Multibiotic

Leaflet attached to the packaging: patient information

MULTIBIOTIC, (5 mg + 10 mg + 0.833 mg)/g, ointment

(Neomycin sulfate + Zinc bacitracin + Polymyxin B sulfate)

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

important information for the patient.
The medicine should always be used exactly as described in the patient leaflet or as advised by
the doctor or pharmacist.

• The leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, the pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform the doctor or pharmacist. See section 4.
• If there is no improvement after 7 days or the patient feels worse, they should contact a doctor.

Table of contents of the leaflet:

• 1. What is Multibiotic and what is it used for
• 2. Important information before using Multibiotic
• 3. How to use Multibiotic
• 4. Possible side effects
• 5. How to store Multibiotic
• 6. Package contents and other information

1. What is Multibiotic and what is it used for

Multibiotic is an ointment that contains three antibiotics - neomycin, polymyxin B, and bacitracin - with
antibacterial action.
Indications
Prevention of secondary infections of minor cuts, scratches, 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 rods, including bacteria of the Pseudomonasgenus.

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;
• on a large area of damaged skin;
• in the eyes;
• on weeping skin lesions;
• in children under 12 years of age;
• during pregnancy and breastfeeding.

Warnings and precautions

The use of the medicine should be discontinued in case of hypersensitivity symptoms, including skin symptoms such as
rash, itching, irritation, and a doctor should be consulted.
Using the medicine on large areas of damaged skin may cause kidney damage and hearing loss, including loss of hearing, as well as toxic effects on the nervous system.
Patients with kidney function disorders or hearing impairment should use the medicine with particular caution.
The medicine may enhance the effects of other medicines that can damage the kidneys or hearing, especially in patients with kidney function disorders.

Children and adolescents

The medicine should not be used in children under 12 years of age.

Multibiotic and other medicines:

The doctor or pharmacist should be informed about all medicines currently being taken or recently taken, as well as any medicines that the patient plans to use.
After applying the medicine to a large area of skin or damaged skin, interactions with other medicines may occur due to the absorption of the active substances into the blood.
Concomitant use of the medicine with orally administered neomycin may increase the risk of hypersensitivity.
The medicine should not be used concomitantly with medicines that can damage the kidneys and hearing, such as potent diuretics (e.g., furosemide, ethacrynic acid). These medicines, when administered concomitantly with aminoglycoside antibiotics, increase their blood concentration, which increases the risk of hearing disorders, up to and including deafness, which may occur even after the medicine is discontinued.
During concomitant use of neomycin on the skin, a cross-reaction to other aminoglycoside antibiotics may occur.
During concomitant use of aminoglycoside antibiotics or other medicines that can damage the kidneys, or medicines with toxic effects on the nervous system, the adverse effects may be additive.

Pregnancy and breastfeeding

The medicine should not be used during pregnancy and breastfeeding.
The use of Multibiotic by pregnant and breastfeeding women is contraindicated.

Driving and using machines

Multibiotic does not affect the ability to drive and use machines.
Multibiotic contains propyl parahydroxybenzoate and methyl parahydroxybenzoate, which may cause a local allergic skin reaction (e.g., contact dermatitis).

3. How to use Multibiotic

The medicine is intended for use on the skin.

• Before starting to use Multibiotic, the membrane of the tube should be pierced with the reverse side of the cap. In the case of a sachet, the packaging should be torn open; the ointment should be applied immediately after opening the sachet.
• Before each application of the ointment, the affected area should be washed with soap and water, then dried thoroughly, and a thin layer of ointment should be applied.
• Unless otherwise advised by the doctor, the medicine should be applied 2 to 5 times a day at equal intervals.
• The area covered with the ointment may be protected with a sterile protective dressing.
• Treatment should not last longer than 7 days.
• The medicine should be used for the entire period.

In case of doubts, the doctor or pharmacist should be consulted.

Using a higher dose of Multibiotic than recommended

When using the medicine as recommended, overdose is unlikely.
Prolonged use of the medicine on large areas of damaged skin may lead to the absorption of antibiotics into the blood and the occurrence of kidney damage, hearing loss (including loss of hearing), and toxic effects on the nervous system.

Missing a dose of Multibiotic

If a dose is missed, it should be applied as soon as possible.
A double dose should not be applied to make up for the missed dose.

Discontinuing Multibiotic

The use of Multibiotic should be discontinued and a doctor should be consulted in the following cases:

• worsening of the condition of the affected skin area;
• occurrence of an allergic reaction (hypersensitivity), the symptoms of which include, among others: rash, redness, itching, swelling. In case of any further doubts related to the use of this medicine, the doctor or pharmacist should be consulted.

4. Possible side effects

Like all medicines, Multibiotic can cause side effects, although not everybody gets them.
The following side effects may occur during use:

• 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 fungi,
• hearing loss.

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the doctor or pharmacist, or nurse should be informed. 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 181 C
02-222 Warsaw
Phone: +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.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Multibiotic

The ointment should be stored in closed packaging, at a temperature below 25 °C.
The ointment should not be stored in an open sachet; the ointment should be applied immediately after opening the sachet.
The medicine should be stored out of sight and reach of children.
The medicine should not be used after the expiry date stated on the carton and the immediate packaging (tube or sachet). The expiry date refers to the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. The pharmacist should be asked how to dispose of medicines that are no longer needed. This will help protect the environment.

• 6.

Package contents and other information

What Multibiotic contains

• The active substances of the medicine are neomycin sulfate, zinc bacitracin, and polymyxin B sulfate. 1 g of the medicine contains the active substances: 5 mg of neomycin sulfate, 10 mg of zinc bacitracin, 0.833 mg of polymyxin B sulfate.
• The other ingredients are: propyl parahydroxybenzoate (E 216), methyl parahydroxybenzoate (E 218), white petrolatum.

What Multibiotic looks like and what the package contains

Multibiotic is a white or cream-colored ointment with a uniform consistency.
The available packaging of the medicine is:

• an aluminum tube containing 3 g or 10 g of ointment, placed in a cardboard box,
• 10 sachets made of paper/polyethylene/aluminum/surlyn, each containing 1 g of ointment, placed in a cardboard box.

For more detailed information, the representative of the marketing authorization holder should be contacted.

Marketing authorization holder and manufacturer

CHEMA-ELEKTROMET Cooperative
ul. Przemysłowa 9
35-105 Rzeszów
phone: 17 862 05 90
e-mail: chema@chema.rzeszow.pl

Date of last revision of the leaflet: 2017-03-22