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Canesten® Thrush Combi Pessary & External Cream 500mg / 2% w/w pessary & cream (clotrimazole 500mg pessary, plus a 10g tube clotrimazole 2% cream w/w). Indications: The pessary is recommended for the treatment of candidal vaginitis. The cream is recommended for the treatment of candidal vulvitis. The cream should be used as an adjunct to treatment of candidal vaginitis. Dosage and Administration: Adults (16 - 60 years): The pessary should be inserted into the vagina using the applicator preferably at bedtime. Apply the cream to the vulva and surrounding area two or three times daily and rub in gently. Children: Paediatric usage is not recommended (in under 16). Contraindications: Hypersensitivity to clotrimazole or any other ingredients. Nail or scalp infections. Warnings and Precautions: Medical advice must be sought if this is the first time the patient has experienced symptoms of candidal vulvovaginitis or if any of the following are applicable: more than two infections of candidal vaginitis in the last six months; previous history of, or exposure to partner with a sexually transmitted disease; pregnancy or suspected pregnancy; aged under 16 or over 60 years; known hypersensitivity to imidazole or other vaginal antifungal products. Medical advice should be sought if the patient has any of the following symptoms: irregular vaginal bleeding; abnormal vaginal bleeding or a blood-stained discharge; vulval or vaginal ulcers, blisters or sores; lower abdominal pain or dysuria; any adverse events such as redness, irritation or swelling associated with the treatment; fever or chills; nausea or vomiting; diarrhoea; foul smelling vaginal discharge. If no improvement in symptoms is seen after seven days, the patient should consult their doctor. The treatment should be finished before the onset of menstruation. Do not use tampons, intravaginal douches, spermicides or other vaginal products while using this product. Vaginal intercourse should be avoided in case of vaginal infection and while using this product because the partner could become infected. This product may damage latex contraceptives therefore patients should use alternative precautions for at least five days after using the product. Administer with caution in patients taking oral tacrolimus and sirolimus; levels must be closely monitored for signs of tacrolimus or sirolimus overdosage. The cream contains cetostearyl alcohol, which may cause local skin reactions (e.g. contact dermatitis). The product also contains benzyl alcohol which may cause allergic reactions and mild local irritation. Undesirable effects: Anaphylactic reaction, angioedema, hypersensitivity, syncope, hypotension, dyspnea, abdominal pain, nausea, rash, urticaria, pruritus, vaginal exfoliation, vaginal discharge, vaginal haemorrhage, vulvovaginal discomfort, vulvovaginal erythema, vulvovaginal burning sensation, vulvovaginal pruritus, vulvovaginal pain, blister, dermatitis contact, erythema, paraesthesia, skin exfoliation, stinging skin/burning sensation skin, application site irritation, application site reaction, oedema, pain. Use in pregnancy: Only under the supervision of a physician or midwife. During pregnancy the pessary should be inserted without using an applicator. RRP: £17.39. MA Number: PL 00010/0300. MA Holder: Bayer plc, 400 South Oak Way, Reading, RG2 6AD, United Kingdom. Legal Category: GSL. Date of Preparation: March 2022. ® Registered trademark of Bayer AG