Flumibact IC vaginal tablets 10 mg blister No. 6

Instructions Flumibact IC vaginal tablets 10 mg blister No. 6

Composition

active ingredient: dequalinium chloride;

1 vaginal tablet contains 10 mg of dequalinium chloride;

excipients: lactose monohydrate, microcrystalline cellulose, magnesium stearate.

Dosage form

Vaginal tablets.

Main physicochemical properties: oblong tablets with a biconvex surface, white in color.

Pharmacotherapeutic group

Antimicrobial and antiseptic agents used in gynecology, except combinations with corticosteroids. Quinoline derivatives. Dequalinium. ATX code G01A C05.

Pharmacological properties

Pharmacodynamics

Flumibact IC contains dequalinium chloride, a quaternary ammonium compound with a broad antimicrobial spectrum of activity against various gram-positive and gram-negative bacteria, fungi and protozoa (Trichomonas vaginalis). Dequalinium chloride has been shown to be active in vitro against the following pathogens of relevance to the vaginal area. This activity is expressed as the minimum inhibitory concentration (MIC).

After dissolving a vaginal tablet of Flumibact IC (10 mg dequalinium chloride) in approximately 2.5-5 ml of vaginal fluid, the concentration of dequalinium chloride in the vaginal fluid is 2000-4000 mg/l, which is higher than the MIC90 for all tested pathogens. The development of resistance of microorganisms to dequalinium chloride has not been reported. As with other surfactants, the main mechanism of action of dequalinium chloride is to increase cell permeability and subsequent loss of enzyme activity, which leads to cell death. Dequalinium chloride in the form of vaginal tablets acts locally in the vagina. A noticeable reduction in discharge and inflammation usually occurs after 24-72 hours.

Pharmacokinetics

Since vaginal absorption of dequalinium chloride is negligible, there are no data on its pharmacokinetics in humans.

Indication

vaginal infections of bacterial and fungal origin (e.g. bacterial vaginosis and candidiasis); trichomoniasis; sanitation before gynecological interventions and childbirth.

Contraindication

increased individual sensitivity to the components of the drug; ulcers of the vaginal and cervical epithelium; children's age.

Interaction with other medicinal products and other types of interactions

Interaction with other drugs is unknown. If it is necessary to use any medications simultaneously, you should consult a doctor.

Flumibact IS is incompatible with soap and other anionic surfactants.

Application features

Flumibact IS contains excipients that do not dissolve completely. Tablet residues can sometimes be found on underwear. This does not affect the effectiveness of the drug.

Sometimes, in case of vaginal dryness, the vaginal tablet may not dissolve and come out of the vagina whole. In this case, the treatment is not effective. To prevent this, before inserting the tablet into a dry vagina, you can moisten the tablet with a small amount of water.

Patients should use sanitary pads or daily pads. The drug does not discolor underwear. Patients should be advised to change underwear daily and wash it at a temperature of at least 80 °C.

Ability to influence reaction speed when driving vehicles or other mechanisms

Does not affect.

Use during pregnancy or breastfeeding

Flumibact IC can be used during pregnancy or breastfeeding. However, as with all medicines, caution should be exercised when prescribing Flumibact IC to pregnant women during the first trimester of pregnancy. Data from the use of dequalinium chloride in pregnant women, including data from post-marketing studies, indicate that dequalinium chloride does not have any adverse effects on pregnancy or the health of the fetus/newborn.

There is no data on the penetration of dequalinium chloride into breast milk.

Given the data on the low vaginal absorption of dequalinium chloride and the fact that the treatment lasts only 6 days, adverse effects on the fetus or newborn are unlikely.

Method of administration and doses

The vaginal tablet should be inserted deep into the vagina in the evening before going to bed. It is best to do this while lying on your back with your legs slightly bent.

During menstruation, treatment should be stopped and the drug should be continued after menstruation has stopped.

Treatment should be continued even if there is no longer any discomfort (itching, discharge, odor). Treatment lasting less than 6 days may lead to relapse.

Children

Since data on the safety and efficacy of dequalinium chloride in children (under 18 years of age) are limited, it is not recommended to prescribe the drug to patients in this age category.

Overdose

No cases of drug overdose have been reported.

Adverse reactions

General disorders and administration site reactions

In rare cases, itching, burning or redness may occur. However, these adverse reactions may also be associated with symptoms of a vaginal infection.

In individual cases, local irritation reactions, such as bleeding from vaginal erosions, are possible. In these cases, previous damage to the vaginal epithelial surface due to estrogen deficiency or local inflammation has been noted.

Fever has been reported very rarely.

Hypersensitivity reactions are possible.

If any adverse reactions occur, you should stop using the medicine and consult a doctor.

Expiration date

2 years.

Storage conditions

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

Keep out of reach of children.

Packaging

6 tablets in a blister, 1 blister in a pack.

Vacation category

Without a prescription.

Producer

Additional Liability Company "INTERCHEM".

Location of the manufacturer and its business address

Ukraine, 65025, Odessa, 21st km. Starokyivska Road, 40-A.