Dequalinium

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 after vaginal administration.

Dequalinium should only be used in pregnancy if clearly necessary.

Systemic exposure of the breast-feeding women to dequalinium is negligible. Therefore, no harmful effects on the breastfed newborn/infant are anticipated.

Dequalinium can be used during lactation if clinically needed.

To minimize exposure of the newborn to dequalinium, 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