Nistatina Teva

Leaflet attached to the packaging: information for the user

Nystatyna Teva, 100,000 IU/ml, granules for oral suspension and use in the mouth
Nystatinum

Read the leaflet carefully before using 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 tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Nystatyna Teva and what is it used for
• 2. Important information before using Nystatyna Teva
• 3. How to use Nystatyna Teva
• 4. Possible side effects
• 5. How to store Nystatyna Teva
• 6. Contents of the pack and other information

1. What is Nystatyna Teva 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 (including Candida albicans).
The medicine is not absorbed into the body fluids and only acts at the site of application.
Indications:

• treatment of fungal infections of the gastrointestinal tract, including the mouth (e.g. mucosal thrush of the gums, tongue, and lip redness) and esophagus,
• prophylactically in patients treated with large doses of antibiotics or corticosteroids.

2. Important information before using Nystatyna Teva

When not to use Nystatyna Teva

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

Warnings and precautions

Before starting to use Nystatyna Teva, discuss it with your doctor or pharmacist.
Do not use oral forms of nystatin to treat systemic fungal infections.
In patients with renal failure, 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

Dosing, see section 3.

Nystatyna Teva and other medicines

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, ask your doctor for advice before using this medicine.
Pregnancy
It is not known whether the medicine can harm the fetus - 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 using machines

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

Sodium

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

Nystatyna Teva contains sucrose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking the medicine.

Nystatyna Teva contains benzoic acid (E 210)

The medicine contains 116.9 mg of benzoic acid in 5.8 g of granules for oral suspension and use in the mouth. 1 ml of 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 life).

Nystatyna Teva contains methyl parahydroxybenzoate (E 218) and propyl parahydroxybenzoate (E 216)

The medicine may cause allergic reactions (possible late reactions).

3. How to use Nystatyna Teva

This medicine should always be used as directed by your doctor. If you are unsure, consult your doctor or pharmacist.
1 ml of prepared suspension contains 100,000 IU of nystatin. The syringe attached to the packaging is marked with 1 ml (100,000 IU).

Adults

Treatment of fungal infections of the mouth: 100,000 IU 4 times a day. The suspension should be kept in the mouth for as long as possible before swallowing.
Treatment of fungal infections of the gastrointestinal tract: 500,000 IU to 1,000,000 IU every 6 hours.
Prophylactically (during antibiotic therapy): 500,000 IU every 8 hours.

Use in infants, children, and adolescents

Treatment of fungal infections of the mouth:
Oral thrush: 100,000 IU 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.
Treatment of fungal infections of the gastrointestinal tract:
200,000 IU to 2,000,000 IU per day in 4 divided doses.
Nystatyna Teva can also be used externally to brush the mouth 2 to 3 times a day.

Preparing the suspension

Add boiled, cooled water to the mark on the bottle, then shake to obtain a suspension (28 ml). If necessary, after settling, refill with water to the mark

• this operation should be performed once only. The shelf life of the prepared suspension is 7 days. Shake before each use of the medicine. Note: after the first opening of the packaging, remove the membrane welded to the bottle.

Using a higher dose of Nystatyna Teva than recommended

Nystatin is practically not absorbed from the gastrointestinal tract, and overdose or accidental ingestion of the medicine does not cause toxic systemic effects.
If you have taken a higher dose of the medicine than recommended, consult your doctor or pharmacist immediately.

Missing a dose of Nystatyna Teva

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 the missed dose.

Stopping use of Nystatyna Teva

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Nystatyna Teva 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, urticaria), including Stevens-Johnson syndrome (very rarely described).

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist.
Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
By reporting side effects, you can help gather more information on the safety of the medicine.
Side effects can also be reported to the marketing authorization holder.

5. How to store Nystatyna Teva

Keep the medicine out of the sight and reach of children.
Store in 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 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 Nystatyna Teva contains

• The active substance of the medicine is nystatin. Each 5.8 g of granules contains 2,784,000 IU of nystatin. 1 ml of prepared suspension contains 100,000 IU of nystatin
• The other ingredients are: propyl parahydroxybenzoate (E 216), methyl parahydroxybenzoate (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 a granule for oral suspension and use in the mouth.
The packaging of the medicine is a 45 ml transparent HDPE bottle with a 28 ml scale, closed with a green PP type P&T (press and turn) cap with an LDPE foam insert and a polystyrene foam membrane, and a 1 ml colorless LDPE oral syringe in a cardboard box.
Note: the membrane is attached to the neck of the bottle under pressure during the packaging process and should be removed after the first opening of the packaging.

Marketing authorization holder

Teva Pharmaceuticals Polska Sp. z o.o.
ul. Emilii Plater 53
00-113 Warsaw
phone: (22) 345 93 00

Manufacturer

Teva Operations Poland Sp. z o.o.
ul. Mogilska 80
31-546 Krakow

Date of last revision of the leaflet: