Tribiotic

Package Leaflet: Information for the Patient

TRIBIOTIC, (400 IU + 5 mg + 5000 IU)/g, ointment
(Zinc Bacitracin + Neomycin Sulfate + Polymyxin B Sulfate)

Read the package leaflet carefully before using the medicine, as it contains

important information for the patient.
This medicine should always be used exactly as described in the package leaflet or as directed by
your doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, ask your pharmacist.
• If you experience any side effects, including any possible side effects not listed in this leaflet, tell
  your doctor or pharmacist. See section 4.
• If after 7 days there is no improvement or you feel worse, contact your doctor.

Table of Contents of the Leaflet

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

1. What is Tribiotic and what is it used for

Tribiotic is a medicine in the form of an ointment for topical use on the skin. The medicine contains three
active substances with antibacterial action, such as: bacitracin, neomycin, and polymyxin B.
The medicine has a broad spectrum of antibacterial action.
Tribiotic is indicated forpreventing the development of bacterial infections in the case of minor wounds,
scratches, and burns.

2. Important information before using Tribiotic

When not to use Tribiotic:

• if you are allergic to neomycin sulfate, polymyxin B sulfate, zinc bacitracin, or any other ingredients of this medicine (listed in section 6);
• in children under 12 years of age (see section: "Children and adolescents");
• on mucous membranes;
• in the eyes;
• on large areas of damaged skin;
• on deep or puncture wounds;
• on severe burns;
• on weeping skin lesions.

Warnings and precautions

Before starting to use Tribiotic, discuss it with your doctor or pharmacist.
If there is no improvement, or if symptoms worsen or signs of hypersensitivity occur, including
skin reactions such as rash, itching, signs of irritation, and severe allergic reactions, discontinue use of
Tribiotic and contact your doctor.
If you experience a severe allergic reaction, discontinue use of Tribiotic immediately and contact your
doctor.
If you are allergic to any antibiotic from the aminoglycoside or polymyxin group, you may also be allergic to
this medicine.
Do not use the medicine on large areas of damaged skin, as its active substances may be absorbed into
the blood and cause hearing loss, kidney damage, and toxic effects on the nervous system.
Tribiotic should be used with caution in patients with kidney disease and/or hearing impairment, due to the
risk of toxic effects on the kidneys and hearing.
Using Tribiotic with other medicines that have harmful effects on the kidneys and hearing may increase the
effects of these medicines (see section: "Tribiotic and other medicines").

Children and adolescents

Do not use the medicine in children under 12 years of age due to the risk of toxic effects on hearing and
kidneys.

Tribiotic and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.
After applying Tribiotic ointment to a large area of skin or damaged skin, interactions with other medicines
may occur.
In particular, inform your doctor:

• if you are taking neomycin orally (an antibiotic), as concurrent use with Tribiotic may increase the risk of
  allergic reactions;
• if you are using medicines that may damage the kidneys and hearing, such as potent diuretics, e.g.,
  furosemide, ethacrynic acid. These medicines, when given with aminoglycoside antibiotics, increase their
  concentration in the blood, which increases the risk of hearing disorders, up to and including deafness,
  which may occur even after discontinuation of this medicine;
• if you are taking or using aminoglycoside antibiotics or other medicines that may have harmful effects on
  the kidneys or nervous system, as the risk of adverse effects may increase.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your
doctor or pharmacist for advice before using this medicine.
Due to the lack of adequate studies, the medicine should not be used during pregnancy and in breastfeeding
women.

Driving and using machines

The effect of Tribiotic on the ability to drive and use machines is not known.

3. How to use Tribiotic

This medicine should always be used exactly as described in the package leaflet or as directed by your
doctor or pharmacist. If you are unsure, ask your doctor or pharmacist.
For use on the skin.

Recommended dose

Apply one to three times a day.
Apply a thin layer of the medicine to the affected area of skin, after cleaning and drying. If necessary,
cover the area with a sterile dressing after applying the ointment.
Do not use the medicine for more than 7 days.
If after 7 days there is no improvement or you feel worse, contact your doctor.

Use in children and adolescents

Do not use in children under 12 years of age.

Using more than the recommended dose of Tribiotic

If you use more than the recommended amount of Tribiotic or accidentally take it orally, contact your doctor
immediately.
Tribiotic used in large doses and on large areas of skin, wounds, or damaged skin may have toxic effects
on the kidneys, hearing, and nervous system. This risk is particularly high in people with impaired kidney
function.

Missing a dose of Tribiotic

Continue using the medicine without increasing the next dose.
Do not use a double dose to make up for a missed dose.
If you have any further doubts about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The frequency of side effects cannot be estimated from the available data.
During treatment, especially long-term, the following may occur:

• infection with resistant bacterial strains or fungi;
• systemic and local signs of hypersensitivity (rash, itching, redness, and other signs of irritation);
• hearing loss;
• kidney damage.

If you experience any of the above symptoms, discontinue use of Tribiotic and contact your doctor.

Reporting side effects

If you experience any side effects, including any possible side effects not listed in this leaflet, tell your doctor
or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to
Medicinal Products, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych,
Al. Jerozolimskie 181C, 02-222 Warsaw, tel: +48 22 49 21 301, fax: +48 22 49 21 309, e-mail:
ndl@urpl.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side
effects, you can help provide more information on the safety of this medicine.

5. How to store Tribiotic

Keep the medicine out of the sight and reach of children.
Store in a temperature below 25°C. Store the container tightly closed to protect from moisture.
Do not use the medicine after the expiry date stated on the packaging. The expiry date refers to the last day
of the month stated.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Tribiotic contains

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

What Tribiotic looks like and contents of the pack

The medicine is a homogeneous ointment of light yellow color.
Packaging: tube or sachet, in a cardboard box.
Pack sizes:
1 tube of 5 g
1 tube of 14 g
1 tube of 28 g
10 sachets of 0.5 g
10 sachets of 1 g
10 sachets of 1 g and 10 dressings.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Kato Labs Sp. z o.o.
ul. Marszałkowska 138/82
00-004 Warsaw

Marketing authorization holder

Kato Labs Sp. z o.o.
ul. Marszałkowska 138/82
00-004 Warsaw

Manufacturer

Tarchomińskie Zakłady Farmaceutyczne "Polfa" Spółka Akcyjna
ul. Fleminga 2
03-176 Warsaw

Date of last revision of the leaflet: