Package leaflet: Information for the patient

Unguentum Neomycini, 5 mg/g, ointment
(Neomycini sulfas)
Please read all of this leaflet carefully before using this medicine, because it contains
important information for the patient.
This medicine should always be used exactly as described in the patient leaflet or as directed by a
physician or pharmacist.

Keep this leaflet, so that you can read it again if necessary.
If you need advice or further information, please consult your pharmacist.
If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, you should inform your doctor or pharmacist. See section 4.
If there is no improvement after 7 days, or if you feel worse, you should contact your doctor.

Contents of the leaflet

What Unguentum Neomycini is and what it is used for
Important information before using Unguentum Neomycini
How to use Unguentum Neomycini
Possible side effects
How to store Unguentum Neomycini
Contents of the pack and other information

1. What Unguentum Neomycini is and what it is used for

Unguentum Neomycini is an ointment for topical use on the skin. This medicine contains the antibiotic neomycin, which belongs to the aminoglycoside antibiotics.
Neomycin exerts a bactericidal effect against staphylococci and numerous Gram-negative bacteria, including Escherichia coli, Haemophilus influenzae, and bacteria of the genera Klebsiella, Proteus, Pseudomonas, Salmonella, and Shigella, as well as against acid-fast bacilli, including streptomycin-resistant strains of Mycobacterium tuberculosis. Neomycin is ineffective against Pseudomonas aeruginosa and bacteria of the genus Streptococcus, and has no activity against fungi, yeasts, or viruses.
Indications
Unguentum Neomycini is indicated for the local treatment of purulent skin diseases, especially those caused by staphylococci (e.g. furunculosis, impetigo), for the treatment of purulent complications of allergic skin diseases, and for infected minor burns and frostbite.

2. Information before using Unguentum Neomycini

When not to use Unguentum Neomycini:

if the patient is allergic to neomycin or to any of the other components of this medicine (listed in section 6);
during pregnancy and breastfeeding;
in children under 12 years of age;
if the patient has been diagnosed with hearing impairment;
on large areas of damaged skin, including diseased lesions and venous ulcers, or for prolonged periods, due to the risk of ototoxic (damaging hearing) or nephrotoxic (damaging kidneys) effects;
concurrently with medications that are toxic to the auditory organ, kidneys, or nervous system;
in elderly patients;
in cases of impaired kidney function;
in cases of hearing or balance disorders.

Warnings and precautions

Before starting treatment with Unguentum Neomycini, consult a doctor or pharmacist.
Do not use the medicine for longer than recommended, as this may lead to increasing bacterial resistance and may also cause fungal superinfection.
The medicine, when applied topically, especially to open wounds and for prolonged periods, may be ototoxic (damaging hearing and the vestibular organ) and nephrotoxic (causing kidney damage).
Children and adolescents
Do not use in children under 12 years of age.

Unguentum Neomycini and other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines you plan to take.
During topical application of Unguentum Neomycini to the skin, a cross-allergic reaction between neomycin and paramycin, kanamycin, tobramycin, amikacin, and isepamicin may occur.
Concurrent or sequential use of oral or topical neomycin and other aminoglycoside antibiotics (e.g. paromomycin) or other medicines potentially toxic to the kidneys or nervous system (e.g. bacitracin, cisplatin, vancomycin, amphotericin B, polymyxin B, colistin, viomycin) is contraindicated due to the risk of additive toxic effects.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Use of Unguentum Neomycini in pregnant women and during breastfeeding is contraindicated.

Driving and operating machinery
Unguentum Neomycini ointment has no effect on the ability to drive or operate machinery.

3. How to use Unguentum Neomycini

This medicine should always be used exactly as described in the patient information leaflet or according to the instructions of a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Before starting to use the medicine, pierce the tube's seal with the reverse side of the cap. In the case of a sachet, open the packaging; the ointment should be applied immediately after opening the sachet.
Unless otherwise directed by a doctor, apply a thin layer of the ointment to the affected areas 2 to 4 times daily. Do not use for longer than 7 days.
After using the medicine, wash your hands.

Use in children and adolescents
Use in children under 12 years of age is contraindicated.

Missed dose of Unguentum Neomycini
Do not use a double dose to make up for a missed dose.
If a dose is missed, continue treatment as usual, applying the medicine to the skin in the same amount as before.

Discontinuation of Unguentum Neomycini
If you have any further questions or concerns regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicinal product may cause adverse reactions, although not in every case do they occur.
Skin reactions and irritations, allergic reactions, redness, erythema, swelling, itching, toxic reactions, and rash-like changes may occur.

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can also be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
{current address, telephone and fax numbers of the above Department}
e-mail: [email protected]
Reporting of adverse reactions enables collection of further information on the safety of using this medicinal product.

5. How to store Unguentum Neomycini

Store below 25°C.
Do not store the ointment outside of its original sachet; use the ointment immediately after opening the sachet.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the outer packaging and on the immediate packaging (tube or sachet). 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 in use. This will help protect the environment.

6. Contents of the packaging and other information

What Unguentum Neomycini contains

The active substance is neomycin sulfate. 1 g of the ointment contains 5 mg of neomycin sulfate.
Other ingredients: white soft paraffin, liquid paraffin.

What Unguentum Neomycini looks like and contents of the pack
Unguentum Neomycini is a homogeneous, white ointment.
Available pack sizes are:

Aluminium tube containing 5 g or 20 g of ointment, with a patient information leaflet, packed in a cardboard box;
10 sachets made of laminate (Paper/Polyethylene/Aluminium/Surlyn), each containing 1 g of ointment, packed in a cardboard box.

Marketing Authorisation Holder and Manufacturer
CHEMA-ELEKTROMET
Labour Cooperative
Przemysłowa Street 9
35-105 Rzeszów
Phone: 17 862 05 90
e-mail: [email protected]