Gynoflor^® E (Tablets) Instructions for Use

Marketing Authorization Holder

Gedeon Richter, Plc. (Hungary)

Manufactured By

Haupt Pharma Amareg, GmbH (Germany)

Quality Control Release

MEDINOVA, AG (Switzerland)

Contact Information

GEDEON RICHTER Plc. (Hungary)

ATC Code

G02CX (Other drugs used in gynecology)

Active Substances

Estriol (Ph.Eur. European Pharmacopoeia)

Lactobacillus acidophilus (Group Group name)

Dosage Form

Gynoflor® E

Vaginal tablets: 6 pcs.

Dosage Form, Packaging, and Composition

Vaginal tablets oval, biconvex, from white to light beige with inclusions.

Excipients: lactose monohydrate, microcrystalline cellulose, magnesium stearate, sodium carboxymethyl starch (type A), sodium hydrogen phosphate.

6 pcs. – contour cell packs (1) – cardboard packs.

Clinical-Pharmacological Group

Drug regulating the balance of vaginal microflora with an estrogenic component

Pharmacotherapeutic Group

Other agents used in gynecology

Pharmacological Action

The active substances that make up the drug Gynoflor^® E, Estriol and Lactobacillus acidophilus, participate in the physiological mechanism of maintaining normal vaginal biocenosis.

Lactobacillus acidophilus are one of the dominant microorganisms in the vagina of a healthy woman, possessing antagonistic activity against pathogenic and opportunistic microorganisms.

Estriol is a female sex hormone, a short-acting estrogen, has a protective trophic effect on the vaginal epithelium and does not have a systemic effect on the woman’s body. The proliferating mature vaginal epithelium accumulates glycogen, which is necessary for the functioning of lactobacilli, which, in turn, produce lactic acid, maintaining an acidic vaginal environment (pH 3.8-4.5), which creates unfavorable conditions for the colonization and development of pathogenic microorganisms. In addition to lactic acid, Lactobacillus acidophilus produce hydrogen peroxide and bacteriocins, which also suppress the development of pathogenic and opportunistic microorganisms.

Changes in the physiological flora of the vagina occur due to various factors: local or systemic use of antibacterial drugs, including due to vaginal infections, systemic diseases, non-compliance with hygiene rules. In these cases, the number of lactobacilli can significantly decrease. Intravaginal use of the drug Gynoflor^® E improves the condition of the vaginal epithelium and restores its normal flora. Lactose, which is contained in the vaginal tablets as a filler, can also be fermented by lactobacilli into lactic acid.

The vaginal epithelium thins and can be damaged during hormonal disorders, which is why Gynoflor^® E can be used in postmenopause to alleviate its local symptoms (itching, burning, vaginal dryness, pain during intercourse), helping to normalize the condition of the vaginal and urethral epithelium, reducing the frequency of dystrophic inflammatory conditions.

In vitro it has been shown that Lactobacillus acidophilus lead to the necessary decrease in pH within a few hours. Estriol, with a treatment duration of 6-12 days, provides a proliferative trophic effect on the vaginal epithelium.

Pharmacokinetics

When the drug is inserted into the vagina, lyophilized bacteria and Estriol are released.

The absorption of estriol from the drug Gynoflor^® E has been 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 using vaginal tablets during treatment with Gynoflor^® E (once/day), the C_max of unbound estriol in 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 woman’s body – estrone and estradiol, since Estriol is the end product of their metabolism.

Indications

• Restoration of normal vaginal microflora after local and/or systemic use of antibiotics or other antimicrobial drugs (including for 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).

ICD codes

Dosage Regimen

Vaginal tablets must be inserted deep into the vagina in the evening before going to bed, preferably in a supine position with knees slightly bent.

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

For treatment of estrogen-dependent atrophic vaginitis in postmenopause 1 vaginal tablet daily for 6-12 days, then a maintenance dose – 1 vaginal tablet 1-2 times a week.

Adverse Reactions

Local reactions possible sensation of burning (heat) in the vagina, rarely – redness and itching of the vulva and vagina.

Contraindications

• Hypersensitivity to the drug or its components;
• Malignant estrogen-dependent neoplasms, including of the breast, uterus, ovaries or vagina (diagnosed, in history and if suspected);
• Endometriosis (suspected or diagnosed);
• Vaginal bleeding of unknown etiology;
• Use in girls before the onset of sexual activity;
• Untreated endometrial hyperplasia.

Use in Pregnancy and Lactation

Use in the first trimester of pregnancy is undesirable. It is possible to use the drug Gynoflor^® E in the II and III trimesters of pregnancy and during breastfeeding. No undesirable effects of lactobacilli and estriol on pregnancy and the condition of the fetus/newborn have been detected. However, long-term clinical studies on the effect of estriol on the fetus have not been conducted.

Pediatric Use

Contraindicated for use in girls before the onset of sexual activity.

Geriatric Use

Can be used according to indications.

Special Precautions

Gynoflor^® E contains components that may not dissolve completely; remnants of the vaginal tablet can sometimes be found on underwear. This does not affect the effectiveness of the drug.

In isolated cases, with vaginal dryness, the vaginal tablet may not dissolve. To prevent such cases, the tablet can be moistened with a small amount of plain water before insertion – this will contribute to its faster dissolution. Patients are advised to use panty liners.

Effect on the ability to drive vehicles and mechanisms

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

Overdose

Overdose of the drug has not been observed.

Drug Interactions

Lactobacillus acidophilus are sensitive to numerous antibacterial medicinal products (local or systemic use). Concomitant treatment with such agents may lead to a decrease in the effectiveness of the drug Gynoflor^® E. Therefore, simultaneous use of the drug with antibacterial agents is not recommended.

It is not recommended to use the drug Gynoflor^® E together with spermicidal agents.

Storage Conditions

The drug should be stored out of the reach of children at a temperature from 2°C (35.6°F) to 8°C (46.4°F). Do not freeze.

Shelf Life

Shelf life – 3 years. Do not use after the expiration date printed on the package.

Dispensing Status

The drug is available without a prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.