Product Information for the User

ERITROMYCIN OINTMENT 5 mg/g Ophthalmic Ointment

Erithromycin

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

• Keep this product information, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed only to 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 product information. See section 4.

1. What you need to know before starting to use ERITROMYCIN OINTMENT
2. How to use ERITROMYCIN OINTMENT
3. Possible adverse effects
4. Storage of ERITROMYCIN OINTMENT
5. Contents of the package and additional information

This is an ophthalmic ointment (for the eyes) that contains an antibiotic (erythromycin), which acts against certain microorganisms that cause eye infections.

Antibiotics are used to treat bacterial infections and do not work for viral infections.

It is essential that you follow the instructions regarding the dose, administration interval, and treatment duration indicated by your doctor.

Do not store or reuse this medication. If you have leftover antibiotic after treatment, return it to the pharmacy for proper disposal. Do not dispose of medications through the drain or in the trash.

This medication is used for the treatment of superficial eye infections caused by microorganisms sensitive to erythromycin; and as a preventive treatment for newborn conjunctivitis (ophthalmia neonatorum).

Do not use Oftalmolosa Cusí Eritromicina

If you are allergic to erythromycin 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 Eritromycin.

Only use this medication in your eye(s).

If you use this medication for a long period of time or in excess, you may become more sensitive to other eye infections, including fungal infections. Consult your doctor if your symptoms worsen or return suddenly.

If you use contact lenses:

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

Other medications and Oftalmolosa Cusí Eritromycin

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

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 medication. This medication is not recommended during pregnancy.

During breastfeeding, decide whether to interrupt it or interrupt the treatment with this medication after considering the benefits of breastfeeding for the child and the benefits of treatment for the mother.

Driving and operating machines

You may notice blurred vision immediately after applying Oftalmolosa Cusí Eritromycin. Do not drive or operate machines until this effect has disappeared.

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

The recommended dose is:

Adults and children

For the treatment of superficial eye infections: Apply approximately 1cm of ointment to the affected eye(s) one or more times a day, according to the severity of the infection (up to a maximum of 6 times a day).

Newborns

A single application is sufficient for the preventive treatment of neonatal conjunctivitis.

Usage recommendations:

• Wash your hands and stand in front of a mirror.

• Take the ointment tube.

• If the application is outside the eye, apply the ointment directly to the affected area,after removing any crusts by soaking them with warm water.

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• Press the tube gently to release the ointment.

• Close the tube tightly after use.

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

If you use more Oftalmolosa Cusí Eritromicina than you should

A overdose in the eyes can be eliminated by rinsing the 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 Eritromicina

Do not apply a double dose to compensate for the missed doses.

Apply it as soon as you remember and continue with the next dose that was 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.

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 may experience them.

The following adverse reactions of unknown frequency have been observed with this medication:(cannot be estimated from the available data):

General effects: mild allergic reaction (hypersensitivity), mild eye irritation, and redness; burning sensation.

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.Reporting adverse effects can help provide more information about 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 tube and on the box 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 first opening it.

Record the date of opening the tube in the reserved box for this purpose.

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

• The active ingredient is erythromycin. Each gram of ointment contains 5 mg of erythromycin (0.5%).

• The other components are cholesterol, liquid paraffin, and white vaseline.

Appearance of the product and contents of the packaging

Oftalmolosa Cusí Erythromycin is an eye ointment (for use in the eyes), a whitish paste, presented in an aluminum tube containing 3.5 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 Ibérica, S.L.

Calle Pinar 5

28006 Madrid, Spain

Date of the last review of this leaflet:January 2020.

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