Neomycin jelfa
Poland
Table of Contents
Package leaflet: Information for the patient
Neomycinum Jelfa, 5 mg/g, ophthalmic ointment
Neomycini sulfas
Please read carefully all the information in this leaflet before using the 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 doubts, please consult your doctor, pharmacist, or nurse.
- This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
- If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse.
Table of contents of the leaflet
- What Neomycinum Jelfa is and what it is used for
- Important information before using Neomycinum Jelfa
- How to use Neomycinum Jelfa
- Possible side effects
- How to store Neomycinum Jelfa
- Contents of the pack and other information
1. What Neomycinum Jelfa is and what it is used for
The active substance in this medicine is neomycin in the form of neomycin sulfate.
Neomycin belongs to the group of aminoglycoside antibiotics (a group of bactericidal antibiotics). It exerts antibacterial activity against aerobic Gram-negative bacteria and some Gram-positive bacteria, including Escherichia coli, Proteus species, Salmonella species, and staphylococci. It is not active against most streptococci and anaerobic bacteria.
After topical application to the eye, neomycin may be absorbed into the systemic circulation only if tissues are damaged.
2. Important information before using Neomycinum Jelfa
When not to use Neomycinum Jelfa
- if the patient is allergic to neomycin, other antibiotics from the aminoglycoside group, or to vaseline, characterized by occurrence of itching, rash, hyperaemia, swelling, or other signs of irritation in the eye area due to use of the medicine.
Warnings and precautions
Before starting to use Neomycinum Jelfa, discuss this with your doctor, pharmacist, or nurse.
Use with caution in patients hypersensitive to aminoglycoside antibiotics. Hypersensitivity to neomycin may manifest as delayed wound healing, e.g. of the cornea.
If irritation or hypersensitivity symptoms worsen, treatment with this medicine should be discontinued.
Do not use Neomycinum Jelfa for longer than prescribed by your doctor, due to the risk of proliferation of resistant bacterial strains.
Do not let the tube tip touch the eye, eyelid, or any other surface, as this may contaminate the contents of the tube.
Neomycinum Jelfa and other medicines
Tell your doctor or pharmacist about all medicines you are currently using, have recently used, or plan to use.
Do not use Neomycinum Jelfa simultaneously with other locally applied eye medicines.
Pregnancy, breastfeeding, and fertility
If you are pregnant, breastfeeding, suspect you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
This medicine may be used during pregnancy only if, in the opinion of the doctor, the benefit to the mother outweighs the potential risk to the fetus.
Use of Neomycinum Jelfa is not recommended in breastfeeding women.
Driving and operating machinery
There are no data regarding the effect of neomycin on the ability to drive motor vehicles or operate mechanical equipment. However, it should be noted that immediately after application of the ointment to the eye, temporary blurred vision may occur, which resolves within a few minutes.
3. How to use Neomycinum Jelfa
This medicine should always be used exactly as recommended by your doctor or pharmacist. If you are unsure,
you should consult your doctor or pharmacist.
The recommended dose is: squeeze a small amount of ointment from the tube into the conjunctival sac or onto
the eyelid margins 3 to 5 times daily.
This medicine should not be used for longer than 10 days.
If you forget to use Neomycinum Jelfa
Do not use a double dose to make up for a missed dose.
Stopping Neomycinum Jelfa
If you have any further questions about the use of this medicine, consult your doctor, pharmacist, or nurse.
4. Possible adverse reactions
Like all medicines, this medicine may cause adverse reactions, although not everyone experiences them.
Eye disorders
Transient burning sensation around the eye, tearing, conjunctival hyperaemia, and transient visual disturbances, subsiding several minutes after application of Neomycinum Jelfa ophthalmic ointment.
Neomycin administered as an ophthalmic ointment very rarely causes adverse reactions typical of aminoglycoside antibiotics.
If any of the listed adverse reactions occur, or any other disturbing symptoms appear, consult a physician immediately.
If any of the adverse reactions worsen or if any adverse reactions not listed in this leaflet occur, inform your doctor or pharmacist.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, Phone: +48 22 49 21 301, Fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl
Adverse reactions may also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.
5. How to store Neomycinum Jelfa
Store below 25°C.
Keep the medicine out of the sight and reach of children. Do not use this
medicine after the expiry date stated on the cardboard packaging after: Expiry date.
The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. These measures will help
protect the environment.
6. Contents of the pack and other information
What Neomycinum Jelfa contains
The active substance is neomycin sulfate.
Each 1 g of ointment contains 5 mg of neomycin sulfate.
The other ingredient is white soft paraffin.
What Neomycinum Jelfa looks like and contents of the pack
Neomycinum Jelfa is a white, semi-transparent, greasy, soft ointment.
The medicine is available in an aluminum tube internally lacquered, with an HDPE nozzle,
closed with a cap made of 90% HDPE + 10% LDPE with a tamper-evident ring, containing 3 g
of ointment, placed in a cardboard box.
Marketing Authorisation Holder and Manufacturer:
Marketing Authorisation 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
Poland