NYSTATIN-ZDOROVYA

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT NYSTATIN-ZDOROVYE

Composition:

Active substance: nystatin;

1 ml of the preparation contains 100,000 IU of nystatin;

Excipients: sucrose; glycerol; ethanol 96%; methylparaben (E 218); propylparaben (E 216); sodium carmellose; sodium hydrogen phosphate; sodium saccharin; neotame; hydrochloric acid concentrated; purified water; "Raspberry" flavouring containing propylene glycol (E 1520), ethanol 96%, alpha-tocopherol (E 307), ascorbic acid (E 300), purified water.

Pharmaceutical form. Oral suspension.

Main physicochemical properties: yellow to yellowish-brown suspension with raspberry odour.

Pharmacotherapeutic group. Antifungal agents for topical use.

ATC code D01A A01.

Pharmacological Properties.

Pharmacodynamics. Nystatin is an antifungal antibiotic active against a broad spectrum of yeast and yeast-like fungi, including Candida albicans.

Pharmacokinetics. Absorption of nystatin from the gastrointestinal tract is negligible. The majority of nystatin is excreted in feces unchanged following oral administration.

Clinical characteristics.

Indications. Prevention and treatment of oral, esophageal, and intestinal candidiasis in adults and children.

The suspension provides effective prophylaxis of oral candidiasis in newborns born to mothers with vaginal candidiasis.

Contraindications. Hypersensitivity to the active substance or to any of the excipients of the medicinal product.

Interaction with other medicinal products and other forms of interaction. Data on drug interactions of the medicinal product are lacking.

Special precautions for use.

The drug should not be used for the treatment of systemic mycoses, as its action is primarily local. If local irritation or allergic reaction develops, treatment should be discontinued.

If a patient has known intolerance to certain sugars, a physician should be consulted before taking this medication.

The drug may be harmful to teeth.

This medicinal product contains a small amount of ethanol (alcohol), less than 100 mg per dose, and methylparaben (E 218), propylparaben (E 216), which may cause allergic reactions (possibly delayed).

Use during pregnancy or breastfeeding.

Pregnancy. Adequate studies with nystatin in animals have not been conducted. It is not known whether nystatin can cause fetal harm when administered during pregnancy or can affect reproductive capacity. Nystatin may be prescribed during pregnancy only if the expected benefit to the mother outweighs the potential risk to the fetus.

Breastfeeding period. It is not known whether nystatin is excreted in human milk. Despite minimal gastrointestinal absorption, caution should be exercised when administering nystatin during breastfeeding.

Ability to influence reaction rate while driving or operating machinery. Unknown.

Method of Administration and Dosage

Shake well before use.

Adults: for the treatment of denture-related ulcers and oral infections caused by Candida albicans, administer 1 mL of the suspension into the oral cavity four times daily. Prolonged contact between the medication and affected areas should be ensured.

Children: for intestinal and oral candidiasis (thrush) in children from birth, administer 1 mL of the suspension into the oral cavity four times daily. The longer the suspension remains in contact with the affected oral areas before swallowing, the greater the therapeutic effect will be.

For prophylaxis of candidiasis in newborns, the recommended dose is 1 mL once daily.

Elderly patients: no specific dosage recommendations or precautions are required.

For prophylaxis and treatment of candidiasis, nystatin administration should be continued for at least 48 hours after symptoms have resolved. If signs and symptoms worsen or persist after 14 days of treatment, the patient should be re-evaluated and alternative therapy considered.

Children: the medicinal product can be used in children from birth.

Overdose. Since absorption of nystatin from the gastrointestinal tract is negligible, overdose or accidental ingestion does not result in systemic toxicity. Oral doses of nystatin exceeding 5,000,000 IU per day have been associated with nausea and gastrointestinal disturbances.

Adverse Reactions.

Nystatin is generally well tolerated in all age groups, even with prolonged use. If irritation or sensitization occurs, treatment should be discontinued. Isolated cases of nausea during therapy have been reported.

Large oral doses of nystatin have occasionally caused diarrhea, gastrointestinal disturbances, nausea, and vomiting. Skin rashes, including urticaria, have been reported rarely. Stevens-Johnson syndrome has been reported very rarely. There have been reports of hypersensitivity and angiodermas, including facial swelling.

Reporting of Adverse Reactions.

Reporting suspected adverse reactions after marketing authorization of the medicinal product is of great importance. It allows continued monitoring of the benefit/risk ratio of the medicinal product. Medical and pharmaceutical professionals, as well as patients or their legal representatives, should report all suspected adverse reactions and lack of efficacy via the Automated Pharmacovigilance Information System at the following link: https://aisf.dec.gov.ua.

Shelf Life. 2 years.

Storage Conditions. Store in the original packaging at a temperature not exceeding 25 °C.

Keep out of reach of children.

Packaging. 50 mL in a bottle closed with a cap; 1 bottle with a dosing syringe, packaged in a cardboard box.

Prescription Category. Prescription only.

Manufacturer. LIMITED LIABILITY COMPANY "CORPORATION "ZDOROVIYA".

Manufacturer's Address and Location of Business Activity.

22, Shevchenka Street, Kharkiv, Kharkiv Oblast, 61013, Ukraine.