Nistatin Tzf

Package Leaflet: Information for the Patient

Nystatin TZF, 100,000 IU/ml,

powder for oral suspension
Nystatinum

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• 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 inform your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Nystatin TZF and what is it used for
• 2. Important information before taking Nystatin TZF
• 3. How to take Nystatin TZF
• 4. Possible side effects
• 5. How to store Nystatin TZF
• 6. Contents of the pack and other information

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

Nystatin is a polyene antibiotic with antifungal activity - fungistatic or fungicidal (due to damage to the fungal cell membrane). Nystatin also acts on many strains of yeast and yeast-like fungi, especially Candida species (including Candida albicans).
The medicine does not absorb into the body fluids and only acts locally at the site of administration.
Indications:

• prevention and treatment of yeast infections of the gastrointestinal tract, particularly the mouth (e.g., oral thrush) and throat;
• prophylaxis of invasive candidiasis in newborns with low birth weight, i.e., <1500 g, in cases where fluconazole cannot be used.< li>

2. Important information before taking Nystatin TZF

When not to take Nystatin TZF

If you are allergic to nystatin or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before taking Nystatin TZF, discuss it with your doctor or pharmacist.
Do not take oral forms of nystatin for the treatment of systemic fungal infections.
In patients with renal failure, nystatin may exceptionally appear in small concentrations in the blood.

Nystatin TZF and other medicines

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Tell your doctor or pharmacist about all the medicines you are taking now or have taken recently, as well as any medicines you plan to take.
There are no data on the interaction of nystatin with other medicines.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor for advice before taking this medicine.
It is not known whether Nystatin TZF can harm the fetus - consult your doctor before taking the medicine.
It is not known whether Nystatin TZF passes into breast milk - consult your doctor before taking the medicine.

Driving and using machines

The effect of the medicine on the ability to drive and use machines is not known.

Nystatin TZF contains sucrose

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

Nystatin TZF contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per 1 ml of prepared oral suspension, i.e., the medicine is considered "sodium-free".

3. How to take Nystatin TZF

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
1 ml of prepared suspension contains 100,000 IU of nystatin. The oral syringe provided with the medicine packaging is marked with 1 ml (100,000 IU).
Dosage
Adults
Treatment of yeast infections of the mouth and throat: 400,000 IU - 600,000 IU 4 times a day.
The suspension should be kept in the mouth for as long as possible before swallowing.
Treatment of yeast infections of the gastrointestinal tract: 500,000 IU to 1,000,000 IU 4 times a day.
Infants, children, and adolescents
Treatment of yeast infections of the mouth:
Oral thrush:
Infants:
100,000 IU 4 times a day (1 ml 4 times a day).
Children (over 2 years of age) and adolescents
100,000 IU 4 times a day (1 ml 4 times a day).
The longer the suspension stays in the mouth in contact with the infected area, the more effective the medicine will be.
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Treatment of yeast infections of the gastrointestinal tract:
Infants:
100,000 IU 4 times a day (1 ml 4 times a day).
Children (over 2 years of age)
100,000 IU 4 times a day (1 ml 4 times a day).
Adolescents
500,000 IU 4 times a day (5 ml 4 times a day).
Prophylaxis of invasive candidiasis in newborns with low birth weight, i.e., <1500 g, in cases where fluconazole cannot be used:
100,000 IU 3 times a day (1 ml 3 times a day).
Elderly patients
There are no special recommendations.
Administration of Nystatin TZF should be continued for at least 48 hours after the disappearance of symptoms. If symptoms worsen or persist (after 14 days of treatment), the patient should be re-evaluated and alternative treatment considered.
Method of administration
Oral administration.
A measuring cup and an oral syringe with a connector are provided with the medicine packaging to facilitate dosing.
Before taking the medicine, shake the bottle well.
Method of preparing the suspension

Before adding water, shake the bottle with the medicine to loosen the powder.

• 1. Add boiled and cooled water to the mark on the measuring cup indicating 20 ml. To prepare the suspension, pour the entire measured amount of water into the bottle with the powder. After adding water, 24 ml of suspension is obtained.

Fig. 1

• 2. Press the connector into the neck of the bottle, screw on the cap, and shake the bottle well to obtain a uniform suspension. Fig. 2

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• 3. The prepared suspension should be measured using the oral syringe. To do this, unscrew the cap, attach the syringe to the connector (insert the syringe tip into the connector recess), turn the bottle upside down, and draw the appropriate amount of suspension. Fig. 3

• 4. Turn the bottle upright (with the cap up), remove the syringe with the suspension (pull the syringe out of the connector), and screw the cap back on, leaving the connector. Administer the suspension using the syringe. Fig. 4

The syringe should be disassembled (pull out the syringe plunger), rinsed with clean water, both parts left to dry completely before the next use, the plunger reinserted into the syringe, and stored in a clean and safe place with the medicine.
Shake the bottle with the prepared suspension well before each administration.

Overdose of Nystatin TZF

Nystatin is practically not absorbed from the gastrointestinal tract, and overdose or accidental ingestion does not cause toxic systemic effects.
Oral doses of nystatin above 5 million IU per day have caused nausea and other stomach disorders.
If you have taken more than the recommended dose of the medicine, consult your doctor or pharmacist immediately.

Missed dose of Nystatin TZF

Take the missed dose as soon as possible. If it is almost time for the next dose, take it at the scheduled time.
Do not take a double dose to make up for a missed dose.

Stopping treatment with Nystatin TZF

If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Nystatin is well tolerated, even during prolonged administration.

Side effects are listed below by frequency of occurrence

Rare (occurring in 1 to 10 people per 10,000):
nausea, vomiting, diarrhea, allergic reactions (e.g., rash, hives), including Stevens-Johnson syndrome (very rarely reported), i.e., skin changes of a non-uniform nature, with an acute and violent course, in the form of polymorphic erythema, extensive, painful ulcers with tissue necrosis, and characterized by peeling of the epidermis.
After oral administration, systemic side effects have been observed sporadically.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please inform your doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181 C, 02-222 Warsaw,
phone: 22 49-21-301, fax: 22 49-21-309,
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Nystatin TZF

Keep the medicine out of the sight and reach of children.
Powder - Store in a temperature below 25 °C.
Oral suspension - Store for no more than 7 days in a temperature below 25 °C.
Do not use this medicine after the expiry date stated on the carton and bottle after "EXP". The expiry date refers to the last day of the month.
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 Nystatin TZF contains

The active substance is nystatin. Each 5 g of powder contains 2,400,000 IU of nystatin.
1 ml of prepared suspension contains 100,000 IU of nystatin.
The other ingredients are: microcrystalline cellulose and sodium carmellose, citric acid, sodium saccharin (E 954), orange flavor (corn maltodextrin, flavor and aroma enhancers, alpha-tocopherol (E 307)), peach flavor (corn maltodextrin, glycerol triacetate (E 1518), flavor and aroma enhancers), sucrose.

What Nystatin TZF looks like and contents of the pack

Yellow or light brown powder; after adding water, a uniform yellow or light brown suspension is obtained.
One bottle of 35 ml capacity containing 5 g of powder in a cardboard box.
The packaging also includes a 20 ml measuring cup and an oral syringe allowing for the administration of up to 1 ml of suspension with an accuracy of 0.1 ml, and a connector.

Marketing authorization holder and manufacturer

Tarchomińskie Zakłady Farmaceutyczne "Polfa" Spółka Akcyjna
ul. A. Fleminga 2
03-176 Warsaw
Phone number: 22-811-18-14

Date of last revision of the leaflet:

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