1. Name of the medicinal product
Fluconazole 150mg Capsules
2. Qualitative and quantitative composition
Each capsule contains fluconazole 150mg
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Hard gelatin capsule
Size 1, blue/blue capsules containing white crystalline powder
4. Clinical particulars
4.1 Therapeutic indications
Fluconazole capsule is indicated in the following fungal infections (see section 5.1).
Fluconazole capsule is indicated in adults for the treatment of:
• Cryptococcal meningitis (see section 4.4).
• Coccidioidomycosis (see section 4.4).
• Invasive candidiasis.
• Mucosal candidiasis including oropharyngeal, oesophageal candidiasis, candiduria and chronic mucocutaneous candidiasis.
• Chronic oral atrophic candidiasis (denture sore mouth) if dental hygiene or topical treatment are insufficient.
• Vaginal candidiasis, acute or recurrent; when local therapy is not appropriate.
• Candidal balanitis when local therapy is not appropriate.
• Dermatomycosis including tinea pedis, tinea corporis, tinea cruris, tinea versicolor and dermal candida infections when systemic therapy is indicated.
• Tinea unguinium (onychomycosis) when other agents are not considered appropriate.
Fluconazole capsule is indicated in adults for the prophylaxis of:
• Relapse of cryptococcal meningitis in patients with high risk of recurrence.
• Relapse of oropharyngeal or oesophageal candidiasis in patients infected with HIV who are at high risk of experiencing relapse.
• To reduce the incidence of recurrent vaginal candidiasis (4 or more episodes a year).
• Prophylaxis of candidal infections in patients with prolonged neutropenia (such as patients with haematological malignancies receiving chemotherapy or patients receiving Hematopoietic Stem Cell Transplantation (see section 5.1)).
Fluconazole capsule is indicated in term newborn infants, infants, toddlers, children, and adolescents aged from 0 to 17 years old:
Fluconazole capsule is used for the treatment of mucosal candidiasis (oropharyngeal, oesophageal), invasive candidiasis, cryptococcal meningitis and the prophylaxis of candidal infections in immunocompromised patients. Fluconazole capsule can be used as maintenance therapy to prevent relapse of cryptococcal meningitis in children with high risk of reoccurrence (see section 4.4).
Therapy may be instituted before the results of the cultures and other laboratory studies are known; however, once these results become available, anti-infective therapy should be adjusted accordingly.
Consideration should be given to official guidance on the appropriate use of antifungals.
4.2 Posology and method of administration
The dose should be based on the nature and severity of the fungal infection. Treatment of infections requiring multiple dosing should be continued until clinical parameters or laboratory tests indicate that active fungal infection has subsided. An inadequate period of treatment may lead to recurrence of active infection.