NEOBIOTIC

Patient Information Leaflet

NEOBIOTIC, 11.72 mg/g, cutaneous aerosol, suspension
Neomycinum
Please read all of this leaflet carefully before using the medicine, because it contains information that is important for you.
This medicine should always be used exactly as described in this patient leaflet or as directed by your doctor or pharmacist.

• Keep this leaflet so that you can read it again if necessary.
• If you need advice or further information, please consult your pharmacist.
• If you experience any side effects, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
• If there is no improvement after 7 days of treatment, or if you feel worse, consult your doctor.

Table of Contents

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

1. What Neobiotic is and what it is used for

Neomycin – the active substance in Neobiotic – is an aminoglycoside antibiotic with broad-spectrum antibacterial activity. Neomycin is effective against many Gram-positive and Gram-negative bacteria.
Indications
Short-term topical treatment of bacterial skin infections, minor wounds (e.g. scratches, abrasions, insect bites), small ulcers, and minor burns.
If there is no improvement after 7 days of treatment, or if you feel worse, consult your doctor.

2. Important information before using Neobiotic

When not to use Neobiotic: if the patient is allergic to neomycin or to any of the other ingredients of this medicine (listed in section 6); on damaged skin, large skin areas, exuding lesions, or venous ulcers; on mucous membranes; concomitantly with other medicines that damage hearing and (or) kidneys; in children under 12 years of age; during pregnancy and breastfeeding.

Warnings and precautions

Before starting to use Neobiotic, discuss this with your doctor or pharmacist.
PL_NR_020819_250121 v6
Exercise special caution:

• Neobiotic aerosol is intended for topical use on the skin only.
• Do not inhale the sprayed substance.
• Protect the eyes from the sprayed substance. If the suspension gets into the eyes, rinse thoroughly with lukewarm water.
• Avoid contact of the medicine with mucous membranes.
• If skin irritation occurs at the application site, discontinue use and consult your doctor.
• Due to the ototoxic (hearing-damaging) and nephrotoxic (kidney-damaging) effects of neomycin, this medicine should not be used long-term, over large skin areas, or on damaged skin. Patients with impaired kidney function or hearing disorders should use this medicine with caution, as they have a higher risk of developing harmful effects on the kidneys and (or) hearing.
• Prolonged use of the medicine may lead to the proliferation of bacterial strains resistant to neomycin and to neomycin allergy. In case of infections caused by organisms insensitive to neomycin or by fungi, your doctor will initiate appropriate treatment.
• Do not use the medicine under occlusive dressings (sealed dressings).
• Do not bandage the skin area to which the medicine has been applied.

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

Neobiotic and other medicines
Inform your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
During treatment, do not simultaneously apply other topical medicines, as this may affect the concentration of active substances at the application site and may lead to interactions or skin irritation.
Prolonged concomitant use with medicines having nephro- and (or) ototoxic effects (e.g. gentamicin, ethacrynic acid, colistin) may increase the toxicity of neomycin.

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, suspect you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before using this medicine.
The use of Neobiotic during pregnancy and breastfeeding is contraindicated due to the risk of potential systemic effects of neomycin [harmful effects on hearing and (or) kidneys].

Driving and operating machinery
There are no data available regarding the effect of this medicine on the ability to drive vehicles or operate machinery.

3. How to use Neobiotic

This medicine should always be used exactly as described in this patient leaflet or as directed by
your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
This medicine is intended for topical use only.
Recommended dose
Spray the affected skin areas with the suspension for 1 to 3 seconds, holding the container upright
with the spray head pointing upwards, at a distance of 15 cm to 20 cm. The medicine is usually
applied 2 or 3 times daily at regular intervals.
Extremely flammable aerosol. Do not spray near open flame or other sources of ignition.
Warning: Protect eyes from the sprayed substance.
Do not inhale the sprayed substance.
After each application, hands should be thoroughly washed with soap and water.
Shake the container vigorously several times before each use
Duration of treatment
This medicine is intended for short-term use (3 to 7 days).
If symptoms worsen or no improvement is seen after 7 days of treatment, discontinue use and
consult your doctor. Do not use this medicine for longer than 7 days without consulting a doctor.
Use in children and adolescents
Do not use in children under 12 years of age.
Use of a higher than recommended dose of Neobiotic
If a higher than recommended dose of Neobiotic has been used, contact your doctor immediately.
Prolonged use over large areas of skin, in high doses, under occlusive dressings (airtight coverings),
or on damaged skin may lead to systemic absorption of neomycin, potentially causing hearing
impairment and/or kidney damage (see sections 2 and 4).
In case of accidental ingestion, seek immediate medical advice or go to the nearest hospital
emergency department. Take the medicine with you in its original packaging so that the medical
staff can identify which medicine has been ingested.
Missed dose of Neobiotic
Do not use a double dose to make up for a missed dose.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Serious adverse reactions
If any of the following adverse reactions occur, discontinue use of the medicine immediately and promptly inform your doctor or go to the nearest hospital emergency department.
Prolonged use of neomycin over large areas of skin, especially damaged skin, may result in absorption into the bloodstream and cause adverse reactions typical of systemic effects – e.g. kidney damage and (or) hearing impairment. These reactions occur at an unknown frequency (cannot be estimated from available data).
Other possible adverse reactions of Neobiotic
These reactions occur at an unknown frequency:

• Hypersensitivity (may occur, especially when the medicine is used for prolonged periods)

• Itching, rash, redness, swelling (may occur at the site of application).

Reporting of adverse reactions
If any adverse symptoms 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 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
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions enables the collection of further information on the safety of medicine use.

5. How to store Neobiotic

Keep this medicine out of sight and reach of children.
Store below 25°C. Do not store in the refrigerator.
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 stated month.

• Extremely flammable aerosol.
• Pressurised container: may burst if heated.
• Keep away from heat, hot surfaces, sparks, open flames, and other sources of ignition. No smoking.
• Do not spray on an open flame or other source of ignition.
• Pressurised container: do not pierce or burn, even after use.
• Protect from sunlight. Do not expose to temperatures exceeding 50°C / 122°F.

Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the packaging and other information

What Neobiotic contains

• The active substance is neomycin in the form of neomycin sulfate. 1 g of the suspension contains 11.72 mg of neomycin.
• Other ingredients: sorbitan trioleate, lecithin (of animal origin), isopropyl myristate, Drivosol 35A [propane (min. 23%), n-butane (max. 5.0%), isobutane (min. 71.5%)]

What Neobiotic looks like and contents of the pack
White or almost white, homogeneous suspension
Packaging: A pressurized aluminium container internally coated with epoxy-phenolic lacquer, closed with a spray valve (PET/POM/PA/stainless steel/LDPE) and a spray head (PP/acetal resin), with a PP cap, placed in a cardboard box.
1 container contains 16 g of medicinal product.
Marketing Authorisation Holder and Manufacturer
Tarchomin Pharmaceutical Works "Polfa" Joint Stock Company
A. Fleminga 2 Street
03-176 Warsaw
Phone number: 22 811-18-14
For further information, please contact the representative of the Marketing Authorisation Holder.