Ginoflor ® E (Gynoflor® E)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Dosage form: & nbspvaginal tablets
Composition:

For 1 tablet vaginal:

active substances: lactobacillus acidophilus (lyophilizate) 50.00 mg (not less than 100 million viable bacteria), estriol 0.03 mg;

Excipients: lactose monohydrate 625.6 mg, microcrystalline cellulose 183.7 mg, magnesium stearate 6.67 mg, sodium carboxymethyl starch 30 mg, sodium dihydrogen phosphate 4 mg.

Description:

Tablets are oval, biconcave, from white to light beige with interspersed.

Pharmacotherapeutic group:Estrogen + eubiotic
ATX: & nbsp
  • Other drugs for use in gynecology
    • Pharmacodynamics:

    The active substances included in the preparation Ginoflor ® E, estriol and lactobacilli acidophilic, participate in the physiological mechanism of maintaining normal vaginal biocinosis.

    Lactobacillus acidophilic - one of the dominant microorganisms of the vagina of a healthy woman, possessing antagonistic activity against pathogenic and conditionally pathogenic microorganisms.

    Estriol is a female sex hormone, a short-acting estrogen. It has a protective trophic effect on the epithelium of the vagina and has no systemic effect on the woman's body.The proliferating mature epithelium of the vagina accumulates glycogen necessary for the functioning of lactobacilli, which in turn produces lactic acid, supporting the acidic environment of the vagina (pH 3,8-4,5), which creates unfavorable conditions for the colonization and development of pathogenic microorganisms. In addition to lactic acid, lactobacilli acidophilic produce hydrogen peroxide and bacteriocins, which also inhibit the development of pathogenic and conditionally pathogenic microorganisms.

    The change in the physiological flora of the vagina occurs due to various factors: local or systemic use of antibacterial drugs, incl. due to vaginal infections, systemic diseases, non-compliance with hygiene rules. In these cases, the amount of lactobacilli can be significantly reduced. Intravaginal application of the drug Ginoflor ® E improves the condition of the epithelium of the vagina and restores its normal flora. Lactose, which is contained in vaginal tablets as a filler, can also be fermented with lactobacilli into lactic acid.

    The epithelium of the vagina is thinned and can be damaged and with hormonal disorders,Therefore, Ginoflor ® E can be used in postmenopause to relieve its local symptoms (itching, burning, dryness in the vagina, soreness in intercourse), contributing to the normalization of the epithelium of the vagina and urethra, reducing the frequency of dystrophic inflammatory conditions.

    In vitro shown, that lactobacilli acidophilic for several hours lead to the necessary decrease in pH. Estriol with a treatment duration of 6-12 days provides a proliferative trophic effect on the epithelium of the vagina.

    Pharmacokinetics:

    When the drug is injected into the vagina, freeze-dried bacteria are released and estriol.

    The absorption of estriol from the Ginoflor ® E preparation was studied in postmenopausal women. After repeated use of the drug, the concentration of estriol in plasma corresponds to the concentration of endogenous unbound estriol. After the 12th day of application of vaginal tablets during the treatment with Ginoflor ® E (1 time per day), the maximum concentration of unbound estriol in the blood plasma does not differ from the initial one, which indicates the absence of systemic absorption.

    The use of the drug does not affect the concentration in the blood plasma of sex hormones present in the body of a woman - estrone and estradiol, because estriol is the final product of their metabolism.

    Indications:

    - Restoration of normal vaginal microflora after local and / or systemic use of antibiotics or antimicrobials (including vaginal infections: bacterial vaginosis, nonspecific vulvovaginitis, urogenital infections and sexually transmitted diseases).

    - Estrogen dependent atrophic vaginitis in postmenopause, including in combination with hormone replacement therapy (HRT).

    Contraindications:

    - Hypersensitivity to the drug or its components;

    - Malignant estrogen-dependent neoplasms, incl. mammary glands, uterus, ovaries or vagina (diagnosed, in history, and with suspicion of them);

    - endometriosis (suspected or diagnosed);

    - bleeding from the vagina of an unclear etiology;

    - use in girls before the onset of sexual activity;

    - untreated endometrial hyperplasia.

    Pregnancy and lactation:

    Application in the I trimester of pregnancy is undesirable.Possible use of the drug Ginoflor ® E in II-III trimester of pregnancy and during breastfeeding.

    The undesirable effects of lactobacilli and estriol on pregnancy and the condition of the fetus / newborn are not detected. However, long-term clinical studies on the effect of estriol on the fetus were not conducted.

    Dosing and Administration:

    Vaginal tablets should be injected deep into the vagina in the evening before bed, preferably in a supine position on the back, slightly bending the legs in the knees.

    To restore normal vaginal microflora after local and / or systemic use of antibiotics or other antimicrobial agents (including vaginal infections: bacterial vaginosis, nonspecific vulvovaginitis, urogenital infections and sexually transmitted diseases): 1-2 vaginal tablets daily for 6-12 days.

    In the treatment of estrogen-dependent atrophic vaginitis in postmenopausal women: 1 vaginal tablet daily for 6-12 days, then the maintenance dose is 1 vaginal tablet 1-2 times a week.

    Side effects:

    Perhaps a burning sensation (heat) in the vagina; rarely - reddening and itching of the vulva and vagina.

    Overdose:

    An overdose of the drug was not observed.

    Interaction:

    Lactobacillus acidophilic sensitive to numerous antibacterial drugs (local or systemic use). Concomitant treatment with such drugs can lead to a decrease in the effectiveness of the drug Ginoflor ® E. Therefore, its simultaneous use with antibacterial drugs is not recommended.

    It is not recommended to use Ginoflor ® E together with spermicide.

    Special instructions:

    Ginoflor ® E contains ingredients that can completely dissolve, the remains of the vaginal tablet can sometimes be found on underwear. The effectiveness of the drug is not affected.

    In isolated cases, with vaginal dryness, the vaginal tablet may not dissolve. To prevent such cases before the introduction of the tablet can be moistened with a small amount of ordinary water - this will facilitate its faster dissolution. Patients are advised to use gaskets.

    Effect on the ability to drive transp. cf. and fur:

    Ginoflor ® E does not affect the ability to drive vehicles and mechanisms.

    Form release / dosage:Tablets are vaginal.
    Packaging:

    For 6 tablets in a contour mesh box made of aluminum foil and PVC film.

    1 or 2 contour cell packs, along with the instructions for medicine, are placed in a pack of cardboard.

    Storage conditions:

    Store at a temperature of 2 to 8 ° C. Do not freeze.

    Keep out of the reach of children.

    Shelf life:

    3 years.

    Do not use after expiry date.

    Terms of leave from pharmacies:Without recipe
    Registration number:LSR-008765/09
    Date of registration:02.11.2009 / 28.03.2017
    Expiration Date:Unlimited
    The owner of the registration certificate:GEDEON RICHTER, OJSC GEDEON RICHTER, OJSC Hungary
    Manufacturer: & nbsp
    MEDINOVA, AG Switzerland
    Representation: & nbspGEDEON RICHTER OJSC GEDEON RICHTER OJSC Hungary
    Information update date: & nbsp17.04.2017
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