Polibiotic

Leaflet attached to the packaging: patient information

Polibiotic, (5 mg + 5000 IU + 400 IU)/g, ointment
Neomycin sulfate + Polymyxin B sulfate + Zinc bacitracin

Please read carefully 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 this patient leaflet or as directed by a doctor or pharmacist.

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

Table of contents of the leaflet

• 1. What is Polibiotic and what is it used for
• 2. Important information before using Polibiotic
• 3. How to use Polibiotic
• 4. Possible side effects
• 5. How to store Polibiotic
• 6. Contents of the packaging and other information

1. What is Polibiotic and what is it used for

Polibiotic is an ointment for topical use on the skin.
The medicine contains three active antibiotic substances: neomycin, polymyxin B, and bacitracin,
with a complementary range of action against bacteria that cause most skin infections.

Indications for use

Polibiotic is used for minor wounds (abrasions, scratches, bites), burns,
and skin ulcers.
If there is no improvement after 7 days or the patient feels worse, they should contact their doctor.

2. Important information before using Polibiotic

When not to use Polibiotic

• if the patient is allergic to neomycin or polymyxin B, or bacitracin, or any of the other ingredients of this medicine (listed in section 6);
• if the patient has hearing disorders (the medicine may have a hearing-damaging effect);
• on deep or puncture wounds, severe burns, or large areas of damaged skin, as well as on oozing lesions; due to the risk of absorption of active substances into the blood and their systemic side effects (hearing-damaging effect, kidney damage);
• in the eyes, on mucous membranes;
• in children under 12 years of age.

Warnings and precautions

Before starting to use Polibiotic, the patient should discuss it with their doctor or pharmacist.
If an allergy to Polibiotic occurs, the patient should stop using the medicine and immediately contact their doctor.
Before using Polibiotic, the patient should tell their doctor:

• if they are allergic to any antibiotic from the aminoglycoside group (such as streptomycin, gentamicin, tobramycin) or polymyxin, as they may also be allergic to Polibiotic,
• if they have kidney function disorders, as there is a greater risk of harmful effects of Polibiotic on the kidneys and hearing.

Prolonged use of Polibiotic may cause excessive growth of bacteria and fungi that are not sensitive to the medicine.
If side effects occur, especially irritation at the site of application or the patient notices a lack of improvement, they should stop using Polibiotic and contact their doctor.
Using the medicine on large areas of damaged skin may cause hearing loss, kidney damage, and toxic effects on the nervous system.

Children

Do not use in children under 12 years of age due to the risk of kidney and hearing damage.

Use in patients with kidney function disorders or hearing impairment

Patients with kidney function disorders, hearing impairment, or using other medicines that may damage the kidneys and hearing, should contact their doctor before using Polibiotic.

Use in elderly patients

There are no special recommendations for use in elderly patients. Patients with kidney function disorders should contact their doctor before using Polibiotic.

Polibiotic and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
After using Polibiotic on a large skin area or damaged skin, interactions with other medicines used at the same time may occur due to the absorption of the medicine into the body.
The patient should tell their doctor if they are taking neomycin orally, as the risk of allergic reactions may increase.
Do not use Polibiotic at the same time as medicines that may damage the kidneys and hearing, such as potent diuretics (e.g., furosemide, ethacrynic acid). These medicines, when given with aminoglycoside antibiotics (such as neomycin contained in Polibiotic), increase their concentration in the blood, which increases the risk of hearing disorders, up to deafness, which may occur even after stopping the use of Polibiotic.
When using Polibiotic with medicines that may damage the kidneys or nervous system, the risk of side effects may increase.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.
Due to the lack of appropriate studies, the medicine should not be used during pregnancy and breastfeeding.

Driving and using machines

No effects of using Polibiotic on the ability to drive and use machines have been found.

3. How to use Polibiotic

This medicine should always be used exactly as described in this patient leaflet or as directed by a doctor or pharmacist. In case of doubts, the patient should contact their doctor or pharmacist.
Apply to the skin.

Recommended dose

Clean the wound and cover it with a small amount of the medicine.
The ointment should be applied to the affected skin 2 to 5 times a day.
The site of application can be covered with a gauze dressing or left uncovered.
Do not use for more than 7 days.
After completing the treatment, do not use Polibiotic again before 3 months have passed.

Use in children

Do not use in children under 12 years of age due to the risk of kidney and hearing damage.

Using more than the recommended dose of Polibiotic

If the medicine is used on mucous membranes or on a large skin area (especially damaged skin), systemic side effects may occur. This applies primarily to patients with kidney function disorders. Symptoms of kidney damage, hearing loss, and toxic effects on the nervous system may occur.
In case of using more than the recommended dose of Polibiotic, the patient should stop using the medicine and contact their doctor.

Missing a dose of Polibiotic

Do not use a double dose to make up for a missed dose.
In case of any further doubts about using this medicine, the patient should contact their doctor or pharmacist.

4. Possible side effects

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

Side effects may include:

• hypersensitivity symptoms, including skin reactions (itching, rash, redness, swelling, and other signs of irritation);
• hearing loss;
• kidney damage;
• infection with bacteria or fungi that are not sensitive to the medicine.

Reporting side effects

If any side effects occur, including any side effects not listed in this leaflet, the patient should inform their doctor or pharmacist. 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 181C, 02-222 Warsaw,
phone: +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 to gather more information on the safety of the medicine.

5. How to store Polibiotic

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date (EXP) stated on the packaging. The expiry date refers to the last day of the month.
Shelf life after first opening the tube:

• aluminum tube 3 g and 5 g: 7 days;
• aluminum tube 15 g: 3 years, but no longer than the expiry date stated on the packaging.

Aluminum tube:
No special precautions for storage.
PET/PE/Aluminum/PE sachets:
Store at a temperature below 25°C.
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. Contents of the packaging and other information

What Polibiotic contains

• The active substances of the medicine are: neomycin sulfate, polymyxin B sulfate, and zinc bacitracin. 1 g of ointment contains 5 mg of neomycin sulfate, 5000 IU of polymyxin B sulfate, and 400 IU of zinc bacitracin.
• The other ingredient is: white petrolatum.

What Polibiotic looks like and contents of the packaging

Polibiotic is an ointment.
The packaging of the medicine is:

• an aluminum tube with a membrane, closed with an HDPE cap, containing 3 g, 5 g, or 15 g of ointment, placed in a cardboard box,
• 10 sachets made of PET/PE/Aluminum/PE film, each containing 1 g of ointment, placed in a cardboard box.

Marketing authorization holder and manufacturer

Aflofarm Farmacja Polska Sp. z o.o.
ul. Partyzancka 133/151,
95-200 Pabianice
Phone: (42) 22-53-100

Date of last revision of the leaflet: