Pimafucin

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT PIMAFUCINâ (PIMAFUCINâ)

Composition:

Active substance: nystatin;

1 suppository contains: nystatin 100 mg;

Excipients: cetyl alcohol, hard fat, sorbitan trioleate, polysorbate, sodium hydrogencarbonate, adipic acid.

Pharmaceutical form. Vaginal suppositories.

Main physicochemical properties: torpedo-shaped suppositories, white to light yellow in colour.

Pharmacotherapeutic group.

Antimicrobial and antiseptic agents used in gynecology, excluding combination products containing corticosteroids. Antibiotics. Nystatin.

ATC Code G01AA02.

Pharmacological properties.

Pharmacodynamics.

Natamycin is a fungicidal agent. It irreversibly binds to sterols in the cell membrane, disrupting its function and integrity, thereby destroying microorganisms. Natamycin is active against a wide range of yeast fungi, yeast-like organisms, dermatophytes, and molds. The average minimum fungicidal concentration (MFC) ranges from 1–10 mcg/mL for most microorganisms, including strains of Candida albicans, the most common pathogen causing fungal infections. Natamycin is inactive against bacteria. In clinical practice, there have been no reported cases of primary resistance of yeasts, molds, or yeast-like microorganisms to natamycin.

Pharmacokinetics.

Natamycin acts locally and is practically not absorbed through the skin or mucous membranes.

Clinical characteristics.

Indications.

Vaginitis caused by Candida albicans.

Contraindications.

Hypersensitivity to any component of the medicinal product.

Interaction with other medicinal products and other forms of interaction.

Unknown.

Special precautions for use.

During menstruation, therapy should be interrupted. Treatment should be started in advance of the onset of menstruation or immediately after its completion.

The medicinal product contains cetyl alcohol, which may cause local skin reactions (e.g., contact dermatitis).

Some excipients of Pimafucin® suppositories may reduce the effectiveness of latex products, such as condoms and diaphragms (vaginal rings).

Use during pregnancy or breastfeeding.

Current data do not indicate any contraindication for the use of Pimafucin® during pregnancy or breastfeeding.

Ability to influence reaction rate when driving or operating machinery.

No effect.

Method of Administration and Dosage.

For use in adult women, 1 suppository daily for 3–6 days. Suppositories should be inserted as deeply as possible into the vagina (in the lying position) once daily (at night).

Children. Nystatin in the form of vaginal suppositories is not used in children.

Overdose.

Prolonged use of high doses of the drug does not cause local or systemic symptoms of overdose.

In case of accidental oral ingestion of vaginal suppositories, toxic effects are not expected, since absorption in the gastrointestinal tract is negligible.

Side effects.

Hypersensitivity reactions to cetyl alcohol may occur sporadically; a mild burning sensation in the genital area after suppository insertion.

Reporting of suspected adverse reactions

Reporting of adverse reactions following drug registration is of great importance. It enables continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals and patients or their legal representatives are encouraged to report all suspected adverse reactions and lack of efficacy via the automated pharmacovigilance information system (https://aisf.dec.gov.ua).

Shelf life.

2 years.

Do not use the medicinal product after the expiry date stated on the packaging.

Storage conditions.

Store at a temperature not exceeding 25 °C. Keep out of reach and sight of children.

Packaging.

3 suppositories per foil strip, 1 or 2 strips per cardboard box.

Supply classification.

Over-the-counter.

Manufacturer.

Temmler Italia S.r.l.

Manufacturer's address and place of business.

Via delle Industrie, 2, 20061, Carugate (MI), Italy.