Mycospor

Mycospor^®
Active ingredient: Bifonazole
Cream
Broad spectrum antimycotic

Composition
1 g cream contains 10 mg bifonazole in inert cream base (O/W)

Properties
Bifonazole, is an imidazole derivative with a broad antimycotic spectrum of action which includes dermatophytes, yeasts, moulds and other fungi such as Malassezia furfur. It is also effective on Corynebacterium minutissimum.
Bifonazole inhibits the biosynthesis of ergosterol on two different levels, distinguishing bifonazole both from other azole derivates and from other antifungals which act only on a single level. Inhibition of ergosterol synthesis leads to structural and functional impairment of the cytoplasmic membrane.

Indications
Skin mycoses caused by dermatophytes, yeasts, moulds and other fungi. e.g. Malassezia furfur and Corynebacterium minutissimum infections, tinea pedum, tinea manuum, tinea corporis, tinea inguinalis, pityriasis, versicolor, candida albicans and erythrasma.

Contraindications
Hypersensitivity to bifonazole or to any other ingredient of the drug.

Use during pregnancy and breastfeeding
Preclinical safety data and pharmacokinetic data in humans give no indication that harmful effects on the mother and child should be anticipated when Bifonazole is used during pregnancy. However, no clinical data are available. In the first 3 months of pregnancy Bifonazole should not be used without first consulting a doctor.
Systemic absorption of the drug from topical application is low but represents a potential hazard to the fetus.
It is not known wether this drug is excreted in human milk. Caution should be exercised when Mycospor is administered to a breasfeedinq mother.

Side efects
The most common adverse reactions based on clinical and PMS studies with all topical bifonazole formulations coded by COSTART and sorted by frequency (n = 36351 patients, status 30.11.1998).

Incidence of frequency  ≥ 0.01 % ‹ 0.1 %
Body as a whole:	allergic reaction
Incidence of frequency  ≥ 0.1 % ‹ 1 %
Body as a whole:	pain
Skin and appendages:	contact dermatitis
	eczema
	pruritus
	rash (vesiculobullous)
	dry skin
	skin disorder

Following cutaneous application of Mycospor, erythema, burning, irritation and scaling have occasionally occurred. These side effects are reversible after discontinuation of the treatment

Interactions
Not known

Dosage and administration
Mycospor cream is used once a day, preferably in the evening before retiring. It should be applied thinly to the affected skin area and rubbed in.
To achieve a lasting cure, treatment with Bifonazole must be carried out reliably and over an adequate period. The usual periods of treatment are:

Foot mycoses, athlete's foot (Tinea-pedum, tinea pedum intergitalis)	3 weeks
Mycoses of the trunk, hands and skin folds (Tinea corporis, Tinea manuum, Tinea inguinalis)	2 - 3 weeks
Pityriasis versicolor, erythrasma	2 weeks
Superficial candidosis of the skin	2 - 4 weeks

A strip of cream (½ cm long) is generally sufficient to treat an area of about the size. of the palm of the hand.

Use in children
No in-depth studies have been performed in children. From a survey of the clinical data reported there is no indication that harmful effects should be anticipated in children. However, in babies, Bifonazole should only be used under medical supervision.

Warning pre-caution
Avoid contact with eyes
If evidence of local intolerance develops, withdrawal of the drug should be considered with substitution of other appropriate therapy. The efficacy and safety of Mycospor in mucosal applications have not been tested. Fungal infections of the mucous membranes should not, therefore, be treated with Mycospor.

Instructions for use/handling:
Keep drug out the reach of children.
Mycospor cream must not be used after expiry date

Store below 30°C.

On doctor's prescription only

Presentation
Cream : Tube 5 g and 15 g

Made by PT Bayer Indonesia, Jakarta under licence and control of Bayer HealthCare AG, Germany (Owner of Trademark)
Packed by PT Pfizer Indonesia

Reg. No. DKL8502000629A1 (cream 5 g)
Reg. No. DKL8502000629A1 (cream 15 g)

Bayer Schering Pharma

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