COLIRCUSI GENTAMICINA 3mg/ml EYE DROPS SOLUTION

Introduction

Package Leaflet: Information for the User

COLIRCUSI GENTAMICINA 3 mg/ml eye drops solution

Read the entire package leaflet carefully before starting to use this medication, as it contains important information for you.

• Keep this package 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 package leaflet. See section 4.

Contents of the Package Leaflet

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

5. Storage of COLIRCUSI GENTAMICINA 3 mg/ml

1. Package Contents and Additional Information

1. What COLIRCUSI GENTAMICINA 3 mg/ml is and what it is used for

COLIRCUSI GENTAMICINA 3 mg/ml is an eye drop that contains an antibiotic, gentamicin, which acts against the microorganisms that cause bacterial infections in the eyes.

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 as 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 such as conjunctivitis, keratitis (inflammation of the cornea), corneal ulcers, blepharitis (inflammation of the eyelids), and dacryocystitis (inflammation of the lacrimal sac).

2. What you need to know before using COLIRCUSI GENTAMICINA 3 mg/ml

Do not use COLIRCUSI GENTAMICINA 3 mg/ml

• 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 COLIRCUSI GENTAMICINA 3 mg/ml.

• 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 of the same family (aminoglycosides).
• If your symptoms worsen or return, consult your doctor.
• If you are using another antibiotic treatment, including oral, consult your doctor.
• If you use this medication for an extended period, you may become more susceptible to eye infections.
• If you use contact lenses –if you experience signs or symptoms of an eye infection, stop using contact lenses and wear glasses. Do not use contact lenses until the signs and symptoms of infection have resolved and you have finished using the medication. For more information, read the instructions in the section "COLIRCUSI GENTAMICINA 3 mg/ml contains benzalkonium chloride".

Using COLIRCUSI GENTAMICINA 3 mg/ml 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.

COLIRCUSI GENTAMICINA 3 mg/ml contains benzalkonium chloride

This medication contains 0.04 mg of benzalkonium chloride per milliliter.

Benzalkonium chloride can be absorbed by soft contact lenses and may alter their color. Remove contact lenses before using this medication and wait 15 minutes before reinserting them.

Benzalkonium chloride can cause eye irritation, especially if you have dry eye or other corneal diseases (the transparent layer of the front of the eye). Consult your doctor if you feel any unusual sensation, itching, or pain in the eye after using this medication.

3. How to use COLIRCUSI GENTAMICINA 3 mg/ml

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist again.

The recommended dose is:

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

The normal dose is 1 or 2 drops every 4 hours. If necessary, it can be increased to 1 drop every hour.

Remember to apply your medication when it is due.

Your doctor will indicate the duration of your treatment with this medication. Do not discontinue treatment unless your doctor advises you to do so.

This medication should only be used as eye drops.

Method of use and/or administration route:

To correctly apply the eye drops, follow these steps:

1. Wash your hands and sit in front of a mirror, if possible.
2. After opening the bottle for the first time, remove the plastic ring from the seal if it is loose.
3. Always be careful not to touch anything with the dropper tip, as it may contaminate the bottle contents.
4. Hold the bottle upside down with one hand.
5. With the other hand, separate the lower eyelid of the affected eye downward and look up, tilting your head back (figure 1).
6. Place the dropper tip close to the eye, without touching it, and gently press the base of the bottle to release the drops into the space between the eye and the eyelid (figure 2).
7. After using this medication, press the edge of the eye, next to the nose, with your finger for 2-3 minutes. This helps prevent the medication from entering the rest of the body and is important in small children (figure 3).
8. Repeat steps 4, 5, and 6 for the other eye, if necessary.
9. Close the bottle tightly after use.

If a drop falls outside the eye, try again.

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

If you use more COLIRCUSI GENTAMICINA 3 mg/ml than you should

If you have applied too much, you can remove it by rinsing your eyes with warm water. Do not apply more drops until the next scheduled 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 COLIRCUSI GENTAMICINA 3 mg/ml

If you forget to use COLIRCUSI GENTAMICINA 3 mg/ml when it is due, apply a drop 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 treatment schedule. Do not apply a double dose to make up for missed doses.

If you interrupt treatment with COLIRCUSI GENTAMICINA 3 mg/ml

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, it is possible that the infection has not been fully cured, and symptoms may return or worsen. Additionally, antibiotic resistance (loss of effectiveness) may occur.

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

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone may 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 drops 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 package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of COLIRCUSI GENTAMICINA 3 mg/ml

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

This medication does not require special storage conditions.

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.

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

Write the opening date of the bottle in the space provided on the carton.

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

6. Package Contents and Additional Information

Composition of COLIRCUSI GENTAMICINA 3 mg/ml

• The active ingredient is gentamicin. Each milliliter of solution contains 3 mg of gentamicin (as sulfate).
• The other ingredients are benzalkonium chloride, sodium chloride, disodium hydrogen phosphate dodecahydrate, sodium phosphate monobasic monohydrate, and purified water.

Appearance of the Product and Package Contents

COLIRCUSI GENTAMICINA 3 mg/ml is a liquid (a clear, colorless, or slightly yellow solution) presented in a 10 ml plastic bottle with a dropper dispenser.

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 package leaflet:July 2018

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