Neobiotic

Package Leaflet: Information for the Patient

NEOBIOTIC, 11.72 mg/g, skin spray, suspension
Neomycin

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

This medicine should always be used exactly as described in this package leaflet for the patient or as directed by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or further information, consult a pharmacist.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.
• If after 7 days there is no improvement or you feel worse, contact a doctor.

Table of Contents of the Leaflet

• 1. What is Neobiotic and what is it 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 is Neobiotic and what is it used for

Neomycin, the active substance of Neobiotic, is an aminoglycoside antibiotic with a broad spectrum of antibacterial activity. Neomycin acts on many Gram-positive and Gram-negative bacteria.

Indications for Use

Short-term local use in cases of bacterial skin infections, minor wounds (scratches, abrasions, insect bites), small ulcers, and burns.
If after 7 days there is no improvement or you feel worse, contact a doctor.

2. Important Information Before Using Neobiotic

When Not to Use Neobiotic:

if you are allergic to neomycin or any of the other ingredients of this medicine (listed in section 6);
on damaged and large areas of skin, oozing lesions, and venous ulcers;
on mucous membranes;
in combination with other medicines that can harm hearing and/or kidneys;
in children under 12 years of age;
during pregnancy and breastfeeding.

Warnings and Precautions

Before starting to use Neobiotic, discuss it with your doctor or pharmacist.
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Be particularly careful:

• Neobiotic spray is for use on the skin only.
• Do not inhale the sprayed substance.
• Protect your eyes from the sprayed substance. If the suspension gets into your eyes, rinse them thoroughly with warm water.
• Avoid contact of the medicine with mucous membranes.
• If skin irritation occurs at the application site, stop using the medicine and contact a doctor.
• Due to the ototoxic (hearing-damaging) and nephrotoxic (kidney-damaging) effects of neomycin, the medicine should not be used for a long time, on large areas of skin, or on damaged skin. 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/or hearing.
• Prolonged use of the medicine may lead to the growth of neomycin-resistant bacterial strains and neomycin allergy. In the case of infections caused by bacteria insensitive to neomycin or fungi, the doctor will use appropriate treatment.
• The medicine should not be used under occlusive dressings.
• Do not bandage the skin surface to which the medicine has been applied.

Children and Adolescents

Do not use in children under 12 years of age.

Neobiotic and Other Medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.
During treatment, do not use other medicines locally at the same time, as this may affect the concentrations of active substances at the application site and cause interactions or skin irritation.
Prolonged use in combination with medicines that are nephro- and/or ototoxic (e.g., gentamicin, etacrynic acid, colistin) may increase neomycin toxicity.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, consult your doctor or pharmacist before using this medicine.
Using Neobiotic during pregnancy and breastfeeding is contraindicated due to the risk of potential systemic effects of neomycin [hearing and/or kidney damage].

Driving and Using Machines

No data are available on the effects of the medicine on the ability to drive and use machines.

3. How to Use Neobiotic

This medicine should always be used exactly as described in this package leaflet for the patient or as directed by a doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The medicine is for local use.
Recommended dose
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Spray the diseased skin areas with a stream of suspension for 1 to 3 seconds, holding the can upright, with the spray head up, at a distance of 15 cm to 20 cm. The medicine is usually used 2 or 3 times a day, at equal intervals.
Highly flammable aerosol. Do not spray near an open flame or other ignition source.
Caution: Protect your eyes from the sprayed substance.
Do not inhale the sprayed substance.
After each application, wash your hands thoroughly with soap and water.
Before each use, shake the can vigorously several times
Duration of treatment
The medicine is intended for short-term use (3 to 7 days).
If symptoms worsen or do not improve after 7 days of use, stop using the medicine and contact a doctor. Do not use the medicine for more than 7 days without consulting a doctor.
Use in children and adolescents
Do not use in children under 12 years of age.

Using More Than the Recommended Dose of Neobiotic

In case of using more than the recommended dose of Neobiotic, contact a doctor immediately.
After prolonged use on large areas of skin, in large doses, under occlusive dressings, or on damaged skin, neomycin may be absorbed into the bloodstream and cause systemic effects, leading to hearing and/or kidney damage (see sections 2 and 4).
In case of accidental ingestion of the medicine, contact a doctor or go to the nearest hospital emergency department immediately. Take the medicine in its original packaging so that the medical staff can check what medicine was ingested.

Missing a Dose of Neobiotic

Do not use a double dose to make up for a missed dose.
If you have any further doubts about using this medicine, consult your doctor or pharmacist.

4. Possible Side Effects

Like all medicines, Neobiotic can cause side effects, although not everybody gets them.

Severe Side Effects

If you experience any of the following side effects, stop using the medicine and immediatelyinform your doctor or go to the nearest hospital emergency department.
Neomycin used for a long time on large areas of skin, especially damaged skin, may be absorbed into the bloodstream and cause reactions characteristic of systemic effects – e.g., kidney damage and/or hearing damage. These effects occur with an unknown frequency (cannot be estimated from the available data)

Other Possible Side Effects of Neobiotic

These effects occur with an unknown frequency

• allergy (may occur, especially if the medicine is used for a long time)

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

Reporting Side Effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Post-Marketing Surveillance 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
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to Store Neobiotic

Keep the medicine out of the sight and reach of children.
Store in a temperature 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 month stated.

• Highly flammable aerosol.
• Pressurized container. Heating may cause a burst.
• Keep away from heat sources, hot surfaces, ignition sources, open flames, and other ignition sources. Smoking is prohibited.
• Do not spray near an open flame or other ignition source.
• Pressurized container. Do not pierce or burn, even after use.
• Protect from sunlight. Do not expose to temperatures above 50°C / 122°F.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the Pack and Other Information

What Neobiotic Contains

• The active substance of Neobiotic is neomycin in the form of neomycin sulfate. 1 g of suspension contains 11.72 mg of neomycin.
• The other ingredients are: 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:Aluminum pressurized container coated internally with epoxy-phenolic lacquer, closed with a valve (PET/POM/PA/stainless steel/LDPE) and a spray head (PP/acetal resin) and a cap made of PP, in a cardboard box.
1 container contains 16 g of medicine.
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Marketing Authorization Holder and Manufacturer

Tarchomińskie Zakłady Farmaceutyczne „Polfa” Spółka Akcyjna
ul. A. Fleminga 2
03-176 Warsaw
Phone number: 22 811-18-14
To obtain more detailed information, contact the representative of the marketing authorization holder.

Date of Last Revision of the Leaflet:

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