INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo CANDIZOLE V CREAM

SCHEDULING STATUS:
S1

PROPRIETARY NAME
(and dosage form):

CANDIZOLE V CREAM

COMPOSITION:
Each 5 g vaginal cream contains 50 mg
clotrimazole.
Preservative: Benzyl alcohol 1% m/m.

PHARMACOLOGICAL CLASSIFICATION:
A 20.2.2 Fungicides

PHARMACOLOGICAL ACTION:
Clotrimazole has a fungicidal action on dermatophytes, yeasts, moulds and other fungi. It also acts on Trichomonas vaginalis and clotrimazole-sensitive bacteria.

INDICATIONS:
For the relief of vaginal itching, burning and discharge associated with recurrent vaginal yeast infections (Vaginal candidiasis).

CONTRA-INDICATIONS:
Patients with a known sensitivity to clotrimazole. The possibility of absorption of clotrimazole when administered vaginally cannot be excluded. Safety in pregnancy has not been established.

WARNING:
Not for oral use.
(i) Use only if you have already had a vaginal yeast infection diagnosed by a medical practitioner and you have the same symptoms now, otherwise consult your doctor. These symptoms include itching and burning of the vagina and sometimes a white discharge.
(ii) If there is no improvement in three days or if symptoms have not disappeared within seven days, then consult a medical practitioner as not all vaginal infections are caused by yeasts.
(iii) Consult a medical practitioner if you have abdominal pain, fever or a foul-smelling vaginal discharge before or during use of this medication.
(iv) If symptoms recur within two months, consult a medical practitioner.
(v) If you are pregnant or think you may be pregnant or are nursing, do not use this medication except on the advice of a medical practitioner.
(vi) Do not use in girls under twelve years of age, except on the advice of a medical practitioner.
(vii) If skin rash or new irritation occurs, discontinue use.

DOSAGE AND DIRECTIONS FOR USE:
One 5 g application to be inserted per vagina at night on retiring for 6 (or 7) consecutive nights, even if symptoms disappear..
The enclosed vaginal applicator should be filled to the top with cream (i.e. 5 g Candizole V) and inserted deeply into the vagina. It is best achieved when lying on the back with the legs pulled in a little towards the body. The treatment should preferably be completed before menstruation begins. However, should menstruation commence before treatment is completed, the treatment should be continued during the menstrual period. The vaginal cream should be applied thinly to the external genitalia 2 to 3 times daily for 1 - 2 weeks for Candida vulvitis.
As the partner may be the source of re-infection, he should concurrently use clotrimazole cream locally.
Recurrence is common if the full course of treatment has not been completed.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Local reactions including irritation and burning may occur in patients treated topically; contact allergic dermatitis has been reported.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Gastro-intestinal disturbance, urinary symptoms, elevation of liver enzymes, neutropenia, and mental depression have been reported after administration of clotrimazole by mouth. Treatment is supportive and symptomatic.

IDENTIFICATION:
A smooth white cream.

PRESENTATION:
Tubes containing 50 g with 6 vaginal applicators.

STORAGE INSTRUCTIONS:
Store in airtight containers. Store below 25°C.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
27/20.2.2/0150

NAME AND BUSINESS ADDRESS OF APPLICANT:
Pharmacare Limited
Building 12, Healthcare Park, Woodlands Drive,
Woodmead, Sandton, 2148

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
04/12/1992

D083
A&S PRINTERS

DIRECTIONS FOR USING THE APPLICATOR: {illustrated}
Preparing the applicator:
1. Wash hands thoroughly.
2. Place the open end of one of the applicators over the opening of the tube of cream. At this stage the plunger of the applicator should be pushed right in.
3. Squeeze the bottom of the tube gently so that the cream fills the applicator to the top, pushing the plunger out to its full extent.
4. Remove the tube of cream and replace the cap.
Inserting the applicator:
5. Insert the end of the applicator carefully as deeply as possible into the vagina. It is best achieved when lying on the back with the legs pulled in a little towards the body.
6. Slowly push the plunger with the forefinger until it stops.
7. Remove the applicator from the vagina and discard it.
USE EACH APPLICATOR ONCE ONLY
Use the surplus cream in the tube to treat any inflammation of the vulva (outer vaginal area) and nearby areas. Apply the cream thinly and rub in gently 2 - 3 times daily.

Updated on this site: March 2006
Source: Community Pharmacy

SAEPI HOME PAGE      TRADE NAME INDEX      GENERIC NAME INDEX      FEEDBACK
Information presented by Malahyde Information Systems © Copyright 1996-2006