Canesten 10mg / 1g Topical Cream
PDF Leaflet Revision Date: April 1995
Clinical Summary
Quick overview from the medicine insert
Indication
Treatment of dermatomycoses and fungal skin infections.
Dosage (summary)
Apply thinly 2-3 times daily; treatment duration varies from 1-4 weeks.
Pregnancy & Breastfeeding
Use with caution; consult healthcare provider.
Key Drug Interactions
- May reduce effectiveness of latex products during treatment.
Contraindications
- Hypersensitivity to clotrimazole or cetostearyl alcohol.
Common side effects
- Skin irritation
- Burning
- Contact allergic dermatitis
Counselling Points
- Apply correctly and for sufficient duration to prevent relapse.
- Dry affected areas thoroughly, especially between toes.
Serious warnings
- For external use only.
- Not for ophthalmic use.
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Clinical Particulars
Section 4 of the official insert — extracted exactly as issued, no alterations
4.1 Therapeutic indications
The range of indications is: 1. All dermatomycoses due to dermatophytes (e.g. Trichophyton species). 2. All dermatomycoses due to yeasts (e.g. Candida species). 3. Dermatomycoses due to moulds and other fungi. 4. Skin diseases with secondary infection by these fungi. The dermatomycoses mentioned under 1 - 4 include among others: 1. Mycoses of the skin and skin folds, (e.g. fungal infections of the groin, perineum, axillae, Dhobiesu2019 or jock itch and barberu2019s itch.) 2. Ringworm. 3. Interdigital mycoses e.g. athlete's foot. 4. Candida vulvitis (vulval thrush). 5. Candida balanitis, (thrush of the glans penis). 6. Pityriasis (Tinea) versicolor. 7. Erythrasma. 8. Paronychias, associated with nail mycoses, (fungal infections of the tissues adjacent to the nail of a finger or toe).
4.3 Contraindications
Possible hypersensitivity to clotrimazole and / or cetostearyl alcohol (cream).
4.4 Special warnings and precautions for use
For external use only. Direct contact with Canesten u00ae Topical Cream may reduce the effectiveness and safety of latex products such as condoms and diaphragms. The effect is temporary and occurs only during treatment.
4.2 Posology and method of administration
Apply thinly to the affected areas 2 - 3 times daily and rub in. A small amount of cream is sufficient for an area about the size of the palm. Successful treatment demands that CANESTEN u00ae Topical Cream 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 yeasts; in Candida vulvitis and Candida balanitis, 1 - 2 weeks; and approximately 2 - 4 weeks in Erythrasma and 1 - 3 weeks in 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. CANESTEN u00ae Topical Cream is odourless, can be washed off and do not stain. Cosmetically well accepted.
4.8 Undesirable effects
Not intended for ophthalmic use. Local reactions including skin irritation and burning may occur. Contact allergic dermatitis has been reported. In cases of systemic absorption, lower abdominal cramps, increase in urinary frequency or skin rash may occur.
4.9 Overdose
See side-effects. In case of accidental ingestion, gastrointestinal disturbances and central nervous system depression may occur. Treatment is symptomatic and supportive.
