Neomicinum Tzf

Package Leaflet: Information for the Patient

Neomycinum TZF, 250 mg, Tablets

Read the leaflet carefully before taking the medicine, as it contains

important information for the patient.

• Keep this leaflet, you may need to read it again.
• Ask your doctor or pharmacist if you have any further questions.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

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

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

Neomycin is an aminoglycoside antibiotic. The antibiotic has a bactericidal effect on many species of Gram-negative and Gram-positive bacteria.

Indications for Use

Neomycinum TZF is used:

• to decontaminate the gastrointestinal tract before surgical procedures in the intestines
• in hepatic encephalopathy.

2. Important Information Before Taking Neomycinum TZF

When Not to Take Neomycinum TZF

• if you are allergic (hypersensitive) to neomycin or other aminoglycoside antibiotics or to any of the other ingredients of this medicine (listed in section 6)
• if you have inflammation, ulcers, or obstruction of the intestines
• if you have hearing disorders
• if you have myasthenia gravis (a disease that causes muscle weakness and excessive fatigue).

Warnings and Precautions

Before starting treatment with this medicine, tell your doctor if:

• you have liver or kidney function disorders
• you have diseases related to neuromuscular disorders, including parkinsonism
• you are dehydrated.

During treatment with Neomycinum TZF, tell your doctor if:

• you experience symptoms of a new bacterial or fungal infection, especially during long-term use of the antibiotic.

In patients who need to take the medicine for a long time, the doctor may recommend regular urine and blood tests, as well as hearing tests.

Using Other Medicines

Tell your doctor about all the medicines you are taking or have recently taken, as well as any medicines you plan to take.
This is especially important if you are taking any of the following medicines:

• methotrexate (a medicine used in cancer diseases)
• beta-lactam antibiotics (e.g., penicillins)
• vitamins A and B
• diuretics (e.g., furosemide, ethacrynic acid)
• cyclosporine (a medicine used after transplants)
• capreomycin (an antibiotic used in the treatment of tuberculosis)
• other aminoglycoside antibiotics (e.g., neostigmine, pyridostigmine)
• vancomycin, teicoplanin (glycopeptide antibiotics)
• polymyxins (peptide antibiotics; e.g., colistin)
• platinum-containing medicines (e.g., cisplatin, carboplatin used in cancer treatment)
• muscle relaxants (e.g., Baclofen)
• medicines that inhibit neuromuscular conduction (e.g., medicines used for anesthesia, opioid painkillers)
• acarbose (used in diabetes)
• bisphosphonates (used in the treatment of osteoporosis)
• oral typhoid vaccines
• oral contraceptives - neomycin may reduce their effectiveness, so during their concurrent use, non-hormonal contraceptive methods should be used.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor or pharmacist for advice before taking this medicine.
Neomycinum TZF should only be used during pregnancy if, in the doctor's opinion, the benefit to the mother outweighs the potential risk to the fetus.
Neomycin passes into breast milk. If it is necessary to give the medicine to a breastfeeding woman, the doctor will recommend stopping breastfeeding.

Driving and Using Machines

There is no data on the adverse effect on the ability to drive and use machines.

Important Information About Some Ingredients of Neomycinum TZF

The medicine contains sucrose. If you have previously been diagnosed with intolerance to some sugars, you should contact your doctor before taking the medicine.

3. How to Take Neomycinum TZF

Neomycinum TZF should always be taken according to the doctor's recommendations. If you have any doubts, contact your doctor or pharmacist.

Adults

• Before surgeryUsually 1 g every hour for 4 hours, then 1 g every 4 hours for the next 24 hours or 1 g 19 hours, 18 hours, and 9 hours before the operation
• In hepatic encephalopathy4 to 12 g per day in divided doses (1 g to 3 g every 6 hours) for 5 to 7 days

Children

• Before surgeryChildren over 12 years:usually 1 g every 4 hours for 2 or 3 days before the operation Children from 6 to 12 years:usually 250 mg to 500 mg every 4 hours for 2 or 3 days before the operation

In children under 6 years, the use of the medicine is not recommended.

Method of Administration

Swallow the tablet whole, with water.
The medicine can be taken regardless of meals.

Taking a Higher Dose of Neomycinum TZF Than Recommended

Taking a higher dose of Neomycinum TZF than recommended by the doctor may cause severe side effects, such as vomiting, diarrhea, hearing disorders, kidney function disorders.
In case of taking a higher dose of Neomycinum TZF than recommended, contact your doctor or go to the nearest emergency department immediately. Take the medicine in its original packaging so that the staff can check exactly which medicine was taken.

Missing a Dose of Neomycinum TZF

If you forget to take a dose, take the next dose as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and take the next dose as recommended. If you forget to take two or more doses, contact your doctor.
Do not take a double dose to make up for a missed dose.

Stopping Treatment with Neomycinum TZF

It is important to take the medicine according to the recommended treatment cycle. Do not stop treatment without consulting your doctor.
If you feel worse during treatment or do not feel well after completing the recommended treatment cycle, contact your doctor.

4. Possible Side Effects

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

• fungal skin and mucous membrane infections, superinfections with resistant bacteria
• abnormal blood count, abnormal breakdown of red blood cells
• allergic reactions - drug fever, anaphylactic shock (sudden difficulty breathing, speaking, and swallowing, swelling of the lips, face, and neck, severe dizziness or fainting)
• neuromuscular blockade, disorientation, tingling, numbness, nystagmus
• hearing disorders (hearing loss, ringing, buzzing, or feeling of plugged ears), dizziness, nausea, vomiting, balance disorders
• nausea, vomiting, diarrhea, increased salivation, oral mucositis, malabsorption syndrome characterized by fatty stools, decreased xylose absorption, weight loss, decreased serum carotene levels, especially in patients treated with high doses of neomycin or for a long time
• skin changes in the form of rash, itching, irritation, or pain in the face area
• significantly decreased urine frequency or amount, increased thirst may occur during treatment with high doses of the medicine and consequently lead to renal tubular necrosis

Reporting Side Effects

If you experience any side effects, including any not listed in this leaflet, please 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 {current address, phone number, and fax of the aforementioned Department}
e-mail: adr@urpl.gov.pl .
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to Store Neomycinum TZF

Keep out of the sight and reach of children.
Store in a temperature below 25°C. Store in the original packaging to protect from light and moisture.
Do not use the medicine after the expiry date (EXP) stated on the packaging. The expiry date refers to the last day of the given month.
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. Contents of the Pack and Other Information

What Neomycinum TZF Contains

The active substance of the medicine is neomycin in the form of neomycin sulfate.
One tablet contains 250 mg of neomycin.
The excipients are: macrogol 4000, sodium carboxymethylcellulose (type A), talc, magnesium stearate, sucrose.

What Neomycinum TZF Looks Like and Contents of the Pack

White or cream-colored, round, biconvex tablets with a scored line, marked with "NEOMYCINUM" on one side.
Packaging:16 tablets

Marketing Authorization Holder and Manufacturer

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

Date of Last Revision of the Leaflet: