Altabactin

Leaflet attached to the packaging: patient information

ALTABACTIN, (250 IU + 5000 IU)/g, ointment

Bacitracin +Neomycin

Please read carefully the contents of the leaflet 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 as directed by a doctor or pharmacist.

• This leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, the doctor or pharmacist should be informed. See section 4.4.
• If after 7 days there is no improvement or the patient feels worse, a doctor should be consulted.

Table of contents of the leaflet:

• 1. What is Altabactin and what is it used for
• 2. Important information before using Altabactin
• 3. How to use Altabactin
• 4. Possible side effects
• 5. How to store Altabactin
• 6. Contents of the packaging and other information

1. What is Altabactin and what is it used for

Altabactin is an ointment for topical use on the skin.
The medicine contains two active substances with antibacterial action - bacitracin and neomycin.
Thanks to the combined action of these substances, the medicine has a wide range of action.
Bacitracin primarily kills Gram-positive bacteria, and neomycin kills both Gram-positive and Gram-negative bacteria.
Altabactin does not act on fungi and viruses.
Altabactin is indicated forlocal treatment of bacterial infections of small skin areas (such as infection of small wounds, skin infection in the course of frostbite and burns).

2. Important information before using Altabactin

When not to use Altabactin

if the patient is allergic to bacitracin, neomycin, other aminoglycoside antibiotics, or any of the other ingredients of this medicine (listed in section 6);
on large skin areas, in severe skin damage, and for a long time, due to the risk of toxic action of the medicine on the kidneys and hearing, including hearing loss;
if the patient has severe heart or kidney function disorders;
if the patient has previously had ear damage (vestibule or cochlea);
if the patient has a perforated eardrum (perforation), the ointment should not be used in the outer ear;
in the eyes and on mucous membranes;
on deep or puncture wounds, draining lesions;
severe burns;
large areas of damaged skin.

Warnings and precautions

Before starting to use Altabactin, the doctor or pharmacist should be consulted if any of the following information raises doubts.
If during the use of Altabactin an allergic reaction or secondary infection occurs, the use of the medicine should be stopped immediately and a doctor consulted.
Patients allergic to any antibiotic from the aminoglycoside group (such as streptomycin, gentamicin, tobramycin) may also be allergic to Altabactin.
If side effects occur, especially irritation at the site of application or the patient notices a lack of improvement, the use of the medicine should be stopped and a doctor consulted.
The medicine can only be used on a small skin area or wound. The medicine should not be used in large doses, as the active substances of the medicine absorbed into the blood may cause kidney and hearing damage.
If the patient has ear diseases or hearing disorders, a doctor should be consulted before using this medicine.
If the patient has liver or kidney function disorders, a doctor should be consulted before using this medicine.
In case of concomitant use of other medicines that may damage the kidneys and hearing, a doctor should be consulted before using the medicine.
During the use of the medicine, superinfection with medicine-resistant microorganisms (especially fungi) may occur, so if the symptoms of the disease worsen, a doctor should be consulted.
It is recommended to avoid sun exposure and sunbathing (including in a solarium) during the use of the medicine, as it may cause sensitivity to sunlight and phototoxic reactions.

Children

Do not use in children under 12 years of age.

Altabactin and other medicines

The doctor or pharmacist should be informed about all medicines used by the patient currently or recently, as well as about medicines that the patient plans to take.
In particular, the doctor should be informed if:

• the patient is to receive general anesthetics;
• the patient uses:
• other antibiotics (medicines used in bacterial infections);
• diuretics (medicines that increase urine production);
• opioid painkillers;
• muscle relaxants.

Do not use the medicine at the same time as:

• medicines that may damage the kidneys and hearing, such as potent diuretics, e.g. furosemide, ethacrynic acid;
• medicines that may damage the kidneys, such as cephalosporins or aminoglycoside antibiotics.

In case of doubts about whether the patient is taking the above-mentioned medicines, a doctor or pharmacist should be asked.

Pregnancy and breastfeeding

If a woman is pregnant or breastfeeding, thinks she may be pregnant, or plans to have a child, she should consult a doctor or pharmacist before using this medicine.

Driving and using machines

The effect of Altabactin on the ability to drive and use machines is not known.

Altabactin contains lanolin

Due to the content of lanolin, the medicine may cause a local skin reaction (e.g. contact dermatitis).

3. How to use Altabactin

This medicine should always be used exactly as described in the patient leaflet or as directed by a doctor or pharmacist. In case of doubts, a doctor or pharmacist should be consulted.
Use 2 to 3 times a day.
A thin layer of ointment should be applied to the affected area of the skin. If necessary, it can be covered with a dressing.
Do not use for more than 7 days.
If after 7 days there is no improvement or the patient feels worse, a doctor should be consulted.
Do not use more than 1 g of neomycin per day (which corresponds to 200 g of Altabactin).

Using a higher dose of Altabactin than recommended

In case of using a higher dose of Altabactin than recommended or accidental oral ingestion, a doctor should be consulted immediately.
Altabactin used in large doses on large skin areas, wounds, or damaged skin may have a toxic effect on the kidneys, hearing, and nervous system.

Missing a dose of Altabactin

The use of the medicine should be continued without increasing the next dose.
A double dose should not be used to make up for a missed dose.
In case of any further doubts about the use of this medicine, a doctor or pharmacist should be consulted.

4. Possible side effects

Like all medicines, Altabactin can cause side effects, although not everybody gets them.
Bacitracin with neomycin used externally on the skin and mucous membranes are generally well tolerated.
Uncommon side effects (may occur in less than 1 in 1000 people):
allergic reactions, mainly in the form of contact dermatitis; in 50% of people allergic to neomycin, there is an allergy to other aminoglycoside antibiotics.
Side effects with unknown frequency (frequency cannot be estimated from the available data):
allergic reactions, such as erythema (red-purple spots on the skin, sometimes with blisters), excessive dryness and flaking of the skin, skin rash, and itching; harmful effects on the kidneys, hearing, or nervous system (damage to the vestibular nerve, neuromuscular blockade).
Allergic reactions may be the cause of the spread of the disease or the lack of treatment results with Altabactin.
There is a risk of sensitivity to light or phototoxic reactions when exposed to sunlight or sunbathing in a solarium (UV radiation).

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 for 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, tel.: +48 22 49 21 301/fax: +48 22 49 21 309/https://smz.ezdrowie.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 Altabactin

The medicine should be stored out of sight and reach of children.
Store at a temperature not exceeding 25°C. Protect from light.
Do not use this medicine after the expiry date stated on the packaging after EXP.
The expiry date refers to the last day of the month stated.
The batch number of the medicine on the packaging is marked as "Lot".
Medicines should not be disposed of via wastewater or household waste. A pharmacist should be asked how to dispose of medicines that are no longer used. This will help protect the environment.

6. Contents of the packaging and other information

What Altabactin contains

• The active substances are bacitracin and neomycin. 1 g of ointment contains 250 IU of bacitracin and 5000 IU of neomycin.
• The other ingredients are lanolin and liquid paraffin.

What Altabactin looks like and what the packaging contains

The medicine is in the form of an ointment.
Packaging: aluminum tube containing 5 g or 20 g of ointment, placed in a cardboard box with a leaflet.

Marketing authorization holder

Sandoz GmbH
Biochemiestrasse 10
A-6250 Kundl, Austria

Manufacturer

Sandoz GmbH
Biochemiestrasse 10
A-6250 Kundl, Austria
Lek Pharmaceuticals d.d.
Verovškova 57
1526 Ljubljana, Slovenia
Salutas Pharma GmbH
Address:
Lange Goehren 3
39171 Osterweddingen, Germany
To obtain more detailed information, please contact:
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warsaw
tel.: 22 209 70 00
e-mail: biuro.pl@sandoz.com

Date of last revision of the leaflet:

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