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

Logo CANESTEN®1 VC

64090 MW 902

SCHEDULING STATUS:
S2

PROPRIETARY NAME
(and dosage form):

CANESTEN®1 VC
Vaginal Cream

COMPOSITION:
Clotrimazole        500 mg
Benzyl Alcohol 1 % (as preservative)
Inactive cream base o/w to 5 g

PHARMACOLOGICAL CLASSIFICATION:
A 20.2.2. Fungicides

PHARMACOLOGICAL ACTION:
CANESTEN 1 VC has a fungicidal action on Candida species.

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

CONTRA-INDICATIONS:
Possible hypersensitivity to clotrimazole and / or cetostearyl alcohol.

WARNINGS:
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 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.
iii) Consult a medical practitioner if you have abdominal pain, fever or a foul-smelling vaginal discharge before or during the use of this medication.
iv) If symptoms recur within 2 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 12 years of age, except on the advice of a medical practitioner.
vii) If skin rash or new irritation occurs, discontinue use.
viii) Canesten® 1 VC may reduce the effectiveness and safety of latex products such as condoms and diaphragms. The effect is temporary and occurs only during treatment.

DOSAGE AND DIRECTIONS FOR USE:
In general, a single dose treatment will be sufficient for candida vaginitis. Unless otherwise prescribed by the doctor, the CANESTEN 1 VC should be inserted, preferably at night, into the vagina as deeply as possible. This is best achieved when lying back with the legs slightly drawn up. If necessary, a second treatment may be carried out.
It is recommended that the treatment should be timed so as to avoid the menstrual period. For prevention of re-infection, the partner should be treated locally with clotrimazole cream at the same time.
Entire contents of the applicator should be inserted.

SIDE EFFECTS AND SPECIAL PRECAUTIONS:
Local reactions including irritation and burning may occur. Contact allergic dermatitis has been reported. In cases of systemic absorption, lower abdominal cramps, increase in urinary frequency or skin rash may occur. CANESTEN 1 VC may only be used during pregnancy on the advice of a medical doctor. CANESTEN 1 VC should not be administered to pregnant women during the first trimester, since the safety in this regard has not been established. The possibility of absorption of clotrimazole when administered vaginally cannot be excluded.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
See side-effects and special precautions. Gastro-intestinal disturbances and central nervous system depression may follow accidental ingestion. Treatment is symptomatic and supportive.

IDENTIFICATION:
Soft, white cream.

PRESENTATION:
Pack containing 5 g CANESTEN 1 VC in applicator.

STORAGE INSTRUCTIONS:
Store below 25°C. Keep out of reach of children.

REGISTRATION NUMBER:
U/20.2.2/205

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Bayer (Pty) Ltd
Wrench Road        Isando        1600
Reg No 68/11192/07

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
April 1995

® = Registered trade mark of Bayer AG, Germany

Inserting the applicator:
{Illustrated}
Slowly push the plunger (A) with the forefinger until it stops.

Remove Cap C.

Carefully insert the end of the applicator (B) as deeply as possible into the vagina and then push in plunger A to deposit the cream. This is best achieved when lying on the back with the legs pulled in a little towards the body.

Remove the applicator from the vagina and discard it.

64090 MW 902

Updated on this site: March 2003
Source: Pharmaceutical Industry

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