Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
FLUCONAZOLE
Kellpharm Limited
150 Milligram
Capsule
2005-10-21
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Flucomel 150 mg Capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 150mg fluconazole. For excipients, see 6.1. 3 PHARMACEUTICAL FORM Hard capsule. Size 1 hard capsule with a white cap and a white body. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS 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. Flucomel is indicated for: 1. Genital candidiasis. Vaginal candidiasis, acute or recurrent. Candidal balanitis. 2. Mucosal candidiasis. These include oropharyngeal, oesophageal, non-invasive bronchopulmonary infections, candiduria, mucocutaneous and chronic oral atrophic candidiasis (denture sore mouth). Normal hosts and patients with compromised immune function may be treated. 3. Systemic candidiasis including candidaemia, disseminated candidiasis and other forms of invasive candidal infection. These include infections of the peritoneum, endocardium and pulmonary and urinary tracts. Candidal infections in patients with malignancy, in intensive care units of those receiving cytotoxic or immunosuppressive therapy, may be treated. 4. Cryptococcosis, including cryptococcal meningitis and infections of other sites (e.g. pulmonary cutaneous). Normal hosts and patients with acquired immune deficiency syndrome (AIDS), organ transplants or other causes of immunosuppression may be treated. Flucomel can be used as maintenance therapy to prevent relapse of cryptococcal disease in patients with AIDS. 5. Prevention of fungal infections in patients with malignancy who are predisposed to such infections as a result of cytotoxic chemotherapy or radiotherapy, including bone marrow transplant patients. 6. Dermatomycoses includ Read the complete document