UNGUENTUM 5 mg /G Ointment

Contents of the leaflet

1. Leaflet included in the packaging: patient information
2. Unguentum Neomycini, 5 mg/g, ointment
   1. Table of contents of the leaflet
3. What is Unguentum Neomycini and what is it used for
   1. Indications for use
4. Important information before using Unguentum Neomycini
   1. When not to use Unguentum Neomycini:
   2. Warnings and precautions
   3. Children and adolescents
   4. Unguentum Neomycini and other medicines
   5. Pregnancy and breastfeeding
   6. Driving and using machines
5. How to use Unguentum Neomycini
   1. Use in children and adolescents
   2. Missing a dose of Unguentum Neomycini
   3. Stopping the use of Unguentum Neomycini
6. Possible side effects
   1. Reporting side effects
7. How to store Unguentum Neomycini
8. Package contents and other information
   1. What Unguentum Neomycini contains
   2. What Unguentum Neomycini looks like and what the package contains
   3. Marketing authorization holder and manufacturer
   4. Date of the last update of the leaflet:

Leaflet included in the packaging: patient information

Unguentum Neomycini, 5 mg/g, ointment

(Neomycin sulfate)
You should carefully read the contents of the leaflet before using the medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in the patient leaflet or according to the
recommendations of a doctor or pharmacist.

• You should keep this leafletso that you can read it again if you need to.
• If you need advice or additional information, you should consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor or pharmacist. See section 4.
• If after 7 days there is no improvement or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

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

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

Unguentum Neomycini is an ointment for skin application. This medicine contains the antibiotic neomycin,
belonging to the aminoglycoside antibiotics.
Neomycin has a bactericidal effect on staphylococci and numerous Gram-negative bacteria, including
Escherichia coli, Haemophilus influenzaeand bacteria of the Klebsiella, Proteus, Pseudomonas,
Salmonellaand Shigellagenera, as well as acid-fast bacilli, including streptomycin-resistant Mycobacterium tuberculosisstrains.
Neomycin does not affect Pseudomonas aeruginosaand Streptococcusbacteria, nor does it affect fungi, yeast, or viruses.

Indications for use

Unguentum Neomycini is used for local treatment of purulent skin diseases, especially those caused by staphylococci (e.g., impetigo, staphylococcal eczema), in the treatment of purulent complications of allergic skin diseases, in infected minor burns and frostbite.

2. Important information before using Unguentum Neomycini

When not to use Unguentum Neomycini:

• if the patient is allergic to neomycin or any of the other ingredients of this medicine (listed in section 6);
• during pregnancy and breastfeeding;
• in children under 12 years of age;
• if the patient has hearing impairment;
• on large areas of damaged skin, including lesions and venous or long-standing ulcers, due to the risk of ototoxic or nephrotoxic effects;
• concomitantly with medicines that are toxic to the ear, kidneys, or nervous system;
• in the elderly;
• in patients with renal impairment;
• in patients with hearing or balance disorders.

Warnings and precautions

• Before starting to use Unguentum Neomycini, the patient should discuss it with their doctor or pharmacist.
• The medicine should not be used for a long time, as this may lead to the development of bacterial resistance and may cause fungal overgrowth.
• Local application of the medicine, especially on open wounds and for a long time, may be ototoxic (damage hearing and balance) and nephrotoxic (cause kidney damage).

Children and adolescents

Unguentum Neomycini should not be used in children under 12 years of age.

Unguentum Neomycini and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
During the use of Unguentum Neomycini on the skin, a cross-allergic reaction to neomycin with paramomycin, kanamycin, tobramycin, amikacin, and isepamycin may occur.
Concomitant or sequential use of oral or topical neomycin and other aminoglycoside antibiotics (e.g., paromomycin) or other medicines with potential nephrotoxic or neurotoxic effects (e.g., bacitracin, cisplatin, vancomycin, amphotericin B, polymyxin B, colistin, variomycin) is contraindicated due to the risk of additive toxic effects.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, or thinks they may be pregnant or plans to have a child, they should consult their doctor or pharmacist before using this medicine.
The use of Unguentum Neomycini in pregnant and breastfeeding women is contraindicated.

Driving and using machines

Unguentum Neomycini ointment does not affect the ability to drive and use machines.

3. How to use Unguentum Neomycini

This medicine should always be used exactly as described in the patient leaflet or according to the
recommendations of a doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist.
Before starting to use the medicine, the patient should pierce the membrane of the tube with the reverse side of the cap. In
the case of a sachet, the packaging should be torn open; the ointment should be applied directly after opening the sachet.
Unless the doctor recommends otherwise, the diseased areas should be covered with a thin layer of ointment 2 to 4
times a day. The medicine should not be used for more than 7 days.
After using the medicine, the patient should wash their hands.

Use in children and adolescents

Unguentum Neomycini should not be used in children under 12 years of age.

Missing a dose of Unguentum Neomycini

The patient should not use a double dose to make up for a missed dose.
In the event of a missed dose, the patient should continue treatment, applying the medicine to the skin in the same amount as before.

Stopping the use of Unguentum Neomycini

In case of any further doubts related to the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Unguentum Neomycini can cause side effects, although not everybody gets them.
Reactions and skin irritations, allergic changes, redness, rash, swelling, itching, toxic reactions, and changes of an eruptive nature may occur.

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the patient should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Post-Marketing Surveillance of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
{current address, phone and fax number of the Department}
e-mail: [email protected]
Reporting side effects helps to gather more information on the safety of the medicine.

5. How to store Unguentum Neomycini

Store at a temperature below 25°C.
The ointment should not be stored in an open sachet; it should be applied directly after opening the sachet.
The medicine should be kept out of sight and reach of children.
The medicine should not be used after the expiry date stated on the carton and the immediate packaging (tube or sachet). The expiry date refers to the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Unguentum Neomycini contains

• The active substance of the medicine is neomycin sulfate. 1 g of ointment contains 5 mg of neomycin sulfate.
• The other ingredients are: white petrolatum, liquid paraffin.

What Unguentum Neomycini looks like and what the package contains

Unguentum Neomycini is a homogeneous, white ointment.
The available packaging of the medicine is:

• an aluminum tube containing 5 g or 20 g of ointment, placed together with the leaflet in a cardboard box;
• 10 sachets made of paper/polyethylene/aluminum/surlyn, each containing 1 g of ointment, placed in a cardboard box.

Marketing authorization holder and manufacturer

CHEMA-ELEKTROMET
Cooperative
ul. Przemysłowa 9
35-105 Rzeszów
tel. 17 862 05 90
e-mail: [email protected]

Date of the last update of the leaflet: