País: Irlanda
Língua: inglês
Origem: HPRA (Health Products Regulatory Authority)
FLUCONAZOLE
Eireceutica Limited
FLUCONAZOLE
150 Milligram
Capsule
Product subject to prescription which may be renewed (B)
Authorised
0000-00-00
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Caneclear 150 mg hard capsule 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 150 mg of fluconazole Excipients: each hard capsule also contains 150 mg lactose, 0.384 mg methyl parahydroxybenzoate (E218) and 0.096 mg propyl parahydroxybenzoate (E216). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Capsule, hard Hard gelatin blue coloured capsule, size “1”. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Caneclear is indicated in the following fungal infections in adults (see section 5.1): - Acute vaginal candidiasis when local therapy is not appropriate. - _Candidal balanitis _when local therapy is not appropriate_._ 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. Consideration should be given to official guidance on the appropriate use of antifungals. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults_ Single dose 150 mg. Special populations _Elderly_ Where there is no evidence of renal impairment, normal dose recommendations should be adopted. _Renal impairment_ Fluconazole is predominantly excreted in the urine as unchanged active substance. No adjustments in single dose therapy are necessary. _Hepatic impairment_ Limited data are available in patients with hepatic impairment, therefore fluconazole should be administered with caution to patients with liver dysfunction (see sections 4.4 and 4.8). _Paediatric population_ Safety and efficacy for genital candidiasis indication in paediatric population has not been established. Current available data for other paediatric indications are described in section 4.8. IRISH MEDIC Leia o documento completo