Nistapol

Package Leaflet: Information for the Patient

NYSTAPOL, 100 000 IU/mL Oral Suspension

Nystatin

Read the package leaflet carefully before taking 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, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. What is Nystapol and what is it used for

The active substance of the medicine is nystatin - a polyene antibiotic with antifungal - fungistatic or fungicidal action (by damaging the fungal cell membrane).
Nystatin acts on many strains of yeast and yeast-like fungi, particularly on Candida(including Candida albicans).

Indications:

Prevention and treatment of yeast infections of the mouth, esophagus, and gastrointestinal tract.

2. Important information before taking Nystapol

When not to take Nystapol:

Warnings and precautions

Before starting to take Nystapol, discuss it with your doctor.
Do not take oral forms of nystatin for the treatment of systemic fungal infections, e.g. lung, skin.
In patients with renal failure, nystatin may exceptionally appear in small concentrations in the blood.

Nystapol and other medicines

Tell your doctor or pharmacist about all the medicines you are taking now or have taken recently, as well as any medicines you plan to take.

Pregnancy and breastfeeding

It is not known whether the medicine can harm the fetus, pass into breast milk, or affect fertility. If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor before taking this medicine.

Driving and using machines

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

Nystapol contains methyl parahydroxybenzoate, propyl parahydroxybenzoate, sucrose, glycerol (excipients) and sodium.

Due to the presence of methyl parahydroxybenzoate (E 218) and propyl parahydroxybenzoate (E 216) - the medicine may cause allergic reactions (possible late reactions).
This medicine contains less than 1 mmol (23 mg) of sodium per 1 mL, which means it can be considered a sodium-free product.
Due to the presence of sucrose (400 mg per 1 mL) - if the patient has previously been diagnosed with intolerance to some sugars, the patient should contact their doctor before taking the medicine.

3. How to take Nystapol

Take this medicine always exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Before use, shake the bottle well. To measure the dose, use the pipette (applicator) provided with the package, which is marked with 1 mL.
Wash the pipette (applicator) by hand in warm water. Do not boil and do not immerse in hot water. Do not wash in a dishwasher.
1 mL of suspension contains 100 000 IU of nystatin.
Doses should be evenly distributed throughout the day.

Adults

Treatment of yeast infections of the mouth: 100 000 IU four 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 every six hours.

Use in infants and children

Treatment of yeast infections of the mouth and gastrointestinal tract: 100 000 IU four times a day. The suspension should be dripped into the mouth.
The longer the suspension stays in the mouth in contact with the infected area, the greater the effectiveness of the medicine.
In the case of newborns, the recommended prophylactic dose is 1 mL once a day.
Nystatin administration should be continued for at least 48 hours after the symptoms have disappeared.
If the symptoms of infection do not disappear after 14 days of taking the medicine, you should consult your doctor to re-analyze the diagnosis and make the necessary changes in treatment.

Overdose of Nystapol

Nystatin is practically not absorbed from the gastrointestinal tract, and overdose or accidental ingestion of the medicine does not cause toxic general actions.
In case of taking a higher dose of the medicine than recommended, consult your doctor or pharmacist immediately.

Missed dose of Nystapol

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

Stopping Nystapol treatment

If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
In case of irritation or allergic reaction, stop taking the medicine.
Immediately consult your doctor if you experience any of the following side effects, such as:

• hypersensitivity reactions, angioedema (swelling of the lips or tongue), including facial swelling;
• Stevens-Johnson syndrome (a serious disease characterized by the formation of blisters on the skin, mouth, eyes, and genitals) occurring very rarely;
• rash, urticaria, occurring rarely.

Other side effects.
There have been reports of occasional cases of nausea.
High doses of nystatin have sometimes caused diarrhea, stomach and intestinal disorders, nausea, and vomiting.

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 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Nystapol

Store in a temperature below 25°C.
Keep the medicine out of the sight and reach of children.
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 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 Nystapol contains

• The active substance is nystatin. 1 mL of the prepared suspension contains 100 000 IU of nystatin.
• The other ingredients are: methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), sucrose (E 473), glycerol (E 422), sodium carmellose, sodium dihydrogen phosphate dihydrate, sodium hydroxide (to adjust pH), liquid banana flavor

(contains propylene glycol, isoamyl acetate, orange oil, hexyl acetate, vanillin), liquid vanilla flavor (contains propylene glycol, vanillin).

What Nystapol looks like and what the pack contains

Nystapol is a yellow to beige suspension for oral administration with a characteristic banana-vanilla flavor.
The pack consists of a type III brown glass bottle with an aluminum screw cap with a guarantee ring and a PE plug, containing 24 mL, 30 mL, 48 mL, 60 mL of suspension, and a PS/LDPE pipette (with a 1 mL scale) and an LDPE adapter, in a cardboard box.

Marketing authorization holder and manufacturer

Polfarmex S.A.
ul. Józefów 9
99-300 Kutno
Poland (Poland)
Phone: 24 357 44 44
Fax: 24 357 45 45
e-mail: [email protected]

Date of last revision of the leaflet: