Nystatin teva
Poland
Table of Contents
Package leaflet: Information for the user
Nystatyna Teva, 500,000 IU, enteric tablets
Nystatinum
Please read the entire leaflet carefully 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 further questions, please consult your doctor or pharmacist.
- This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, 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 Nystatyna Teva is and what it is used for
- Important information before taking Nystatyna Teva
- How to take 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 fungistatic and fungicidal activity (by damaging the fungal cell membrane). Nystatin is also active against many strains of yeasts and yeast-like fungi. It acts particularly against Candida species (including Candida albicans).
The drug is not absorbed into body fluids and acts only within the gastrointestinal tract.
Indications:
- Treatment of gastrointestinal fungal infections;
- 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 any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Before starting treatment with Nystatyna Teva, discuss this with a 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.
Nystatyna Teva with food and drink
The medicine can be taken before or after food, at regular intervals, which may coincide with meal times.
Children
In children, nystatin in the form of a suspension is recommended. Nystatin tablets are not recommended for use in young children.
Use of Nystatyna Teva in patients with impaired kidney and/or liver function
There are no data regarding the need for dose adjustment in patients with liver or kidney impairment.
Use of Nystatyna Teva in elderly patients
Dose adjustment is not required in this age group.
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 a doctor or pharmacist before using this medicine.
Although absorption of nystatin from the gastrointestinal tract is practically negligible, it is unknown whether the medicine may harm the unborn child. Therefore, during pregnancy, nystatin should be administered only when the benefit to the mother outweighs the potential risk to the fetus.
It is unknown whether nystatin passes into human milk. Therefore, caution should be exercised when administering the medicine to breastfeeding women.
Driving and operating machinery
Nystatyna Teva has no influence on the ability to drive or operate machinery.
Other medicines and Nystatyna Teva
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
Nystatyna Teva contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".
3. How to use Nystatyna Teva
Nystatyna Teva should always be used exactly as directed by the physician. In case of doubt,
consult the physician or pharmacist again.
Nystatyna Teva in the form of enteric-coated tablets is intended for oral use.
Adults
Prophylactic (during antibiotic therapy): 500,000 IU every 12 or 8 hours (1 enteric-coated tablet
2 to 3 times daily);
Therapeutic: usually 500,000 IU every 6 hours (1 enteric-coated tablet 4 times daily). The physician may
increase the dose up to 1,000,000 IU every 6 hours (2 enteric-coated tablets 4 times daily).
The maximum dose of nystatin is 6,000,000 IU per day, given in divided doses. Treatment
may last up to 3 weeks.
Administration of the drug should be continued for an additional 48 hours after the disappearance of clinical symptoms.
Use in children
Nystatin in children is administered in the form of oral suspension; nystatin in tablet form is not recommended for use in young children.
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.
If a higher than recommended dose of the drug is taken, seek immediate advice from a physician or pharmacist.
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 take a double dose to make up for a missed dose.
4. Possible adverse reactions
Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
The medicine is well tolerated, even during prolonged administration.
Adverse reactions are listed below using the following convention:
very common (>1/10), common (>1/100, <1/10), uncommon (>1/1000, <1/100), rare (>1/10,000, <1/1000), very rare /including single cases/ (<1/10,000).
Gastrointestinal disorders
Rare: nausea, vomiting, diarrhoea
Immune system disorders
Rare: allergic reactions (e.g. rash, urticaria), including Stevens-Johnson syndrome (reported very rarely)
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a 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 181C, 02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps to provide more information on the safety of the medicine.
Adverse reactions may also be reported to the responsible entity.
5. How to store Nystatyna Teva
- Keep the medicine out of the sight and reach of children.
- Store below 25°C. Keep 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 label: “Expiry date (EXP):” and “EXP:”. The expiry date refers to the last
day of the stated month.
Medicines must not be disposed of via the sewage system 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 packaging and other information
What Nystatyna Teva contains
- The active substance is nystatin. Each enteric tablet contains 500,000 IU of nystatin.
- The other ingredients are: microcrystalline cellulose, sodium glycolate starch type A, povidone, colloidal anhydrous silica, magnesium stearate; Coating composition: acryl-eze 93018359 white (copolymer of methacrylic acid type C, talc, titanium dioxide, triethyl citrate, colloidal anhydrous silica, sodium bicarbonate, sodium lauryl sulfate).
What Nystatyna Teva looks like and contents of the pack
Nystatyna Teva enteric tablets are white, round, biconvex.
The tablets are packed in blisters placed in a cardboard box.
Pack size: 16 enteric tablets.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Teva Pharmaceuticals Polska Sp. z o.o.
ul. Emilii Plater 53
00-113 Warsaw
tel.: (22) 345 93 00
Manufacturer
Teva Operations Poland Sp. z o.o.
ul. Mogilska 80
31-546 Kraków