Gynoflor

Gynoflor Special Precautions

Manufacturer:

Medinova

Distributor:

The Glory Medicina
/
DKSH
Full Prescribing Info
Special Precautions
Gynoflor contains only a small amount of estriol, and of this, only very little is absorbed. In addition, as Gynoflor is used only for a short period of time, there is minimal risk in the case of serious liver, heart and kidney function disturbances, epilepsy or migraine (also when reported in the anamnesis), hypertonia, diabetes mellitus, porphyria and hyperlipidemia. There is also minimal risk for patients with serious itching, rash or worsening otosclerosis during early pregnancy, and for those with thrombophlebitis or thromboembolic disorders in the anamnesis. However, during long-term treatment with Gynoflor, regular clinical check-ups should be performed for patients with the previously mentioned disorders, as for higher-dosed estrogen preparations, for safety reasons.
In the event of worsening of the previously mentioned disorders, recurrence of the mentioned symptoms or occurrence of thrombosis or jaundice, therapy with Gynoflor should be discontinued.
If bleeding takes place, therapy should be discontinued and the cause of bleeding determined.
Effects on the Ability to Drive or Operate Machinery: Not relevant.
Use in pregnancy: Experiments on animals have shown that estriol has an adverse effect on the foetus. There are no controlled trials on humans. Under these circumstances, Gynoflor should only be used if the potential benefits outweigh the foetal risk.
Due to the facts that Gynoflor contains a very low dose of estriol and that estriol is only minimally absorbed, adverse effects on the foetus when the preparation is used during pregnancy are improbable. In spite of this, Gynoflor should be used for the treatment of vaginal infections or for restoration of the Lactobacillus flora after anti-infective therapy only if such treatment is strictly indicated.
There is no indication for treatment with estriol alone during pregnancy.
Inform the physician if patient becomes pregnant during therapy with Gynoflor.
Use in lactation: There is not enough data on the application of estriol during lactation to be able to estimate possible risks for the newborn infant. However, it is known that estriol enters the mother's milk and can reduce the production of milk. However, considering the low dose and the minimal absorption of estriol after vaginal application, adverse effects on the infant are improbable.
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