Neomicinum Ielfa

Leaflet attached to the packaging: patient information

Neomycinum Jelfa, 5 mg/g, eye ointment

Neomycin sulfate

Please read the contents of the leaflet carefully before using the medicine, as it contains important information for the patient.

• -You should keep this leaflet, so you can read it again if you need to.
• -If you have any doubts, you should consult a doctor, pharmacist, or nurse.
• -This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• -If you experience any side effects, including any not listed in the leaflet, you should tell your doctor, pharmacist, or nurse.

Table of contents of the leaflet

• 1. What is Neomycinum Jelfa and what is it used for
• 2. Important information before using Neomycinum Jelfa
• 3. How to use Neomycinum Jelfa
• 4. Possible side effects
• 5. How to store Neomycinum Jelfa
• 6. Package contents and other information

1. What is Neomycinum Jelfa and what is it used for

The active substance of the medicine is neomycin in the form of neomycin sulfate.
Neomycin belongs to the group of aminoglycoside antibiotics (a group of bactericidal antibiotics).
It exhibits antibacterial activity against aerobic Gram-negative and some Gram-positive bacteria, including Escherichia coli,rods of the genus Proteusand Salmonella,as well as staphylococci.
It does not exhibit activity against most streptococci and anaerobic bacteria.
After local application to the eye, neomycin may be absorbed into the circulatory system only in the case of tissue damage.

2. Important information before using Neomycinum Jelfa

When not to use Neomycinum Jelfa

Warnings and precautions

Before starting to use Neomycinum Jelfa, you should discuss it with your doctor, pharmacist, or nurse.
The medicine should be used with caution in patients with hypersensitivity to aminoglycoside antibiotics.
Hypersensitivity to neomycin may manifest as slowed wound healing, e.g., of the cornea.
If symptoms of irritation and hypersensitivity worsen, treatment with this medicine should be discontinued.
The medicine should not be used for longer than prescribed by the doctor, due to the possibility of the development of resistant bacterial strains.
The tip of the tube should not be touched to the eye, eyelid, or any other surface, as this may contaminate the contents of the tube.

Neomycinum Jelfa and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
The medicine should not be used at the same time as other medicines applied locally to the eye.

Pregnancy, breastfeeding, and fertility

In pregnancy and during breastfeeding, or if you suspect you are pregnant or plan to become pregnant, you should consult your doctor or pharmacist before using this medicine.
The medicine may be used in pregnant women only in cases where the benefit to the mother outweighs the potential risk to the fetus.
The use of Neomycinum Jelfa is not recommended in breastfeeding women.

Driving and operating machinery

There are no data on the effect of neomycin on the ability to drive vehicles and operate machinery.
However, you should remember that immediately after applying the ointment to the eye, there may be temporary vision disturbances that resolve within a few minutes.

3. How to use Neomycinum Jelfa

This medicine should always be used according to the doctor's or pharmacist's recommendations.
In case of doubts, you should consult a doctor or pharmacist.
The recommended dose is: a small amount of ointment should be squeezed from the tube into the conjunctival sac or onto the eyelid margins 3 to 5 times a day.
The medicine should not be used for longer than 10 days.

Missing a dose of Neomycinum Jelfa

A double dose should not be used to make up for a missed dose.

Stopping the use of Neomycinum Jelfa

If you have any further doubts about using this medicine, you should consult a doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Eye disorders

Transient burning sensation in the eye area, tearing, conjunctival redness, and transient vision disturbances that resolve a few minutes after using Neomycinum Jelfa.
Neomycin used in the form of eye ointment very rarely causes side effects characteristic of aminoglycoside antibiotics.
If any of the listed side effects occur or if you experience any other disturbing symptoms, you should immediately consult a doctor.
If any of the side effects worsen or if you experience any side effects not listed in the leaflet, you should inform your doctor or pharmacist.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your 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, Al. Jerozolimskie 181 C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Neomycinum Jelfa

Store at a temperature below 25°C.
The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after: Expiry date.
The expiry date refers to the last day of the month stated.
Medicines should not be disposed of via wastewater or household waste.
You should ask your pharmacist how to dispose of medicines that are no longer needed.
This will help protect the environment.

6. Package contents and other information

What Neomycinum Jelfa contains

The active substance of the medicine is neomycin sulfate.
1 g of ointment contains 5 mg of neomycin sulfate.
The other ingredient of the medicine is white petrolatum.

What Neomycinum Jelfa looks like and what the package contains

Neomycinum Jelfa is a white, semi-transparent, greasy, soft mass.
The available package of the medicine is an aluminum tube, internally lacquered, with an HDPE nozzle, sealed with a 90% HDPE + 10% LDPE cap with a guarantee ring, containing 3 g of ointment, placed in a cardboard box.

Marketing authorization holder and manufacturer:

Marketing authorization holder

Bausch + Lomb Ireland Limited
3013 Lake Drive
Citywest Business Campus
Dublin 24, D24PPT3
Ireland

Manufacturer

Przedsiębiorstwo Farmaceutyczne Jelfa SA
ul. Wincentego Pola 21
58-500 Jelenia Góra

Date of last update of the leaflet: