International non-proprietary name: Metronidazole+Neomycin Sulfate+Nystatin+Hydrocortisone

 

Composition

Active ingredient: 1 vaginal suppository contains 500 mg of metronidazole, 100 mg of neomycin

sulfate, 100,000 IU nystatin, 5 mg hydrocortisone acetate.

Excipients: solid oil.

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Description

They are yellow, smooth homogeneous candles.

 

Pharmacotherapeutic group

Anti-infective and antiseptic agents, in combination with corticosteroids.

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ATC code: G01B.

 

pharmacological properties

Pharmacodynamics

The composition of Femines vaginal suppositories consists of four active components designed to act simultaneously in the treatment of vaginal or vulvovaginal inflammatory diseases associated with protozoal or microbial infections. Metronidazole, the first ingredient of Femines, is an effective tool for the prevention and treatment of vaginal protozoal infections such as Trichomonas vaginalis. It also kills Bacteroids spp., Gardnerella vaginalis, Mobiluncus spp. and Peptostreptococcus spp. has a bactericidal effect against many anaerobic microorganisms. Neomycin, the second ingredient of Femines, is an aminoglycoside antibiotic known for its highly effective and proven bactericidal effect against a wide variety of gram-negative and gram-positive bacteria. Nystatin, the third ingredient in Femines, is an antifungal antibiotic known to have a fungistatic effect against most yeasts and yeast-like fungi, including Candida species. Hydrocortisone, the fourth ingredient of Femines, is a corticosteroid with minimal side effects and a fast-acting anti-allergic, anti-pruritic and anti-inflammatory effect.

In the form of vaginal suppositories, Femines has the advantage of rapid symptomatic relief of the itching and burning sensation observed during infections. Therefore, Femines provides a wide range of therapeutic effects as well as patient satisfaction. In addition, Femines in the form of vaginal suppositories is extremely safe due to the fact that the ingredients act locally in the vagina with poor systemic absorption.

Pharmacokinetics

Femines vaginal suppositories act locally with minimal systemic absorption.

 

Instructions for use

Femines in the form of vaginal suppositories is highly effective in the treatment of vaginitis caused by various causes listed below:

• Leukorrhea accompanied by itching and burning in the vagina and vulva, especially when candidiasis or bacterial infection is suspected.

• Bacterial vaginitis, including cases caused by anaerobic bacteria (anaerobic vaginosis).

• Trichomonad vaginitis.

• Vaginal or vulvovaginal candidiasis.

• Mixed vaginal infections caused by Trichomonas vaginalis, fungi and/or bacteria.

 

Contraindications

Cases of hypersensitivity to any components of the preparation.

 

Special instructions and precautions

In case of severe local irritation or hypersensitivity reactions, stop the treatment and consult your doctor.

 

Interaction with other drugs

Due to the weak systemic absorption of the components after intrauterine administration, the possibility of interactions with other drugs is minimal.

 

Use during pregnancy and lactation

Femines vaginal suppositories are not recommended for use during pregnancy and lactation.

 

Effects on the ability to drive a vehicle and other potentially dangerous mechanisms

During the treatment period, it is necessary to avoid driving a vehicle and engaging in other potentially dangerous activities that require high attention and quick psychomotor reactions.

 

Method of use and dosage

Femines vaginal suppositories should be inserted deep into the vagina once a day (in bed) or twice a day for 5-10 consecutive days or as prescribed by the doctor. Even if menstruation occurs during treatment, it should be continued for the recommended period. 

 

Side effects

Femines vaginal suppositories are safe and well tolerated. In rare cases, transient local itching and vaginal irritation may occur at the beginning of treatment.

 

Overdose

There is no information on exceeding the dose limit during intravaginal use of the drug. Systemic side effects are observed when taking intravaginal metronidazole together with oral metronidazole.

When vaginal suppositories are suddenly ingested in large quantities, gastric lavage can be performed. If any symptoms of overdose appear, symptomatic and maintenance therapy is recommended. 

 

Release form

5 vaginal suppositories in a PVC-PE strip. 2 strips are packed in a cardboard box with an insert.

 

Store condition

It should be stored at a temperature not higher than 25ºС, protected from light and out of the reach of children.

 

Shelf life

3 years.

Do not use after the expiration date.

 

Condition of release from pharmacy

It is released on the basis of a prescription.

 

Manufacturer/Registration Card Holder

Faraonia Pharmaceuticals (Faro Farma).

3rd Industrial zone, Block 16, Part I, New Borg El Arab city, Alexandria, Egypt.