Oftalmolosa Cusi hydrocortisone 15 mg/g ophthalmic ointment

Spain
Brand name Oftalmolosa Cusi hydrocortisone 15 mg/g ophthalmic ointment
Form ointment, ophthalmic
Active substance / Dosage
HYDROCORTISONE ACETATE · 15 mg
Prescription type Prescription Only Medicine
ATC code
S01B S01BA S01BA02
Registration number 21989
Manufacturer Omnivision Gmbh
Oftalmolosa Cusi hydrocortisone 15 mg/g ophthalmic ointment ointment, ophthalmic

Table of Contents

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

OFTALMOLOSA CUSÍ HIDROCORTISONA 15 mg/g eye ointment

hydrocortisone acetate

Read the entire 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 adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

  1. What OFTALMOLOSA CUSÍ HIDROCORTISONA is 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
  5. How to store OFTALMOLOSA CUSÍ HIDROCORTISONA
  6. Contents of the pack and other information

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

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

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

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

Do not use Oftalmolosa Cusí Hydrocortisone:

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

  • If you have or think you have:

  • Untreated bacterial eye infections.

  • Corneal inflammation (keratitis) due to herpes simplex or any other viral eye infection such as smallpox or varicella.

  • Fungal diseases of the eye.

  • Tuberculosis affecting the eye.

  • Simple glaucoma.

Warnings and precautions

Talk to your doctor or pharmacist before starting to use Oftalmolosa Cusí Hydrocortisone.

  • Use this medicine only in your eye(s).

  • If you use this medicine for a long time, you may:

  • Develop ocular hypertension and/or glaucoma (with optic nerve damage and reduced visual acuity). You should have your eye pressure monitored regularly while using this medicine. Consult your doctor if in doubt. The risk of elevated intraocular pressure and/or corticosteroid-induced cataract formation is higher in children and predisposed patients (e.g. diabetes and myopia).

  • Develop cataracts. You should visit your doctor frequently.

  • If your symptoms worsen or reappear, consult your doctor. You may become more susceptible to eye infections while using this medicine. Corticosteroids may also mask signs of infection or make it worse, especially with prolonged use in purulent eye infections.

  • If you already have a bacterial eye infection, you should consult your doctor about its treatment.

  • Prolonged use of corticosteroids in the eyes may lead to fungal infections of the cornea. If this occurs, treatment should be discontinued. Excessive doses of ocular corticosteroids may delay healing of eye wounds. Ophthalmic NSAIDs (Non-Steroidal Anti-Inflammatory Drugs) are also known to slow or delay healing (see section "Other medicines and Oftalmolosa Cusí Hydrocortisone").

  • If you have a condition causing thinning of ocular tissue (the outer layers of the eye), using this medicine could lead to corneal perforation.

  • Contact your doctor if you experience blurred vision or other visual disturbances.

If you wear contact lenses

Wearing contact lenses (rigid or soft) is not recommended during treatment for 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 taking, have recently taken, or might need to take any other medicines.

Inform your doctor if you are using ophthalmic NSAIDs (Non-Steroidal Anti-Inflammatory Drugs). The combined use of corticosteroids and ophthalmic NSAIDs may 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 used for HIV: ritonavir, cobicistat).

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.

Use of Oftalmolosa Cusí Hydrocortisone is not recommended during pregnancy.

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

Driving and use of machines

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

Oftalmolosa Cusí Hydrocortisone contains lanolin and butylated hydroxytoluene (BHT)

This medicine may cause local skin reactions (such as contact dermatitis) because it contains lanolin and butylated hydroxytoluene. This medicine may cause irritation of the eyes and mucous membranes because it contains butylated hydroxytoluene.

3. How to use OFTALMOLOSA CUSÍ HYDROCORTISONE

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

Ophthalmic use (in the eye[s]).

Recommended dose:

Adults:

Generally, apply approximately 1 cm of ointment about two or three times a day in the affected eye(s).

It is not recommended to use this product for longer than 14 days, unless otherwise indicated by a physician.

Instructions for use:

  • Take the tube.
  • Position yourself in front of a mirror and wash your hands.
  • If the application is inside the eye, pull down the eyelid with a clean finger. Apply the ointment into the pouch formed between the eyelid and the eye while looking upward.
  • If the application is outside the eye, apply the ointment directly to the affected area, first softening any crusts with warm water.
  • Place the tip of the tube near the eye. Use a mirror if needed.
  • Do not touch the eye(s), eyelids, surrounding areas, or other surfaces with the tip of the tube to prevent eye infections.
  • Gently press the tube to release the ointment.
  • Close the eye(s) for a few seconds after applying the ointment.
  • Close the tube tightly after use.

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

If you use more Oftalmolosa Cusí Hidrocortisona than you should

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

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 medication and the amount used.

If you forget to use Oftalmolosa Cusí Hidrocortisona

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 according to 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 may cause adverse effects, although not everyone experiences them.

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

  • Eye effects: blurred vision

Prolonged use of corticosteroids in the eyes may also cause:

  • Increased intraocular pressure and/or glaucoma with optic nerve damage and reduced visual acuity.
  • Cataract formation.
  • Delayed healing of the cornea.
  • In diseases causing corneal thinning, there is an increased risk of perforation.

Corticosteroids may reduce resistance to ocular infections, thereby favoring their occurrence.

In addition, the following adverse effects have been observed with the use of ophthalmic corticosteroids in general:

  • Eye effects: transient burning sensation, eyelid swelling (palpebral edema), redness of the eyelid (palpebral erythema), inflammation of the middle layer of the eye (anterior acute uveitis), paralysis of the eye's ciliary muscle (cycloplegia), dilation of the pupil, drooping of the 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 in body and face), and local skin reactions such as allergic contact dermatitis, redness, and irritation.

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 HYDROCORTISONE

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

Do not store above 25°C.

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.

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

Medicines must not be disposed of via wastewater drains or in household waste. Dispose of unused containers and medicines at the SIGRE collection point located at your pharmacy. If in doubt, please consult your pharmacist on how to properly dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of Oftalmolosa Cusí Hydrocortisone

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

Appearance of the medicine and contents of the pack

Oftalmolosa Cusí Hydrocortisone is a yellowish ophthalmic ointment.

It is presented in an aluminum tube 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

Fl: 6 P: 2

08034 Barcelona

Spain

Date of the most recent review of this leaflet: September 2024

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