Country: Írland
Tungumál: enska
Heimild: HPRA (Health Products Regulatory Authority)
FLUCONAZOLE
Actavis Group PTC ehf
100 Milligram
Capsules Hard
2011-04-15
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Fluconazole Actavis 100 mg capsules, hard 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 100 mg fluconazole. Excipient: Each hard capsule contains 82 mg lactose monohydrate. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Capsule, hard. Fluconazole Actavis 100 mg consists of light blue cap and white body, size “2” hard gelatine capsules, filled with white powder. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Fluconazole Actavis is indicated for treatment of following infections caused by fungi which are known to be or are likely to be susceptible to fluconazole: - Acute and recurrent vaginal candidiasis when systemic therapy is considered appropriate. - Verified fungal infections of the skin such as tinea corporis/tinea cruris/tinea pedis (caused by dermatophytes), tinea versicolor or candidiasis when topical treatment has not succeeded or is considered inadequate. Fluconazole should only be used to treat tinea versicolor when the infection is resistant to first line therapy or when the patient is immunocompromised. - Mucosal candidiasis, including oropharyngeal, oesophagal, mucocutaneous and non-invasive bronchopulmonary candidiasis. - Candiduria in immunocompromised patients. - Systemic candidiasis (candidaemia, disseminated deep candidiasis, peritonitis) in non-neutropenic patients. - Prophylaxis of _Candida _infections in patients with neutropenia (e.g. due to AIDS or bone marrow transplantation). - Treatment and maintenance therapy to prevent relapse of cryptococcal meningitis in immunocompromised patients. _Paediatric use_ Fluconazole Actavis should not be used for tinea capitis. Not all indications are applicable for paediatric patients; see details in section 4.2. Consi Lestu allt skjalið