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

Logo MYCOSPOR® ONYCHO-SET

SCHEDULING STATUS:
S2

PROPRIETARY NAME
(and dosage form):

MYCOSPOR® ONYCHO-SET

COMPOSITION:
Bifonazole 10 mg
Urea 400 mg
Inert ointment base to 1 g
PHARMACOLOGICAL CLASSIFICATION:
A.13.9.2. Fungicides

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

In this formulation the addition of urea allows for the softening of the infected nail keratin, which permits non-invasive and painless detachment of the infected nail.

INDICATIONS:
Treatment of nails infected with dermatophytes, Candida species, yeasts and Aspergillus species.

CONTRA-INDICATIONS:
Sensitivity to bifonazole and urea.

WARNING:
For external use only.

DOSAGE AND DIRECTIONS FOR USE:
Apply sufficient Mycospor Onycho-Set Ointment to cover the entire nail, once a day.

Cover the treated nail for 24 hours with a waterproof plaster. Change dressing daily. Remove plaster and soak nails in warm water for about 10 minutes. Remove as much of the softened infected nail as possible. Dry nail and apply Mycospor Onycho-Set Ointment as before and cover with plaster. This treatment must be carried out carefully each day and continued until no more softened, fungally infected nail substance can be scraped off. Mycospor Onycho-set ointment acts only on fungally infected nails; healthy areas remain unaffected.

The treating physician should check that the infected nail has been completely removed. After detachment of the nail, antimycotic treatment of the nail bed with Mycospor Cream or Solution should be carried out for about 4 weeks.

Treatment can only be successful if the instructions for use are followed exactly:

    Bathe the foot or hand in warm water, then dry thoroughly       Turn the threaded base of the ointment dispenser slowly to the right, until the ointment revealed is the length of the infected nail.
    Apply the ointment to the nail. Do not rub in.       Place one half of the plaster on the underside of the toe or finger, as shown. The plaster can also be placed on the uppersideof the toe or finger. For smaller nails, cut the plaster in half.
    Fold the adhesive side flaps of the plaster up and press on.       Now bring the other half of the plaster up so that it covers the nail. Then pull the adhesive side flaps round the nail and press down firmly.
    The plaster is now in position over the infected nail, like a protective cap. Leave the nail like this in the plaster dressing for 24 hours.       Remove the plaster after 24 hours. Bathe the foot or hand in warm water again, then dry thoroughly.
    With the scraper, carefully remove the softened nail substance.   Repeat treatment steps 1 - 9 until the infected nail material has been removed. 

SIDE EFFECTS AND SPECIAL PRECAUTIONS:
Skin reactions may occur. Account has to be taken of the fact that a nail which has undergone traumatic damage will, in spite of a mycological cure, exhibit growth abnormalities. Local reactions including burning and itching have been reported. Urea may be irritant to sensitive skin.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Absorption of bifonazole through the skin is minimal and therefore no systemic effect need be expected.

IDENTIFICATION:
Yellowish ointment.

PRESENTATION:
Rotary dispenser containing 10 g ointment, supplied with scraper and waterproof plasters.

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

REGISTRATION NO.:
Z/13.9.2/77

NAME AND BUSINESS ADDRESS OF APPLICANT:
Bayer (Pty) Ltd
27 Wrench Road Isando 1600
68/11192/07

DATE OF PUBLICATION:
June 1992

® = Registered trade mark of Bayer, Germany

5202/0/3 SA(1) 033702/1094

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