Country: South Africa
Language: English
Source: South African Health Products Regulatory Authority (SAHPRA)
Bayer
CANESTEN® DUOPAK SCHEDULING STATUS: S2 PROPRIETARY NAME (and dosage form): CANESTEN ® DUOPAK Vaginal Tablet and Topical Cream COMPOSITION: Each vaginal tablet contains clotrimazole 500 mg; 10 g Cream contains clotrimazole 100 mg and benzyl alcohol 1% m/m (as preservative) PHARMACOLOGICAL CLASSIFICATION: A 20.2.2. Fungicides PHARMACOLOGICAL ACTION: Clotrimazole is a broad spectrum antimycotic and has a fungicidal action on Candida species. INDICATIONS: Vaginal Tablet: For the relief of vaginal itching, burning and discharge associated with recurrent vaginal yeast infections (vaginal candidiasis). Vaginitis due to Candida species. Topical Cream: Infections of the labia and adjacent areas as well as inflammation of the glans and prepuce of the sexual partner caused by yeast fungi (Candidal vulvitis and Candidal balanitis). CONTRA-INDICATIONS: Vaginal Tablet:Possible hypersensitivity to clotrimazole. Topical Cream: Possible hypersensitivity to clotrimazole and cetostearyl alcohol. WARNINGS: (Vaginal Tablet ) i) Not for oral use. ii) Use only if you have already had a vaginal yeast infection diagnosed by a medical practitioner and you have the same symptoms now, otherwise consult your doctor. These symptoms include itching and burning of the vagina and sometimes a white discharge. For the treatment of vaginal candidiasis in first-time sufferers the condition must be diagnosed by a medical practitioner, and the use of CANESTEN Vaginal Tablet be prescribed by the medical practitioner. iii) If there is no improvement in 3 days or if symptoms have not disappeared in 7 days, then consult a medical practitioner as not all vaginal infections are caused by yeasts. iv) Consult a medical practitioner if you have abdominal pain, fever or a foul-smelling vaginal discharge before or during the use o Read the complete document