Država: Irska
Jezik: angleščina
Source: HPRA (Health Products Regulatory Authority)
FLUCONAZOLE
Intas Pharmaceuticals Limited
150 Milligram
Capsules Hard
2012-03-30
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Fluconazole 150 mg hard capsule 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 150 mg fluconazole Excipients: Contains 157 mg of Lactose monohydrate For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Hard capsule Capsule shell: Size 1, blue body and blue 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 Preberite celoten dokument