Nystatin tzf
Poland
Table of Contents
Package leaflet: Information for the patient
Nystatin TZF, 100,000 IU/mL,
powder for oral suspension
Nystatinum
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 doubts, please consult your doctor or pharmacist.
- This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are the same.
- If any adverse reactions occur in the patient, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
Table of contents
- What Nystatin TZF is and what it is used for
- Important information before taking Nystatin TZF
- How to take Nystatin TZF
- Possible side effects
- How to store Nystatin TZF
- Contents of the pack and other information
1. What Nystatin TZF is and what it is used for
Nystatin is a polyene antibiotic with antifungal activity—fungistatic or fungicidal (due to damage to the fungal cell membrane). Nystatin is also active against many strains of yeasts and yeast-like fungi, particularly Candida species (including Candida albicans).
The drug is not absorbed into body fluids and acts only at the site of administration.
Indications:
- Prevention and treatment of yeast infections of the gastrointestinal tract, particularly the oral cavity (e.g., oral thrush of the mucous membranes of the gums, tongue, and lips) and pharynx;
- Prophylaxis of invasive candidiasis in newborns with low birth weight, i.e., <1500 g, when fluconazole cannot be used.
2. Important information before using the medicine Nystatin TZF
When not to use Nystatin TZF
If the patient is allergic to nystatin or to any of the other ingredients of this medicine
(listed in section 6).
Warnings and precautions
Before starting treatment with Nystatin TZF, discuss this with your doctor or pharmacist.
Oral forms of nystatin should not be used in the treatment of systemic fungal infections.
In patients with renal impairment, nystatin may exceptionally appear in small concentrations
in the blood.
Nystatin TZF and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
There are no data available regarding interactions between nystatin and other medicines.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor before using this medicine.
It is not known whether Nystatin TZF may harm the unborn child – consult your doctor before using the medicine.
It is not known whether Nystatin TZF passes into breast milk – consult your doctor before using the medicine.
Driving and operating machinery
The effect of the medicine on the ability to drive and operate machinery is unknown.
Nystatin TZF contains sucrose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult their doctor before taking this medicine.
Nystatin TZF contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per 1 ml of prepared oral suspension, meaning the medicine is considered "sodium-free".
3. How to use Nystatin TZF
This medicine should always be used as directed by a doctor or pharmacist. If in doubt,
consult a doctor or pharmacist.
1 ml of the prepared suspension contains 100,000 IU of nystatin. The oral syringe supplied with the
package is marked at 1 ml (100,000 IU).
Dosage
Adults
Treatment of oral and pharyngeal candidiasis: 400,000 IU – 600,000 IU four times daily.
The suspension should be held in the mouth as long as possible before swallowing.
Treatment of gastrointestinal candidiasis: 500,000 IU to 1,000,000 IU four times daily.
Infants, children and adolescents
Treatment of oral candidiasis:
Oral thrush:
Infants:
100,000 IU four times daily (1 ml four times daily).
Children (over 2 years of age) and adolescents:
100,000 IU four times daily (1 ml four times daily).
The longer the suspension remains in contact with the infected area in the mouth before swallowing, the greater the effectiveness of the medicine.
Treatment of gastrointestinal candidiasis:
Infants:
100,000 IU four times daily (1 ml four times daily).
Children (over 2 years of age):
100,000 IU four times daily (1 ml four times daily).
Adolescents:
500,000 IU four times daily (5 ml four times daily).
Prophylaxis of invasive candidiasis in low birth weight neonates (<1500 g) when fluconazole cannot be used:
100,000 IU three times daily (1 ml three times daily).
Elderly patients
No special recommendations.
Treatment with Nystatin TZF should continue for at least 48 hours after symptoms have resolved. If symptoms worsen or persist (after 14 days of treatment), the patient should be re-evaluated and alternative treatment considered.
Method of administration
Oral use.
An oral syringe with a connector is supplied with the package to facilitate dosing.
Shake the bottle vigorously before each use.
Instructions for preparing the suspension
Before adding water, shake the bottle with the medicine to loosen the powder.
- Add boiled and cooled water to the measuring cup up to the mark indicating 20 ml or 25 ml. Pour the entire measured amount of water into the bottle containing the powder to prepare the suspension. After adding water, 24 ml or 30 ml of suspension will be obtained.
Fig. 1
- Press the connector into the neck of the bottle, screw on the cap, and shake the bottle vigorously to obtain a uniform suspension. Fig. 2
- Measure the prepared suspension using the oral syringe. To do this, unscrew the cap, attach the syringe to the connector (insert the tip of the syringe into the depression of the connector), turn the bottle upside down, and draw the required amount of suspension. Fig. 3
- Return the bottle to an upright position (cap up), remove the syringe with the suspension (pull the syringe out of the connector), and screw the cap back on, leaving the connector in place. Administer the suspension using the syringe. Fig. 4
After use, disassemble the syringe (pull out the plunger), rinse both parts with clean water, allow to dry completely before next use, reinsert the plunger into the syringe, and store in a clean and safe place together with the medicine.
Shake the bottle containing 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 systemic toxic effects.
Oral doses of nystatin exceeding 5 million IU per day have caused nausea and other gastrointestinal disturbances.
In case of ingestion of more than the recommended dose, consult a doctor or pharmacist immediately.
Missed dose of Nystatin TZF
If a dose is missed, take it as soon as possible. If it is almost time for the next dose, take the next dose at the scheduled time.
Do not take a double dose to make up for a missed dose.
Discontinuation of Nystatin TZF
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.
4. Possible adverse reactions
Like any medicine, this medicine may cause adverse reactions, although not everyone experiences them.
Nystatin is well tolerated, even during prolonged administration.
Adverse reactions are listed below according to their frequency of occurrence
Rare (occurs in 1 to 10 people per 10,000):
nausea, vomiting, diarrhoea, allergic reactions (e.g. rash, urticaria), including Stevens-Johnson syndrome (reported very rarely), i.e. skin lesions of heterogeneous character, with acute and severe course, presenting as erythema multiforme, extensive painful erosions with areas of tissue necrosis and characterized by epidermal detachment.
General systemic adverse reactions have been occasionally observed after oral administration.
Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181 C, 02-222 Warsaw,
tel.: +48 22 49-21-301, fax: +48 22 49-21-309,
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.
5. How to store Nystatin TZF
Keep this medicine out of sight and reach of children.
Powder – Store below 25 °C.
Oral suspension – Store for no longer than 7 days at 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.
6. Contents of the package and other information
What Nystatin TZF contains
The active substance is nystatin. Each 5 g/6.25 g of powder contains 2,400,000 IU/3,000,000 IU of nystatin.
1 ml of the prepared suspension contains 100,000 IU of nystatin.
The other ingredients are: microcrystalline cellulose and sodium carmellose, citric acid, sodium saccharin (E 954), orange flavour (corn maltodextrin, flavouring agents, alpha-tocopherol (E 307)), apricot flavour (corn maltodextrin, glyceryl triacetate (E 1518), flavouring agents), sucrose.
What Nystatin TZF looks like and contents of the pack
A yellow or slightly brownish powder; after adding water, a homogeneous yellow or slightly brownish suspension is formed.
One bottle with a capacity of 35 ml or 60 ml, containing 5 g or 6.25 g of powder, in a cardboard box.
The package also contains a measuring cup with a capacity of 20 ml or 30 ml, an oral syringe allowing administration of up to 1 ml of suspension with an accuracy of 0.1 ml, and a connector.
Marketing Authorisation Holder and Manufacturer
Tarchomińskie Zakłady Farmaceutyczne „Polfa” Spółka Akcyjna
ul. A. Fleminga 2
03-176 Warszawa
Telephone number: 22-811-18-14
For further information, please contact the representative of the Marketing Authorisation Holder.