Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
FLUCONAZOLE
Milpharm Limited
J02AC01
FLUCONAZOLE
200 Milligram
Capsules Hard
Product subject to prescription which may be renewed (B)
Triazole derivatives
Authorised
2011-10-07
PACKAGE LEAFLET: INFORMATION FOR THE USER FLUCONAZOLE MILPHARM 50 MG CAPSULES, HARD FLUCONAZOLE MILPHARM 150 MG CAPSULES, HARD FLUCONAZOLE MILPHARM 200 MG CAPSULES, HARD Fluconazole 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 questions, 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 any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. WHAT IS IN THIS LEAFLET: 1. What Fluconazole Milpharm is and what it is used for 2. What you need to know before you take Fluconazole Milpharm 3. How to take Fluconazole Milpharm 4. Possible side effects 5. How to store Fluconazole Milpharm capsules 6. Contents of the pack and other information 1. WHAT FLUCONAZOLE MILPHARM IS AND WHAT IT IS USED FOR Fluconazole Milpharm is one of a group of medicines called “antifungals”. The active substance is fluconazole Milpharm. Fluconazole Milpharm is used to treat infections caused by fungi and may also be used to stop you from getting a candidal infection. The most common cause of fungal infections is a yeast called _Candida_. ADULTS You might be given this medicine by your doctor to treat the following types of fungal infections: - Cryptococcal meningitis – a fungal infection in the brain - Coccidioidomycosis – a disease of the bronchopulmonary system - Infection Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Fluconazole Milpharm 200 mg capsules, hard 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule, hard contains 200 mg fluconazole. Excipient: 202.24mg lactose/hard capsule For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Capsules, hard. Size ‘0’ hard gelatin capsule filled with white to off-white powder and imprinted with ‘E’ on white to off-white opaque cap and ‘98’ on white to off-white opaque body with yellow ink. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Fluconazole Milpharm is indicated in the following fungal infections (see section 5.1). Fluconazole Milpharm is indicated in adults for the treatment of: Cryptococcal meningitis (see section 4.4). Coccidioidomycosis (see section 4.4). Invasive candidiasis. Mucosal candidiasis including oropharyngeal, oesophageal candidiasis, candiduria and chronic mucocutaneous candidiasis. Chronic oral atrophic candidiasis (denture sore mouth) if dental hygiene or topical treatment are insufficient. Vaginal candidiasis, acute or recurrent; when local therapy is not appropriate. _Candidal balanitis _when local therapy is not appropriate. Dermatomycosis including _tinea pedis_, _tinea corporis_, _tinea cruris_, _tinea versicolor _and dermal _candida_ infections when systemic therapy is indicated. _Tinea unguinium (onychomycosis) _when other agents are not considered appropriate. Fluconazole Milpharm is indicated in adults for the prophylaxis of: Relapse of cryptococcal meningitis in patients with high risk of recurrence. Relapse of oropharyngeal or oesophageal candidiasis in patients infected with HIV who are at high risk of experiencing relapse. To reduce the incidence of recurrent vaginal candidiasis (4 or more episodes a year). Prophylaxis of candidal Read the complete document