Oftalmolosa Cusí prednisone neomycin 5 mg/g + 5 mg/g ophthalmic ointment

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Oftalmolosa cusí prednisone neomycin 5 mg/g + 5 mg/g ophthalmic ointment

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 others, even if they have the same symptoms as you, because it could 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 prednisone neomycin is and what it is used for
2. What you need to know before using Oftalmolosa cusí prednisone neomycin
3. How to use Oftalmolosa cusí prednisone neomycin
4. Possible side effects
5. Storage of Oftalmolosa cusí prednisone neomycin
6. Contents of the pack and other information

1. What Oftalmolosa cusí prednisone neomycin is and what it is used for

Oftalmolosa cusí prednisone neomycin is an ophthalmic ointment containing a combination of a corticosteroid (prednisone) that suppresses the inflammatory response and an antibiotic (neomycin) used to treat infections.

Antibiotics are used to treat bacterial infections and are not effective against viral infections.

It is important to follow your doctor's instructions regarding dosage, dosing interval, and duration of treatment.

Do not store or reuse this medicine. If you have any antibiotic left over after completing the treatment, return it to the pharmacy for proper disposal. Do not dispose of medicines by flushing them down the sink or in household waste.

This medicine is used to treat superficial inflammatory conditions of the anterior segment of the eye caused by or associated with bacteria sensitive to neomycin.

2. What you need to know before using Oftalmolosa cusí prednisone neomycin

Do not use Oftalmolosa cusí prednisone neomycin

• If you are allergic to prednisone, neomycin, other aminoglycoside antibiotics, or any of the other components of this medicine (listed in section 6).

• If you think you have:

• Simple glaucoma or a family history of glaucoma.

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

• Eye diseases caused by fungi (fungal).

• Eye infections caused by mycobacteria (ocular tuberculosis, uveitis, scleritis).

Warnings and precautions

Consult your doctor or pharmacist before starting to use Oftalmolosa cusí prednisone neomycin.

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

• If you develop symptoms of an allergic reaction while using this medicine, stop treatment and consult your doctor. Allergic reactions may range from localized itching or skin redness to severe allergic reactions (anaphylactic reaction) or serious skin reactions. These allergic reactions may occur with other topical or systemic antibiotics of the same family group (aminoglycosides).

• If you are simultaneously using another antibiotic treatment, consult your doctor.

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

• Experience increased pressure in the eye(s).

• Develop cataracts.

During treatment with this medicine, intraocular pressure should be monitored regularly. Consult your doctor. This is especially important in pediatric patients, as the risk of corticosteroid-induced ocular hypertension may be higher in children and may occur more rapidly than in adults. The risk of elevated intraocular pressure and/or corticosteroid-induced cataract formation is greater in predisposed patients (e.g., diabetes).

• 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 exacerbate it, especially with prolonged use.
• The use of corticosteroids in the eye may delay healing of ocular wounds. Ophthalmic NSAIDs (Non-Steroidal Anti-Inflammatory Drugs) are also known to slow or delay healing. Concomitant use of NSAIDs and ophthalmic steroids may increase the potential for healing problems.
• Consult your doctor or pharmacist if you have a disorder causing thinning of ocular tissues before using this medicine.
• Contact your doctor if you experience blurred vision or other visual disturbances.
• If you have an overactive thyroid gland (hyperthyroidism).

Contact your doctor immediately if you experience muscle weakness, muscle pain, cramps, or muscle stiffness while using prednisone. These may be symptoms of a condition called thyrotoxic periodic paralysis, which may occur in patients with an overactive thyroid gland (hyperthyroidism) treated with prednisone. You may require additional treatment to relieve this condition.

If you wear contact lenses:

• Wearing contact lenses (rigid or soft) is not recommended during treatment of an eye infection or inflammation.

Children and adolescents

The safety and efficacy of this medicine have not been established in children.

Patients with hepatic and renal impairment

The safety and efficacy of this medicine have not been established in patients with hepatic or renal impairment.

Other medicines and Oftalmolosa cusí prednisone neomycin

Inform 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. Concomitant use of steroids and ophthalmic NSAIDs may increase corneal healing problems.

Pregnancy, breastfeeding, and fertility

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

This medicine is not recommended during pregnancy or breastfeeding.

During breastfeeding, your doctor will decide whether breastfeeding should be discontinued or treatment with this medicine stopped, taking into account the benefit of breastfeeding for the child and the benefit of treatment for the mother.

Driving and using machines

The use of this medicine does not affect the ability to drive or operate machinery.

However, as with any other ophthalmic ointment, transient blurred vision and other visual disturbances may occur, which could affect the ability to drive or operate machinery. If blurred vision occurs after use, the patient should wait until vision is clear before driving or operating machinery.

3. How to use Oftalmolosa cusí prednisone neomycin

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

The recommended dose is:

Use in adults (including elderly patients)

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 directed by your doctor.

Use in hepatic and renal impairment

The safety and efficacy of this medicine have not been established in patients with hepatic or renal impairment.

Use in children and adolescents

The safety and efficacy of this medicine have not been established in children and adolescents.

Instructions for use:

• Take the tube.
• Stand in front of a mirror and wash your hands.
• The ointment should be applied inside the eye.
• Pull down the eyelid with a clean finger.
• Apply the ointment into the pouch formed between the eyelid and the eye. Use the mirror if needed.
• Avoid touching any surface with the tip of the tube.
• Gently press the tube so that the ointment comes out.
• It is sufficient to apply an amount of ointment equivalent to the size of a grain of rice into the conjunctival sac.
• Close the eye(s) for a few seconds after applying the ointment.
• Close the tube tightly after use.
• Wash your hands after applying the ointment.

If you are using other ophthalmic medicines, wait at least 5 minutes between administering this ointment and other ophthalmic medicines. Ophthalmic ointments should be administered last.

If you use more Oftalmolosa cusí prednisone neomycin than you should, remove the excess by rinsing your eyes with lukewarm water. Do not apply more ointment until your next scheduled dose.

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

If you forget to use Oftalmolosa cusí prednisone neomycin, apply a single dose as soon as you remember, and then continue with your next scheduled dose. However, if it is almost time for your next dose, do not apply the missed dose and continue with your next dose as planned. Do not apply a double dose to make up for a missed dose.

If you stop treatment with Oftalmolosa cusí prednisone neomycin

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 adverse reactions have been observed with frequency not known (cannot be estimated from available data):

• Eye disorders: blurred vision.
• Cushing's syndrome and/or adrenal suppression.

The use of this medicine may cause skin redness, irritation, and discomfort.

If you use this medicine for a long time, you may (see section 2. Warnings and precautions):

• Experience increased pressure in the eye(s).
• Develop cataracts.

The use of this medicine or a similar one may cause superinfections and fungal infections.

You may have an increased risk of eye damage if, while using this medicine, you have a disorder causing thinning of the eye tissues (cornea or sclera) (see section 2. Warnings and precautions).

Reporting of side 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 can also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: 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 prednisone neomycin

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

This medicine does not require any special storage conditions.

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.

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

Record the date of first opening of 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 Point located at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the package and other information

Composition of Oftalmolosa cusí prednisona neomicina

• The active substances are prednisone and neomycin (as sulfate). Each gram of ointment contains 5 mg of prednisone and 5 mg of neomycin sulfate (equivalent to 3.5 mg of neomycin base).
• The other components are lanolin, liquid paraffin, and white soft paraffin.

Appearance of the medicinal product and contents of the packaging

Oftalmolosa cusí prednisona neomicina is a yellowish ointment supplied in an aluminum tube containing 3 g, with a polyethylene cap.

Marketing Authorization Holder and Manufacturer

Immedica Pharma AB
SE-113 63 Stockholm
Sweden

Manufacturer

Siegfried El Masnou, S.A.
C/ Camil Fabra, 58
08320 El Masnou – Barcelona, Spain

Date of the most recent revision of this leaflet: 01/2026.