Instructions for Gynoflor vaginal tablets No. 6
Composition
active ingredients: viable bacteria Lactobacillus acidophilus, estriol;
1 vaginal tablet contains 100 million viable Lactobacillus acidophilus bacteria, 0.03 mg of estriol;
Excipients: lactose monohydrate; microcrystalline cellulose; sodium starch glycolate (type A); magnesium stearate; sodium hydrogen phosphate anhydrous.
Dosage form
Vaginal tablets.
Main physicochemical properties: tablets are slightly beige in color with inclusions, biconvex, oval in shape.
Pharmacotherapeutic group
Antimicrobial and antiseptic agents used in gynecology. ATX code G01A X14.
Pharmacological properties
Pharmacodynamics
Lactobacilli acidophili are one of the dominant microorganisms in the vaginal flora of a healthy woman. Lactobacilli perform a protective function in the vagina. They ferment glycogen of the vaginal epithelium to lactic acid. The resulting acidic environment (pH 3.8–4.5) creates unfavorable conditions for the colonization and development of pathogenic microorganisms and provides an optimal environment for the proliferation of Lactobacilli. In addition to lactic acid, Lactobacilli produce hydrogen peroxide and bacteriocins, which also inhibit the development of pathogenic microorganisms.
Estriol is an endogenous estrogenic hormone that specifically affects the vagina and has no effect on the endometrium. Estriol promotes the proliferation of the vaginal epithelium. The proliferating and mature epithelium is a physiological barrier and contains glycogen, a nutrient substrate for Lactobacilli. In hormonal disorders, which are more common in older women, the vaginal epithelium is damaged and the amount of glycogen decreases.
Exogenous estriol, even in low doses, restores proliferating and mature epithelium and thus provides a glycogen reserve for feeding Lactobacilli.
Disruption or destruction of the physiological vaginal flora mainly occurs as a result of local or systemic treatment with anti-infective agents, serious systemic diseases, improper hygiene measures and vaginal infections. In a non-physiological vaginal environment, the number of Lactobacilli may decrease or even disappear, their protective function is no longer ensured.
The therapeutic effect of Gynoflor is the restoration of the vaginal flora due to the introduction of exogenous Lactobacilli and the improvement of the condition of the vaginal epithelium due to the introduction of exogenous estriol. The result is the restoration of physiological balance in the vagina and the restoration of the vaginal epithelium.
Lactobacilli and estriol act locally, exclusively in the vagina.
Lactose, which is contained in vaginal tablets as a filler, can also be fermented by Lactobacilli into lactic acid. The proliferation of Lactobacilli and recolonization of the vagina by these bacteria begins after the first use of the drug.
Pharmacokinetics
As soon as the vaginal tablets come into contact with the vaginal secretion, they begin to break down and release Lactobacilli and estriol. In vitro experiments have shown that Lactobacilli resume their metabolism and reduce the pH value within a few hours. The positive estrogenic effects caused by estriol begin quickly, and during the course of treatment (6–12 days) the condition of the proliferative and mature vaginal epithelium gradually improves.
After the 12th application of vaginal tablets (at the end of Gynoflor treatment once a day), the peak level of unbound estriol in plasma compared to the baseline level was not increased.
No accumulation of estriol was observed during the twelve-day treatment. Plasma concentrations observed after repeated administration of the drug were within the normal range of endogenous unbound estriol levels in plasma.
Estriol therapy does not affect plasma concentrations of estrone and estradiol, as estriol is the end product of their metabolism.
Due to the low dose of estriol (0.03 mg), topical application, and limited duration of treatment (6–12 days), estriol accumulation does not occur and systemic estrogen effects are unlikely.
Indication
Restoration of Lactobacillus acidophilus flora after local and/or systemic treatment with anti-infective agents; atrophic vaginitis caused by estrogen deficiency during menopause and the postmenopausal period, or as a concomitant agent in systemic hormone replacement therapy; mild to moderate cases of bacterial vaginosis and candidiasis, vaginal discharge of unknown origin (Fluor vaginalis), in which the use of anti-infective therapy is not absolutely necessary; prophylactic treatment of recurrent vaginal infections.
Contraindication
Hypersensitivity to the active substances or to any of the excipients; malignant neoplasms of the breast, uterus or vagina (diagnosed, suspected or history); estrogen-dependent malignant tumor (diagnosed or suspected, especially endometrial carcinoma); endometriosis (diagnosed or suspected); vaginal bleeding of unknown origin; untreated endometrial hyperplasia; acute vaginitis with severe inflammation and purulent infiltrates; thromboembolic venous disease (diagnosed or history, especially deep vein thrombosis, pulmonary embolism); diagnosed thrombophilia (with protein C or S or antithrombin deficiency); embolic arterial disease (diagnosed or recent, especially angina and myocardial infarction); acute liver disease or history of liver disease, if the level of relevant liver enzymes has not returned to normal; porphyria; Do not use in young girls who have not reached puberty.
Interaction with other medicinal products and other types of interactions
Lactobacillus acidophilus is sensitive to numerous anti-infective agents (topical or systemic). Concomitant treatment with such agents may result in reduced efficacy of the drug.
Due to the fact that the medicinal product contains a very small dose of estriol and is applied topically, clinically significant interactions are unlikely.
There are no data from studies on the possible interaction of the drug with latex products (e.g. condoms, diaphragms, etc.). As a precautionary measure, other methods of contraception should be used during treatment and during the first days after completion of treatment.
Application features
The medicine contains components that may not completely dissolve; tablet residues can sometimes be found on underwear. This does not affect the effectiveness of the medicine.
If the vagina is very dry, the tablet can be moistened with a small amount of plain water, which will help it dissolve.
Patients should use a sanitary napkin or pad.
Gynoflor contains only a small amount of estriol, and only a small part of it is absorbed. In the presence of severe liver, kidney or heart dysfunction, epilepsy or migraine (including a history), hypertension, diabetes mellitus, porphyria and hyperlipidemia, the risk of side effects is insignificant provided that the drug is used for a short period of 6-12 days.
This also applies to patients with severe pruritus, gestational herpes or exacerbation of otosclerosis in early pregnancy and those with thrombophlebitis or a history of thromboembolism.
However, if any of these conditions worsen, treatment should be discontinued, as should the development of abnormal vaginal bleeding during use of the medicinal product.
The following precautions apply to long-term treatment.
Topical estrogen therapy should only be initiated for the treatment of postmenopausal symptoms that negatively impact quality of life. A careful risk-benefit assessment should be performed at least annually. Treatment should only be continued if the benefits outweigh the risks.
Medical examinations/follow-up.
Before initiating/resuming treatment, a complete personal and family medical history should be obtained. In addition, the patient should undergo regular, thorough physical and gynecological examinations during treatment. The frequency and nature of the examinations should be based on the patient's individual risk. Patients should be informed of any changes that should be reported to their physician (e.g., sudden genital bleeding or breast changes).
Screenings, including imaging procedures such as mammography, should be performed in accordance with current standard surveillance practices and based on the needs of the individual patient.
Cases when special medical supervision is necessary.
Postmenopausal patients with vaginal atrophy receiving maintenance therapy with Gynoflor should be carefully monitored for any of the following conditions/circumstances, including those that have occurred in the past or worsened during pregnancy or previous hormone therapy.
This also applies if the following circumstances/conditions arise or worsen during the current course of treatment:
Risk factors for estrogen-dependent tumors, such as breast cancer in a close relative; history of endometrial hyperplasia; leiomyoma (fibrous tumor) or endometriosis; risk factors for thromboembolic disorders; migraines or severe headaches; systemic lupus erythematosus; liver disease (e.g., liver adenoma); diabetes mellitus with or without vascular involvement; cholelithiasis; hypertension; epilepsy; asthma; otosclerosis.
Reasons for immediate discontinuation of maintenance therapy.
Treatment should be discontinued in the following cases:
jaundice or liver dysfunction; significant increase in blood pressure; development of migraine-like headaches or increased frequency of severe headaches.
The risk of endometrial hyperplasia and carcinoma increases with oral estrogen monotherapy, depending on the duration of treatment and estrogen dose. No increased risk of endometrial hyperplasia or uterine cancer has been found with vaginal estriol monotherapy. If long-term treatment is required, regular check-ups are recommended, but special attention should be paid to symptoms that may indicate endometrial hyperplasia or malignancy.
If unscheduled bleeding occurs during treatment or continues after treatment has ended, the cause should be investigated. Endometrial biopsy may be necessary to rule out malignancy.
Uncontrolled estrogen stimulation may lead to precancerous transformation of residual endometrial lesions. Therefore, the drug should be used with caution in women who have undergone hysterectomy for endometriosis and who have residual endometriosis.
Breast, uterine and ovarian cancer.
Systemic estrogen treatment increases the risk of developing certain types of cancer, especially uterine, ovarian and breast cancer. Gynoflor, vaginal tablets, are applied topically, contain a low dose of estriol, and systemic absorption of estriol after use of the drug is minimal and transient. Therefore, an increased risk of cancer is not expected with Gynoflor treatment.
Venous thromboembolic disease, stroke and coronary heart disease.
Systemic hormone replacement therapy is associated with an increased risk of venous thromboembolism (VTE), stroke, and coronary heart disease. Gynoflor, a vaginal tablet containing low-dose estriol and applied topically, should not increase the risk of VTE, stroke, or coronary heart disease.
Risk factors for VTE include: personal or family history of VTE, significant excess body weight (BMI > 30 mg/m2), and systemic lupus erythematosus (SLE). There is no consensus on the possible role of varicose veins in the development of VTE. Close monitoring of these patients is recommended.
Other diseases.
Systemic estrogens may cause fluid retention or an increase in plasma triglyceride levels. Therefore, patients with heart disease, renal impairment, or hypertriglyceridemia should be carefully monitored during the first few weeks of treatment. Gynoflor vaginal tablets contain a low dose of estriol and are administered topically. Therefore, systemic effects are not expected.
Patients with severe renal insufficiency should be carefully monitored as increased estriol levels in the blood may occur.
Ability to influence reaction speed when driving vehicles or other mechanisms
Studies on the effect on reaction speed when driving vehicles or working with other mechanisms have not been conducted.
Use during pregnancy or breastfeeding
Gynoflor can be used during pregnancy and lactation. However, like all other medicines, Gynoflor should be prescribed with caution to women in the first trimester of pregnancy.
The data do not indicate any adverse effects of estriol and Lactobacillus acidophilus on pregnancy or the health of the fetus/newborn child.
Method of administration and doses
Restoration of Lactobacillus flora after local and/or systemic treatment with anti-infective agents, Fluor vaginalis (vaginal discharge), vaginal infections.
1-2 vaginal tablets are inserted daily for 6-12 days. Vaginal tablets 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 knees slightly bent.
Treatment should be suspended during menstruation and resumed after menstruation.
Atrophic vaginitis, vaginal discharge (Fluor vaginalis) in the postmenopausal period.
1 vaginal tablet is administered daily for 12 days, then the maintenance dose is 1 vaginal tablet 1-2 times a week. Regular use of the drug in atrophic changes of the vaginal epithelium is necessary for the prevention of atrophic vaginitis.
Treatment of recurrent vaginal infections.
The recommended dose is 1 vaginal tablet daily for 12 days.
Children
Do not use in young girls who have not started menstruating and who have not reached puberty.
Overdose
After an overdose with vaginal use, no adverse reactions occur, but the number of lactobacilli in the vaginal environment increases. In any case, this is a desirable effect of the drug. As for estriol, a temporary increase in its serum concentration is possible. Usually, systemic effects do not occur.
Adverse reactions
During clinical trials and post-marketing experience, the following adverse reactions were reported, listed by system organ class and frequency:
uncommon (≥ 1/1000, < 1/100), rare (≥ 1/10000, < 1/1000).
Immune system.
Rare: allergic reaction with redness and itching.
Reproductive system and mammary glands.
Uncommon: vulvovaginal itching, vaginal discharge, burning sensation in the vulvovaginal area (especially at the beginning of treatment).
Infectious and parasitic diseases.
No adverse reactions are expected if the drug is accidentally taken orally.
Expiration date
3 years.
Storage conditions
Store in the original packaging. Store in a refrigerator (2 to 8°C).
Storing the medicine at room temperature for 1-2 weeks does not affect its effectiveness. Keep out of the reach of children.
Packaging
6 tablets in a blister, 1 blister in a cardboard box.
Vacation category
Without a prescription.
Producer
Medinova AG/Medinova AG.
Location of the manufacturer and its business address
Eggbuhlstrasse 28, 8050 Zurich, Switzerland.
