BELLS HEALTHCARE THRUSH RELIEF

For oral administration. Adults Vaginal candidiasis or candidal balanitis - 150mg as a single oral dose. 2). Elderly Not recommended in patients aged over 60 years. Use in renal impairment Fluconazole is excreted predominantly in the urine as unchanged drug.

No adjustments in single dose therapy are required. 4).

4 Special Warnings and Special Precautions for Use) have been observed during treatment with fluconazole and comparative agents, but the clinical significance and relationship to treatment is uncertain. 4). The most frequently (≥1/100 to <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 undesirable effects have been observed and reported during treatment with fluconazole with the following frequencies: Very common (≥1/10); common (≥ 1/100 to <1/10); uncommon (≥1/1000, <1/100), rare (≥1/10000, <1/1000) and very rare (<1/10000), not known (cannot be estimated form the available data).

4), dermatitis exfoliative, angioedema, face oedema, alopecia Skin and subcutaneous tissue disorders Not known Drug reaction with eosinophilia and systemic symptoms (DRESS) Musculoskeletal and connective tissue disorders Uncommon Myalgia General disorders and administration site conditions Uncommon Fatigue, malaise, asthenia, fever *: Including fixed drug eruption.

Paediatric Population The pattern and incidence of side effects 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.

2). 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. 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. 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 discontinued immediately 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. Fluconazole causes QT prolongation via the inhibition of Rectifier Potassium Channel current (Ikr).

The QT prolongation caused by other medicinal products (such as amiodarone) may be amplified via the inhibition of cytochrome P450 (CYP) 3A4. 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 medicines that may have been contributory. 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 should be administered with caution to patients with these potentially proarrhythmic conditions. 5). 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. AIDS patients are more prone to the development of severe cutaneous reactions to many drugs.

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.

Drug reaction with eosinophilia and systemic symptoms (DRESS) has been reported. albicans. g. 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.

3). Cytochrome P450 Fluconazole is a moderate CYP2C9 and CYP3A4 inhibitor. Fluconazole is also an inhibitor of CYP2C19. 5). 5). The product intended for pharmacy availability without prescription will carry a leaflet which will advise the patient: Do not use Fluconazole 150mg capsule 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 Fluconazole 150mg capsule or other antifungals and other thrush treatments. • If you are taking any medicine other than the contraceptive 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 about the cause of your symptoms. Women only: • If you are pregnant, suspect you might be pregnant or are breast feeding. • 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 on passing urine. Men only: • If your sexual partner does not have vaginal 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. The product should never be used again if the […]

1 or to related azole compounds. Co-administration of terfenadine is contraindicated in patients receiving Fluconazole at multiple doses of 400 mg per day or higher based upon results of a multiple dose interaction study. 5). Fluconazole should not be used in patients with porphyria.