Package leaflet: Information for the patient

MAXIBIOTIC, (5 mg + 5000 IU + 400 IU)/g, ointment
(Neomycin sulfate + Polymyxin B sulfate + Bacitracin zinc)
Please read all of this leaflet carefully before using this medicine, because 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, as you may need to read it again.
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 after 7 days, or if you feel worse, you should contact your doctor.

Contents of the leaflet

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

1. What M is and what it is used for

M is a medicine in the form of an ointment, intended for topical application to the skin. The active substances of the medicine are three antibiotics with complementary antibacterial spectra effective against bacteria responsible for most skin infections.
Indications:

Minor wounds (abrasions, scratches, insect bites);
Burns;
Skin ulcers.

2. Information before using medicine M

When not to use medicine M:

if the patient is allergic to neomycin sulfate, polymyxin B sulfate, bacitracin zinc, 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, and on oozing lesions, due to the risk of absorption of active substances into the bloodstream and causing systemic adverse effects (harmful effects on hearing and kidneys);
in the eyes.

Warnings and precautions
Before starting to use medicine M, discuss it with your doctor or pharmacist.
Prolonged use of medicine M may lead to overgrowth of microorganisms resistant to the medicine, including fungi, as is the case with other antibiotics.
Patients allergic to aminoglycoside antibiotics or polymyxins may also be allergic to this medicine. In case of severe allergic reactions, treatment should be discontinued and medical advice sought.
If adverse effects occur, especially irritation at the site of application, or if the patient notices no improvement, use of medicine M should be discontinued and medical advice sought.
Using the ointment on large areas of damaged skin may cause hearing loss, kidney damage, and neurotoxic effects.

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

Medicines and M
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
After applying ointment M on large areas or damaged skin, interactions with other concurrently used medicines may occur.
Concurrent use of medicine M with orally administered neomycin may increase the risk of allergic reactions.
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 aminoglycosides, they increase their blood concentration, thereby increasing the risk of hearing disorders, up to deafness, which may occur even after discontinuation of the medicine.
Concurrent use of orally or topically administered aminoglycoside antibiotics or other medicines with possible nephrotoxic or neurotoxic effects may result in additive adverse effects.
When used concurrently with other medicines having harmful effects on the kidneys and hearing, medicine M may enhance the effects of these medicines.

Use in patients with kidney dysfunction or hearing impairment
Patients with kidney dysfunction or hearing impairment should use this medicine cautiously, as they have a higher likelihood of developing harmful effects on the kidneys and hearing.

Use in elderly patients
There are no special requirements for using the medicine in elderly patients.
However, it should be remembered that the highest doses should be reduced in patients with impaired kidney function.

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 a doctor before using this medicine.
Due to lack of adequate studies, this medicine should not be used during pregnancy and breastfeeding.

Driving and operating machinery
No effects of medicine M on the ability to drive or operate machinery have been observed.

3. How to use M

This medicine should always be used exactly as described in the patient leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
After removing the tube from the packaging and unscrewing the cap, use the inverted cap to pierce the aluminum seal covering the tube opening, then squeeze out the required amount of ointment.
Clean the affected area and apply a small amount of the medicine to the diseased skin surface.
After applying the medicine, the area may be covered with a gauze dressing or left uncovered.
Apply 2 to 5 times daily.
Do not use for longer than 7 days.
After completing treatment, do not reapply medicine M before 3 months have passed.

Use of a higher than recommended dose of medicine M
When used on mucous membranes and/or over a large skin surface (especially damaged skin), systemic adverse effects may occur. This particularly concerns patients with impaired kidney function. Symptoms may include kidney damage, hearing impairment, and neurotoxic effects of the drug. In such cases, discontinue use of medicine M and contact a doctor immediately.

Missed dose of medicine M
Do not use a double dose to make up for a missed dose.
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions
Like all medicines, this product can cause adverse reactions, although not everyone experiences them.
The frequency of adverse reactions cannot be determined from available data.

Infections and parasitic infections:
Infection with resistant strains of bacteria or fungi.

Immune system disorders:
Local hypersensitivity reactions (itching, rash, redness, swelling, and other signs of irritation).

Ear and labyrinth disorders:
Hearing impairment.

Renal and urinary disorders:
Kidney damage.

Reporting of adverse reactions
If any adverse effects occur, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions, 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]
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store M

Store below 30°C.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton or tube. The expiry date refers to the last day of the specified month.
Medicines should 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 pack and other information

What M contains

The active substances 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 soft paraffin.

What M looks like and contents of the pack
M is an ointment.
The packaging consists of an aluminium tube and sachets in a cardboard box.
Pack sizes:
1 tube of 3 g
1 tube of 5 g
1 tube of 15 g
10 sachets of 1 g.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
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: [email protected]
tel. + 48/42/212 80 85