CANESTEN THRUSH DUO is a brand name for Fluconazole. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Canesten Thrush Oral Capsule is indicated for the treatment of candidal vaginitis, acute or recurrent. It should also be used for the treatment of partners with associated candidal balanitis. Canesten Thrush External Cream is indicated for the treatment of candida vulvitis. It should be used as an adjunct to treatment…
Verbatim from this product's MHRA label. Tap a section to expand.
Adults (16 to 60):
One capsule should be swallowed whole. The cream should be applied thinly two or three times daily to the vulva and surrounding area 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 doctor. If the cream is being used for treatment of the sexual partner’s penis it should be applied two or three times daily for up to two weeks.
Children (under 16):
Paediatric use is not recommended.
Elderly:
Not recommended in patients over 60.
Renal Impairment:
There is no separate dosage schedule in patients with renal impairment for single dose therapy.
The listed undesirable effects are based on spontaneous reports, thus assigning accurate frequency of occurrence for each is not possible. 4). The most frequently (>1/10) reported adverse reactions are headache, abdominal pain, diarrhoea, nausea, vomiting, alanine aminotransferase increased, aspartate aminotransferase increased, blood alkaline phosphatase increased and rash.
The following adverse reactions have been observed and reported during treatment with Fluconazole with the following frequencies: Common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000) not known (cannot be estimated from the available data).
Blood and lymphatic system disorders Uncommon:
Anaemia.
Rare:
Agranulocytosis, leukopenia, thrombocytopenia, neutropenia.
Immune System Disorders Rare:
Anaphylaxis.
Not known:
Hypersensitivity.
Metabolism and nutrition disorders Uncommon:
Decreased appetite.
Rare:
Hypercholesterolaemia, hypertriglyceridaemia, hypokalaemia.
Psychiatric disorders Uncommon:
Somnolence, insomnia.
Nervous system disorders Common:
Headache.
Uncommon:
Medical advice should be sought if this is the first time the patient has experienced symptoms of candidal vaginitis. The product is available from pharmacies without prescription and includes a leaflet that advises the patient - Do not use Canesten Thrush Duo Oral Capsule & External Cream without first consulting your doctor: If you are under 16 or over 60 years of age If you are allergic to any of the ingredients in Canesten Thrush Duo Oral Capsule & External Cream or other antifungals and other thrush treatments If you are taking any other medicine other than the Pill.
If you are taking the antihistamine terfenadine or the prescription medicine cisapride If you have had thrush more than twice in the last six months If you have any disease or illness affecting your liver or kidneys or have had unexplained jaundice.
If you suffer from any other chronic disease or illness. If you or your partner have had exposure to a sexually transmitted disease. If you are unsure of the cause of your symptoms.
Women only:
If you are pregnant, suspect you might be pregnant or are breastfeeding. If you have any abnormal or irregular vaginal bleeding or a blood stained discharge If you have vulval or vaginal sores, ulcers or blisters. If you are experiencing lower abdominal pain or burning sensation on passing water.
If you are experiencing any adverse events such as redness, irritation or swelling associated with the treatment. If you are experiencing fever or chills, nausea, vomiting or diarrhoea. If you have foul smelling vaginal discharge.
Men only:
If your sexual partner does not have thrush. If you have penile sores, ulcers or blisters. If you have an abnormal penile discharge (leakage). If your penis has started to smell. If you have pain on passing urine. Recurrent use (men and women): patients should be advised to consult their physician if the symptoms have not been relieved within one week of taking Canesten Oral Capsule.
1. 5). Coadministration of terfenadine is contraindicated based upon results of a multiple dose interaction study.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Seizures, paraesthesia, dizziness, dysgeusia.
Rare:
Tremor.
Ear and labyrinth disorders Uncommon:
Vertigo. 4).
Gastrointestinal disorders Common:
Abdominal pain, vomiting, diarrhoea, nausea.
Uncommon:
Constipation, dyspepsia, flatulence, dry mouth. 4).
Uncommon:
Jaundice, cholestasis, bilirubin increased. 4). 4). 4), pruritus, hyperhidrosis.
Rare:
Toxic epidermal necrolysis, Stevens-Johnson syndrome, acute generalised exanthematous-pustulosis, dermatitis exfoliative, angioedema, face oedema, alopecia.
Not Known:
Drug reaction with eosinophilia and systemic symptoms (DRESS). . *including Fixed Drug Eruption.
Musculoskeletal and connective tissue disorders Uncommon:
Myalgia.
General disorders and administration site conditions Uncommon:
Fatigue, malaise, asthenia, pyrexia. Canesten Thrush External Cream Immune System Disorders Anaphylactic reaction, angioedema, hypersensitivity. Skin and subcutaneous tissue disorders Blister, dermatitis contact,, erythema, paraesthesia, skin exfoliation, pruritus, rash, urticaria, stinging skin/burning sensation skin.
General disorders and administration site conditions:
Application site irritation, application site reaction, oedema, pain. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
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Canesten Oral Capsule can be used 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.
Candidiasis:
Studies have shown an increasing prevalence of infections with Candida species other than C. albicans. g. C. krusei and C. auris) or show reduced susceptibility to fluconazole (C. glabrata). Such infections may require alternative antifungal therapy secondary to treatment failure.
Therefore, prescribers are advised to take into account the prevalence of resistance in various Candida species to fluconazole. 2). Adrenal insufficiency Ketoconazole is known to cause adrenal insufficiency and this could also, although rarely seen, be applicable to fluconazole.
Hepatobiliary system Fluconazole should be administered with caution to patients with liver dysfunction. Fluconazole has been associated with rare cases of serious hepatic toxicity, including fatalities primarily in patients with serious underlying medical conditions.
The patient should be informed of suggestive symptoms of serious hepatic effect (important asthenia, anorexia, persistent nausea, vomiting and jaundice) and be advised to consult a doctor. Cardiovascular system Some azoles, including fluconazole, have been associated with prolongation of the QT interval on the electrocardiogram.
5). Patients with hypokalaemia and advanced cardiac failure are at an increased risk for the occurrence of life threatening ventricular arrhythmias and torsades de pointes. Fluconazole must be administered with caution in patients with congenital or acquired QT prolongation, known cardiomyopathy, sinus bradycardia, cardiac arrhythmia, or history of torsades de pointes or other proarrhythmic conditions.
Dermatological reactions Patients have rarely developed exfoliative cutaneous reactions such as Stevens Johnson syndrome and toxic epidermal necrolysis during treatment with fluconazole. Drug reaction with eosinophilia and systemic symptoms (DRESS) has been reported.
The patient should be advised to consult a doctor if a rash, which is considered attributable to fluconazole, develops. Hypersensitivity The product should never be used again if the patient experiences a rash or anaphylaxis following the use of the drug.
5). Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine. g. contact dermatitis). The cream also contains benzyl alcohol which may cause allergic reactions and mild local irritation.