GYNOFLOR Lactobacillus Acidophilus / Estriol 100million organisms / 30mcg Vaginal Tablet 1's

No case of overdose has been reported.

 

Lactobacillus acidophilus + Estriol vaginal tablets can be used during pregnancy and lactation.
However, as with medicinal products in general, caution should be exercised when prescribing Lactobacillus acidophilus + Estriol vaginal tablets to pregnant women in the first trimester.
Data on a limited number (54) of exposed pregnancies indicate no adverse effects of estriol and Lactobacillus acidophilus on pregnancy or on the health of the foetus/new-born child. Furthermore, Lactobacillus acidophilus + Estriol vaginal tablets have been used for more than 15 years without apparent adverse effects.
Animal studies have shown harmful effects of estriol on male foetuses (see Pharmacology: Toxicology: Preclinical safety data under Actions). However, estriol is a sexual hormone which is specific for humans and is not found in other mammalian species. Thus, toxicological data from animal studies are of limited use and can not be extrapolated to humans.
Lactobacillus acidophilus + Estriol vaginal tablets contain estriol only in a very low dose. It has been shown in non-pregnant women that after the first application of Lactobacillus acidophilus + Estriol vaginal tablets, the plasma concentration of estriol increases transiently, whereas after the 12^th application no increase was observed. After repeated application, the plasma concentration of estriol is within the normal range of post-menopausal women.
Furthermore, the maternal plasma concentration of estriol during pregnancy is increased about 1000 times as compared to non-pregnant women.

 

Instructions for use / handling: Lactobacillus acidophilus + Estriol vaginal tablet contains excipients which do not dissolve completely, such that remains of the tablet are occasionally found in the panties. This is of no importance for the efficacy of Lactobacillus acidophilus + Estriol vaginal tablets.
In rare cases of a very dry vagina, it is possible that the vaginal tablet does not dissolve and is discharged by the vagina as intact tablet. As consequence, the treatment is not optimal. However, this is not harmful to the vagina. For prevention, the vaginal tablet can be moistened with a drop of water before insertion into a very dry vagina.
Patients should use a sanitary towel or panty liner.
Patients should not use vaginal douches or rinses during treatment with Lactobacillus acidophilus + Estriol vaginal tablets.
Incompatibilities: Not applicable.

 

Store in a refrigerator (2°C - 8°C).
Storage of Lactobacillus acidophilus + Estriol vaginal tablet at room temperature during the 1-2 weeks treatment period does not affect its efficacy.
Shelf-Life: 36 months.

 

Pharmacotherapeutic Group: Gynaecological anti-infective and antiseptic. ATC Code: G01AX99.
Pharmacology: Pharmacodynamics: Lactobacillus acidophilus is one of the predominant microorganisms of the vaginal flora in healthy women. Lactobacilli are non-pathogenic bacteria and have a protective function in the vagina. They ferment glycogen stored in the vaginal epithelium to lactic acid. The resulting acidic environment (pH 3.8 - 4.5) provides unfavourable conditions for the colonisation and growth of pathogenic microorganisms and provides an optimal medium for the proliferation of the lactobacilli. In addition to lactic acid, lactobacilli produce hydrogen peroxide and bacteriocins, which also inhibit the growth of pathogenic microorganisms.
Estriol is an endogenous estrogenic hormone which has a specific effect on the vagina, but not on the endometrium. The purpose of the estriol in Lactobacillus acidophilus + Estriol vaginal tablets is to ensure proliferation and maturation of the vaginal epithelium. A proliferated and matured vaginal epithelium acts as physical barrier and stores glycogen, a nutritional substrate for lactobacilli. In the case of hormonal disorders, more commonly observed at advanced age, the vaginal epithelium is disturbed and the glycogen content decreased. Vaginal infections can also lead to a damaged vaginal epithelium.
Exogenous estriol, even in the very low dose contained in Lactobacillus acidophilus + Estriol vaginal tablets, improves the proliferation and maturation of the epithelium, and thus provides the optimal conditions for the restoration of the vaginal lactobacilli flora.
Disturbance or elimination of the physiological vaginal flora can occur mainly as a result of local or systemic treatment with anti-infective agents, serious general illnesses, improper hygienic measures and vaginal infections. In a non-physiological vaginal environment, the lactobacilli are reduced in numbers or even absent, and their protective function is no longer assured.
The therapeutic concept of Lactobacillus acidophilus + Estriol vaginal tablets is based on the restoration of the vaginal flora through exogenous lactobacilli and the improved proliferation and maturation of the vaginal epithelium by exogenous estriol, resulting in the re-establishment of the physiological equilibrium of the vaginal flora and the vaginal epithelium.
Lactobacillus acidophilus and estriol exert their actions locally within the vagina.
Lactose, used for the manufacturing of the vaginal tablets, can also be fermented to lactic acid by the lactobacilli. Reproduction of the lactobacilli and re-colonisation of the vagina by these bacteria does start alter the first application of the preparation.
Pharmacokinetics: As soon as the vaginal tablet comes into contact with vaginal secretion, the tablet begins to disintegrate, and lactobacilli as well as estriol are released. In vitro experiments have demonstrated that the lactobacilli resume their metabolism and cause a reduction in pH within a few hours.
The positive estrogenic effect induced by estriol is also quickly initiated, and the proliferation and maturation status of the vaginal epithelium improves progressively over the course of treatment (6 -12 days).
The absorption of estriol from Lactobacillus acidophilus + Estriol vaginal tablets was investigated in healthy, post-menopausal women with atrophic epithelia. After a single, intravaginal application of Lactobacillus acidophilus + Estriol tablet, there was an increase in the plasma concentration of unconjugated estriol (biologically active form) above the basal level, and the maximum estriol concentration was reached alter 3 hours. After 8 hours, the plasma concentration of unconjugated estriol was no longer elevated. However alter the 12^th application at the end of the therapy with Lactobacillus acidophilus + Estriol vaginal tablets (once daily), the peak plasma level of unconjugated estriol was not elevated as compared to the basal level.
During the 12-day treatment, no accumulation of estriol was observed. The plasma concentrations observed alter repeated application of Lactobacillus acidophilus + Estriol vaginal tablets were within the normal range of the endogenous, post-menopausal plasma level of unconjugated estriol.
The plasma concentrations of estrone and estradiol are not affected by estriol therapy, since estriol is their metabolic end-product. Estriol is eliminated rapidly in the urine, primarily in biologically inactive forms (glucuronides, sulphates).
Due to the low dose of estriol (0.03 mg), the local application and the limited duration of treatment (6-12 days), no accumulation of estriol occurs and systemic estrogen effects are very unlikely.
Toxicology: Preclinical safety data: Two toxicological aspects must be considered for drugs administered by the vaginal route: local tolerance and the possibility of systemic toxicity due to absorption of the components.
Lactobacilli are the predominant microorganisms in the healthy human vagina and are regarded as non-pathogenic. For this reason, the introduction of these bacteria into the vagina is not expected to cause any local irritation or epithelial damage.
Results of animal experiments (Wistar rats) have demonstrated that only high doses of estriol can lead to a feminisation of the male foetus.
It should be noted that toxicological data obtained in rodents are of limited value and can not be extrapolated to man, since estriol is specific for humans and does not occur in other mammalian species.
Considering the low dose of estriol in Lactobacillus acidophilus + Estriol vaginal tablets, no acute or chronic toxicity is to be expected.