Fluomizin Special Precautions

Fluomizin contains excipients which do not dissolve completely, such that remains of the tablet could occasionally be found in the underwear. This is of no importance for the efficacy of Fluomizin.
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 considered harmful to the vagina.
The vaginal tablet can be moistened with a drop of water before insertion into a very dry vagina for the prevention of such situations.
Patients should use a sanitary towel or panty liner. There is no change in colour of the underwear. Patients should be instructed to change their underwear and flannel daily and launder them at a temperature of at least 80°C. Patients should not use vaginal douches or rinses during treatment with Fluomizin.
Effects on the Ability to Drive or Operate Machinery: Not relevant.
Use in pregnancy & lactation: Fluomizin can be used during pregnancy and lactation.
However, as with medicinal products in general, caution should be exercised when prescribing Fluomizin to pregnant women in the 1st trimester.
Data on a limited number of exposed pregnancies in a clinical study with dequalinium chloride (55) and in a drug utilization study with Fluomizin (60) indicate no adverse effects of dequalinium chloride on pregnancy or on the health of the foetus/newborn child.
Data from post-marketing surveillance on a number of exposed pregnancies (estimated 0.5-1.1 million) indicate no adverse effects of dequalinium chloride on pregnancy or on the health of the foetus/newborn child.
No animal studies have been conducted with dequalinium chloride. However, animal studies with quaternary ammonium compounds have not shown reproductive toxicity (see Toxicology under Actions).
No data regarding the uptake of dequalinium chloride into breast milk are available. Based on the absorption data and the fact that the duration of the treatment is only 6 days, adverse effects on the foetus or newborn are improbable.