Cusi erythromycin 0.5%

Package leaflet: Information for the user

Warning! Keep the leaflet – the information on the immediate packaging is 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 medicinal product.
Please read the following information carefully before using this 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 questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Cusi Erythromycin 0.5% is and what it is 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 Cusi Erythromycin 0.5% is and what it is 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 as a bactericidal agent. This 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 treatment with Cusi Erythromycin 0.5%, consult a doctor or
pharmacist.

• Cusi Erythromycin 0.5% is for ophthalmic use only.
• After each use, the tube must be tightly closed.
• If Cusi Erythromycin 0.5% is used for a prolonged period, resistant bacteria or fungi may develop.

Children
No special recommendations regarding use in children.
The medicine is used for prophylaxis of ophthalmia neonatorum in newborns. In such cases, it should be administered as a single dose (see section 3: Dosage).
Cusi Erythromycin 0.5% and other medicines
Inform your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
There have been no reports so far 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 a doctor or pharmacist before using this medicine.
The use of this medicine in pregnant or breastfeeding women should be evaluated by a physician.
Consult a doctor before use.
Driving and operating machinery
Ophthalmic 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 instillation, driving or operating machinery should be delayed until vision clears.

3. How to use Cusi Erythromycin 0.5%

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

Dosage

The following dosage regimen is most commonly used:

Adults:

For superficial eye infections – once daily or more frequently, depending on the severity of the infection.

To achieve complete recovery, the medicine should be used regularly throughout the entire treatment period prescribed by the doctor, even if symptoms of infection improve earlier. Premature discontinuation of treatment may result in recurrence of symptoms. Do not skip doses.

If there is no improvement within a few days of using the medicine, consult your doctor.

For newborns, for prevention of ophthalmia neonatorum:

Administer the medicine once only.

If you feel the effect of the medicine is too strong or too weak, consult your doctor.

Method of administration

Wash your hands thoroughly before using the medicine.

Administration into the eye:

Tilt the head backward and gently pull down the lower eyelid with one finger to create a small pocket 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 pocket. 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 procedure to ensure correct administration.

Administration externally around the eye:

If crusts are present, soften them with warm water and gently remove them, then apply the ointment directly from the tube to the affected area.

After each use, close the tube tightly and store it out of sight and reach of children.

Warning: To avoid contamination of the medicine, avoid contact between the tip of the tube and 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 medicine after completion of treatment.

If the patient is using other medicines in the form of eye drops or ointments, wait at least 5 minutes between the administration of each medicine. Eye ointments should be used last.

Use of more than the 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.

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, the missed dose should be skipped and treatment continued as prescribed. Do not use a double dose to make up for a missed dose.

Stopping Cusi Erythromycin 0.5% treatment

Avoid stopping treatment prematurely. See section 3 – Dosage.

If you have any further doubts concerning the use of this medicine, consult your 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 (allergic reactions).

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can also be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, al. Jerozolimskie 181C, 02-222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions enables continued monitoring of the safety of the 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.
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.
Discard 4 weeks after first opening.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Cusi Erythromycin 0.5% contains

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

What Cusi Erythromycin 0.5% looks like and contents of the pack
Aluminium tube with a cannula containing 3.5 g of ointment; in a cardboard box.
For more detailed information, please contact the responsible party or the parallel importer.
Responsible party 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
0830 El Masnou – Barcelona
Spain
Parallel importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Marketing Authorization number in Spain, the country of export: 653528.8
Parallel import license number: 42/21