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

Logo CLOSCRIPT VAGINAL Cream

SCHEDULING STATUS:
S2

PROPRIETARY NAME
(and dosage form):

CLOSCRIPT VAGINAL Cream

COMPOSITION:
Each 1 g of cream contains
clotrimazole 10 mg
Preservatives: Nipastat 0,275% (m/m) and Imidurea 0,3% (m/m)

PHARMACOLOGICAL CLASSIFICATION:
A: 20.2.2 Fungicides

PHARMACOLOGICAL ACTION:
CLOSCRIPT VAGINAL cream is a broad spectrum antimycotic with fungicidal properties.

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

CONTRA-INDICATIONS:
Possible hypersensitivity to clotrimazole.
The possibility of absorption of clotrimazole when administered vaginally cannot be excluded.
The safety in pregnancy has not been established.

WARNINGS:
1. Use only if you have already had a 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.
2. If there is no improvement in 3 days or if symptoms have not disappeared within seven days, then consult a medical practitioner as not all vaginal infections are caused by yeasts.
3. Consult a medical practitioner if you have abdominal pain, fever or a foul-smelling vaginal discharge before or during use of this medication.
4. If symptoms recur within 2 months, consult a medical practitioner.
5. 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.
6. Do not use in girls under 12 years of age, except on the advice of a medical practitioner.
7. If skin rash or new irritation occurs, discontinue use.

DOSAGE AND DIRECTIONS FOR USE:
Fill enclosed vaginal applicator to the top (ie 5 mL CLOSCRIPT VAGINAL cream). Insert deeply into the vagina every night on retiring for six or seven consecutive nights, even during menstruation. This is best achieved when lying on the back with legs pulled in a little towards the body.
For the prevention of re-infection the partner should be treated locally with CLOSCRIPT TOPICAL cream at the same time. This preparation does not stain the underwear.

DIRECTIONS FOR USING THE APPLICATOR: {graphics included here}
PREPARATION OF THE APPLICATOR:
1. Wash your hands thoroughly.
2. Screw the open end of the applicator over the opening of the tube of cream. The plunger of the applicator should be pushed right in at this stage.
3. Gently squeeze the bottom of the tube so that the cream fills the applicator to the top, pushing the plunger out to almost its full extend.
4. Unscrew the tube of cream and replace its cap.
INSERTING THE APPLICATOR:
5. Carefully insert the end of the applicator as deeply as possible into the vagina. (Make sure the plunger does not fall out). This 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 rinse thoroughly in warm water.
The surplus cream may be used to treat any inflammation of the vulva (outer vaginal area) and nearby areas. The cream should be applied thinly and rubbed in gently 2 - 3 times a day.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Local reactions such as irritation, itching and burning may occur in which case treatment should be discontinued. In case of systemic absorption, lower abdominal cramps, increase in urinary frequency or skin rash may occur.

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:
Soft white cream.

PRESENTATION:
Tube of 50 g with vaginal applicator.

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

REGISTRATION NUMBER:
28/20.2.2/0630

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
RANBAXY (SA) (PTY) LTD.
Lincoln House
Epsom Downs Office Park,
13 Sloane Street
Epsom Downs
BRYANSTON

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
27 May, 1994

                        PM 0308 3/99
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