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

Logo CLOMADERM (Cream)

SCHEDULING STATUS:
S1

PROPRIETARY NAME
(and dosage form):

CLOMADERM (Cream)

COMPOSITION:
Each 1g of cream contains:
Clotrimazole        10 mg
Preservative:
  Nipastat 0,275% m/m
  Biopure 100 0,3% m/m

PHARMACOLOGICAL CLASSIFICATION:
A: 20.2.2 Fungicides

PHARMACOLOGICAL ACTION:
A broad spectrum antimycotic with fungicidal properties.

INDICATIONS:
Clomaderm
cream indications are:
All dermatomycoses due to dermatophytes (e.g. Trichophyton species).
Dermatomycoses due to moulds and other fungi.
Skin diseases with secondary infection by these fungi.

The dermatomycoses mentioned under 1-3 include among others:
Mycoses of the skin and skin folds
Ringworm
Interdigital mycoses, e.g. athlete’s foot
Pityriasis versicolor
Erythrasma
Paronychias (associated with nail mycosis).

CONTRA-INDICATIONS:
Possible hypersensitivity to clotrimazole.

DOSAGE AND DIRECTIONS FOR USE:
For external use only.
Apply thinly to the affected areas 2-3 times daily and rub in. Successful treatment demands that Clomaderm 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 approximately 3 week in Erythrasma and Pityriasis versicolor.
TREATMENT OF FUNGAL INFECTION SHOULD BE CONTINUED FOR APPROX. 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.
Clomaderm is odourless, can be washed off and does not stain.
Clomaderm is not indicated for ophthalmic use and should be used with caution around the eyes.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Local reactions including irritation and burning may occur.
Contact allergic dermatitis can occur. If this occurs, treatment should be discontinued.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
See “Side-Effects and Special Precautions”. In case of accidental ingestion, gastro-intestinal disturbances and central nervous system depression may occur. Treatment is symptomatic and supportive.

IDENTIFICATION:
A soft white cream.

PRESENTATION:
Tube of 20 g

STORAGE INSTRUCTIONS:
Store below 25ºC in a dry place.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
28/20.2.2/0419

NAME AND BUSINESS ADDRESS OF APPLICANT:
GULF DRUG COMPANY (PTY) LTD.
22 BURNSIDE DRIVE
OLD MILL INDUSTRIAL PARK
MOUNT EDGECOMBE
4300

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
2 November 1993

New addition to this site: July 2010
Source: Pharmaceutical Industry

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