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

Logo NORMOSPOR Cream

SCHEDULING STATUS:
S2

PROPRIETARY NAME
(and dosage form):

NORMOSPOR Cream

COMPOSITION:
Each gram of cream contains:
Clotrimazole         10 mg
Preservatives: 
Nipastat 0,275% m/m
Imidurea 0,300% m/m

PHARMACOLOGICAL CLASSIFICATION:
A 20.2.2 Fungicides

PHARMACOLOGICAL ACTION:
A broad spectrum antimycotic with fungicidal properties.

INDICATIONS:
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 in above-mentioned 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 mycoses)

CONTRA-INDICATIONS:
Possible sensitivity to clotrimazole.

DOSAGE AND DIRECTIONS FOR USE:
Apply thinly to the affected areas 2 - 3 times daily and rub in. Successful treatment demands that Normospor cream be applied correctly and over a sufficiently long period of time. The duration of treatment varies. In general, it is three to four weeks in the case of dermatomycoses due to dermatophytes and approximately three weeks in erythrasma and pityriasis versicolor.
TREATMENT OF FUNGAL INFECTION SHOULD BE CONTINUED FOR APPROXIMATELY TWO 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.
Normospor cream is odourless, can be washed off and does not stain.
Normospor cream 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:
Tubes with 20 gram.

STORAGE INSTRUCTIONS:
Store below 25°C.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
27/20.2.2/0201

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
ADCOCK INGRAM LTD
Adcock Ingram Park
17 Harrison Avenue
Bryanston, Ext . 77
Private Bag X69, Bryanston, 2021

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
20 October 1992

New addition to this site: May 2004
Source: Pharmaceutical Industry

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