Soft Gel Pessary combination: How comforting
Canesten® Soft Gel Pessary Combi has a teardrop shape, designed to be soft and comfortable to insert. Together with the 2% w/w cream, it works to clear the internal infection and soothe the external symtoms. Oral & Cream O
Combi
Pessary & Cream eam e Clotrimazole
Canesten® Combi 500mg Soft Gel Pessary & 2% Cream (clotrimazole 500mg soft gel pessary and clotrimazole 2% w/w cream). Indications: Treatment of candidal vaginitis and mixed vaginal infections where Trichomonas is present or suspected, and candidal vulvitis. Not recommended as sole treatment for pure Trichomoniasis except when systemic therapy is contra-indicated. It can also be used for treatment of the sexual partner’s penis to prevent reinfection. Dosage and Administration: Adults: The soft gel pessary should be inserted into the vagina at night using the applicator. Treatment should be finished before the onset of menstruation. The cream should be applied to the vulva and surrounding area two or three times daily and rubbed in gently. Treatment with the cream should be continued until symptoms of the infection disappear. However, if after concomitant treatment of the vaginitis, the symptoms do not improve within seven days, the patient should consult a physician. For treatment of the sexual partner’s penis, the cream should be applied two or three times daily for up to two weeks. Children: Not recommended in children under 16 as the product is used with an applicator. Contraindications: Hypersensitivity to clotrimazole or any other ingredients in the medicine e.g. cetostearyl alcohol. Warnings and Precautions: Patients should be advised to consult their physician if the symptoms have not been relieved within one week of using Canesten 500mg Soft Gel Pessary. Canesten 500mg Soft Gel Pessary can be used again if the candidal infection returns after 7 days. However, if the candidal infection recurs more than twice within six months, patients should be advised to consult their physician. This product may damage latex contraceptives therefore patients should use alternative precautions for at least five days after using the product. Side-effects: Allergic reaction, genital peeling/exfoliation, blisters, pruritis, rash, oedema, discomfort/ pain, stinging/burning, irritation, pelvic pain, abdominal pain. Use in Pregnancy: Only when considered necessary by a physician. During pregnancy the pessary should be inserted without using an applicator. Cost: £12.00 (Excl. VAT). MA Number: PL 00010/0636. MA Holder: Bayer plc, Consumer Care Division, Newbury, Berkshire RG14 1JA, UK. Legal Category: POM. Date of Preparation: February 2012. Canesten® Combi 500mg Pessary & 2% Cream (clotrimazole 500mg pessary and clotrimazole 2% w/w cream). Indications: Treatment of candidal vaginitis and mixed vaginal infections where Trichomonas is present or suspected, and candidal vulvitis. Not recommended as sole treatment for pure Trichomoniasis except when systemic therapy is contra-indicated. It can also be used for treatment of the sexual partner’s penis to prevent re-infection. Dosage and Administration: Adults: The pessary should be inserted into the vagina using the applicator. The cream should be applied to the vulva and surrounding area two or three times daily and rubbed in gently. If the cream is being used for treatment of the sexual
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Soft Gel Pessary Combi
500mg Soft Gel Pessary & 2% w/w Cream Clotrimazole
partner’s penis it should be applied two or three times daily for up to two weeks. Children: Paediatric use is not recommended. Contraindications: Hypersensitivity to clotrimazole or any other ingredients in the medicine e.g. cetostearyl alcohol. Warnings and Precautions: Creams contain cetostearyl alcohol which may cause local skin reactions (e.g. contact dermatitis). Do not use during menstrual period. Known hypersensitivity to imidazoles or other vaginal antifungal products. These products may damage latex contraceptives and therefore patients should use alternative precautions for at least five days after using them. Side-effects: Rarely, local mild burning or irritation immediately after use. Allergic reaction, pelvic pain, pruritis and rash. Blisters, discomfort/pain, oedema, irritation, genital peeling/exfoliation and burning/stinging. Use in Pregnancy: Only when considered necessary by a physician. During pregnancy the pessary should be inserted without using an applicator. Cost: Cost: £11.20 (Excl. VAT). MA Numbers: PL 00010/0258 & PL 00010/0077. MA Holder: Bayer plc, Consumer Care Division, Newbury, Berkshire RG14 1JA, UK. Legal Category: POM. Date of Preparation: February 2012. Canesten® Oral & Cream Duo (fluconazole 150mg capsule, plus 10g tube of clotrimazole 2% w/w cream). Indications: The capsule is for treatment of candidal vaginitis, acute or recurrent. Also for treatment of partners with associated candidal balanitis. The cream is for the treatment of candidal vulvitis. Dosage and Administration: Adults (16 – 60 years): Swallow one capsule whole. Apply cream to vulva and surrounding area two or three times daily and rub in gently. Treatment with the cream should be continued until symptoms of the infection disappear. If after concomitant treatment of vaginitis, symptoms do not improve within seven days, the patient should consult a physician. For treatment of sexual partner’s penis, cream should be applied two or three times daily for two weeks. Children: Paediatric usage is not recommended (in under 16). Contraindications: Hypersensitivity to fluconazole, clotrimazole, related azole compounds or any of the excipients e.g. cetostearyl alcohol; coadministration with terfenadine, cisapride or ergot-derivatives. Warnings and Precautions: Adequate contraception necessary. A physician should be consulted if the patient or partner have had exposure to sexually transmitted disease, or if the patient: has had more than two infections of thrush in the last six months; is experiencing thrush for the first time; has known hypersensitivity to other vaginal antifungal products; is taking any medicine other than the Pill; has any disease or illness affecting the liver or kidneys or has had unexplained jaundice; suffers from any other chronic disease or illness; is uncertain of the cause of symptoms. Or if the patient has any of the following symptoms: abnormal or irregular vaginal bleeding or a blood-stained discharge; vulval or vaginal sores, ulcers or blisters; lower abdominal pain or dysuria; any adverse events such as redness, irritation or swelling associated with the treatment; fever or
Duo®
Fluconazole & F C Clotrimazole
chills; nausea or vomiting; diarrhoea; foul smelling vaginal discharge. In men, medical advice should be sought if they have penile sores, ulcers or blisters, there is abnormal penile discharge, the penis has started to smell, they have dysuria, or their sexual partner does not have thrush. Patients should consult their doctor if symptoms have not been relieved within one week of treatment. Fluconazole has been associated with rare cases of serious hepatic toxicity, including fatalities primarily in patients with serious underlying medical conditions. Fluconazole must be taken with particular care in patients with congenital or acquired QT prolongation and torsades de pointes or a history thereof, known cardiomyopathy, sinus bradycardia, cardiac arrhythmia, or are treated with a co-medication potentially leading to QT prolongation. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucosegalactose malabsorption should not take this capsule. The cream contains cetostearyl alcohol, which may cause local skin reactions (e.g. contact dermatitis). The cream may damage latex contraceptives so patients should be advised to use alternative precautions for at least five days after using the product. Side-effects: Oral capsule may cause nausea, diarrhoea, vomiting, gastrointestinal and abdominal pains, abdominal distension and flatulence. Leukopenia, neutropenia, agranulocytosis and thrombocytopenia. Torsades de pointes/QT prolongation. Mild transient elevations in transaminases, hepatitis (non infective), jaundice, cholestatis and acute hepatic failure, including fatalities. Allergic reaction, anaphylactic reaction, anaphylactic shock. Hypersensitivity reactions including rash, urticaria, oedema, pruritus, cardio-respiratory distress. Electrocardiogram QT prolonged, electrocardiogram QT corrected interval prolonged, hypercholesterolaemia, hypertriglyceridaemia and hypokalaemia. Seizures, dizziness, headache, dysgeusia. Rash, pruritis, alopecia, exfoliative skin reactions including Stevens-Johnson syndrome, toxic epidermal necrolysis. Cream may cause allergic reactions, blisters, discomfort/pain, oedema, irritation, peeling/exfoliation, pruritus, rash, stinging/burning. Use in pregnancy: Do not use during pregnancy, suspected pregnancy and breast-feeding. Cost: £11.20 (Excl. VAT). MA Number: PL 00010/0282 & PL 00010/0077. MA Holder: Bayer plc, Consumer Care Division, Newbury, Berkshire RG14 1JA, UK. Legal Category: P. Date of Preparation: February 2012. Adverse events should be reported. Reporting forms and information can be found at ‘www.mhra.gov.uk/yellowcard’. Adverse events should also be reported to Bayer plc, Consumer Care Division. ® = Registered trademark of Bayer AG.
Item code: CGY349 Date of preparation: May 2013