Package leaflet: Information for the user

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
Cusi Erythromycin 0.5% (Oftalmolosa Cusi Eritromicina)
5 mg/g, eye ointment
Erythromycinum
Cusi Erythromycin 0.5% and Oftalmolosa Cusi Eritromicina are different trade names for the
same medicine.
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

Keep this leaflet so that you can read it again if necessary.
If you have any doubts, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform the doctor or pharmacist. See section 4.

Table of contents of the leaflet

What is Cusi Erythromycin 0.5% and what is it used for
Important information before using Cusi Erythromycin 0.5%
How to use Cusi Erythromycin 0.5%
Possible side effects
How to store Cusi Erythromycin 0.5%
Contents of the pack and other information

1. What is Cusi Erythromycin 0.5% and what is it used for

Cusi Erythromycin 0.5% is a sterile eye ointment. It contains the active substance erythromycin at a concentration of 5 mg per 1 g of ointment. Erythromycin belongs to a group of medicines called antibiotics. It acts bactericidally. The medicine is indicated for the treatment of eye and ocular adnexa infections caused by bacteria sensitive to erythromycin. It may also be used for the prevention of certain eye infections in newborns.

2. Important information before using Cusi Erythromycin 0.5%

When not to use Cusi Erythromycin 0.5%

if the patient is allergic to erythromycin or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before starting to use Cusi Erythromycin 0.5%, discuss it with your doctor or
pharmacist.

Cusi Erythromycin 0.5% should be used for the eyes only.
After each use, the tube must be closed tightly.
If the patient uses Cusi Erythromycin 0.5% for a prolonged period, bacteria or fungi resistant to erythromycin may develop.

Children
There are no special recommendations regarding the use of this medicine in children.
The medicine is used for the prevention of ophthalmia neonatorum in newborns. In such cases, it should be administered once only (see section 3: Dosage).
Cusi Erythromycin 0.5% and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
To date, there have been no reports indicating that other medicines used concomitantly with Cusi Erythromycin 0.5% cause worsening of existing or emergence of new adverse effects.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.
The use of this medicine in pregnant or breastfeeding women should be evaluated by a doctor.
Consult a doctor before use.
Driving and operating machinery
Eye ointments may cause blurred vision and therefore should not be used when the patient intends to drive or operate machinery.
Transient blurred vision or other visual disturbances may affect the ability to drive and operate machinery. If blurred vision occurs after application, the patient should wait until vision clears before driving or operating machinery.

3. How to use Cusi Erythromycin 0.5%

This medicine should always be used as directed by the physician. If in doubt, consult a doctor or pharmacist.

Dosage
The following dosage regimen is most commonly used:
Adults:
In case of superficial eye infection – once daily or more frequently, depending on the severity of the infection.
To ensure complete recovery, the medicine should be used regularly throughout the entire treatment period prescribed by the physician, even if symptoms of infection subside earlier. Stopping treatment too early may cause symptoms to recur. Do not skip any doses.
If there is no improvement within a few days of using the medicine, consult a doctor.
For newborns, for prevention of ophthalmia neonatorum:
Administer the medicine once.
If the effect of the medicine seems too strong or too weak, consult a doctor.

Administration method
Wash hands thoroughly before applying the medicine.
Administration into the eye:
Tilt the head backward and gently pull down the lower eyelid with the finger of one hand, creating a small space between the eyelid and the eye. Remove the cap and squeeze a small amount of ointment—about the size of a grain of rice—from the tube into this space. Gently close the eye. Do not blink. Keep the eye closed for about 1–2 minutes to allow the medicine to be absorbed.
If a small amount of ointment does not enter the eye, repeat the attempt to properly administer it.
External application around the eye:
If crusts are present, soften them with warm water and carefully remove them, then apply the ointment directly from the tube to the affected area.
After each use, close the tube tightly and store it in a place inaccessible and out of sight of children.
Warning: To avoid contamination of the medicine, avoid contact of the tube tip with any surface, including the surface of the eye.
Keep the tube tightly closed.
This medicine should be used by only one person.
Dispose of the tube after completing treatment.
If the patient is using other medicines in the form of eye drops or eye ointments, wait at least 5 minutes between administering each medicine. Eye ointments should be applied last.

Use of a higher than recommended dose of Cusi Erythromycin 0.5%
In case of overdose, excess medicine can be rinsed from the eye with lukewarm water. Do not administer additional medicine to the eye until the next scheduled dose time.

Missed dose of Cusi Erythromycin 0.5%
If the patient forgets to apply Cusi Erythromycin 0.5%, they should continue treatment by applying the next dose according to the prescribed schedule. If it is almost time for the next dose, skip the missed dose and continue treatment according to the prescribed dosage regimen. Do not use a double dose to make up for the missed dose.

Stopping treatment with Cusi Erythromycin 0.5%
Avoid stopping treatment prematurely. See section 3 – Dosage.
If there are any further doubts regarding the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The following adverse reactions have been observed during the use of Cusi Erythromycin 0.5%.
The frequency of occurrence of these reactions is unknown (cannot be estimated from the available data).

General adverse reactions: hypersensitivity (allergy).

Reporting of adverse reactions
If any adverse reactions occur, including any unlisted side effects not mentioned in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 4921301, fax: +48 22 4921309, website: https://smz.ezdrowie.gov.pl.
Reporting adverse reactions helps to provide more information on the safety of using this medicine.

5. How to store Cusi Erythromycin 0.5%

Keep this medicine out of the sight and reach of children.
Do not store above 25°C.
Discard 4 weeks after first opening the tube.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Cusi Erythromycin 0.5% contains

The active substance is erythromycin. 1 g of ointment contains 5 mg of erythromycin.
The other ingredients are: cholesterol, white soft paraffin, liquid paraffin.

What Cusi Erythromycin 0.5% looks like and contents of the pack
A tube containing 3.5 g of eye ointment, in a cardboard box.
For further information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in Spain, the country of export:
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
Parallel importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorisation number in Spain, the country of export: 653528.8
Parallel import licence number: 163/16