Expiration date: 01/2025
INSTRUCTIONS
for medical use of the drug Gynoflor E (GYNOFLOR® E)
Registration number: LSR-008 765/09
The trading (patented) name of preparation: E Gynoflor
International (non-proprietary) name of the drug:
Dosage form: vaginal tablets
Composition 1 vaginal tablet:
Active substance: Lactobacillus acidophilus (lyophilisate) 50.00 mg (not less than 100 million viable bacteria), estriol, 0.03 mg,
Excipients: lactose monohydrate, microcrystalline cellulose, magnesium stearate, sodium carboxymethyl starch, sodium dihydrogen
Description
The tablets are oval, biconvex, white to light beige color with a splash.
Pharmacotherapeutic group
Estrogen + eubiotics
KodATH: G02CX
pharmacological properties
pharmacodynamics
Both active substances included in the preparation Gynoflor Uh, estriol and lactobacillus Lactobacillus acidophilus, are involved in maintaining normal physiological mechanism biotsinoza vagina.
Lactobacillus acidophilus - one of the dominant vaginal healthy woman microorganisms having antagonistic activity against pathogenic and conditionally pathogenic microorganisms.
Estriol - estrogen is a short-acting, has a protective effect on trophic vaginal epithelium and has no systemic effects on a woman's body. Proliferating mature vaginal epithelium glycogen accumulates in itself necessary for the operation of lactobacilli, which, in turn, produce lactic acid, keeping the acidic environment of the vagina (pH 3.8-4.5), which creates unfavorable conditions for the development and colonization of pathogenic microorganisms. Furthermore lactic acid, Lactobacillus acidophilus produce hydrogen peroxide and bacteriocins, and inhibits the development of pathogenic and conditionally pathogenic microorganisms.
Changes in physiological vaginal flora is due to various factors, local or systemic use of antimicrobials, including due to vaginal infections, systemic diseases, poor hygiene. In these cases, the number of lactobacilli can be significantly reduced. Vaginal application Gynoflor E improves the condition of the vaginal epithelium and restores its normal flora. Lactose, which is contained in a vaginal tablet filler can also be fermented by lactobacilli to lactic acid.
The vaginal epithelium is thinner and can be damaged and hormonal disorders, and therefore Gynoflor E can be used in postmenopausal women, weakening its local symptoms (itching, burning, vaginal dryness, pain during intercourse), contributing to the normalization of the vaginal epithelium and urethra, reducing frequency degenerative inflammatory conditions.
In vitro demonstrated that Lactobacillus acidophilus for several hours leads to the desired pH reduction and estriol, for a duration of treatment of 6-12 days, the proliferative provides trophic effect on the vaginal epithelium.
Pharmacokinetics
With the introduction of the drug into the vagina, lyophilized bacteria are released and estriol.
The absorption of estriol from Gynoflor e studied in postmenopausal women. After repeated use of the drug concentration in plasma corresponds to the concentration of endogenous unbound estriol. After the 12th day of application of vaginal tablets during treatment Gynoflor E (1 per day), the maximum concentration of unbound plasma estriol does not differ from the original, indicating a lack of systemic absorption.
The product has no effect on the concentration of estrone and estradiol in the blood plasma estriol as the end product of their metabolism.
Testimony
• Restoration of Lactobacillus acidophilus flora after local and / or systemic antibiotic treatment or other chemotherapeutic agents
• estrogen atrophic vaginitis in postmenopausal women, including in conjunction with hormone replacement therapy (HRT)
• Bacterial Vaginosis
Contraindications:
• Hypersensitivity to the drug or its components,
• Malignant neoplasm of estrogen-dependent, including breast, uterus and vagina (diagnosed in history, and is suspected to them)
• Endometriosis (suspected or diagnosed)
• Bleeding from the vagina of unknown etiology,
• Application of the girls before sexual debut,
• Untreated endometrial hyperplasia.
Pregnancy and breast-feeding
Application in I trimester of pregnancy is not desirable. Perhaps the use of the drug Gynoflor E in II-III trimesters of pregnancy and lactation. Adverse effect of lactobacilli and estriol on pregnancy and the fetus / newborn were found. However, long-term clinical studies on the effects of estriol on the fetus have not been conducted.
Dosing and Administration
Vaginal tablets need to enter deep into the vagina at night before bedtime, better lying on his back slightly bent knees.
To restore the flora of Lactobacillus acidophilus after local and / or systemic antibiotic treatment or other chemotherapeutic agents, as well as in the treatment of bacterial vaginosis: 1-2 vaginal tablets daily for 6-12 days.
In the treatment of estrogen-dependent atrophic vaginitis in postmenopausal women: 1 vaginal tablet for 6-12 days daily, then maintenance dose is 1 vaginal tablet 1-2 times a week.
Side effect
Perhaps a burning sensation (heat) into the vagina rarely redness and itching of the vulva and vagina.
Overdose:
An overdose of the drug was observed.
Interaction with other drugs
Lactobacillus acidophilus susceptible to numerous antibacterial drugs (local or systemic application). Concomitant treatment with these agents may reduce the effectiveness of Gynoflor E.
Special instructions:
Gynoflor E contains components that can not be dissolved completely, the remains of the vaginal tablets can sometimes be found on the underwear. The effectiveness of the drug is not affected.
In rare cases, if vaginal dryness, vaginal tablets can not dissolve. To prevent such cases, prior to introducing the tablet may be a small amount of conventional hydrated water - this will contribute to its more rapid dissolution. Patients were encouraged to use liners.
Effects on ability to drive and use other mechanisms
Gynoflor E does not affect the ability to drive and use machines.
Release Form
Vaginal tablets. On 6 tablets in blisters of aluminum foil and PVC film.
1 or 2 contour cell packages with instruction on the medical application are placed in a pile of cardboard.
Shelf life
3 years. Do not use beyond the expiration date.
Storage conditions
Store at 2 to 8 ° C. Do not freeze!
Keep out of the reach of children.
