Oftalmolosa Cusi erythromycin 5 mg/g ophthalmic ointment

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

OFTALMOLOSA CUSÍ ERITROMICINA 5 mg/g eye ointment

erythromycin

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

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

2. What you need to know before using OFTALMOLOSA CUSÍ ERITROMICINA

3. How to use OFTALMOLOSA CUSÍ ERITROMICINA

4. Possible side effects

5. How to store OFTALMOLOSA CUSÍ ERITROMICINA

6. Contents of the pack and other information

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

It is an ophthalmic ointment (for the eyes) containing an antibiotic (erythromycin) that acts against certain microorganisms causing eye infections.

Antibiotics are used to treat bacterial infections and are not effective against viral infections.

It is important that you follow your doctor's instructions regarding dosage, dosing interval, and duration of treatment.

Do not store or reuse this medicine. If you have any antibiotic left over after completing the treatment, return it to the pharmacy for proper disposal. Do not dispose of medicines down the drain or in household waste.

This medicine is used for the treatment of superficial ocular infections caused by microorganisms sensitive to erythromycin, and as preventive treatment for ophthalmia neonatorum (neonatal conjunctivitis).

2. What you need to know before using OFTALMOLOSA CUSÍ

Do not use Oftalmolosa Cusí Erythromycin

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

Warnings and precautions

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

Use this medicine only in your eye(s).

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

If you wear contact lenses:

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

Other medicines and Oftalmolosa Cusí Erythromycin

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning 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 to discontinue treatment with this medicine, taking into account 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 Erythromycin. Do not drive or operate machinery until this effect has disappeared.

3. How to use OFTALMOLOSA CUSÍ ERITROMICINA

Follow exactly the instructions for use of this medicine as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

Recommended dose:

Adults and children

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

Newborns

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

Instructions for use:

• Wash your hands and position yourself in front of a mirror.

• Take the tube of ointment.

• If applying inside the eye, pull the eyelid downward with a clean finger. Apply the ointment into the pocket formed between the eyelid and the eye.

• If applying outside the eye, apply the ointment directly to the affected area, after removing crusts by softening them with warm water.

• Hold the tip of the tube close to the eye. The mirror may be helpful.

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  • Avoid letting the tip of the tube touch the eye, eyelid, surrounding areas, or any other surface.

• Gently press the tube so that the ointment comes out.

• 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 the administration of this ointment and other ophthalmic medications. Ophthalmic ointments should be administered last.

If you use more Oftalmolosa Cusí Eritromicina than you should

An overdose in the eyes can be removed by rinsing the eyes with lukewarm water. Do not apply more ointment until the next scheduled dose.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 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 missed doses.

Apply it as soon as you remember and continue with the next dose as scheduled. 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 the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

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

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

Reporting of 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 leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of OFTALMOLOSA CUSÍ ERYTHROMYCIN

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

Do not use this medicine after the expiry date stated on the tube and on the carton after EXP. The expiry date refers to the last day of the month indicated.

Do not store above 25°C.

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

Record the date of first opening of the tube in the box provided for this purpose on the carton.

Medicines must not be disposed of via wastewater drains or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

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

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

Appearance of the product and contents of the pack

Oftalmolosa Cusí Erythromycin is a whiteish ophthalmic ointment (for use in the eyes), supplied in an aluminium tube containing 3.5 g with a polyethylene cap.

Marketing Authorization Holder:

NTC S.r.l.

Via Luigi Razza, 3

20124 Milan, Italy

Manufacturer responsible for manufacturing

Siegfried El Masnou, S.A.

C/ Camil Fabra, 58

08320 El Masnou – Barcelona, Spain.

Further information on this medicinal product can be obtained by contacting the local representative of the Marketing Authorization Holder:

NTC Ophthalmics Ibérica, S.L.

Calle Pinar 5

28006 Madrid, Spain

Date of the most recent revision of this leaflet: January 2020.

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