Patient Information Leaflet

Nystatyna VP, 100,000 IU, vaginal tablets
Nystatinum
Please read the entire leaflet before using this medicine, as it contains important information for the patient.

Keep this leaflet for possible future reference.
If you have any questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm someone else, even if their symptoms are the same.
If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents:

What is Nystatyna VP and what is it used for
Important information before using Nystatyna VP
How to use Nystatyna VP
Possible side effects
How to store Nystatyna VP
Contents of the pack and other information

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

Nystatin is an antibiotic. It binds to ergosterol, a component present in the cell membrane of fungi sensitive to its action, thereby disrupting membrane permeability. As a result, the fungal cell loses vital intracellular components. Depending on its concentration and the susceptibility of the target organism, nystatin exerts either fungistatic (inhibiting fungal growth) or fungicidal effects.
Organisms sensitive to nystatin include numerous fungi and yeasts, such as Candida spp., Cryptococcus spp., Coccidioides spp., Histoplasma spp., Blastomyces spp., and Aspergillus spp. Due to this activity, the drug is used in the treatment of vaginal and vulvar candidiasis.

2. Important information before using Nystatyna VP

When not to use Nystatyna VP

if the patient is allergic to nystatin or to any of the other ingredients of this medicine (listed in section 6),
if the patient is a child under 12 years of age.

Warnings and precautions
Before starting to use Nystatyna VP, discuss this with your doctor or pharmacist.
This medicine is intended for vaginal use. Do not take it orally.
Do not use higher doses of the medicine than those recommended by your doctor.

Nystatyna VP 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 planned for future use.
To date, no interactions have been reported whereby nystatin affects the action of other medicines, or other medicines affect the action of nystatin.

Nystatyna VP with food, drink and alcohol
This medicine is administered vaginally – it can be used regardless of meals.

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she might be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.
Do not use this medicine during pregnancy unless clearly recommended by a doctor.
Exercise caution when using this medicine during breastfeeding.

Driving and operating machinery
Nystatyna VP does not affect the ability to drive or operate machinery.

3. How to use the medicine Nystatyna VP

This medicine should always be used exactly as directed by your doctor. If in doubt, consult your doctor or pharmacist.

Recommended dose:
Female patients aged 12 years and older:
Insert one tablet deeply into the vagina. Use 1–2 tablets per day.
Treatment usually lasts 14 days.
Female patients under 12 years of age:
Do not use.
Elderly patients, patients with impaired liver or kidney function:
No dosage adjustment is necessary.

Hands should be washed both before and after administering the medicine.
The best treatment outcomes for vaginal and vulvar candidiasis are achieved when Nystatyna VP is used at the same time each day. Regular use helps prevent missed doses.
If you feel the effect of the medicine is too strong or too weak, consult your doctor.

Use of more than the recommended dose of Nystatyna VP
To date, no adverse effects have been reported following overdose with this medicine. However, in case of accidental or intentional ingestion of a very large amount of the product, contact a doctor immediately. The doctor will initiate measures to remove the substance from the body (e.g. inducing vomiting, gastric lavage, administration of activated charcoal).

Missed dose of Nystatyna VP
If you miss a dose at the scheduled time, take it as soon as possible. However, if it is almost time for the next dose, skip the missed dose. Do not use a double dose to make up for a missed dose.

Stopping treatment with Nystatyna VP
Discontinuing treatment with Nystatyna VP may lead to worsening of symptoms of vaginal and vulvar candidiasis.

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

4. Possible adverse reactions

Like all medicines, this medicinal product may cause adverse reactions, although not everybody experiences them.
These include local skin and mucous membrane irritation symptoms (itching, redness).
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, inform a doctor or pharmacist. Adverse reactions 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions enables further information on the safety of the medicine to be collected.

5. How to store Nystatyna VP

Store in the refrigerator (2°C - 8°C). Keep in the original packaging. Do not freeze.
Keep Nystatyna VP out of the sight and reach of children.
Do not use Nystatyna VP after the expiry date stated on the packaging.
Medicines should 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 packaging and other information

What Nystatyna VP contains

The active substance is nystatin (100,000 IU in each tablet).
Other ingredients are: rice starch, lactose monohydrate, ethylcellulose, magnesium stearate.

What Nystatyna VP looks like and contents of the pack
2 blisters made of Al + PVC/Al/OPA foil containing 5 tablets each, in a cardboard box.
Marketing Authorisation Holder
Bausch Health Ireland Limited
3013 Lake Drive
Citywest Business Campus
Dublin 24, D24PPT3
Ireland
Manufacturer
ICN Polfa Rzeszów S.A.
Przemysłowa 2 Street
35-105 Rzeszów, Poland