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

Logo ADCO-CLOTRIMAZOLE VAGINAL CREAM

SCHEDULING STATUS:
S2

PROPRIETARY NAME:
(and dosage form)

ADCO-CLOTRIMAZOLE VAGINAL CREAM

COMPOSITION:
Each 5 g cream contains
clotrimazole 50 mg and benzyl alcohol 1% m/m (as a preservative).

PHARMACOLOGICAL CLASSIFICATION:
A.20.2.2 Fungicides

PHARMACOLOGICAL ACTION:
A broad spectrum antimycotic acting as a fungicide. Clotrimazole possesses fungicidal activity on Candida species. Clotrimazole is an imidazole antifungal agent.

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

CONTRA-INDICATIONS:
Possible allergy to clotrimazole or any other imidazole agents. The possibility of absorption of clotrimazole when administered vaginally cannot be excluded. Safety in pregnancy has not been established.

WARNINGS:
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.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.
Consult a medical practitioner if you have abdominal pain, fever or a foul-smelling vaginal discharge before or during use of this medication.
If symptoms recur within two months, consult a medical practitioner.
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.
Do not use in girls under twelve years of age, except on the advice of a medical practitioner.
If skin rash or new irritation occurs, discontinue use.

DOSAGE AND DIRECTIONS FOR USE:
Fill enclosed vaginal applicator to the top (i.e. 5 g ADCO-CLOTRIMAZOLE VAGINAL CREAM). Insert deeply into the vagina every night on retiring for six consecutive days. This is best achieved when lying on the back with the legs pulled in a little towards the body. If individual cases should require it, two applications of 5 g ADCO-CLOTRIMAZOLE VAGINAL CREAM can be used daily, i.e. one in the morning and one in the evening, for six to twelve days. Use even during menstruation, although it is recommended that the treatment should not be carried out during menstruation but should be completed before this begins. For candida vulvitis or vulvo-vaginitis the vaginal cream should be applied thinly to the external genitalia two or three times a day for one to two weeks.
For the prevention of re-infection the partner should be treated locally with ADCO-CLOTRIMAZOLE VAGINAL CREAM at the same time. ADCO-CLOTRIMAZOLE VAGINAL CREAM preparations are colourless and do not stain the underwear.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Local reactions including irritation and burning may occur. Contact allergic dermatitis has been reported. If this occurs, treatment should be discontinued.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
See "Side-effects and Special precautions". In case of accidental ingestion, gastro-intestinal disturbances and central nervous system depression may occur. Treatment is symptomatic and supportive.

IDENTIFICATION:
Smooth, white cream.

PRESENTATION:
ADCO-CLOTRIMAZOLE VAGINAL CREAM
, tube of 50 g with 6 vaginal applicators.

STORAGE INSTRUCTIONS:
Store below 25°C, in a well-closed container. Keep out of reach of children.

REGISTRATION NUMBER:
28/20.2.2/0311

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Adcock Ingram Limited
Adcock Ingram Park
17 Harrison Avenue
Private Bag X69
Bryanston 2021.

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
May 1996

New addition to this site: April 2004
Source: Pharmaceutical Industry

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