WARIMAZOL VAG 1% Vaginal cream Ref.[49795] Active ingredients: Clotrimazole

In the first third of pregnancy, vaginal creams should only be used under special precaution and previous consideration of possible alternative therapeutics (see also section 4.2).

Using the applicator during pregnancy, it might be possible that the amniotic sac and the unborn child respectively get hurt.

Cetostearyl alcohol might generate regional skin irritations (e. g. contact dermatitis).

Clotrimazole reduces the efficacy of amphotericin and other polyene antibiotics (e. g. nystatin, natamycin). Dexamethasone in high doses can possibly reduce the efficacy of clotrimazole.

In the first third of pregnancy, vaginal creams and vaginal tablets should only be used under special precaution and previous consideration of possible alternative therapeutics (see also section 4.2, 4.4).

There are no experiences available regarding effects on ability to drive and use machines.

When evaluating side effects, the following definitions are taken as a basis: Very common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1000 to <1/100), Rare (≥1/10000 to <1/1000), Very rare (<1/10000), Not known (frequency cannot be estimated from the available data).

Skin disorders

Uncommonly skin reactions (e.g., burning, stinging) can occur. Rarely erythema, skin rashes, blisters, peelings, pruritus, urticaria and edema may occur.

Disorders of immune system

Contact allergies were very rarely observed. In cases of hypersensitivity to clotrimazole or any other excipients, allergic reactions of the skin can appear.

Disorders of sexual organs

In the woman’s vagina light burning can uncommonly occur. On the woman’s labia light skin irritation can uncommonly occur. In case the sexual partner is also treated, he might be faced with irritations on his penis and inside the urethra.

Other undesirable effects

Women reported very rarely about abdominal cramps and increased urination.

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 to Pharmaceutical Services, Ministry of Health, CY-1475, Nicosia, Tel: +357 22608607, Fax: +357 22608669, Website: www.moh.gov.cy/phs.

Not applicable.