CLOMAZOL Vaginal cream Ref.[50650] Active ingredients: Clotrimazole

Clomazol 1% vaginal cream (6-day treatment):

Once daily, preferably in the evening for six successive days, one applicator should be filled with cream (approx. 5 g) and inserted as deeply as possible into the vagina with the patient lying on her back. The 35 g tube of cream for vaginal use provides for six such doses.

Clomazol 2% vaginal cream (3-day treatment):

Once daily, preferably in the evening for three successive days, one applicator should be filled with cream (approx. 5 g) and inserted as deeply as possible into the vagina with the patient lying on her back. The 20 g tube of cream for vaginal use provides for three such doses.

Generally

If symptoms persist for more than 7 days or do not improve within 4 days, the patient may have a medical condition that requires treatment by a doctor.

The treatment can be repeated if necessary, however recurrent infections may indicate an underlying medical cause, including diabetes or HIV infection. Patients should seek medical advice if symptoms return within 2 months or they have had 3 or more infections within 6 months.

If the labia and adjacent areas are simultaneously infected, local treatment with an external cream should also be given in addition to the intravaginal treatment (combination treatment). The sexual partner should also undergo local treatment if symptoms e.g. pruritis, inflammation, etc. are present.

Treatment during the menstrual period should not be performed. The treatment should be finished before the onset of menstruation.

Do not use tampons, intravaginal douches, spermicides or other vaginal products while using this product.

Avoidance of vaginal intercourse is recommended in case of vaginal infection and while using this product as the partner could become infected.

Clotrimazole vaginal products are intended for use by adults aged 18–60 years, unless use is advised by a doctor.

Paediatric Population

Clotrimazole vaginal products are intended for use by adults aged 18–60 years. There are no data available for paediatric use.

No risk of acute intoxication is seen as it is unlikely to occur following a single vaginal or dermal application of an overdose (application over a large area under conditions favourable to absorption) or inadvertent oral ingestion. There is no specific antidote.

For advice on the management of overdose please contact the National Poisons Centre on 0800 POISON (0800 764766).

3 years.

Store at or below 25°C.

Clomazol 1%: tube containing 35 g of vaginal cream, 10 mg clotrimazole per gram (1% w/w) packed in a carton with six single-use disposable applicators and patient instruction sheet.

Clomazol 2%: tube containing 20 g of vaginal cream, 20 mg clotrimazole per gram (2% w/w) packed in a carton with three single-use disposable applicators and patient instruction sheet.

Not all strengths may be marketed.

Medicines should not be disposed of via wastewater or household waste. Ask a pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.