Cusi Erithromicin 0,5%

Leaflet attached to the packaging: information for the user

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Cusi Erythromycin 0.5% (Oftalmolosa Cusí Eritromicina)

5 mg/g, eye ointment

Erythromycin
Cusi Erythromycin 0.5% and Oftalmolosa Cusí 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.

• The leaflet should be kept so that it can be re-read if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This drug has been prescribed for 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 the leaflet, they should inform their doctor, pharmacist, or nurse. 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 to use 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 tightly closed.
• 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 in the prevention of ophthalmia neonatorum in newborns. It should then be administered once (see section 3: Dosage)
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Cusi Erythromycin 0.5% and other drugs

The patient should tell their doctor or pharmacist about all the drugs they are currently taking or have recently taken, as well as any drugs they 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 they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this drug.
The possibility of using the drug by pregnant or breastfeeding women should be assessed by a doctor.
Before using, the patient should consult their 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.
Transient blurred vision or other visual disturbances may affect the ability to drive or operate machines. If blurred vision occurs after administration, the patient should wait until their vision clears 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, the patient should consult their doctor or pharmacist.

Dosage

The following dosage regimen is usually used:
Adults:
In the case of superficial eye infection - 1 time a 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 period of treatment prescribed by the doctor, even if the symptoms of the infection disappear earlier. Stopping treatment too early may cause a relapse of symptoms. The patient should not skip any doses.
In the case of lack of improvement within a few days of using the drug, the patient should consult their doctor.
In newborns, to prevent ophthalmia neonatorum:
The drug should be administered once.
If the patient feels that the effect of the drug is too strong or too weak, they should consult their doctor.

Method of administration

Before using the drug, the patient should wash their hands thoroughly.
Administration into the eye:
Tilt the head back and gently press the skin under the lower eyelid with one 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 the eye. Do not blink. Do not open the eye for about 1-2 minutes, so the drug can be absorbed.
If a small amount of ointment does not get into the eye, the patient should try to administer it correctly again.
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.
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After each use, the tube should be tightly closed and put away in a place that is invisible and inaccessible to children.
Warning: to avoid contaminating the drug, the patient should avoid touching the tip of the tube to any surface, including the surface of the eye.
The tube should be kept tightly closed.
The drug can only be used by one person.
The drug should be discarded after the treatment is finished.
If the patient uses other eye drops or ointments, they should wait at least 5 minutes between administering the different drugs. Eye ointments should be used last.

Using a higher dose of Cusi Erythromycin 0.5% than recommended

In case of overdose, the excess drug can be rinsed out of the eye with lukewarm water. The patient should 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 the treatment by administering the next dose according to the dosage regimen. If the time for the next dose is near, the patient should skip the missed dose and continue the treatment according to the recommended dosage regimen. The patient should not use a double dose to make up for the missed dose.

Stopping the use of Cusi Erythromycin 0.5%

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

4. Possible side effects

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

• General side effects: allergic reaction (hypersensitivity).

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the patient should inform their doctor, pharmacist, or nurse. 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:
Aleje Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309, website:
https://smz.ezdrowie.gov.pl
By reporting side effects, more information can be collected on the safety of the use of the drug.

5. How to store Cusi Erythromycin 0.5%

The drug should be stored in a place that is invisible and inaccessible to children.
Do not store at a temperature above 25°C.
Do not use this drug after the expiry date stated on the packaging.
The expiry date means the last day of the specified month.
Shelf life after opening the tube: 4 weeks.
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Drugs should not be thrown into the sewage system or household waste containers. The patient should ask their 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, liquid paraffin, white petrolatum.

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

An aluminum tube containing 3.5 g of ointment, in a cardboard box.
For more detailed information, the patient should contact the marketing authorization holder or the 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:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Spanish marketing authorization number: 653528.8

Parallel import authorization number: 142/23

Date of leaflet approval: 14.07.2023

[Information about the trademark]
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