Package leaflet: Information for the patient

NEOMYCINUM TZF, 11.72 mg/g, cutaneous aerosol, suspension
Neomycinum
Please read carefully the entire leaflet before using the medicine, as it contains
important information for the patient.

Keep this leaflet, as you may need to read it again.
If you have any questions, please consult your doctor or nurse.
This medicine has been prescribed for a specific individual. Do not share it with others. The medicine may harm another person, even if their symptoms are the same.
If the patient experiences any adverse reactions, including any not listed in this leaflet, they should inform their doctor or nurse. See section 4.

Table of contents

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

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

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

Bacterial skin infections, especially those caused by staphylococci (e.g. furunculosis, impetigo contagiosa).
Infected 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

if the patient is allergic to neomycin or to any of the other ingredients of this medicine (listed in section 6);
the medicine should not be used:
- on damaged skin, large skin surfaces, oozing lesions or venous ulcers;
- concurrently with other medicines that damage hearing or kidneys.

Warnings and precautions

Neomycinum TZF in aerosol form 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 site of application, discontinue use and consult a doctor.
Due to the ototoxic (hearing-damaging) and nephrotoxic (kidney-damaging) effects of neomycin, the medicine should not be used for prolonged periods, over large skin areas or on damaged skin.
The medicine should not be used under occlusive dressings (sealed dressings).
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 bacteria or fungi insensitive to neomycin, the doctor will initiate appropriate treatment.

Neomycinum TZF and other medicines
Inform your doctor or pharmacist about all medicines currently or recently used,
as well as any medicines you plan to use.
During treatment, do not simultaneously apply other topical medicines, as this may
affect the concentrations of active substances at the site of application and may cause interactions or skin irritation.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor before using this medicine.

If the patient is pregnant or suspects she may be pregnant
Avoid using Neomycinum TZF during pregnancy unless the doctor considers its use necessary.

If the patient is breastfeeding
The decision to use Neomycinum TZF aerosol in breastfeeding women should be made by a doctor.

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

3. How to use Neomycinum TZF

Neomycinum TZF should be used as directed by the physician.
In case of doubt, consult the physician again.
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 vertically with the spray head 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.
Before each use, shake the container vigorously
Duration of treatment
The physician will determine the appropriate duration of treatment.
If you feel the effect of the medicine is too strong or too weak, consult your physician.
Use of a higher than recommended dose of Neomycinum TZF
With prolonged use over large areas of skin, in high doses, under occlusive dressings (sealed), or on damaged skin, neomycin may be absorbed into the bloodstream and produce systemic effects (see section 2: "When to be cautious when using Neomycinum TZF").
In case of accidental ingestion, seek immediate medical advice from a physician or go to the nearest hospital emergency department. Bring the medicine in its original packaging so that medical staff can identify the product ingested.
Missed dose of Neomycinum TZF
If a dose is missed at the usual scheduled time, apply the medicine as soon as possible, then continue with the regular dosing schedule.
Do not use a double dose to make up for a missed dose.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Adverse reactions that may occur during the use of Neomycinum TZF
These reactions occur at an unknown frequency (cannot be estimated from available data):

hypersensitivity (may occur, especially if the medicine is used long-term)
itching, rash, redness, swelling (may occur at the site of application)
Neomycin used long-term over large areas of skin, especially damaged skin, may be absorbed into the bloodstream and cause adverse reactions characteristic of systemic effects – e.g. kidney damage and (or) hearing damage.

Reporting of adverse reactions
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can also be reported directly to the Department of Monitoring of 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
e-mail: [email protected]
By reporting adverse reactions, additional information on the safety of this medicine can be collected.

5. How to store Neomycinum TZF

Keep the medicine out of the sight and reach of children.
Store below 25°C.
Do not use the medicine after the expiry date (EXP) stated on the packaging.
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 sources, 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 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 package and other information

What Neomycinum TZF contains
The active substance is neomycin in the form of neomycin sulfate.
1 g of the suspension contains 11.72 mg of neomycin.
Other components 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 contents of the pack
White or almost white, homogeneous suspension.

Packaging: container containing 16 g or 32 g of suspension in a cardboard box.

Marketing Authorisation Holder and Manufacturer
Tarchomin Pharmaceutical Works "Polfa" Joint Stock Company
A. Fleminga Street 2
03-176 Warsaw, Poland
Telephone number: +48 22 811-18-14

For further information, please contact the Marketing Authorisation Holder's representative.