Effectiveness in the fight against infections and inflammations of the skin

Indispensable for cuts, burns, skin infections.

Details

Scratches and wounds

It is used on minor scratches and superficial wounds of the skin, Tribiotic® protects againstthe development of bacterial infections, accelerates healing and minimizes the risk of complications.

Inflammations

Inflammation is an ideal place for bacteria to grow. They can occur not only after injuries, butalso after cosmetic procedures, tattoos or piercings. Tribiotic® minimizes risk of infection.

Burns

Tribiotic® used as indicated on the leaflet or as directed by a doctor or pharmacist, is ideallysuited for minor burns, minimizing the symptoms and risks, resulting from changes – dangers.

Convenience and efficiency

Tribiotic® used as indicated on the leaflet or as directed by a doctor or pharmacist, is ideallysuited for minor burns, minimizing the symptoms and risks, resulting from changes – dangers.

Accessibility

You can find our preparations in pharmacies all over the country

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Leaflet – information for patient

TRIBIOTIC®, (400 j.m. + 5 mg + 5000 j.m.)/g, maść
(Bacitracinum zincum + Neomycini sulfas + Polymyxini B sulfas)

What is Tribiotic® and what is it used for:

Tribiotic® is a topical skin ointment used locally. The medicine contains three active substances with antibacterial properties, such as bacitracin, neomycin, and polymyxin B. The medication has a broad spectrum of antibacterial activity.

Tribiotic® is indicated for preventing bacterial infections in cases of minor cuts, scratches, and burns.
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 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 a large area of damaged skin;
- on deep wounds or punctures;
- on severe burns; on oozing skin lesions.

Warnings and precautions:
Before starting to use Tribiotic®, discuss it with a doctor or pharmacist. If there is no improvement, if symptoms worsen, or if signs of hypersensitivity occur, including skin reactions such as rash, itching, irritation, and severe allergic reactions, discontinue use of Tribiotic® and consult a doctor. If a severe allergic reaction occurs, immediately stop using Tribiotic® and seek medical attention. If the patient is allergic to any antibiotic from the aminoglycoside or polymyxin group, they may also be allergic to this medicine. Do not use the medication on large areas of damaged skin because its active ingredients, when absorbed into the bloodstream, can cause hearing loss, kidney damage, and neurotoxic effects. Use Tribiotic® with caution in patients with kidney disease and/or hearing impairment due to the risk of toxic effects on the kidneys and hearing. Concurrent use of Tribiotic® with other medications harmful to the kidneys and hearing may enhance the effects of these drugs (see section: "Tribiotic® and other drugs").

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

Tribiotic® and other drugs:
Inform the doctor or pharmacist about all medications currently or recently taken by the patient, as well as any medications the patient plans to take. After applying Tribiotic® ointment to a large skin area or damaged skin, interactions with other concurrently used medications may occur. In particular, inform the doctor: if the patient is taking neomycin orally (an antibiotic), as concurrent use with Tribiotic® may increase the risk of allergic reactions; if the patient is using medications that may damage the kidneys and organs of hearing, such as potent diuretics like furosemide, ethacrynic acid. These medications, when used concurrently with aminoglycoside antibiotics, increase their blood concentration, enhancing the risk of hearing impairment, up to deafness, which may occur even after discontinuation of this medication; if the patient is concurrently taking orally or using topically aminoglycoside antibiotics or other drugs with possible harmful effects on the kidneys or nervous system, as adverse effects may be intensified.

Pregnancy and breastfeeding:
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult a doctor or pharmacist before using this medication. Due to the lack of adequate studies, the medication should not be used during pregnancy and in breastfeeding women.

Driving and using machines:
The effect of Tribiotic® on driving and operating machinery is unknown.
Possible adverse reactions:
Like any medication, this medication may cause adverse reactions, although not everyone experiences them. The frequency of adverse reactions cannot be determined based on available data. During treatment, especially long-term treatment, the following may occur: infection with non-sensitive strains of bacteria or fungi; systemic and local symptoms of hypersensitivity (rash, itching, redness, and other signs of irritation); hearing loss; kidney damage. If any of the above symptoms occur, discontinue use of Tribiotic® immediately and consult a doctor.

Reporting adverse reactions:
If any adverse reactions occur, including any adverse reactions not listed in the leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products 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: ndl@urpl.gov.pl Adverse reactions can also be reported to the responsible authority. Reporting adverse reactions will help gather more information about the safety of using the medicine.
How to use Tribiotic®:
This medication should always be used as described in the patient leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist. For use on the skin.

Recommended dose:
Apply once to three times daily. Apply a thin layer of the medication to the affected skin area after prior cleansing and drying. If necessary, the area can be covered with a sterile dressing after applying the ointment. Do not use the medication for more than 7 days. If there is no improvement or the patient feels worse after 7 days, consult a doctor.

Use in children and adolescents:
Do not use in children under 12 years of age.

Exceeding the recommended dose of Tribiotic®:
In case of using a larger than recommended dose of Tribiotic® or accidental oral intake, immediately contact a doctor. Tribiotic® used in large doses and on large skin areas, wounds, or damaged skin may act toxically on the kidneys, hearing, and nervous system. This risk primarily concerns individuals with impaired kidney function.

Missed application of Tribiotic®:
Continue using the medication without increasing the next dose. Do not use a double dose to make up for a missed dose. If there are any further doubts about using this medication, consult a doctor or pharmacist.
Contents of the package and other information:
What Tribiotic® contains:
The active ingredients of the medication 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 what the package contains:
The medication is a homogeneous ointment of a slightly yellow color. Packaging: tube or sachet, in a cardboard box.
Package sizes:
1 tube of 5g
1 tube of 14g
1 tube of 28g
10 sachets of 0.5g
10 sachets of 1g
10 sachets of 1g and
10 adhesive bandages.
Not all packaging sizes may be available. Responsible entity and manufacturer:
Kato Labs Sp. z o.o.
ul. Marszałkowska 138/82
00-004 Warsaw.

Date of last leaflet update:
08.01.2024 r.
How to store Tribiotic®:
Store the medication out of sight and reach of children. Store at a temperature below 25⁰C. Keep the package tightly closed to protect it from moisture. Do not use the medicine after the expiration date stated on the packaging. The expiry date refers to the last day of the month. Do not dispose of medicines in the sewage system or household waste containers. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.