OFTALMOLOSA CUSI GENTAMICIN 3mg/g OPHTHALMIC OINTMENT

Introduction

Leaflet: information for the user

OFTALMOLOSA CUSÍ GENTAMICINA 3 mg/g eye ointment

Read the entire leaflet carefully before starting to use this medication, as 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 medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet:

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

5 Conservation of OFTALMOLOSA CUSÍ GENTAMICINA

1. Package contents and additional information

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

OFTALMOLOSA CUSÍ GENTAMICINA is an eye ointment that contains an antibiotic from the aminoglycoside group, gentamicin, which acts against microorganisms that cause eye infections.

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

It is essential to follow the instructions regarding dosage, administration interval, and treatment duration indicated by your doctor.

Do not store or reuse this medication. If you have any leftover antibiotic after completing the treatment, return it to the pharmacy for proper disposal. Do not throw away medications down the drain or in the trash.

This medication is used to treat external bacterial eye infections caused by gentamicin-sensitive germs, such as conjunctivitis, keratitis (corneal inflammation), corneal ulcers, blepharitis (eyelid inflammation), and dacryocystitis (inflammation of the lacrimal sac).

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

Do not use OFTALMOLOSA CUSÍ GENTAMICINA

• If you are allergic to gentamicin or any other component of this medication (listed in section 6).

Warnings and precautions

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

• Use this medication only in your eye(s).
• If you experience symptoms of an allergic reaction, such as itching of the eyelids, swelling, or redness of the eye, discontinue treatment immediately and consult your doctor. Allergic reactions can range from localized itching or redness to severe allergic reactions (anaphylaxis) or severe skin reactions. These allergic reactions can occur with other topical or systemic antibiotics from the same family (aminoglycosides).
• If your symptoms worsen or recur, consult your doctor.
• If you are using another antibiotic treatment at the same time, even if taken orally, consult your doctor.
• If you use this medication for an extended period, you may become more susceptible to eye infections.
• If you wear contact lenses:

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

Use of OFTALMOLOSA CUSÍ GENTAMICINA with other medications

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

Pregnancy, breastfeeding, and fertility

Consult your doctor or pharmacist before using any medication.

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

Your doctor will assess whether you should use this medication or not.

Driving and using machines

Immediately after applying this medication, you may notice that your vision becomes blurry. Do not drive or use machines until your vision is clear.

3. How to use OFTALMOLOSA CUSÍ GENTAMICINA

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

The recommended dose is:

Adults (including elderly patients), adolescents, and children:

Generally, apply approximately 1 cm of ointment two or three times a day.

The number of daily applications and the duration of treatment may be modified according to medical criteria.

Recommendations for use:

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

If you use more OFTALMOLOSA CUSÍ GENTAMICINA than you should, you can remove it by washing your eyes with warm water. Do not apply more ointment until the next dose.

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 medication and the amount used.

If you forget to use OFTALMOLOSA CUSÍ GENTAMICINA, apply a single dose as soon as you remember and continue with the next scheduled dose. However, if it is almost time for the next dose, do not apply the missed dose and continue with your regular regimen. Do notapply a double dose to make up for missed doses.

If you interrupt treatment with OFTALMOLOSA CUSÍ GENTAMICINA

It is essential to complete the treatment cycle indicated by your doctor, even if you start to feel better after a few days. If you stop using this medication too soon, the infection may not be fully cured, and symptoms may recur or worsen. Resistance to the antibiotic (loss of effectiveness) may also develop.

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

The most common side effects observed with this medication were eye itching, eye discomfort, and eye redness.

The following side effects have been observed with this medication:

Common side effects (may affect up to 1 in 10 people)

• Eye effects: sensitivity to light, eye itching, eye discomfort, eye redness.
• General effects: allergy (hypersensitivity).

Uncommon side effects (may affect up to 1 in 100 people)

• Eye effects: inflammation of the eye surface, blurred vision, dry eye.

Generally, you can continue using the ointment unless the effects are severe. If you are concerned, discuss it with your doctor or pharmacist.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Conservation of OFTALMOLOSA CUSÍ GENTAMICINA

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

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

Do not store above 25°C.

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

Write the opening date of the tube in the box provided for this purpose on the packaging.

Medications should not be thrown away down the drain or in the trash. Deposit the packaging and unused medications in the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the packaging and unused medications. This will help protect the environment.

6. Package contents and additional information

Composition of OFTALMOLOSA CUSÍ GENTAMICINA

• The active ingredient is gentamicin. Each gram of ointment contains 3 mg of gentamicin (as sulfate).
• The other ingredients are cholesterol, liquid paraffin, and white petrolatum.

Appearance of the product and package contents

OFTALMOLOSA CUSÍ GENTAMICINA is a white ointment presented in a 5g aluminum tube with a polyethylene cap.

Marketing authorization holder

NTC s.r.l.,

via Luigi Razza 3,

20124 Milan, Italy

Manufacturer

Siegfried El Masnou, S.A.

C/ Camil Fabra, 58

08320 El Masnou – Barcelona, Spain

You can request more information about this medication from the local representative of the marketing authorization holder:

NTC Ophthalmics Iberica SL,

Calle Pinar, 5,

28006 Madrid, Spain

Date of the last revision of this leaflet:July 2018

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/