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

Logo CLOSCRIPT TOPICAL Cream

SCHEDULING STATUS:
S2

PROPRIETARY NAME
(and dosage form):

CLOSCRIPT TOPICAL Cream

COMPOSITION:
Each 1 g of cream contains
clotrimazole 10 mg.
Preservatives: Nipastat 0,275% (m/m) and Imidurea 0,3% (m/m).

PHARMACOLOGICAL CLASSIFICATION:
A: 20.2.2 Fungicides

PHARMACOLOGICAL ACTION:
A broad spectrum antimycotic with fungicidal properties.

INDICATIONS:
CLOSCRIPT TOPICAL cream indications are:
1. All dermatomycoses due to dermatophytes (eg. Trichophyton species).
2. Dermatomycoses due to moulds and other fungi.
3. Skin diseases with secondary infection by these fungi.
The dermatomycoses mentioned under 1 - 3 include among others:
1. Mycoses of the skin and skin folds.
2. Ringworm.
3. Interdigital mycoses eg. Athlete’s foot
4. Pityriasis versicolor.
5. Erythrasma.
6. Paronychias (associated with nail mycoses).

CONTRA-INDICATIONS:
Possible hypersensitivity to clotrimazole.

DOSAGE AND DIRECTIONS FOR USE:
Apply thinly to the affected areas 2 - 3 times daily and rub in. Successful treatment demands that CLOSCRIPT TOPICAL Cream be applied correctly and over a sufficiently long period of time. A small amount of cream is usually sufficient for an area about the size of the palm. The duration of treatment varies. In general, it is 3 - 4 weeks in the case of dermatomycoses due to dermatophytes and approximately 3 weeks in Erythrasma and Pityriasis versicolor.

TREATMENT OF FUNGAL INFECTION SHOULD BE CONTINUED FOR APPROXIMATELY 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.
CLOSCRIPT TOPICAL Cream is odourless, can be washed off and does not stain.
CLOSCRIPT TOPICAL Cream is not indicated for ophthalmic use and should be used with caution around the eyes.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Hypersensitivity reactions, such as itching and burning, and contact allergic dermatitis may occur, in which case 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 in a cool place (below 25°C).
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
28/20.2.2/0629

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
RANBAXY (S.A.) (PTY) LTD.
LINCOLN HOUSE
EPSOM DOWNS OFFICE PARK
13 SLOANE STREET
EPSOM DOWNS
BRYANSTON

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
27 May, 1994

                PM0445
                Davbar Dbn.

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