OFTALMOLOSA CUSI ERYTHROMYCIN 5 mg/g OPHTHALMIC OINTMENT

Introduction

Package Leaflet: Information for the User

OFTALMOLOSA CUSÍ ERITROMICINA 5 mg/g Ophthalmic Ointment

erythromycin

Read the entire package leaflet carefully before starting to use this medicine, 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 medicine 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 side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

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

1. What you need to know before using OFTALMOLOSA CUSÍ ERITROMICINA
2. How to use OFTALMOLOSA CUSÍ ERITROMICINA
3. Possible side effects
4. Storage of OFTALMOLOSA CUSÍ ERITROMICINA
5. Package Contents and Additional Information

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

It 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 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 medicine. If you have any leftover antibiotic after completing treatment, return it to the pharmacy for proper disposal. Do not throw medicines down the drain or in the trash.

This medicine is used to treat superficial eye infections caused by microorganisms sensitive to erythromycin; and as a preventive treatment for neonatal ophthalmia (neonatal conjunctivitis).

2. What you need to know before using OFTALMOLOSA CUSÍ

Do not use Oftalmolosa Cusí Eritromicina

If you are allergic to erythromycin or any of the other components of this medicine (listed in section 6).

Warnings and Precautions

Consult your doctor or pharmacist before starting to use Oftalmolosa Cusí Eritromicina.

Use this medicine only in your eye(s).

If you use this medicine for a long 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 wear contact lenses:

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

Other Medicines and Oftalmolosa Cusí Eritromicina

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicine.

Pregnancy, Breastfeeding, and Fertility

If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine. This medicine is not recommended during pregnancy.

During breastfeeding, a decision should be made whether to discontinue breastfeeding or discontinue treatment with this medicine, considering the benefit of breastfeeding for the child and the benefit of treatment for the mother.

Driving and Using Machines

You may experience blurred vision immediately after applying Oftalmolosa Cusí Eritromicina. Do not drive or use machines until this effect has disappeared.

3. How to use OFTALMOLOSA CUSÍ ERITROMICINA

Follow your doctor's instructions for administering this medicine exactly. If you are unsure, consult your doctor or pharmacist again.

The recommended dose is:

Adults and Children

In the treatment of superficial eye infections: Apply approximately 1 cm of ointment to the affected eye(s) one or more times a day, depending on 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 ophthalmia.

Usage Recommendations:

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

• Take the ointment tube.

• If the application is inside the eye, separate the lower eyelid with a clean finger. Apply the ointment to the pouch formed between the eyelid and the eye.

• If the application is outside the eye, apply the ointment directly to the affected area, first softening any crusts with warm water.

• Place the tip of the tube near the eye. A mirror may be helpful.

• 2 -
  • Avoid touching the tip of the tube to the eye, eyelid, or surrounding areas.

• Gently squeeze the tube to release the ointment.

• Close the eye(s) for a few seconds after applying the ointment.

• Close the tube tightly after use.

If you are using other ophthalmic medicines, wait at least 5 minutes between administering this ointment and other ophthalmic medicines. Ophthalmic ointments should be administered last.

If you use more Oftalmolosa Cusí Eritromicina than you should

An 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 Toxicology Information Service. Telephone 91 562 04 20, indicating the medicine and the amount used.

If you forget to use Oftalmolosa Cusí Eritromicina

Do not apply a double dose to make up for forgotten doses.

Apply it 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 dosing schedule.

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

4. Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.

The following adverse reactions have been observed with this medicine, with a frequency that cannot be estimated from the available data:

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

Reporting Side Effects

If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this package leaflet. You can also report them directly through the Spanish Medicines and Health Products Agency's (AEMPS) website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of OFTALMOLOSA CUSÍ ERITROMICINA

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiration date stated on the tube and carton after EXP. 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 first opening.

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

Medicines should not be disposed of via wastewater or household waste. Place unwanted medicines and their packaging in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of unwanted medicines and packaging. This will help protect the environment.

6. Package Contents and Additional Information

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

• The other ingredients are cholesterol, liquid paraffin, and white petrolatum.

Appearance of the Product and Package Contents

Oftalmolosa Cusí Eritromicina is a white ophthalmic ointment (for use in the eyes), presented in an aluminum tube containing 3.5 g 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 medicine from the local representative of the marketing authorization holder:

NTC Ophthalmics Ibérica, S.L.

Calle Pinar 5

28006 Madrid, Spain

Date of the Last Revision of this Package Leaflet:January 2020.

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