Package Leaflet: Information for the User

OFTALMOLOSA CUSÍ HIDROCORTISONA 15 mg/g Ophthalmic Ointment

hydrocortisone acetate

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, ask your doctor or pharmacist. This medicine has been prescribed for you only. Do not pass it on to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

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

2.What you need to know before using OFTALMOLOSA CUSÍ HIDROCORTISONA

3.How to use OFTALMOLOSA CUSÍ HIDROCORTISONA

4.Possible side effects

5Storage of OFTALMOLOSA CUSÍ HIDROCORTISONA

6.Contents of the pack and additional information

It is an eye ointment that contains hydrocortisone as its active ingredient, a corticosteroid used in the treatment of some inflammatory eye disorders.

Oftalmolosa Cusí Hidrocortisona is indicated for the treatment ofnon-infectious allergic or allergic-inflammatory processes of the anterior segment of the eye, eyelid eczema, eyelid inflammation (blepharitis), inflammation of the iris or colored part of the eye (iritis), ciliary body (cyclitis), or conjunctival inflammation (iridocyclitis).

No use Oftalmolosa Cusí Hidrocortisona:

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

• Untreated bacterial eye infections.
• Corneal inflammation (keratitis) caused by herpes simplex or any other viral eye infection such as smallpox or chickenpox.
• Fungal eye infections.
• Tuberculosis affecting the eye.
• Simple glaucoma.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Oftalmolosa Cusí Hidrocortisona.

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

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

• If your symptoms worsen or return, consult your doctor.You may become more sensitive to eye infections with the use of this medication. Corticosteroids can also mask the signs of an infection or intensify it, especially with prolonged use in pus-producing 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 infections of the cornea.In case of occurrence, treatment should be suppressed. The use of corticosteroids in the eye in excessive doses may delay the healing of the same eye injuries. It is also known that ocular NSAIDs (Non-Steroidal Anti-Inflammatory Drugs) delay or slow down the healing (see section "Other medications and Oftalmolosa Cusí Hidrocortisona").

• If you suffer from a condition causing thinning of the ocular tissue (the outer layers of the eye) the use of this medication could produce corneal perforation.
• Contact your doctor if you experience blurry vision or other visual disturbances.

If you use 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 medication have not been established in children. Therefore, its use is not recommended in children.

Other medications and Oftalmolosa Cusí Hidrocortisona

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

Inform your doctor if you are using ocular NSAIDs (Non-Steroidal Anti-Inflammatory Drugs). The combined use of corticosteroids and ocular NSAIDs may increase the problems of corneal healing.

Some medications may increase the effects of Oftalmolosa Cusí Hidrocortisona, so your doctor will make meticulous controls if you are taking these medications (including some for HIV: ritonavir, cobicistat).

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

The use of Oftalmolosa Cusí Hidrocortisona is not recommended during pregnancy.

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

Driving and operating machinery

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

Oftalmolosa Cusí Hidrocortisona contains lanolin and butylhydroxytoluene (BHT)

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

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Ophthalmic route (in the eye/eyes).

The recommended dose is:

Adults:

Generally apply1cm of ointment approximately two or three times a day in the affected eye(s).

This product should not be used for more than 14 days, unless otherwise indicated by your doctor.

Usage recommendations:

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

If you use more Oftalmolosa Cusí Hidrocortisona than you should

A possible overdose in the eyescan be eliminated by rinsing the eyes with warm water.

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

If you forgot to use Oftalmolosa Cusí Hidrocortisona

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

Apply a single dose as soon as you remember andcontinue 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 all people may experience them.

The following adverse effects have been reported with this medication.The frequency of these effects cannot be estimated from the available data:

• Eye effects: blurred vision

The prolonged use of corticosteroids in the eyes may also cause:

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

Corticosteroids may reduce resistance to ocular infections, favoring their appearance.

Additionally, the following adverse effects have been observed with the use of corticosteroid eye drops in general:

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

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

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 on the safety of this medication.

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

Do not store at a temperature above 25°C.

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

Note the date of opening of the tube in the reserved box in the carton.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

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

Composition of Oftalmolosa Cusí Hidrocortisona

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

Appearance of the product and contents of the packaging

Oftalmolosa Cusí Hidrocortisonais a yellowish eye ointment.

It is presented in an aluminum tube with a polyethylene plug containing 3 g of ointment.

Holder of the marketing authorization andmanufacturer responsible

Holder of the marketing authorization

OmniVision GmbH

Lindberghstrasse 9

82178 Puchheim

Germany

Manufacturer responsible

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:September 2024

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/