CANESTEN® Solution; CANESTEN® Cream

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

CANESTEN® Solution
CANESTEN® Cream

SCHEDULING STATUS:

PROPRIETARY NAME
(and dosage form):

CANESTEN^® Solution
CANESTEN^® Cream

COMPOSITION:

Solution:	Clotrimazole 200 mg Inert solvent to 20 mL
Cream:	Clotrimazole 200 mg Benzyl alcohol 1% (as preservative) Inert ointment base (o/w) to 20 g.

PHARMACOLOGICAL CLASSIFICATION:
A 20.2.2 Fungicides

PHARMACOLOGICAL ACTION:
A broad spectrum antimycotic acting as fungicide.

INDICATIONS:
The range of indications is:

1.	All dermatomycoses due to dermatophytes (e.g. Trichophyton species).
2.	All dermatomycoses due to yeasts (e.g. Candida species).
3.	Dermatomycoses due to moulds and other fungi.
4.	Skin diseases with secondary infection by these fungi.

The dermatomycoses mentioned under 1 - 4 include among others:

1.	Mycoses of the skin and skin folds.
2.	Ringworm.
3.	Interdigital mycoses e.g. athlete's foot.
4.	Candida vulvitis.
5.	Candida balanitis.
6.	Pityriasis versicolor.
7.	Erythrasma.
8.	Paronychias (associated with nail mycoses).

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

WARNING:
Solution is inflammable. Keep away from open flame. For external use only.

DOSAGE AND DIRECTIONS FOR USE:
Apply thinly to the affected areas 2 - 3 times daily and rub in. Because of its excellent efficacy a small amount of cream or a few drops of solution is usually sufficient for an area about the size of the palm. Successful treatment demands that CANESTEN be applied correctly and over a sufficiently long period of time.

The duration of treatment varies. In general, it is 3 - 4 weeks in the case of dermatomycoses due to dermatophytes and yeasts; in Candida vulvitis and Candida balanitis, 1 - 2 weeks; and approximately 2 - 4 weeks in Erythrasma and 1 - 3 weeks in Pityriasis versicolor.

TREATMENT OF FUNGAL INFECTION SHOULD BE CONTINUED FOR APPROXIMATELY 2 WEEKS AFTER THE DISAPPEARANCE OF ALL SYMPTOMS DESPITE A RAPID, SUBJECTIVE IMPROVEMENT, IN ORDER TO PREVENT RELAPSE.

Athlete's foot: Always dry the feet carefully, especially between the toes.

CANESTEN preparations are odourless, can be washed off and do not stain. Cosmetically well accepted.

SIDE EFFECTS AND SPECIAL PRECAUTIONS:
Not intended for ophthalmic use. Local reactions including skin 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.

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

IDENTIFICATION:
Solution: A clear to pale yellow liquid
Cream: A soft, white cream.

PRESENTATION:
CANESTEN Solution: Bottle of 20 mL.
CANESTEN Cream: Tube of 20 g.

STORAGE DIRECTIONS:
Store below 25^o C. Keep out of reach of children.

REGISTRATION NO:
Solution: E/20.2.2/48
Cream: E/20.2.2/49

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

ZIMBABWE: PID 74/14.1.3/242
CREAM ONLY

^® = Registered trade mark of Bayer Germany.

025400-0995