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

To minimize 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 physician 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 10 mg 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.

Breast-feeding

Systemic exposure of the breast-feeding 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 minimize 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.

In clinical trials, the following undesirable effects possibly or probably related to dequalinum chloride have been reported.

Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

Common (≥1/100 to <1/10)
Uncommon (≥1/1,000 to <1/100)
Not known (cannot be estimated from the available data)

Infections and infestations

Common: vaginal candidiasis

Uncommon: bacterial vaginitis, fungal skin infection, vulvitis, vulvovaginitis

Not known: cystitis

Nervous system disorder

Uncommon: headache

Gastrointestinal disorders

Uncommon: nausea

Reproductive system and breast disorders

Common: vaginal discharge, vulvovaginal pruritus, vulvovaginal burning sensation

Uncommon: vaginal haemorrhage, vaginal pain

Not known: ulceration and maceration of vaginal epithelium, uterine bleeding, redness, vaginal dryness

General disorders and administration site conditions

Not known: allergic reactions with symptoms like urticarial, erythema, exanthema, swelling, rash or pruritus, fever

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

Fluomizin is incompatible with soaps and other anionic surfactants.