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

Source: Υπουργείο Υγείας (CY)  Revision Year: 2021  Publisher: COSTAKIS TSISIOS & CO. LTD, 22, Filopoimenos street, 4002 Mesa Geitonia, Limassol, Cyprus

4.1. Therapeutic indications

Inflammation of the vagina and discharge caused by fungi – usually Candida – as well as superinfections by Clotrimazole-sensitive bacteria.

4.2. Posology and method of administration

Posology

Unless otherwise prescribed, one applicator filling (approx. 5 g) per day – in the evening on 6 consecutive days – is emptied as deeply as possible into the vagina. If necessary, a second course of treatment can be carried out for a further 6 days.

Method of administration

For purposes of expediency treatment should not be carried out during menstruation and be completed before its onset.

During and two days after treatment sexual intercourse should only occur using a condom. For every treatment a new applicator has to be used. If a vaginal fungal infection is clearly detected, special care should be taken in the last 4–6 weeks of pregnancy so that non-pathogenic conditions prevail in the birth canal. This should be supervised by the physician.

Vaginal creams should not be used during pregnancy as they are inapplicable without applicator. Using the applicator during pregnancy, it might be possible that the amniotic sac and the unborn child respectively get hurt. For this reason it is recommended that treatment during pregnancy should only be effected by the physician, or instead of using the vaginal cream, clotrimazole-containing vaginal tablets should be used, since these can be applied without an applicator.

If labia and adjacent areas are also affected by fungal infection, as well as glans and foreskin of the partner, both of them should be treated with local antimycotics. To avoid a possible reinfection also the partner should be medically checked.

Hint:

The patient should be advised of the correct application of the applicators.

4.9. Overdose

Not known.

6.3. Shelf life

3 years.

6.4. Special precautions for storage

Not to be stored above 30°C.

6.5. Nature and contents of container

Aluminum tube, containing 35 g cream (1% clotrimazole) and 6 applicators.

6.6. Special precautions for disposal and other handling

No special precautions.

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