Gynoflor Special Precautions

Gynoflor contains excipients which do not dissolve completely such that remains of the tablet are occasionally found in the underwear. This is of no importance to the efficacy of Gynoflor.
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 an intact tablet. As a 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 and should not use vaginal douches or rinses during treatment of Gynoflor.
Effects on the Ability to Drive or Operate Machinery: Not relevant.
Use in pregnancy & lactation: Gynoflor can be used in pregnancy and lactation. However, as with other medicinal products in general, caution should be exercised when prescribing Gynoflor to pregnant women in the 1st 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/newborn child. Furthermore, Gynoflor has 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 cannot be extrapolated to humans.
Gynoflor contains estriol only in a very low dose. It has been shown in non-pregnant women that after the 1st application of Gynoflor, the plasma concentration of estriol increases transiently, whereas after the 12th application, no increase was observed. After repeated application, the plasma concentration of estriol is within the normal range of postmenopausal women.
Furthermore, the maternal plasma concentration of estriol during pregnancy is increased about 1000 times as compared to non-pregnant women.