INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION
MYCOSPOR®Cream
MYCOSPOR® Solution

SCHEDULING STATUS:
S2

PROPRIETARY NAME
(and dosage form):

MYCOSPOR^®Cream
MYCOSPOR^® Solution

COMPOSITION:

CREAM:	Bifonazole 10 mg
	Benzyl Alcohol (as preservative) 1% m/m
	Inert cream base o/w to 1 g.
SOLUTION:	Bifonazole 10 mg
	Inert solvent to 1 mL.

PHARMACOLOGICAL CLASSIFICATION:
A.13.9.2. Fungicides

PHARMACOLOGICAL ACTION:
Bifonazole is a broad-spectrum antifungal, which suppresses cell wall synthesis.
Its in vitro activity against dermatophytes (e.g. Trichophyton spp.) is primarily fungicidal whereas that against yeasts is primarily fungistatic.

INDICATIONS:
Indicated in mycoses of the skin and mucocutaneous parts due to dermatophytes,Candida species, Malassezia furfur, Corynebacterium minutissimum and Aspergillus species.

CONTRA-INDICATIONS:
Hypersensitivity to bifonazole and cetyl stearyl alcohol (cream).

WARNINGS:
In the first 3 months of pregnancy MYCOSPOR should not be used without first consulting a doctor.
Solution is inflammable. Keep away from open flame.
For external use only.

DOSAGE AND DIRECTIONS FOR USE:
MYCOSPOR Cream or Solution is used once daily, preferably before retiring. It is applied thinly to the affected skin areas, and rubbed in. Usually only a few drops (about 3 drops) of solution or when using the pump spray, 1 or 2 depressions of the spray head, or a small amount (approximately ½ cm) of cream, will suffice for the treatment of an area the size of the palm of the hand.
For hygienic support of treatment it is advisable to wash and thoroughly dry the skin areas affected before applying MYCOSPOR Cream or Solution.
Treatment with MYCOSPOR Cream or Solution should not be stopped when the acute inflammatory symptoms and signs have subsided, but depending on the disease being treated, be continued for 2 to 4 weeks.
Safety for periods exceeding 4 weeks has not been established.
MYCOSPOR preparations are odourless and can be washed off.
MYCOSPOR Cream and Solution should not be applied to the eyes.
Candida balanitis should be treated with MYCOSPOR Cream only.

SIDE EFFECTS AND SPECIAL PRECAUTIONS:
Skin reactions which may occur include mild and transient reddening, pruritus, skin disorder, itching, dry skin, irritation, eczema, vesiculobullous rash or burning sensation. The development of a contact dermatitis has been reported occasionally. Pain may occur infrequently. These side effects are reversible after discontinuation of the treatment.
Hypersensitivity to cetyl stearyl alcohol may cause allergic reactions. In this case MYCOSPOR Solution should be used.
Desquamation (scaling) may occur when using MYCOSPOR Solution.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Topical absorption of bifonazole is minimal and therefore no systemic effect need be expected.

IDENTIFICATION:

MYCOSPOR CREAM:	Soft white cream.
MYCOSPOR SOLUTION:	Clear, colourless liquid.

PRESENTATION:

MYCOSPOR CREAM:	Tubes of 15 g
MYCOSPOR SOLUTION:	Bottles of 15 mL         Spray bottles of 25 mL

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

REGISTRATION NO.:

MYCOSPOR CREAM:	R/13.9.2/203
MYCOSPOR SOLUTION:	R/13.9.2/204

Cream: Zimbabwe PID 86/14.1.3/1989

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:
19 July 2000

^® Registered trade mark of Bayer AG, Germany

G.02.02-01         C9259/0500

Updated on this site: February 2003
Source: Pharmaceutical Industry
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