Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2017 Publisher: Kora Corporation Ltd t/a Kora Healthcare, Swords Business Park, Swords, Co. Dublin, Ireland
Fluomizin 10 mg vaginal tablets are indicated for the treatment of Bacterial vaginosis (see section 4.4).
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
One vaginal tablet daily for six days.
The vaginal tablets should be inserted deeply into the vagina in the evenings before retiring. This is best performed in a reclining position with the legs slightly bent.
The treatment should be interrupted during menstruation and resumed afterwards.
Although relief of discharge and inflammation generally occurs within 24 to 72 hours, the treatment should be continued even when there is no subjective discomfort (itching, discharge, smell) anymore. A treatment less than six days could result in a relapse.
Fluomizin contains excipients which do not dissolve completely, such that remains of the tablet are occasionally 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 intact tablet. As consequence, the treatment is not optimal. 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. There is no change in colour of the underwear.
There is a lack of data on the efficacy and safety of dequalinium chloride in women above 55 years of age.
There is a lack of data on the efficacy and safety of dequalinium chloride in children below 18.
For vaginal use.
No case of overdose has been reported. However, use of a higher daily dose might result in vaginal ulcerations. In case of overdose with adverse events, a vaginal lavage can be performed.
3 years.
This medicinal product does not require any special storage conditions.
PVC/PE/PVdC/aluminium blisters.
Packs of 6 vaginal tablets.
No special requirements.
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