Cusi Erithromicin 0,5%

Leaflet attached to the packaging: information for the user

Warning! Keep the leaflet, information on the immediate packaging in a foreign language!

Cusi Erythromycin 0.5%(Oftalmolosa Cusi Eritromicina)

5 mg/g, eye ointment

Erythromycin
Cusi Erythromycin 0.5% and Oftalmolosa Cusi Eritromicina are different trade names for the same drug.

You should carefully read the contents of the leaflet before using the drug, as it contains important information for the patient.

• You should keep this leaflet so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This drug has been prescribed to a specific person. It should not be given to others. The drug may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Cusi Erythromycin 0.5% and what is it used for
• 2. Important information before using Cusi Erythromycin 0.5%
• 3. How to use Cusi Erythromycin 0.5%
• 4. Possible side effects
• 5. How to store Cusi Erythromycin 0.5%
• 6. Contents of the packaging 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 drugs called antibiotics. It has a bactericidal effect. The drug is indicated for the treatment of eye and adnexal infections caused by bacteria sensitive to erythromycin. It can also be used to prevent certain eye infections in newborns.

2. Important information before using Cusi Erythromycin 0.5%

When not to use Cusi Erythromycin 0.5%

Warnings and precautions

Before starting treatment with Cusi Erythromycin 0.5%, you should discuss it with your doctor or pharmacist.

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

Children

There are no special recommendations for the use of the drug in children.
The drug is used to prevent conjunctivitis in newborns. It should then be administered once (see section 3: Dosage).

Cusi Erythromycin 0.5% and other drugs

You should tell your doctor or pharmacist about all the drugs you are currently taking or have recently taken, as well as any drugs you plan to take.
So far, there have been no reports of other drugs used concurrently with Cusi Erythromycin 0.5% causing an increase in existing or new side effects.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks she may be pregnant, or plans to have a child, she should consult her doctor or pharmacist before using this drug.
The possibility of using the drug during pregnancy or breastfeeding should be assessed by the doctor.
Before using, consult a doctor.

Driving and using machines

Eye ointments can cause blurred vision, so they should not be used when the patient intends to drive or operate machines.
Temporary blurred vision or other visual disturbances may affect the ability to drive or operate machines. If blurred vision occurs after administration, you should wait until your vision returns before driving or operating machines.

3. How to use Cusi Erythromycin 0.5%

This drug should always be used in accordance with the doctor's recommendations. In case of doubts, you should consult a doctor or pharmacist.
Dosage
The following dosage regimen is usually used:
Adults:
In the case of superficial eye infection - 1 time per day or more often, depending on the severity of the infection.
To completely cure the infection, the drug should be taken regularly, for the entire treatment period prescribed by the doctor, even if the symptoms of the infection disappear earlier. Stopping treatment too early may cause a relapse of symptoms. Do not skip subsequent doses.
If there is no improvement within a few days of using the drug, you should consult a doctor.
In newborns to prevent conjunctivitis:
The drug should be administered once.
If you feel that the effect of the drug is too strong or too weak, you should consult a doctor.
Method of administration
Before using the drug, wash your hands thoroughly.
Administration into the eye:
Tilt your head back and gently press the skin under the lower eyelid with your finger.
Pull the lower eyelid down to create a free space between the eyelid and the eye. Remove the cap and squeeze a small amount of ointment from the tube into the free space, equivalent to a grain of rice.
Gently close your eye. Do not blink. Do not open your eye for about 1-2 minutes, so the drug can be absorbed.
If a small amount of ointment does not get into the eye, you should repeat the attempt to administer it correctly.
Administration to the outside, in the eye area:
In case of crusts, soften them with warm water and gently remove them, then apply the ointment directly from the tube to the affected area.
After each use, the tube should be closed tightly and put in a place that is out of sight and reach of children.
Note: To avoid contaminating the drug, you should avoid touching the tip of the tube to any surface, including the surface of the eye.
Store the tube tightly closed.
The drug can only be used by one person.
The drug should be discarded after the end of treatment.
If the patient is using other eye drops or ointments, you should keep an interval of at least 5 minutes between administering the next drugs. Eye ointments should be used last.

Using a higher dose of Cusi Erythromycin 0.5% than recommended

In case of overdose, excess drug can be rinsed out of the eye with lukewarm water. Do not administer an additional amount of the drug to the eye until the next scheduled dose.

Missing a dose of Cusi Erythromycin 0.5%

If the patient forgets to use Cusi Erythromycin 0.5%, they should continue treatment by administering the next dose according to the dosage regimen. If the time for the next dose is approaching, the missed dose should be skipped and treatment continued according to the recommended dosage regimen. Do notuse a double dose to make up for the missed dose.

Stopping the use of Cusi Erythromycin 0.5%

You should avoid stopping treatment too early. See section 3 - Dosage.
In case of any further doubts related to the use of this drug, you should consult a doctor or pharmacist.

4. Possible side effects

Like all drugs, this drug can cause side effects, although not everyone will experience them.
During the use of Cusi Erythromycin 0.5%, the following side effects have been observed.
The frequency of these effects is unknown (cannot be determined based on available data).

• General side effects: hypersensitivity (allergy).

Reporting side effects

If any side effects occur, including any side effects not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
By reporting side effects, you can help gather more information on the safety of the drug.

5. How to store Cusi Erythromycin 0.5%

The drug should be stored in a place that is out of sight and reach of children.
Do not store above 25°C.
Do not use this drug after the expiration date stated on the packaging.
The expiration date means the last day of the given month.
Discard 4 weeks after first opening.
Drugs should not be disposed of in the sewage system or household waste containers. You should ask your pharmacist how to dispose of unused drugs. This will help protect the environment.

6. Contents of the packaging and other information

What Cusi Erythromycin 0.5% contains

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

What Cusi Erythromycin 0.5% looks like and what the packaging contains

An aluminum tube with a nozzle containing 3.5 g of ointment; in a cardboard box.
To obtain more detailed information, you should contact the marketing authorization holder or parallel importer.

Marketing authorization 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:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź

Repackaged by:

CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warsaw
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warsaw
Synoptis Industrial Sp. z o.o.
ul. Szosa Bydgoska 58
87-100 Toruń
IVA Pharm Sp. z o.o.
ul. Drawska 14/1
02-202 Warsaw
CANPOLAND SPÓŁKA AKCYJNA
ul. Beskidzka 190
91-610 Łódź
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Marketing authorization number in Spain, the country of export: 653528.8
Parallel import authorization number: 42/21
Date of leaflet approval: 09.02.2023
[Information about the trademark]