Nistatina Teva

Package Leaflet: Information for the User

Nystatyna Teva, 500,000 IU, enteric-coated tablets
Nystatinum

Read the package 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, 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 those not listed in this leaflet, 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 fungistatic and fungicidal action (by damaging the fungal cell membrane). Nystatin is also active against many strains of yeast and yeast-like fungi. It acts particularly on yeast of the genus Candida(including Candida albicans).
The medicine is not absorbed into the body fluids and acts only in the gastrointestinal tract.
Indications:

• Treatment of fungal infections of the gastrointestinal tract;
• 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 the patient is 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.
Oral forms of nystatin should not be used to treat systemic fungal infections.
In patients with renal failure, nystatin may exceptionally appear in small concentrations in the blood.

Nystatyna Teva with food and drink

The medicine can be used before or after meals, at regular intervals, which may coincide with meal times.

Children

In children, it is recommended to use nystatin in the form of a suspension. Nystatyna in the form of tablets is not recommended for use in small children.

Using Nystatyna Teva in patients with kidney and/or liver impairment

There are no data on the need to adjust the dosage of the medicine in patients with liver and kidney failure.

Using Nystatyna Teva in elderly patients

No dose adjustment is required in this age group.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks she may be pregnant or plans to have a child, she should consult her doctor or pharmacist before using this medicine.
Although the absorption of nystatin from the gastrointestinal tract is practically insignificant, it is not known whether the medicine can harm the fetus. Therefore, during pregnancy, nystatin should only be given when the benefit to the mother outweighs the potential risk to the fetus.
It is not known whether nystatin passes into breast milk. Therefore, caution should be exercised when using the medicine in breastfeeding women.

Driving and using machines

Nystatyna Teva does not affect the ability to drive and use machines.

Nystatyna Teva and other medicines

Tell your doctor or pharmacist about all the medicines you are taking, or have recently taken, and about the medicines you plan to take.
Nystatyna Teva contains less than 1 mmol (23 mg) of sodium per tablet, i.e. the medicine is considered "sodium-free".

3. How to use Nystatyna Teva

Nystatyna Teva should always be used exactly as directed by your doctor. If you are unsure, consult your doctor or pharmacist again.
Nystatyna Teva in the form of enteric-coated tablets is intended for oral use.

Adults

Prophylactically (during antibiotic therapy): 500,000 IU every 12 or 8 hours (1 enteric-coated tablet 2 to 3 times a day);
Therapeutically: usually 500,000 IU every 6 hours (1 enteric-coated tablet 4 times a day). The doctor may increase the dose to 1,000,000 IU every 6 hours a day (2 enteric-coated tablets 4 times a day).
The maximum dose of nystatin is 6,000,000 IU per day, in divided doses. Treatment may last up to 3 weeks.
Administration of the medicine should be continued for another 48 hours after the disappearance of clinical symptoms.

Use in children

Nystatin is used in children in the form of a suspension, nystatin in the form of tablets is not recommended for use in small children.

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 general effects.
In case of ingestion of a higher dose of the medicine than recommended, you should immediately consult a doctor or pharmacist.

Missing a dose of Nystatyna Teva

A missed dose should be taken as soon as possible. If it is already close to the time for the next dose, it should be taken at the scheduled time. Do not take a double dose to make up for a missed dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The medicine is well tolerated, even during prolonged administration.
Side effects are listed below using the following convention:
very common (>1/10), common (>1/100, <1>1/1000, <1>1/10,000, <1>Gastrointestinal disorders
Rare: nausea, vomiting, diarrhea
Immune system disorders
Rare: allergic reactions (e.g. rash, urticaria), including Stevens-Johnson syndrome (reported very rarely)

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of 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 provide more information on the safety of this medicine.
Side effects can also be reported to the marketing authorization holder.

5. How to store Nystatyna Teva

• The medicine should be stored out of 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 this medicine after the expiry date stated on the carton and blister after the statement: "Expiry date:" and "EXP:". The expiry date refers to the last day of the month stated.
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 Nystatyna Teva contains

• The active substance of the medicine is nystatin. Each enteric-coated tablet contains 500,000 IU of nystatin.
• The other ingredients are: microcrystalline cellulose, sodium starch glycolate type A, povidone, colloidal anhydrous silica, magnesium stearate; Coating: acryl-eze 93018359 white (methacrylic acid copolymer type C, talc, titanium dioxide, triethyl citrate, colloidal anhydrous silica, sodium hydrocarbonate, sodium lauryl sulfate).

What Nystatyna Teva looks like and contents of the pack

Nystatyna Teva enteric-coated tablets are white, round, and biconvex.
The tablets are packaged in blisters placed in a cardboard box.
Pack size: 16 enteric-coated tablets.

Marketing authorization holder and manufacturer

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: