Package leaflet: Information for the user

Nystatyna Teva, 100,000 IU/ml, granules for oral suspension and oral cavity use
Nystatinum
Please read this leaflet carefully before using this medicine because it contains important
information for you.

Keep this leaflet as you may need to read it again.
If you have any questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

What Nystatyna Teva is and what it is used for
What you need to know before using Nystatyna Teva
How to use Nystatyna Teva
Possible side effects
How to store Nystatyna Teva
Contents of the pack and other information

1. What Nystatyna Teva is and what it is used for

Nystatin is a polyene antibiotic with antifungal activity – fungistatic or fungicidal (due to damage of 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:

Treatment of gastrointestinal tract fungal infections, including the oral cavity (e.g. mucosal candidiasis of the gums, tongue, and vermilion border of the lips) and the oesophagus;
Prophylactic use in patients treated with high doses of antibiotics or corticosteroids.

2. Important information before using Nystatyna Teva

When not to use Nystatyna Teva

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 Nystatyna Teva, 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.
In patients sensitive to benzoic acid and its derivatives, Nystatyna Teva may cause allergic reactions.

Children and adolescents
Dosage: see section 3.

Nystatyna Teva and other medicines
There are no data available on interactions between nystatin and other medicines. Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient intends to take.

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

Pregnancy
It is not known whether this medicine may harm the unborn child. Consult your doctor before using the medicine.

Breastfeeding
It is not known whether the medicine 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.

Excipients:

Sodium
Nystatyna Teva contains less than 1 mmol (23 mg) of sodium per 1 ml of prepared oral suspension, meaning the medicine is considered "sodium-free".

Nystatyna Teva contains sucrose
If the patient has been previously diagnosed with intolerance to certain sugars, the patient should consult their doctor before taking this medicine.

Nystatyna Teva contains benzoic acid (E 210)
The medicine contains 116.9 mg of benzoic acid in 5.8 g of granules for the preparation of oral suspension for oral use. One ml of the prepared suspension contains 4.17 mg of benzoic acid.
Benzoic acid may cause local irritation.
Benzoic acid may increase the risk of jaundice (yellowing of the skin and whites of the eyes) in newborns (up to 4 weeks of age).

Nystatyna Teva contains methyl parahydroxybenzoate (E 218) and propyl parahydroxybenzoate (E 216)
The medicine may cause allergic reactions (including delayed-type reactions).

3. How to use Nystatyna Teva

This medicine should always be used as directed by the physician. In case of doubt, consult your
doctor or pharmacist.
1 ml of the prepared suspension contains 100,000 IU of nystatin. The syringe supplied with the
packaging is marked at 1 ml (100,000 IU).
Adults
Treatment of oral fungal infections: 100,000 IU four times daily. The suspension should be held in
the mouth as long as possible before swallowing.
Treatment of gastrointestinal fungal infections: 500,000 IU to 1,000,000 IU every 6 hours.
Prophylactic use (during antibiotic therapy): 500,000 IU every 8 hours.
Use in infants, children, and adolescents
Treatment of oral fungal infections:
Oral candidiasis: 100,000 IU four times daily. The longer the suspension remains in contact with the
infected area in the oral cavity before swallowing, the greater the effectiveness of the medicine.
Treatment of gastrointestinal fungal infections:
200,000 IU to 2,000,000 IU per day divided into 4 doses.
Nystatyna Teva may also be used topically, applied by brushing the oral cavity 2 to 3 times daily.
Preparation of the suspension
Add boiled, cooled water up to the mark indicated on the bottle, then shake well to obtain a
homogeneous suspension (28 ml). If necessary, after settling, add water again up to the mark.

This procedure should be performed only once. The stability of the prepared suspension is 7 days. Shake well before each use. Caution: After first opening the container, remove the membrane sealed to the bottle.

Use of a higher than recommended dose of Nystatyna Teva
Nystatin is practically not absorbed from the gastrointestinal tract, and overdose or accidental
ingestion does not cause systemic toxic effects.
In case of ingestion of a higher than recommended dose, consult your doctor or pharmacist
immediately.
Missed dose of Nystatyna Teva
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 use a double dose to make up for a missed dose.
Discontinuation of Nystatyna Teva
If you have any further doubts regarding the use of this medicine, consult your doctor or
pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everybody will experience them.
Nystatin is well tolerated, even during prolonged administration.
Adverse effects listed below are categorized by their frequency of occurrence.
Rare (occur in 1 to 10 people in 10,000):
nausea, vomiting, diarrhoea, allergic reactions (e.g. rash, urticaria), including Stevens-Johnson syndrome (reported very rarely).
Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist.
Adverse effects can be reported directly to the Department of Monitoring 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
Website: https://smz.ezdrowie.gov.pl
By reporting adverse effects, additional information on the safety of the medicine can be collected.
Adverse effects may also be reported to the responsible entity.

5. How to store Nystatyna Teva

Keep this medicine out of sight and reach of children.
Store at a temperature of 2°C - 8°C. Protect from light.
The shelf life of the prepared suspension (after reconstitution of the medicinal product) is 7 days.
Do not use this medicine after the expiry date stated on the carton and bottle following: 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. Such measures will help protect the environment.

6. Contents of the pack and other information

What Nystatyna Teva contains

The active substance is nystatin. Each 5.8 g of granules contains 2,784,000 IU nystatin. 1 ml of prepared oral suspension contains 100,000 IU nystatin.
Other ingredients are: propyl p-hydroxybenzoate (E 216), methyl p-hydroxybenzoate (E 218), benzoic acid (E 210), sodium citrate, pectin, vanillin, sodium saccharin, sucrose.

What Nystatyna Teva looks like and contents of the pack
The medicine is in the form of granules for the preparation of an oral suspension for oral use.
The packaging consists of a white, transparent HDPE bottle with a capacity of 45 ml, marked with a 28 ml scale, closed with a green polypropylene (PP) P&T (press and turn) cap, fitted with an LDPE foam liner and a polystyrene foam membrane, and a 1 ml colourless oral syringe made of LDPE, packed in a cardboard box.
Note: The membrane is adhered to the neck of the bottle under pressure during the product packaging process and must be removed after the first opening of the container.
Marketing Authorisation Holder
Teva Pharmaceuticals Polska Sp. z o.o.
Emilii Plater 53
00-113 Warsaw
Tel.: (22) 345 93 00
Manufacturer
Teva Operations Poland Sp. z o.o.
Mogilska 80
31-546 Kraków