Leaflet: information for the user

OFTALMOLOSA CUSÍ ANTIEDEMA 50 mg/g eye ointment

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, consult your doctor or pharmacist.

- This medicine has been prescribed for you only, and you must not give it to other people

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.

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. Storage of OFTALMOLOSA CUSÍ ANTIEDEMA

6. Contents of the pack and additional information

It is an eye ointment that contains sodium chloride as its active ingredient. Sodium chloride is present in a hypertonic concentration, so when it comes into contact with the corneal epithelium, it causes the extraction of water from the cornea. In this way, it helps to keep the cornea free of inflammation.

Oftalmolosa Cusí Antiedema is indicated to reduce corneal edema (accumulation of fluid in the cornea) that can 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).

? 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. S Only use this medicine in your eye(s).

Children

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

Other medicines and Oftalmolosa Cusí Antiedema

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

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.

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

Driving and operating machinery

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

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

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

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, 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 sit in front of a mirror.

- Take the tube.

- The ointment must be applied inside the eye.

- Bring the tube tip close to the eyes. Use the mirror if needed.

- Separate the lower eyelid with a clean finger.

- Apply the ointment to the sac that forms between the eyelid and the eye.

- Avoid touching the eyes, eyelids, surrounding areas, or other surfaces with the tube tip.

- 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 well after use.

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

If you use more OFTALMOLOSA CUSÍ ANTIEDEMA than you should

A overdose in the eyes can be eliminated by rinsing the eyes with warm water. Do not apply more ointment until it is needed again.

In case of adverse effects due to an eye 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 use of this medication as an eye drop or in the case 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 Toxicological Information Service, Telephone 91 562 04 20, indicating the medication and the amount used.

If you forgot to use OFTALMOLOSA CUSÍ ANTIEDEMA

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

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 of 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 everyone 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. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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 that appears on the tube and on the box after CAD. The expiration date is the last day of the month indicated.

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

Record the date of opening the tube in the designated space on the box.

Medications should not be disposed of through drains or in the trash. Deposit containers and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of containers and unused medications. By doing so, you will help protect the environment.

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 components are methylparaben (E-218), propylparaben (E-216), lanolin, liquid paraffin, white vaseline, and purified water.

Appearance of the product and contents of the packaging

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

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:June 2019.

The detailed information of this medication is available on the website of the

Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es