Femifucin pessaries 100 mg No. 3

Instructions for Femifucin pessaries 100 mg No. 3

Composition

active ingredient: natamycin;

1 pessary contains natamycin 100 mg;

excipients: solid fat, sorbitan trioleate, polysorbate-80, cetyl alcohol, sodium bicarbonate, adipic acid.

Pharmacotherapeutic group

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

Dosage form

Pessaries.

Main physicochemical properties: pessaries are white to light yellow in color and torpedo-shaped.

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 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).

Special precautions.

Use during pregnancy or breastfeeding

The drug can be used during pregnancy or breastfeeding, since natamycin is not absorbed through the skin or mucous membranes.

Ability to influence reaction speed when driving vehicles or other mechanisms

Does not affect.

Method of administration and doses

Apply to adult women 1 pessary for 3-6 days. It is recommended to insert the pessary as deeply as possible into the vagina (in the supine position) once a day (at night). If treatment is necessary for several days, the course of therapy should be completed before the onset of menstruation or treatment should be started after it has ended.

Children

Natamycin in the dosage form of a pessary should not be used in children.

Overdose

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

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

Side effects

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

Do not use the drug after the expiration date indicated on the package.

Storage conditions

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

Keep out of reach of children.

Packaging

3 pessaries in a strip of polyvinyl chloride film. 1 or 2 strips in a cardboard pack.

Vacation category

Without a prescription.

Producer

PJSC "Monpharm", Ukraine.

Location of the manufacturer and address of its place of business

Ukraine, 19100, Cherkasy region, Monastyryshche, Zavodska st., 8.