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FLUCONAZOLE is a brand name for Fluconazole. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Fluconazole 150mg Hard Capsules are for the treatment of the following conditions: • Vaginal candidiasis, acute or recurrent; or candidal balanitis associated with vaginal candidiasis.
Verbatim from this product's MHRA label. Tap a section to expand.
In Adults aged 16 – 60 years:
Vaginal candidiasis or candidal balanitis – 150 mg single oral dose.
In Children:
Not recommended in children aged under 16 years.
Use in Elderly:
Not recommended in patients aged over 60 years. Renal Impairment Fluconazole is predominantly excreted in the urine as unchanged active substance. No adjustments in single dose therapy are necessary. 8). Method of administration The capsules should be swallowed whole and independent of food intake.
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: Very common (≥1/10); 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).
4). 4), dermatitis exfoliative, angioedema, face oedema, alopecia Drug reaction with eosinophilia and systemic symptoms (DRESS) Musculoskeletal and connective tissue disorders Myalgia General disorders and administration site conditions Fatigue, malaise, asthenia, fever * including Fixed Drug Eruption Paediatric Population The pattern and incidence of adverse reactions and laboratory abnormalities recorded during paediatric clinical trials, excluding the genital candidiasis indication, are comparable to those seen in adults.
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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
The product intended for pharmacy availability without prescription will carry a leaflet which will advise the patient: Do not use Fluconazole 150mg Hard Capsules without first consulting your doctor or pharmacist: if you • develop signs of ‘adrenal insufficiency’ where the adrenal glands do not produce adequate amounts of certain steroid hormones such as cortisol (chronic, or long lasting fatigue, muscle weakness, loss of appetite, weight loss, abdominal pain).
• are under 16 or over 60 years of age. • are allergic to any of the ingredients in Fluconazole 150mg Hard Capsules or other antifungals and other thrush treatments. • are taking any medicine other than the Pill. • are taking the antihistamine terfenadine or the prescription medicine cisapride.
• have had thrush more than twice in the last six months. • have any disease or illness affecting your liver or kidneys or have had unexplained jaundice. • suffer from any other chronic disease or illness. • or your partner have had exposure to a sexually transmitted disease.
• are unsure about the cause of your symptoms. Women only if you: • are pregnant, suspect you might be pregnant or are breast feeding. • have any abnormal or irregular vaginal bleeding or a blood stained discharge. • have vulval or vaginal sores, ulcers or blisters.
• are experiencing lower abdominal pain or burning on passing urine. Men only if you: • have penile sores, ulcers or blisters. • have an abnormal penile discharge (leakage). • have pain on passing urine. If your: • penis has started to smell.
• sexual partner does not have thrush. The product should never be used again if the patient experiences a rash or anaphylaxis follows the use of the drug. 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 Fluconazole 150mg Hard Capsules.
1. Coadministration of terfenadine is contraindicated in patients receiving fluconazole at multiple doses of 400mg per day or higher based upon results of a multiple dose interaction study. 5).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Fluconazole in United Kingdom.
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Fluconazole 150mg Hard Capsules 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). Hepatobiliary system Fluconazole has been associated with rare cases of serious hepatic toxicity including fatalities, primarily in patients with serious underlying medical conditions. In cases of fluconazole associated hepatotoxicity, no obvious relationship to total daily dose, duration of therapy, sex or age of patient has been observed.
Fluconazole hepatotoxicity has usually been reversible on discontinuation of therapy. Patients who develop abnormal liver function tests during fluconazole therapy must be monitored closely for the development of more serious hepatic injury.
The patient should be informed of suggestive symptoms of serious hepatic effect (important asthenia, anorexia, persistent nausea, vomiting and jaundice). Treatment of fluconazole should be immediately discontinued and the patient should consult a physician.
Cardiovascular system Some azoles, including fluconazole, have been associated with prolongation of the QT interval on the electrocardiogram. During post-marketing surveillance, there have been very rare cases of QT prolongation and torsades de pointes in patients taking fluconazole.
These reports included seriously ill patients with multiple confounding risk factors, such as structural heart disease, electrolyte abnormalities and concomitant treatment that may have been contributory. Fluconazole should be administered with caution to patients with these potentially proarrhythmic conditions.
5). Adrenal insufficiency Ketoconazole is known to cause adrenal insufficiency and this could also, although rarely seen, be applicable to fluconazole. 5 (The effect of fluconazole on other medicinal products). Halofantrine Halofantrine has been shown to prolong QTc interval at the recommended therapeutic dose and is a substrate of CYP3A4.
5). 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.
AIDS patients are more prone to the development of severe cutaneous reactions to many medicinal products. If a rash, which is considered attributable to fluconazole, develops in a patient treated for a superficial fungal infection, further therapy with this medicinal product should be discontinued.
If patients with invasive/systemic fungal infections develop rashes, they should be monitored closely and fluconazole discontinued if bullous lesions or erythema multiforme develop. 3). Cytochrome P450 Fluconazole is a potent CYP2C9 inhibitor and a moderate CYP3A4 inhibitor.
Fluconazole is also an inhibitor of CYP2C19. Fluconazole treated patients who are concomitantly treated with medicinal products with a narrow therapeutic window metabolised through CYP2C9, CYP2C19 and CYP3A4, should be […]