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SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Fluconazole 50 mg hard capsule
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains 50 mg fluconazole
Excipients: Contains 52 mg of Lactose monohydrate
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Hard capsule
Capsule shell: Size 4, white body and green cap.
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 C
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