Fluomizin Vaginal 10 mg Tablets

FLUOMIZIN is indicated for the treatment of bacterial vaginosis in adult patients (see section 4.4).

Consideration should be given to official guidance on the appropriate use of antibacterial medicines.

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 on underwear. This will not affect 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 clean water before insertion into a very dry vagina. Patients should use a sanitary towel or panty liner. The tablet will not discolour the underwear.

Women more than 55 years and elderly

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

Paediatric population

There is a lack of data on the efficacy and safety of FLUOMIZIN in children below 18 years of age.

Method of administration

For vaginal use.

• Hypersensitivity to dequalinium chloride or to any of the excipients listed in section 6.1.
• Ulceration of the vaginal epithelium and the vaginal portion of the cervix.
• Young girls who have not yet had their first menstruation, and thus did not reach sexual maturity must not use FLUOMIZIN.

To minimise exposure of the newborn to dequalinium chloride, vaginal tablets should not be used within 12 hours before birth. There are no efficacy and safety data available on the re-treatment of patients who did not respond to or relapsed immediately after initial therapy with FLUOMIZIN. Patients should be advised to consult their medical practitioner if the symptoms persist at the end of the treatment or in case of recurrence. Using a higher daily dose or increasing the recommended treatment duration might increase the risk of vaginal ulcerations. No efficacy and safety data on the treatment of bacterial vaginosis in women aged less than 18 years or more than 55 years are available.

Anionic substances such as soaps, detergents and surfactants can reduce the antimicrobial activity of dequalinium chloride. Thus, concomitant intravaginal use of soaps, spermicides or vaginal douches (vaginal washes) is not recommended. FLUOMIZIN vaginal tablets do not impair the functionality of latex condoms. There are no data on the interaction with non-latex condoms and other intravaginal devices such as diaphragms. Thus, concomitant use of non-latex condoms and other intravaginal devices is not recommended for at least 12 hours following the treatment.

Pregnancy

Limited data from four clinical studies in 181 pregnant patients did not suggest adverse effects on the pregnancy or on the foetus / neonate. No reproductive toxicity studies have been conducted in animals because of the expected low systemic exposure to dequalinium chloride after vaginal administration. FLUOMIZIN should only be used in pregnancy if clearly necessary.

Breastfeeding

Systemic exposure of the breastfeeding women to FLUOMIZIN is negligible. Therefore, no harmful effects on the breastfed newborn/infant are anticipated. FLUOMIZIN can be used during lactation if clinically needed. To minimise exposure of the newborn to dequalinium chloride, vaginal tablets should not be used within 12 hours before birth.

Fertility

No studies on effects on fertility have been conducted in animals.

No studies on the effects on the ability to drive and use machines have been performed.

The following undesirable effects possibly or probably related to dequalinum chloride (e.g. FLUOMIZIN) have been reported. Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

Tabulated list of adverse reactions

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Healthcare providers are asked to report any suspected adverse reactions to SAHPRA via the u201c6.04 Adverse Drug Reactions Reporting Formu201d, found online under SAHPRAu2019s publications: https://www.sahpra.org.za/publications/index/8.

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.