Prospecto: Information for the User

CUVITAN GENTAMICIN 3 mg/g Ophthalmic Ointment

Read this entire prospect carefully before starting to use this medicine, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you and should not be given 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 prospect. See section 4.

1.What is CUVITAN GENTAMICIN and for what it is used

2.What you need to know before starting to use CUVITAN GENTAMICIN

3.How to use CUVITAN GENTAMICIN

4.Possible adverse effects

5Storage of CUVITAN GENTAMICIN

6.Contents of the package and additional information

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

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

Do not use OFTALMOLOSA CUSÍ GENTAMICINA

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

Warnings and precautions

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

• 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 group (aminoglycosides).
• If your symptoms worsen or return, consult your doctor.
• If you are using another antibiotic treatment at the same time, even if it is taken orally, consult your doctor.
• If you use this medication for a long period of time, you may become more sensitive to eye infections.
• If you use contact lenses:

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

Use of OFTALMOLOSA CUSÍ GENTAMICINA with other medications

Inform your doctor or pharmacist if you are using, have used recently, 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.

Driving and operating machinery

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

Follow exactly the administration instructions of this medication 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:

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.

Usage recommendations:

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

If you use more OFTALMOLOSA CUSÍ GENTAMICINA than you should,, you may 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 Toxicological Information Service. Phone 91 562 04 20, indicating the medication and the amount used.

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

If you interrupt the treatment with OFTALMOLOSA CUSÍ GENTAMICINA

It is essential to complete the treatment cycle indicated by your doctor even if you start feeling better after a few days. If you stop using this medication too soon, it is possible that the infection may not have been fully cured, and symptoms may return or worsen. You may also develop antibiotic resistance (lose effectiveness).

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

Like all medications, this medication may 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 to 1 in 10 people)

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

Rare Adverse Effects (may affect up to 1 in 100 people)

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

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

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

Do not store at a temperature above 25°C.

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

Record the date of tube opening in the designated space on the box.

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

Composition of OFTALMOLOSA CUSÍ GENTAMICINA

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

Appearance of the product and content of the container

OFTALMOLOSA CUSÍ GENTAMICINAis a white ointment that is presented in an aluminum tube containing 5 g with a polyethylene plug.

Holder of the marketing authorization

NTC s.r.l.,

via Luigi Razza 3,

20124 Milan, Italy

Responsible for manufacturing

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 holder of the marketing authorization:

NTC Ophthalmics Iberica SL,

Calle Pinar, 5,

28006 Madrid, Spain

Date of the last review of this leaflet:July 2018

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