Nistatina Vp

Leaflet attached to the packaging: patient information

Nystatyna VP, 100,000 IU, vaginal tablets
Nystatinum

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Nystatyna VP and what is it used for
• 2. Important information before using Nystatyna VP
• 3. How to use Nystatyna VP
• 4. Possible side effects
• 5. How to store Nystatyna VP
• 6. Package contents and other information

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

Nystatin is an antibiotic. It binds to ergosterol, a substance present in the cell membrane of sensitive fungi, disrupting the permeability of this membrane, resulting in the loss of essential substances for the fungus cell. Depending on the concentration and type (sensitivity) of the organism it acts on, nystatin has a fungistatic (inhibiting fungal growth) or fungicidal effect.
Organisms sensitive to nystatin include numerous fungi and yeasts, including Candida spp., Cryptococcus spp., Coccidioides spp., Histoplasma spp., Blastomyces spp.and Aspergillus spp.Thanks to this effect, the medicine is used to treat vaginal and vulvar candidiasis.

2. Important information before using Nystatyna VP

When not to use Nystatyna VP

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

Warnings and precautions

Before starting to use Nystatyna VP, discuss it with your doctor or pharmacist.
The medicine is intended for vaginal use only. Do not take it orally.
Do not use higher doses of the medicine than recommended by your doctor.

Nystatyna VP and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.
So far, no interactions between nystatin and other medicines have been found.

Nystatyna VP with food, drink, and alcohol

The medicine is used vaginally and can be used independently of meals.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before using this medicine.
Do not use the medicine during pregnancy without your doctor's explicit recommendation.
Use the medicine with caution during breastfeeding.

Driving and using machines

Nystatyna VP does not affect driving or using machines.

3. How to use Nystatyna VP

Always use this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
Recommended dose:
Patients aged 12 and over:
Insert the tablet deep into the vagina. Use 1-2 tablets per day.
Treatment usually lasts 14 days.
Patients under 12 years of age:
Do not use.
Patients of advanced age, with liver or kidney function disorders:
No need to change the dosage.
Wash your hands before and after using the medicine.
The best treatment results for vaginal and vulvar candidiasis are achieved when Nystatyna VP is used at the same time every day. Regular use prevents forgetting to use the medicine.
If you feel that the effect of the medicine is too strong or too weak, consult your doctor.

Using a higher dose of Nystatyna VP than recommended

So far, no side effects have been reported due to the use of too high a dose of the medicine. In case of accidental or intentional ingestion of a very large amount of the product, contact your doctor, who will take actions to remove it from the body (induce vomiting, flush the stomach, administer activated charcoal).

Missing a dose of Nystatyna VP

If you miss a dose at the scheduled time, use the medicine as soon as possible. However, if it is close to the time for the next dose, skip the missed dose. Do not use a double dose to make up for the missed dose.

Stopping the use of Nystatyna VP

Stopping the use of Nystatyna VP may cause the symptoms of vaginal and vulvar candidiasis to worsen.
If you have any further doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
They include local symptoms of skin and mucous membrane irritation (itching, redness).

Reporting side effects

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

5. How to store Nystatyna VP

Store in a refrigerator (2°C - 8°C). Store in the original packaging. Do not freeze.
Keep the medicine out of 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 that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Nystatyna VP contains

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

What Nystatyna VP looks like and what the pack contains

2 blisters of Al + PVC/Al/OPA foil containing 5 tablets each, in a cardboard box.

Marketing authorization holder

Bausch Health Ireland Limited
3013 Lake Drive
Citywest Business Campus
Dublin 24, D24PPT3
Ireland

Manufacturer

ICN Polfa Rzeszów S.A.
ul. Przemysłowa 2
35-105 Rzeszów
Date of last update of the leaflet:April 2025