Cusi Erithromicin 0,5%

Package Leaflet: Information for the User

CUSI ERYTHROMYCIN 0.5%, 5 mg/g, Eye Ointment

Erythromycin
Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your 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 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 has a bactericidal effect. The medicine 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%

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

Warnings and precautions

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

• Cusi Erythromycin 0.5% should only be used for the eyes.
• After each use, close the tube tightly.
• If you use Cusi Erythromycin 0.5% for a long time, you may develop bacteria or fungi that are not sensitive to erythromycin.

Children

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

Cusi Erythromycin 0.5% and other medicines

Tell your doctor or pharmacist about all the medicines you are taking, or have recently taken, and about the medicines you plan to take.
So far, there are no reports of other medicines used concurrently with Cusi Erythromycin 0.5% causing an increase in existing or new side effects.

Pregnancy, breastfeeding, and fertility

If you are pregnant, breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medicine.
The possibility of using the medicine during pregnancy or breastfeeding should be assessed by your doctor.
Consult your doctor before use.

Driving and using machines

Eye ointments can cause blurred vision, so do not use them if you plan to drive or operate machinery.
Temporary blurred vision or other vision disturbances may affect your ability to drive or operate machinery. If blurred vision occurs after administration, wait until your vision returns to normal before driving or operating machinery.

3. How to use Cusi Erythromycin 0.5%

Always use this medicine exactly as your doctor has told you. If you are not sure, ask your 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, you should take the medicine regularly, for the entire treatment period prescribed by your doctor, even if the symptoms of the infection disappear earlier. Stopping treatment too early may cause the symptoms to return. Do not skip any doses.
If there is no improvement within a few days of using the medicine, consult your doctor.
In newborns to prevent conjunctivitis:
The medicine should be administered once.
If you feel that the effect of the medicine is too strong or too weak, consult your doctor.
Method of administration
Before using the medicine, 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 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, into the space.
Gently close your eye. Do not blink. Do not open your eye for about 1-2 minutes to allow the medicine to be absorbed.
If a small amount of ointment does not get into the eye, repeat the attempt to administer it correctly.
Administration to the outside of the eye:
If there are crusts, 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 put it in a place out of sight and reach of children.
Note: To avoid contaminating the medicine, avoid touching the tip of the tube to any surface, including the surface of the eye.
Store the tube tightly closed.
The medicine should only be used by one person.
The medicine should be discarded after the treatment is finished.
If you are using other eye drops or ointments, wait at least 5 minutes between administering the different medicines. Eye ointments should be used last.

Using more than the recommended dose of Cusi Erythromycin 0.5%

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

Missing a dose of Cusi Erythromycin 0.5%

If you forget to use Cusi Erythromycin 0.5%, continue the treatment by administering the next dose according to the dosage regimen. If it is almost time for the next dose, skip the missed dose and continue the treatment 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%

Be careful not to stop the treatment too early. See section 3 - Dosage.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, 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 (it cannotbeestimatedfromtheavailabledata).

• General side effects: hypersensitivity (allergy).

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department for 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, tel.: 22 49-21-301, fax: 22 49-21-309,
email: ndl@urpl.gov.pl.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Cusi Erythromycin 0.5%

Keep the medicine out of sight and reach of children.
Store in a temperature below 25°C. Store the packaging tightly closed.
Do not use this medicine after the expiry date stated on the packaging after: EXP.
The expiry date refers to the last day of the month stated.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. 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, soft white paraffin, liquid paraffin.

What Cusi Erythromycin 0.5% looks like and contents of the pack

Aluminum tube with a nozzle containing 3.5 g of ointment; in a cardboard box.

Marketing Authorization Holder

Pharm Supply Sp. z o.o.
ul. Marconich 2/9,
02-954 Warsaw,
Poland

Manufacturer:

Siegfried El Masnou, S.A.
c/Camil Fabra, 58
08320 El Masnou (Barcelona)
Spain

Date of the last revision of the leaflet: