FLUOMIZIN Vaginal tablet Ref.[9713] Active ingredients: Dequalinium

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

Therapeutic indications

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.

Posology and method of administration

Posology

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.

Women more than 55 years and elderly

There is a lack of data on the efficacy and safety of dequalinium chloride in women above 55 years of age.

Paediatric population

There is a lack of data on the efficacy and safety of dequalinium chloride in children below 18.

Method of administration

For vaginal use.

Overdose

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.

Shelf life

3 years.

Special precautions for storage

This medicinal product does not require any special storage conditions.

Nature and contents of container

PVC/PE/PVdC/aluminium blisters.

Packs of 6 vaginal tablets.

Special precautions for disposal and other handling

No special requirements.

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