Maxibiotic

Leaflet accompanying the packaging: patient information

MAXIBIOTIC, (5 mg + 5000 IU + 400 IU)/g, ointment

(Neomycin sulfate + Polymyxin B sulfate + Zinc bacitracin)

Please read the contents of the 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 patient leaflet or according to
the doctor's or pharmacist's instructions.

• 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 their doctor or pharmacist. See section 4.
• If there is no improvement after 7 days or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

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

1. What is M and what is it used for

M is a medicine in the form of an ointment, used locally on the skin. The active substances of the medicine are
three antibiotics with a complementary range of antibacterial activity against bacteria
causing most skin infections.

Indications for use:

• minor wounds (abrasions, scratches, bites);
• burns;
• skin ulcers.

2. Important information before using M

When not to use M:

• 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);
• if the patient has hearing disorders (in such cases, the use of the medicine may cause harmful effects on hearing);
• on deep or puncture wounds, severe burns, or large areas of damaged skin, as well as on oozing lesions, due to the risk of absorption of the active substances into the blood and the occurrence of systemic side effects (harmful effects on hearing, kidneys);
• in the eyes.

Warnings and precautions

Before starting to use M, the patient should discuss it with their doctor or pharmacist.
Prolonged use of M may cause excessive growth of insensitive microorganisms, including fungi, similar to the use of other medicines containing antibiotics.
Patients allergic to aminoglycoside or polymyxin antibiotics may be allergic to this medicine. In the event of severe allergic reactions, treatment should be discontinued and the doctor consulted.
If side effects occur, especially irritation at the site of application or the patient notices no improvement, the use of M should be discontinued and the doctor consulted.
Using the medicine on large areas of damaged skin may cause hearing loss, kidney damage, and toxic effects on the nervous system.

Children and adolescents

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

M and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
After applying the M ointment to a large area or damaged skin, interactions with other medicines used at the same time may occur.
Concomitant use of M with orally administered neomycin may increase the risk of allergic reactions.
M should not be used with medicines that may damage the kidneys and hearing, such as potent diuretics (e.g., furosemide, ethacrynic acid). These medicines, when used with aminoglycosides, increase their concentration in the blood, which increases the risk of hearing disorders, up to deafness, which may occur even after the medicine is discontinued.
During concomitant use of oral or topical aminoglycoside antibiotics or other medicines with potential harmful effects on the kidneys or nervous system, the risk of side effects may increase.
During concomitant use with other medicines with harmful effects on the kidneys and hearing, M may enhance the effects of these medicines.

Use in patients with kidney function disorders or hearing impairment

Patients with kidney function disorders or hearing impairment should use this medicine with caution, as they are more likely to experience harmful effects on the kidneys and hearing.

Use in elderly patients

There are no special requirements for the use of M in elderly patients.
However, it should be remembered that the highest doses used should be reduced in patients with kidney function disorders.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor before using this medicine.
Due to the lack of appropriate studies, the medicine should not be used during pregnancy and breastfeeding.

Driving and operating machinery

No effects of using M on driving and operating machinery have been reported.

3. How to use M

This medicine should always be used exactly as described in the patient leaflet or according to
the doctor's or pharmacist's instructions. In case of doubts, the doctor or pharmacist should be consulted.
After removing the tube from the box and unscrewing the cap, the inverted cap should be used to pierce the aluminum seal on the tube and squeeze out the required amount of ointment.
The wound area should be cleaned and a small amount of the medicine applied to the affected skin area.
The area can be covered with a gauze dressing or left uncovered.
Apply 2 to 5 times a day.
Do not use for more than 7 days.
After completing the treatment, M should not be used again before 3 months have passed.

Using a higher dose of M than recommended

In the event of using the medicine on mucous membranes and/or on a large skin area (especially damaged skin), systemic side effects may occur. This applies primarily to patients with kidney function disorders. Symptoms of kidney damage, hearing loss, and toxic effects on the nervous system may occur. In such cases, the use of M should be discontinued and the doctor consulted.

Missing a dose of M

A double dose should not be used to make up for a missed dose.
In case of any further doubts about using this medicine, the doctor or pharmacist should be consulted.

4. Possible side effects

Like all medicines, M can cause side effects, although not everybody gets them.
The frequency of side effects cannot be determined based on available data.
Infections and infestations:
infection with insensitive strains of bacteria or fungi .
Immune system disorders:
local symptoms of hypersensitivity (itching, rash, redness, swelling, and other symptoms of irritation).
Ear and labyrinth disorders:
hearing loss.
Kidney and urinary disorders:
kidney damage.

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the doctor, 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 181C, 02-222 Warsaw
Phone: + 48 22 49 21 301
Fax: + 48 22 49 21 309
e-mail: ndl@urpl.gov.pl
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store M

Store at a temperature below 30°C.
The medicine should be stored in a place out of sight and reach of children.
Do not use this medicine after the expiry date stated on the box or tube. The expiry date refers to the last day of the given 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 used. This will help protect the environment.

6. Package contents and other information

What M contains

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

What M looks like and what the package contains

M is an ointment.
The package consists of an aluminum tube and a sachet in a cardboard box.
Package sizes:
1 tube of 3 g
1 tube of 5 g
1 tube of 15 g
10 sachets of 1 g.
Not all package sizes may be marketed.

Responsible entity

Bausch Health Ireland Limited
3013 Lake Drive
Citywest Business Campus
Dublin 24, D24PPT3
Ireland

Manufacturer

EMO-FARM Sp. z o.o.
ul. Łódzka 52
95-054 Ksawerów
e-mail: emo-farm@valeant.com
phone: + 48/42/212 80 85

Date of the last update of the leaflet: