Pimafucin vaginal suppositories 100 mg strip No. 6

Instructions for use Pimafucin vaginal suppositories 100 mg strip No. 6

Composition

active ingredient: natamycin;

1 suppository contains: natamycin 100 mg;

excipients: cetyl alcohol, solid fat, sorbitan trioleate, polysorbate, sodium bicarbonate, adipic acid.

Dosage form

Vaginal suppositories.

Main physicochemical properties: torpedo-shaped suppositories from white to light yellow in color.

Pharmacotherapeutic group

Antimicrobial and antiseptic agents used in gynecology, except combined preparations containing corticosteroids. Antibiotics. Natamycin. ATX code G01A A02.

Pharmacological properties

Pharmacodynamics

Natamycin is a fungicidal agent. It irreversibly binds to cell membrane steroids, contributing to the disruption of the function and integrity of the latter, thereby destroying microorganisms. A large number of yeasts, yeast-like organisms, dermatophytes and fungi are sensitive to natamycin. The average minimum fungicidal concentration (MIC) is 1–10 μg/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 cases of primary resistance of yeasts, fungi and yeast-like microorganisms.

Pharmacokinetics

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

Indication

Vaginitis caused by Candida albicans.

Contraindication

Hypersensitivity to any components of the drug.

Interaction with other medicinal products and other types of interactions

Unknown.

Application features

Therapy should be interrupted during menstruation. Treatment should be started well 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).

Ability to influence reaction speed when driving vehicles or other mechanisms

Does not affect.

Use during pregnancy or breastfeeding

The medicine can be used during pregnancy or breastfeeding.

Method of administration and doses

Adult women should use 1 suppository for 3–6 days. It is recommended to insert the suppositories as deeply as possible into the vagina (in a lying position) once a day (at night).

Children

Natamycin in the dosage form of vaginal suppositories should not be used in children.

Overdose

When using vaginal suppositories, systemic effects are practically excluded, because the drug is not absorbed through the mucous membrane.

In case of accidental ingestion of vaginal suppositories, no toxicity is expected, as absorption from the digestive tract is negligible.

Adverse reactions

Rare (≥0.01% to <0.1%).

Skin and subcutaneous tissue disorders: hypersensitivity reaction, burning sensation and irritation.

Hypersensitivity to cetyl alcohol may occur.

Reporting of suspected adverse reactions

It is important to report suspected adverse reactions after a medicinal product has been authorised. This allows for continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system.

Expiration date

2 years.

Do not use the medicine after the expiry date stated on the packaging.

Storage conditions

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

Packaging

3 suppositories in a foil strip, 2 strips in a cardboard pack.

Vacation category

Without a prescription.

Producer

Temmler Italia S.r.l.

Location of the manufacturer and its business address

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