Patient Information Leaflet

TRIBIOTIC, (400 IU + 5 mg + 5000 IU)/g, ointment
(Bacitracinum zincum + Neomycini sulfas + Polymyxini B sulfas)
Please read all of this leaflet carefully before using this medicine, as it contains
important information for you.
This medicine should always be used exactly as described in this patient leaflet or as directed by your
doctor or pharmacist.

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

Contents of this leaflet

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

1. What Tribiotic is and what it is used for

Tribiotic is an antibiotic ointment for topical application to the skin. The medicine contains three active substances with antibacterial properties: bacitracin, neomycin, and polymyxin B. Tribiotic has a broad spectrum of antibacterial activity.
Tribiotic is indicated for the prevention of bacterial infections in minor cuts, wounds, scrapes, and burns.

2. Important information before using Tribiotic

When not to use Tribiotic:

if the patient is allergic to neomycin sulfate, polymyxin B sulfate, zinc bacitracin, or any of the 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 this 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, irritation, or severe allergic reactions—discontinue use of Tribiotic and contact your doctor.
If the patient experiences a severe allergic reaction, discontinue use of Tribiotic immediately and seek medical advice without delay.
If the patient is allergic to any antibiotic from the aminoglycoside or polymyxin group, they may also be allergic to this medicine.
Do not apply the medicine over large areas of damaged skin, as its active substances, when absorbed into the bloodstream, may cause hearing loss, kidney damage, and neurotoxic effects.
Tribiotic should be used with caution in patients with kidney disease and/or hearing disorders due to the risk of nephrotoxic and ototoxic effects of this medicine.
Concurrent use of Tribiotic with other medicines that have harmful effects on the kidneys and hearing may intensify these effects (see section: "Tribiotic and other medicines").

Children and adolescents
Do not use this medicine in children under 12 years of age due to the risk of ototoxic and nephrotoxic effects of this medicine.

Tribiotic and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently using or has recently used, as well as any medicines the patient plans to use.
After applying Tribiotic ointment to large areas of skin or to damaged skin, interactions with other concurrently used medicines may occur.
In particular, inform the doctor:

if the patient is taking oral neomycin (an antibiotic), as concomitant use with Tribiotic may increase the risk of allergic reactions;
if the patient is using medicines that may damage the kidneys and hearing organs, such as potent diuretics (e.g., furosemide, ethacrynic acid). When these drugs are administered together with aminoglycoside antibiotics, they increase their blood concentration, thereby increasing the risk of hearing disturbances up to complete deafness, which may occur even after discontinuation of the medicine;
if the patient is concurrently taking oral or topically applied aminoglycoside antibiotics or other medicines with potential nephrotoxic or neurotoxic effects, as additive adverse effects may occur.

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 her doctor or pharmacist before using this medicine.
Due to lack of adequate studies, Tribiotic should not be used during pregnancy or in women who are breastfeeding.

Driving and operating machinery
The effect of Tribiotic on the ability to drive and operate machinery is unknown.

3. How to use Tribiotic

This medicine should always be used as described in the patient leaflet or as directed by a physician or pharmacist.
If in doubt, consult a physician or pharmacist.
For topical use only.
Recommended dose
Apply once to three times daily.
A thin layer of the medicine should be applied to the affected area of skin after it has been previously cleaned and dried.
If necessary, the area may be covered with a sterile dressing after application.
Do not use this medicine for longer than 7 days.
If there is no improvement after 7 days, or if symptoms worsen, consult a physician.
Use in children and adolescents
Do not use in children under 12 years of age.
Use of a higher than recommended dose of Tribiotic
In case of application of a higher than recommended amount of Tribiotic, or accidental oral ingestion, contact a physician immediately.
Tribiotic, when used in large amounts or applied over large skin areas, wounds, or damaged skin, may have toxic effects on the kidneys, hearing, and nervous system. This risk particularly applies to individuals with impaired kidney function.
Missed dose of Tribiotic
Continue using the medicine as prescribed without increasing the next dose.
Do not use a double dose to make up for a missed dose.
If you have any further questions regarding the use of this medicine, consult your physician or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone will experience them.
The frequency of occurrence of adverse reactions cannot be determined based on the available data.
During treatment, especially long-term, the following may occur:

infection with resistant strains of bacteria or fungi;
systemic and local hypersensitivity reactions (rash, itching, redness, and other irritation symptoms);
hearing damage;
kidney damage.

If any of the symptoms listed above occur, treatment with Tribiotic must be stopped immediately and the patient should contact a physician.
Reporting of adverse reactions
If any adverse symptoms occur, including any adverse reactions not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
tel.: +48 22 49 21 301
fax: +48 22 49 21 309
e-mail: [email protected]
Adverse reactions can 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 Tribiotic

Keep the medicine out of the sight and reach of children.
Store below 25 ⁰C. Keep 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 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 package and other information

What Tribiotic contains

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

What Tribiotic looks like and contents of the pack
The medicine is a homogeneous ointment of a pale yellow colour.
Packaging: tube or sachet, in a cardboard box.
Pack sizes:
1 tube containing 5 g
1 tube containing 14 g
1 tube containing 28 g
10 sachets containing 0.5 g each
10 sachets containing 1 g each
10 sachets containing 1 g and 10 medicated plasters.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Kato Labs Sp. z o.o.
ul. Marszałkowska 138/82
00-004 Warsaw
Marketing Authorisation Holder
Kato Labs Sp. z o.o.
ul. Marszałkowska 138/82
00-004 Warsaw
Manufacturer
Tarchomin Pharmaceutical Works "Polfa" Joint Stock Company
ul. Fleminga 2
03-176 Warsaw