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

Logo CANDIZOLE® TOPICAL CREAM

SCHEDULING STATUS:
S2

PROPRIETARY NAME:
(and dosage form)

CANDIZOLE® TOPICAL CREAM

COMPOSITION:
CANDIZOLE TOPICAL CREAM: Each 20 g contains 200 mg clotrimazole
Preservative: Benzyl alcohol 1%
PHARMACOLOGICAL CLASSIFICATION:
A 20.2.2: Fungicides.

PHARMACOLOGICAL ACTION:
A broad spectrum
anti-mycotic acting as a fungicide.

INDICATIONS:
The range of indications is:
1. Dermatomycoses due to dermatophytes (eg Trychophyton species)
2. Dermatomycoses due to yeasts (eg Candida species)
3. Dermatomycoses due to moulds and other fungi
4. Skin diseases with secondary infection by these fungi.
Dermatomycoses mentioned above include among others:
1. Ringworm.
2. Athlete’s foot.
3. Pityriasis versicolor.
4. Mycosis of the skin and skin folds.
5. Candida vulvitis + balanitis.
6. Paronychia (inflammation including the folds of tissue surrounding the finger nail).
CONTRA-INDICATIONS:
Patients with a known hypersensitivity to clotrimazole.

WARNING:
FOR EXTERNAL USE ONLY.

DOSAGE AND DIRECTIONS FOR USE:
Apply lightly to the affected and surrounding area twice daily (morning and evening).
Treatment should continue for at least 2 weeks after all symptoms have disappeared in order to prevent relapse.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Local reactions may occur. These may include erythema; stinging, blistering, and peeling of the skin oedema, pruritus, and urticaria.
If general irritation becomes uncomfortable, the preparation should be discontinued and appropriate corrective therapy instituted.
Clotrimazole is not indicated for ophthalmic use and should be used with caution around the eyes.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Gastro-intestinal disturbances and central nervous system depression may occur following accidental ingestion. Treatment should be supportive and symptomatic.

IDENTIFICATION:
Cream:
A smooth white cream.

PRESENTATION:
Cream:
Tubes containing 20 g.

STORAGE INSTRUCTIONS:
Store below 25°C and protect from light.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBERS:
Cream:
P/20.2.2/164.

NAME AND BUSINESS ADDRESS OF APPLICANT:
Lennon Limited
7 Fairclough Road
PORT ELIZABETH 6001

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
20/05/1992

        K965A
Tradepak PE

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