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Fluconazole 50mg Capsule POM x7

Fluconazole 50mg Capsule POM x7

Generic

Pharmaceutical Product
  • UK Prescription Only Medicine (POM) with MHRA Granted Marketing Authorisations for fluconazole 50mg hard capsules.
  • Manufactured in accordance with EU/UK Good Manufacturing Practice (GMP) for medicinal products.
  • Meets European Pharmacopoeia/British Pharmacopoeia specifications for fluconazole capsules where applicable.
  • Subject to pharmacovigilance monitoring and periodic safety review by regulatory authorities.
Oral antifungal hard capsules

Description

Fluconazole 50mg Capsule POM x7 is a UK prescription-only generic antifungal medicine containing 50mg fluconazole per hard capsule. Fluconazole is a triazole antifungal agent used in adults and paediatric patients for the treatment and prophylaxis of a wide range of fungal infections, including mucosal and invasive candidiasis, cryptococcal meningitis and certain dermatophyte infections, and for prophylaxis of candidal infections in high-risk patients. This 7-capsule pack is typically used for short-course regimens such as mucosal candidiasis or as part of longer treatment schedules according to the severity and type of infection and prescriber guidance.

Bnefits

  • Broad-spectrum triazole antifungal active against many Candida species, Cryptococcus neoformans and certain dermatophytes.
  • Oral hard capsule formulation with high oral bioavailability, allowing convenient outpatient or home treatment.
  • 50mg strength enables flexible dosing regimens for a wide range of indications, including mucosal and invasive infections.
  • Suitable for both treatment and prophylaxis of fungal infections in adults and paediatric patients, when prescribed.
  • Well-characterised safety and efficacy profile with extensive clinical experience and guideline support.
  • Oral absorption is not significantly affected by food, allowing dosing independent of meals.

Indications

  • Cryptococcal meningitis and maintenance therapy to prevent relapse in patients at high risk of recurrence.
  • Coccidioidomycosis, including chronic and disseminated forms where systemic therapy is indicated.
  • Invasive candidiasis, including candidemia and disseminated candidal infections.
  • Mucosal candidiasis, including oropharyngeal and oesophageal candidiasis, candiduria and chronic mucocutaneous candidiasis.
  • Chronic oral atrophic candidiasis (denture sore mouth) when dental hygiene or topical treatment alone is insufficient.
  • Vaginal candidiasis (acute or recurrent) and candidal balanitis when systemic therapy is appropriate and local therapy is not suitable.
  • Dermatomycosis including tinea pedis, tinea corporis, tinea cruris, tinea versicolor and cutaneous candidal infections where systemic therapy is indicated.
  • Onychomycosis (tinea unguium) when other agents are not considered appropriate.
  • Prophylaxis of relapse of cryptococcal meningitis in high-risk patients.
  • Prophylaxis of relapse of oropharyngeal or oesophageal candidiasis in HIV-infected patients at high risk of recurrence.
  • Prophylaxis to reduce the incidence of recurrent vaginal candidiasis (four or more episodes per year).
  • Prophylaxis of candidal infections in patients with prolonged neutropenia, such as those receiving chemotherapy for haematological malignancies or undergoing haematopoietic stem cell transplantation.

Composition

  • Active ingredient: fluconazole 50mg per hard capsule.
  • Excipient with known effect: lactose monohydrate (approximately 38–52mg per capsule, depending on manufacturer).
  • Other typical excipients: pregelatinised starch, maize starch, colloidal anhydrous silica, magnesium stearate (capsule fill).
  • Capsule shell: hard gelatin capsule (commonly size 4) with colourants such as titanium dioxide (E171) and iron oxides (E172) depending on the specific generic presentation.
  • Printing ink (if present): may contain shellac (E904), propylene glycol (E1520), titanium dioxide (E171), iron oxides (E172) and other standard ink excipients.

Formulation

  • Pharmaceutical form: hard gelatin capsule containing a white to off-white powder.
  • Strength: 50mg fluconazole per capsule.
  • Route of administration: oral.
  • Pharmacotherapeutic group: triazole antifungal, ATC code J02AC01.
  • Oral bioavailability greater than 90% of that achieved by intravenous administration; oral absorption not affected by food.
  • Low plasma protein binding (approximately 11–12%) and extensive distribution into body fluids, including cerebrospinal fluid.

Packaging

  • Pack size: 7 hard capsules (POM), typically blister packed.
  • Blister material: PVC/PVdC-aluminium or similar thermoformed blister laminate (varies by manufacturer).
  • Outer carton or pharmacy label indicating product name, strength, legal category (POM), batch number, expiry date and storage conditions.
  • Intended for supply to registered medical professionals and authorised prescribers via WMS under pharma account approval.

Usage

  • Use only as prescribed by a qualified healthcare professional; dosing and duration depend on the type and severity of fungal infection, patient age, weight, renal function and immune status.
  • Capsules should be swallowed whole with water and can be taken with or without food.
  • For mucosal candidiasis in adults (example regimens): 50mg once daily for 7–14 days (longer in severely immunocompromised patients) as per SmPC and local guidelines.
  • For dermatophyte infections and onychomycosis, higher doses (e.g. 150mg once weekly) and longer durations are commonly used; dosing must follow the specific product SmPC and specialist guidance.
  • For prophylaxis in neutropenic patients and other high-risk groups, dose and duration are determined by the expected period and severity of neutropenia and underlying risk factors.
  • In patients with renal impairment (creatinine clearance ≤50ml/min), maintenance doses should generally be reduced according to the SmPC dose-adjustment table; a normal loading dose may be given on day 1.
  • Therapy should be continued until clinical signs and symptoms of infection have resolved and laboratory tests indicate eradication; inadequate treatment duration may lead to recurrence.
  • If a dose is missed, it should be taken as soon as remembered unless it is almost time for the next dose; patients should not double up doses.
  • Patients should be advised to read the Patient Information Leaflet (PIL) in full and to seek medical advice promptly if they experience signs of liver problems, severe skin reactions, or cardiac symptoms such as palpitations or syncope.

Contraindications

  • Hypersensitivity to fluconazole, other azole antifungal agents, or any of the excipients (including lactose).
  • Coadministration with terfenadine in patients receiving multiple doses of 400mg fluconazole per day or higher.
  • Coadministration with other medicinal products that are known to prolong the QT interval and are metabolised via CYP3A4, such as cisapride, astemizole, pimozide, quinidine and erythromycin.
  • Use in patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption due to lactose content.
  • General contraindications as outlined in the relevant fluconazole 50mg capsule SmPC, including known severe hypersensitivity reactions to azoles.

Adverse Effects

  • Common: headache, nausea, abdominal pain, diarrhoea, dyspepsia and elevated liver enzymes.
  • Uncommon: vomiting, constipation, dry mouth, taste disturbance, rash, pruritus, urticaria, fatigue and malaise.
  • Rare: leukopenia (including neutropenia), thrombocytopenia, agranulocytosis, anaemia, eosinophilia, alopecia.
  • Serious hepatic reactions: hepatitis, cholestasis, jaundice, liver failure (including fatalities), particularly in patients with serious underlying disease; liver function tests should be monitored when indicated.
  • Serious cutaneous adverse reactions: Stevens–Johnson syndrome, toxic epidermal necrolysis, acute generalised exanthematous pustulosis and exfoliative skin reactions, especially in AIDS patients or those with malignancy.
  • Cardiac: QT prolongation and torsades de pointes, particularly in patients with risk factors (e.g. structural heart disease, electrolyte disturbances) or receiving concomitant QT-prolonging drugs.
  • Hypersensitivity reactions: anaphylaxis, angioedema, facial oedema, bronchospasm.
  • Metabolic: electrolyte disturbances (e.g. hypokalaemia) and changes in serum cholesterol or triglycerides have been reported.
  • Other: seizures, dizziness, insomnia, somnolence, paresthesia and other neurologic events have been observed in post-marketing experience.

Storage Conditions

  • Store below 25°C (or as specified on the dispensed pack) in the original package to protect from moisture and light.
  • Keep the blister strips or container tightly closed when not in use.
  • Do not use after the expiry date printed on the carton and blister pack.
  • Keep out of the sight and reach of children.
  • Dispose of any unused medicine in accordance with local requirements (e.g. return to pharmacy); do not dispose of via wastewater or household waste.

Duration

Treatment duration varies widely by indication: often 7\u201314 days for mucosal candidiasis, several weeks to months for cryptococcal meningitis or onychomycosis, and for the full at-risk period in prophylactic use. The exact course length must be determined by the prescriber based on clinical response and relevant guidelines.

Onset

Clinical improvement in susceptible infections is typically observed within several days of starting appropriate therapy, although full resolution and mycological cure may require sustained treatment for the entire prescribed course.

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