Label: Information for the User

COLIRCUSÍ GENTAMICINA 3 mg/ml Eye Drops in Solution

Read this label carefully before starting to use this medication,because it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, 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 any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

1.What is COLIRCUSÍ GENTAMICINA 3 mg/ml and how is it used

2.What you need to know before starting to use COLIRCUSÍ GENTAMICINA 3 mg/ml

3.How to use COLIRCUSÍ GENTAMICINA 3 mg/ml

4.Possible adverse effects

5Storage of COLIRCUSÍ GENTAMICINA 3 mg/ml

6.Contents of the package and additional information

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

This medicationis used for the treatment of external eye bacterial infections such as conjunctivitis, keratitis (corneal inflammation), corneal ulcers, blepharitis (eyelid inflammation), and dacryocystitis (lacrimal sac inflammation).

Do not use COLIRCUSÍ GENTAMICINA 3 mg/ml

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

Warnings and precautions

Consult your doctor or pharmacist before starting to useCOLIRCUSÍ GENTAMICINA 3mg/ml.

• Only use this medication in your eye(s).
• If you experience symptoms of an allergic reaction, such as itchy eyelids, swelling, or redness of the eye, stop using the medication immediately and consult your doctor. Allergic reactions can range from localized itching or skin redness to severe allergic reactions (anaphylaxis) or severe skin reactions. These allergic reactions can occur with other topical or systemic antibiotics in 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 a long period of time, you may become more sensitive to eye infections.
• If you wear contact lenses –if you experience signs or symptoms of an eye infection, stop wearing the contact lenses and use glasses. Do not use the contact lenses until the signs and symptoms of infection have resolved and the medication has been completed. For more information,see the instructions in the section “ COLIRCUSÍ GENTAMICINA 3 mg/mlcontains benzalkonium chloride”.

Use ofCOLIRCUSÍ GENTAMICINA 3 mg/ml withother medications

Inform your doctor or pharmacist if you are using, have used recentlyor may need to use anyother medication.

Pregnancy, breastfeedingand fertility

Consult your doctor or pharmacist before using any medication.

If you are pregnant or breastfeeding, think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before usingthis medication.

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

Driving and operating machinery

Immediately after applyingthis medicationyou may notice that your vision becomes blurry. Do not drive or operate machinery until your vision is clear.

COLIRCUSÍ GENTAMICINA 3 mg/mlcontains benzalkonium chloride

This medication contains 0.04 mg of benzalkonium chloride in each ml.

Benzalkonium chloride can be absorbed by soft contact lenses and may alter the

color of the contact lenses. Remove the contact lenses before using this medication and wait 15 minutes before reinserting them.

Benzalkonium chloride may cause eye irritation, especially if you have dry eye or other corneal diseases (transparent layer at the front of the eye). Consult your doctor if you experience a strange sensation, itching, or pain in the eye after using this medication.

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

The recommended dose is:

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

The usual dose is 1 or 2 drops every 4 hours. If necessary, it can be increased to 1 drop per 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 instructs you to do so.

This medication should only be used as eye drops.

Administration method and/or route:

To properly apply the eye drops, follow the steps indicated:

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 cap if it is loose.

3. Always be careful not to touch anything with the tip of the dropper, as it may contaminate the contents of the bottle.

4. Hold the bottle upside down with one hand.

5. With the other hand, separate the lower eyelid of the affected eye and direct your gaze upwards, tilting your head backwards (figure 1).

6. Place the tip of the dropper close to the eye, but do not touch it, and gently press the base of the bottle to allow the drops to fall into the space between the eye and the eyelid (figure 2).

7. After using this medication, press the edge of the eye, near the nose, with your finger for 2-3 minutes. This helps prevent the medication from passing into the rest of the body, and is especially important in young 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 the other eye medications. Eye ointments should be administered last.

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

If too much has been applied, 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 COLIRCUSÍ GENTAMICINA 3 mg/ml

If you forget to use COLIRCUSÍ GENTAMICINA 3 mg/ml when due, apply one 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 the next scheduled dose of your regular treatment. Do not apply a double dose to compensate for the missed dose.

If you interrupt treatment withCOLIRCUSÍ GENTAMICINA 3 mg/ml

It is essential to complete the treatment cycle indicated by your doctor, even if you start feeling better after a few days. If you discontinue treatment too soon, it is possible that the infection may not be fully cured, and symptoms may return or worsen. Additionally, antibiotic resistance (loss of effectiveness) may be generated.

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

Like all medications,this medicationcan produce adverse effects, although not all people will experience them.

The most frequent adverse effects observed with this medication were eye itching, eye discomfort, and eye redness.

The following adverse effects have been observed with this medication:

Frequent Adverse Effects (may affect up to1 in 10 people)

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

Rare Adverse Effects (may affect up to1 in 100 people)

• Eye effects: conjunctival inflammation, 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 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 about the safety of this medication.

Keepthis medication out of sight andout of reach of children.

This medication does not require special conservation conditions.

Do not usethis medicationafter the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

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

Note the opening date of the bottle in the reserved box for this purpose in the box.

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

Composition of COLIRCUSÍ GENTAMICINA 3 mg/ml

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

Appearance of the product and contents of the packaging

COLIRCUSÍ GENTAMICINA 3 mg/ml is a liquid (a transparent, colorless, or slightly yellowish 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

Responsible manufacturer

Siegfried El Masnou, S.A.

C/ Camil Fabra, 58

08320 El Masnou – Barcelona, Spain

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

NTC Ophthalmics Iberica SL,

Calle Pinar, 5,

28006 Madrid, Spain

Last review date of this leaflet:July 2018

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