GINOFLOR E

General characteristics. Structure:

Active agents: Lactobacilli acidophilic (lyophilisate) of 50,00 mg (not less than 100 million viable bacteria), estriol of 0,03 mg;
Excipients: lactoses monohydrate, cellulose microcrystallic, magnesium stearate, sodium carboxymethylstarch, sodium dihydrophosphate

Description: Tablets are oval, biconvex from white till light-beige color with impregnations.

Pharmacological properties:

Pharmacodynamics
Both active substances which are a part of drug Ginoflor E, estriol and lactobacilli of Lactobacillus acidophilus participate in the physiological mechanism of maintenance of a normal biocenosis of a vagina.
Lactobacillus acidophilus - one of the dominating microorganisms of a vagina of the healthy woman having antagonistic activity concerning pathogenic and conditionally pathogenic microorganisms.
Estriol - is estrogen of short action, has protective trophic action on a vulval epithelium and has no system impact on the woman's organism. The proliferating mature epithelium of a vagina accumulates in itself the glycogen necessary for functioning of lactobacilli which, in turn, produce lactic acid, supporting acid medium of a vagina (рН 3,8-4,5) that creates unfavorable conditions for colonization and development of pathogenic microorganisms. Except lactic acid, Lactobacillus acidophilus produce the peroxide of hydrogen and bacteriocines which are also oppressing development of pathogenic and conditionally pathogenic microorganisms.
Change of physiological vaginal flora happens owing to various factors: topical or system administration of antibacterial drugs, including owing to vaginal infections, general diseases, non-compliance with rules of hygiene. In these cases the quantity of lactobacilli can decrease considerably. Intravaginalny use of Ginoflor E improves a condition of an epithelium of a vagina and recovers its normal flora. Lactose which contains in vaginal tablets as a filler, can be also fermented by lactobacilli in lactic acid.
The vaginal epithelium becomes thinner and can be damaged also at hormonal disturbances in this connection Ginoflor E can be used in a postmenopause, weakening its local symptoms (an itch, burning, dryness in a vagina, morbidity at sexual intercourse), contributing to normalization of a condition of an epithelium of a vagina and urethra, reducing the frequency of dystrophic inflammatory states.
In vitro is shown that Lactobacillus acidophilus within several hours lead to necessary decrease рН, and estriol, lasting treatment of 6-12 days, provides proliferative trophic effect on a vagina epithelium.

Pharmacokinetics
At administration of drug in a vagina, the lyophilized bacteria and estriol are released.
Absorption of estriol from Ginoflor E is investigated at women in a postmenopause. After repeated use of drug its concentration in plasma corresponds to concentration of endogenous untied estriol. After the 12th day of use of vaginal tablets in the course of treatment by Ginoflor E (once a day), the maximum concentration of untied estriol in a blood plasma does not differ from initial that testifies to lack of system absorption.
Use of drug does not influence concentration of estrone and oestradiol in a blood plasma as estriol is an end product of their metabolism.

Indications to use:

- Recovery of flora of Lactobacillus acidophilus after topical and/or system treatment by antibiotics or other chemotherapeutic means
- Estrogenzavisimy atrophic vaginita in a postmenopause, including in combination with the replacement hormonal therapy (RHT)
- Bacterial vaginosis

Route of administration and doses:

Vaginal tablets need to be entered deeply into a vagina in the evening before going to bed, it is better in a dorsal decubitus, having slightly bent legs in knees.
For recovery of flora of Lactobacillus acidophilus after topical and/or system treatment by antibiotics or other chemotherapeutic means, and also at treatment of a bacterial vaginosis: on 1-2 vaginal tablets daily for 6-12 days.
At treatment of estrogenzavisimy atrophic vaginit in a postmenopause: on 1 vaginal tablet daily for 6-12 days, further the maintenance dose makes 1 vaginal tablet 1-2 times a week.

Features of use:

Ginoflor E contains components which can not be dissolved completely, the remains of a vaginal tablet sometimes it is possible to find on underwear. It does not influence efficiency of drug.
In isolated cases, at dryness of a vagina, the vaginal tablet can not be dissolved. For the prevention of such cases before introduction the tablet can be moistened with a small amount of usual water - it will promote its more bystry dissolution. Patients are recommended to use laying.

Side effects:

The burning sensation (heat) in a vagina is possible, reddening and an itch of a vulva and vagina is rare.

Interaction with other medicines:

Ginoflor E does not influence ability to manage vehicles and mechanisms.

Contraindications:

- Hypersensitivity to drug or its components;
- Malignant estrogenzavisimy new growths, including mammary glands, a uterus and vaginas (diagnosed, in the anamnesis, and at suspicion on them);
- The endometriosis (suspected or diagnosed);
- Bleedings from a vagina of not clear etiology;
- Use for girls prior to the beginning of sex life;
- Not treated hyperplasia of an endometria.

Pregnancy and feeding by a breast
Use in the I trimester of pregnancy is undesirable. Drug use Ginoflor E in the II-III trimesters of pregnancy and in the period of a lactation is possible. Undesirable influence of lactobacilli and estriol on pregnancy and a condition of the fruit/newborn is not revealed. However long-term clinical trials on influence of estriol on a fruit were not conducted.

Overdose:

The overdose by drug was not observed. Interaction with other medicines
Lactobacillus acidophilus are sensitive to numerous antibacterial medicines (topical or system administration). The accompanying treatment by such means can lead to reduction of efficiency of Ginoflor E.

Storage conditions:

Period of validity 3 years. Not to use after a period of validity. To store at a temperature from 2 to 8 °C. Not to freeze! To store in the place, unavailable to children.

Issue conditions:

According to the recipe

Packaging:

Tablets are vaginal. On 6 tablets in a blister strip packaging from aluminum foil and a film of PVC.
1 or 2 blister strip packagings together with the instruction on a medical use place in a pack from a cardboard.