NEOMYCINUM 11.72 mg/g Aerosol

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
   1. Read the leaflet carefully before using the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
2. What is Neomycinum TZF and what is it used for
   1. Indications for use
3. Important information before using Neomycinum TZF
   1. When not to use Neomycinum TZF
   2. Warnings and precautions
   3. Neomycinum TZF and other medicines
   4. Pregnancy and breastfeeding
   5. Driving and using machines
4. How to use Neomycinum TZF
   1. Treatment duration
   2. Using more than the recommended dose of Neomycinum TZF
   3. Missing a dose of Neomycinum TZF
5. Possible side effects
   1. Side effects that may occur when using Neomycinum TZF
   2. Reporting side effects
6. How to store Neomycinum TZF
7. Package contents and other information
   1. What Neomycinum TZF contains
   2. What Neomycinum TZF looks like and what the package contains
   3. Responsible entity and manufacturer
   4. Date of the last update of the leaflet:

Leaflet attached to the packaging: patient information

NEOMYCINUM TZF, 11.72 mg/g, spray for the skin, suspension
Neomycinum

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

• Keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, consult your doctor or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or nurse. See section 4.

Table of contents of the leaflet

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

1. What is Neomycinum TZF and what is it used for

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

Indications for use

• Purulent skin diseases, especially those caused by staphylococci (e.g., impetigo, infectious eczema).
• Purulent complications of allergic skin diseases (in combination with corticosteroids).
• Infected minor burns and frostbite.

2. Important information before using Neomycinum TZF

When not to use Neomycinum TZF

• the medicine should not be used:
• on damaged and large areas of skin, exuding lesions, and venous ulcers;
• in combination with other medicines that damage hearing or kidneys.

Warnings and precautions

• Neomycinum TZF spray is intended 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 between the medicine and mucous membranes.
• If skin irritation occurs at the site of application, discontinue use and consult your 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.
• The medicine should not be used under occlusive dressings.
• Prolonged use of the medicine may lead to the growth of neomycin-resistant bacterial strains and allergy to neomycin. In the case of infections caused by bacteria or fungi insensitive to neomycin, the doctor will use appropriate treatment.

Neomycinum TZF and other medicines

Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to use.
During treatment, do not use other medicines locally at the same time, as this may affect the concentrations of active substances at the site of application and cause interactions or skin irritation.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor before using this medicine.
If you are pregnant or think you may be pregnant
Neomycinum TZF should be avoided during pregnancy, unless your doctor considers it necessary.
If you are breastfeeding
The use of Neomycinum TZF spray in breastfeeding women should be decided by your doctor.

Driving and using machines

There are no data on the effect of the medicine on the ability to drive and use machines.

3. How to use Neomycinum TZF

Use Neomycinum TZF according to your doctor's recommendations.
In case of doubts, consult your doctor again.
The medicine is intended for local use.
Recommended dose
Spray the affected areas of skin 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 open flames or other ignition sources.
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.
Shake the can vigorously before each use

Treatment duration

Your doctor will determine the correct treatment duration.
If you feel that the effect of the medicine is too strong or too weak, consult your doctor.

Using more than the recommended dose of Neomycinum TZF

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 act systemically (see section 2: "When to be particularly careful when using Neomycinum TZF").
In case of accidental ingestion, consult your doctor or go to the nearest emergency department immediately. Take the medicine in its original packaging so that the staff can check which medicine was ingested.

Missing a dose of Neomycinum TZF

If you miss a dose at a fixed, specified time, use the medicine as soon as possible, and then continue using it regularly.
Do not use a double dose to make up for a missed dose.

4. Possible side effects

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

Side effects that may occur when using Neomycinum TZF

These effects occur with an unknown frequency (cannot be determined from available data)

• allergy (may occur, especially if the medicine is used for a long time)
• itching, rash, redness, swelling (may occur at the site of application)
• Neomycin used for a long time on large areas of skin, especially damaged skin, may be absorbed into the bloodstream and cause systemic side effects, such as kidney damage and/or hearing damage.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301; fax: +48 22 49 21 309, e-mail: [email protected]. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Neomycinum TZF

Keep the medicine out of sight and reach of children.
Store at a temperature below 25°C.
Do not use the medicine after the expiration date (EXP) stated on the packaging.
The expiration date is the last day of the specified month.

• Highly flammable aerosol.
• Pressurized container. Heating can cause an explosion.
• Keep away from heat sources, hot surfaces, sparks, open flames, and other ignition sources. Smoking is prohibited.
• Do not spray near open flames or other ignition sources.
• Pressurized container. Do not puncture 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 that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Neomycinum TZF contains

The active substance of the medicine is neomycin in the form of neomycin sulfate.
1 g of suspension contains 11.72 mg of neomycin.
The other ingredients of the medicine are: sorbitan trioleate (Span 85), lecithin, isopropyl myristate, Drivosol 35 (a mixture of isobutane 72%, n-butane 4%, and propane 24%).

What Neomycinum TZF looks like and what the package contains

White or almost white, homogeneous suspension
Package:a container containing 16 g or 32 g of suspension in a cardboard box.

Responsible entity 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 responsible entity.

Date of the last update of the leaflet: