Patient Information Leaflet

MULTIBIOTIC, (5 mg + 10 mg + 0.833 mg)/g, ointment
(Neomycini sulfas + Bacitracinum zincum + Polymyxini B sulfas)
Please read this leaflet carefully 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.

Keep this leaflet for future reference.
If you need advice or further information, consult your pharmacist.
If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement within 7 days, or if your condition worsens, consult your doctor.

Leaflet Contents:

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

1. What Multibiotic is and what it is used for

Multibiotic is an ointment containing three antibiotics – neomycin, polymyxin B, and bacitracin – with antibacterial activity.

Indications:
Prevention of secondary infections of minor cuts, scrapes, abrasions, and burns.
Primary and secondary bacterial skin infections (e.g., infected minor wounds, bacterial skin infections in burns and frostbite) caused by Gram-positive bacteria (staphylococci, streptococci) and Gram-negative bacilli, including bacteria of the genus Pseudomonas.

2. Important information before using Multibiotic

When not to use Multibiotic:

if the patient is allergic to the active substances, aminoglycosides, polymyxins, or any of the other ingredients of this medicine (listed in section 6);
on mucous membranes;
on deep or puncture wounds, severe burns;
over large areas of damaged skin;
in the eyes;
on weeping skin lesions;
in children under 12 years of age;
during pregnancy and breastfeeding.

Warnings and precautions
Treatment must be discontinued if signs of hypersensitivity occur, including skin symptoms such as
rash, itching, irritation symptoms, and medical advice should be sought.
Application of Multibiotic over large areas of damaged skin may cause kidney and hearing damage,
including hearing loss, and may lead to neurotoxic symptoms.
Particular caution should be exercised by patients with impaired kidney function or hearing impairment.
The medicine may enhance the effects of other medicines taken concomitantly that damage the kidneys or hearing, especially in patients with impaired kidney function.
Children and adolescents
Do not use in children under 12 years of age.
Multibiotic and other medicines:
Inform your doctor or pharmacist about all medicines currently used or recently used, as well as any medicines you plan to use.
After application over large areas of skin or damaged skin, active substances may be absorbed into the bloodstream, potentially leading to interactions with other concomitantly used medicines.
Concurrent use of this medicine with orally administered neomycin may increase the risk of hypersensitivity.
Do not use this medicine simultaneously with medicines that may damage the kidneys or hearing, such as potent diuretics (e.g., furosemide, ethacrynic acid). When these medicines are administered together with aminoglycoside antibiotics, they increase their blood concentration, thereby increasing the risk of hearing disorders, including deafness, which may occur even after discontinuation of the medicine.
When neomycin is applied to the skin, cross-reactive allergic reactions to other aminoglycoside antibiotics may occur.
Concomitant use of aminoglycoside antibiotics or other medicines that may damage the kidneys, or medicines with neurotoxic effects, may result in additive adverse effects.
Pregnancy and breastfeeding
Do not use during pregnancy and breastfeeding.
The use of Multibiotic in pregnant and breastfeeding women is contraindicated.
Driving and operating machinery
Multibiotic has no effect on the ability to drive or operate machinery.
Multibiotic contains propyl parahydroxybenzoate and methyl parahydroxybenzoate, which
may cause local allergic skin reactions (e.g., contact dermatitis).

3. How to use Multibiotic

The medicine is intended for use on the skin.

Before first use of Multibiotic medicine, pierce the membrane of the tube with the reverse side of the cap. In the case of a sachet, tear open the packaging; the ointment should be applied immediately after opening the sachet.
Before each application, wash the affected area with soap and water, then dry the skin thoroughly and cover it with a thin layer of ointment.
Unless otherwise directed by a physician, apply 2 to 5 times daily at regular intervals.
The affected area covered with ointment may be protected with a sterile gauze dressing.
Treatment should not last longer than 7 days.
The medicine should be used for the entire duration of this period.

If in doubt, consult a doctor or pharmacist.
Use of a higher than recommended dose of Multibiotic
When used as recommended, overdose is unlikely.
Prolonged use of the medicine over large areas of damaged skin may lead to absorption of antibiotics into the bloodstream, resulting in symptoms of kidney damage, hearing impairment (including hearing loss), and toxic effects on the nervous system.
Missed dose of Multibiotic
If a dose is missed, apply the medicine as soon as possible.
Do not use a double dose to make up for the missed dose.
Discontinuation of Multibiotic
Discontinue use of Multibiotic and consult a doctor if:

the condition of the affected skin area worsens;
signs of allergy (hypersensitivity) occur, such as: rash, redness, itching, swelling.

In case of any further doubts regarding the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everybody experiences them.
The following may occur during treatment:

allergic reactions, including skin reactions, with symptoms such as itching, rash, redness, swelling;
irritation at the site of application;
superinfection with resistant bacterial strains or yeasts;
hearing damage.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181 C
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 enables continued monitoring of the medicine's safety.

5. How to store Multibiotic

Keep the ointment in closed packaging, at a temperature below 25 °C.
Do not store the ointment in an opened sachet; the ointment should be used immediately after opening the sachet.
Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and on the primary packaging (tube or sachet). The expiry date refers to the last day of the stated month.
Medicines should not be disposed of via sewage systems or household waste. Ask your pharmacist how to dispose of medicines no longer in use. Such measures will help protect the environment.

Contents of the pack and other information

What Multibiotic contains

The active substances are neomycin sulfate, bacitracin zinc, and polymyxin B sulfate. 1 g of the medicine contains the following active substances: 5 mg neomycin sulfate, 10 mg bacitracin zinc, 0.833 mg polymyxin B sulfate.
Other components: propyl parahydroxybenzoate (E 216), methyl parahydroxybenzoate (E 218), white soft paraffin.

What Multibiotic looks like and contents of the pack
Multibiotic is a white or cream ointment of uniform consistency.
Available pack sizes are:

aluminium tube containing 3 g or 10 g of ointment, placed in a cardboard box,
10 sachets made of laminate (Paper/Polyethylene/Aluminium/Surlyn), each containing 1 g of ointment, placed in a cardboard box.

For more detailed information, please contact the responsible party.
Marketing Authorisation Holder and Manufacturer
CHEMA-ELEKTROMET Cooperative
Przemysłowa 9
35-105 Rzeszów
Poland
Tel: +48 17 862 05 90
E-mail: [email protected]