Land: Irland
Sprog: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
FLUCONAZOLE
Teva Pharma B.V.
J02AC01
FLUCONAZOLE
150 Milligram
Capsules Hard
Product subject to prescription which may be renewed (B)
Triazole derivatives
Authorised
2010-09-10
PACKAGE LEAFLET: INFORMATION FOR THE USER Diflazole 150 mg Capsules, hard READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Keep this leaflet. You may need to read it again. If you have any further question, ask your doctor or pharmacist. This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. If you get any side effects talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet, See section 4. WHAT IS IN THIS LEAFLET 1. What Diflazole is and what it is used for? 2. What you need to know before you take Diflazole 3. How to take Diflazole 4. Possible side- effects 5. How to store Diflazole 6. Contents of the pack and other information 1. WHAT DIFLAZOLE IS AND WHAT IT IS USED FOR Diflazole is one of a group of medicines called “antifungals”. The active substance is fluconazole. _ _ Diflazole 150 mg Capsules, hard is used in adults to treat infections caused by fungi. The most common cause of fungal infections is a yeast called_ Candida_. You might be given this medicine by your doctor to treat genital thrush, infection of the vagina or penis. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DIFLAZOLE _ _ DO NOT TAKE DIFLAZOLE_ _ If you are allergic to fluconazole, to other medicines you have taken to treat fungal infections or to any of the other ingredients of this medicine (listed in section 6). The symptoms may include itching, reddening of the skin or difficulty in breathing If you are taking astemizole, terfenadine (antihistamine medicines Læs hele dokumentet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Diflazole 150 mg Capsules, hard. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 150 mg fluconazole. Excipient(s) with known effect: Also contains 50 mg lactose and 0.02mg Sunset yellow (E110) per capsule. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Capsule, hard. Diflazole 150 mg Capsules, hard are yellow capsules. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Fluconazole is indicated for the treatment of 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 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). H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ __ Læs hele dokumentet