects, although not everyone will experience them.

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

? Eye 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 Medicinal Products: https://www.notificaRAM.es . By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of OFTALMOLOSA CUSÍ ANTIEDEMA

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

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

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

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

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

6. Contents of the package and other information

Composition of OFTALMOLOSA CUSÍ ANTIEDEMA

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

Appearance of the product and contents of the package

Oftalmolosa Cusí Antiedema is a homogeneous, yellowish ophthalmic ointment (for the eyes). It is supplied in an aluminum tube containing 5 g of ointment.

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

6th floor, 2nd building

08034 Barcelona

Spain

Date of the most recent revision of this package leaflet: June 2019.

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