Fluconazol-BP (caps)

Fluconazolum

Fluconazol-BP 150 mg capsules: each capsule contains fluconazole 150 mg (excipient with known effect: lactose monohydrate 149.12 mg). Fluconazol-BP 200 mg capsules: each capsule contains fluconazole 200 mg (excipient with known effect: lactose monohydrate 198.83 mg).

Indication: Treatment of fungal infections in adults: cryptococcal meningitis, coccidioidomycosis, invasive candidiasis, mucosal candidiasis (oropharyngeal, oesophageal, chronic mucocutaneous), vaginal candidiasis or candidal balanitis, dermatomycoses (tinea) including onychomycosis. Prevention of relapse of cryptococcal and Candida infections in high-risk patients (including AIDS, prolonged neutropenia).

Contraindications (SmPC sec. 4.3): 4.3 Contraindications − Hypersensitivity to the active substance, to other related azole compounds, or to any of the excipients listed in section 6.1. − Concomitant administration of terfenadine is contraindicated in patients receiving Fluconazol-BP at multiple doses of 400 mg daily or higher, based on the results of a multiple-dose drug interaction study. − Concomitant administration of other medicinal products that prolong the QT interval and are metabolised via the cytochrome P450 CYP3A4 isoenzyme, such as cisapride, astemizole, pimozide, quinidine and erythromycin, is contraindicated in patients receiving fluconazole (see sections 4.4 and 4.5). − Children under 12 years of age (due to the pharmaceutical form).

Special warnings and precautions (SmPC sec. 4.4, excerpt): 4.4 Special warnings and precautions for use Tinea capitis Studies have been conducted on the use of fluconazole for the treatment of tinea capitis in children. It was shown not to be superior to griseofulvin, and the overall success rate was less than 20%. Fluconazol-BP should therefore not be used for the treatment of tinea capitis. Cryptococcosis Data on the efficacy of fluconazole in treating cryptococcosis at other sites (e.g. pulmonary and cutaneous cryptococcosis) are limited, and no dosage recommendation can be made. Deep endemic mycoses Data on the efficacy of fluconazole in treating other forms of endemic mycosis, such as paracoccidioidomycosis, lymphocutaneous sporotrichosis and histoplasmosis, are limited, and no dosage recommendation can be made. Candidiasis Studies have shown […]