OFTALMOLOSA CUSI HYDROCORTISONE 15 mg/g OPHTHALMIC OINTMENT

Introduction

Package Leaflet: Information for the User

OFTALMOLOSA CUSÍ HYDROCORTISONE 15 mg/g Ophthalmic Ointment

Hydrocortisone Acetate

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

1. What OFTALMOLOSA CUSÍ HYDROCORTISONE is and what it is used for
2. What you need to know before you use OFTALMOLOSA CUSÍ HYDROCORTISONE
3. How to use OFTALMOLOSA CUSÍ HYDROCORTISONE
4. Possible side effects

5 Storage of OFTALMOLOSA CUSÍ HYDROCORTISONE

1. Contents of the pack and other information

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

It is an ophthalmic ointment (for the eyes) that contains hydrocortisone as the active ingredient, a corticosteroid used in the treatment of certain inflammatory eye disorders.

OFTALMOLOSA CUSÍ HYDROCORTISONE is indicated for the treatment of non-infectious allergic or allergic-inflammatory processes of the anterior segment of the eye, eyelid eczema, blepharitis (inflammation of the eyelid), iritis (inflammation of the iris or colored part of the eye), cyclitis (inflammation of the ciliary body), or iridocyclitis (inflammation of the iris and ciliary body).

2. What you need to know before you use OFTALMOLOSA CUSÍ HYDROCORTISONE

Do not use OFTALMOLOSA CUSÍ HYDROCORTISONE:

• If you are allergic to hydrocortisone or any of the other ingredients of this medicine (listed in section 6).
• If you have or think you have:

• Untreated bacterial eye infections.
• Herpes simplex keratitis (inflammation of the cornea caused by the herpes simplex virus) or any other viral eye infection, such as smallpox or chickenpox.
• Fungal eye diseases.
• Tuberculosis that affects the eye.
• Simple glaucoma.

Warnings and Precautions

Consult your doctor or pharmacist before starting to use OFTALMOLOSA CUSÍ HYDROCORTISONE.

• Only use this medicine in your eye(s).
• If you use this medicine for a long time, you may:

• Develop increased eye pressure and/or glaucoma (with damage to the optic nerve and decreased visual acuity). You should regularly check your eye pressure while using this medicine. Consult your doctor if you have any doubts. The risk of increased intraocular pressure and/or cataract formation induced by corticosteroids is higher in children and prone patients (e.g., diabetes and myopia).
• Develop cataracts. You should visit your doctor frequently.

• If your symptoms worsen or come back, consult your doctor. You may become more sensitive to eye infections with the use of this medicine. Corticosteroids can also mask the signs of an infection or worsen it, especially with prolonged use in purulent eye infections.
• If you already have a bacterial eye infection, you should consult your doctor about your treatment.

• Prolonged use of corticosteroids in the eyes could produce fungal corneal infections. If this occurs, treatment should be discontinued. The use of corticosteroids in the eye in excessive doses can delay the healing of eye wounds. It is also known that ophthalmic non-steroidal anti-inflammatory drugs (NSAIDs) slow down or delay healing (see "Other medicines and OFTALMOLOSA CUSÍ HYDROCORTISONE").

• If you have a disorder that causes thinning of the ocular tissue (the outermost layers of the eye), the use of this medicine could cause corneal perforation.
• Contact your doctor if you experience blurred vision or other visual disturbances.

If you wear contact lenses

Wearing contact lenses (hard or soft) is not recommended during the treatment of an eye inflammation.

Children

The safety and efficacy of this medicine in children have not been established. Therefore, its use is not recommended in children.

Other medicines and OFTALMOLOSA CUSÍ HYDROCORTISONE

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

Tell your doctor if you are using ophthalmic NSAIDs. The combined use of corticosteroids and ophthalmic NSAIDs can increase corneal healing problems.

Some medicines may increase the effects of OFTALMOLOSA CUSÍ HYDROCORTISONE, so your doctor will monitor you closely if you are taking these medicines (including some for HIV: ritonavir, cobicistat).

Pregnancy, Breastfeeding, and Fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

The use of OFTALMOLOSA CUSÍ HYDROCORTISONE is not recommended during pregnancy.

If you are breastfeeding, your doctor should decide whether to discontinue breastfeeding or discontinue treatment with this medicine, taking into account the benefit of breastfeeding for the child and the benefit of treatment for the mother.

Driving and Using Machines

You may notice that your vision becomes blurred for a while after applying the ointment. Do not drive or use machines until these effects have disappeared.

OFTALMOLOSA CUSÍ HYDROCORTISONE contains lanolin and butylhydroxytoluene (BHT)

This medicine may cause local skin reactions (such as contact dermatitis) because it contains lanolin and butylhydroxytoluene. This medicine may cause eye and mucous membrane irritation because it contains butylhydroxytoluene.

3. How to use OFTALMOLOSA CUSÍ HYDROCORTISONE

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

Ophthalmic route (in the eye/eyes).

The recommended dose is:

Adults:

Apply approximately 1 cm of ointment two or three times a day to the affected eye(s).

It is not recommended to use this product for more than 14 days, unless otherwise indicated by your doctor.

Recommendations for use:

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

If you use more OFTALMOLOSA CUSÍ HYDROCORTISONE than you should

An overdose in the eyes can be eliminated by rinsing the eyes with lukewarm water.

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

If you forget to use OFTALMOLOSA CUSÍ HYDROCORTISONE

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 your regular dosing schedule.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following side effects have been reported with this medicine. The frequency cannot be estimated from the available data:

• Eye effects: blurred vision

Prolonged use of corticosteroids in the eyes can also cause:

• Increased eye pressure and/or glaucoma with damage to the optic nerve and decreased visual acuity.
• Cataract formation.
• Delayed healing of the cornea.
• In diseases that cause thinning of the cornea, there is a higher risk of perforation.

Corticosteroids can reduce resistance to eye infections, favoring their appearance.

Additionally, the following side effects have been observed with the use of ophthalmic corticosteroids in general:

• Eye effects: transient burning sensation, eyelid edema (fluid retention), eyelid erythema (redness), anterior uveitis (inflammation of the uvea), cycloplegia (paralysis of the ciliary muscle), mydriasis (pupil dilation), ptosis (drooping eyelid), thinning of the sclera (white of the eye) after prolonged use, and keratitis (inflammation of the cornea).

• General effects: hypersensitivity (allergy), rare cases of Cushing's syndrome (swelling and weight gain of the body and face) and local skin reactions such as allergic contact dermatitis, redness, and irritation.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaRAM.es.By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of OFTALMOLOSA CUSÍ HYDROCORTISONE

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

Do not store above 25°C.

To avoid infections, the tube should be discarded 4 weeks after the first opening.

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

Do not use this medicine after the expiry date which is stated on the packaging after EXP. The expiry date is the last day of the month shown.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of OFTALMOLOSA CUSÍ HYDROCORTISONE

• The active ingredient is hydrocortisone acetate. Each gram of ointment contains 15 mg of hydrocortisone acetate (1.5%).
• The other ingredients are: lanolin (contains butylhydroxytoluene), liquid paraffin, and white petrolatum.

Appearance of the product and contents of the pack

OFTALMOLOSA CUSÍ HYDROCORTISONE is a yellowish ophthalmic ointment.

It is available in aluminum tubes with a polyethylene cap containing 3 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

Pl: 6 Pt: 2

08034 Barcelona

Spain

Date of the last revision of this leaflet:September 2024

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/