Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Fluconazole
Rowex Ltd
J02AC; J02AC01
Fluconazole
200 milligram(s)
Capsule, hard
Product subject to prescription which may be renewed (B)
Triazole derivatives; fluconazole
Marketed
2004-07-30
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT FLUCOL 50 MG HARD CAPSULES FLUCOL 150 MG HARD CAPSULES FLUCOL 200 MG HARD CAPSULES 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 you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Flucol is and what it is used for 2. What you need to know before you take Flucol 3. How to take Flucol 4. Possible side effects 5. How to store Flucol 6. Contents of the pack and other information 1. WHAT FLUCOL IS AND WHAT IT IS USED FOR Flucol is one of a group of medicines called “antifungals”. The active substance is fluconazole. Flucol 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 - infections caused by _Candida _ and found in the blood stream, body organs (e.g. heart, lungs) or urinary tract - mucosal thrush - infection affecting the lining of the mouth, throat and denture sore mouth - genital thrush - infection of the vagina or penis - skin infections - e.g. athlete's foot, ringworm, jock itch, nail infection. You might also be given Flucol to: - stop cryptococcal meningitis from coming back - stop mucosal thrush from coming back - reduce recurrence of vaginal thrush - stop you from getting an infection caused by _Candida _ (if your immu Read the complete document
Health Products Regulatory Authority 22 March 2024 CRN00F4SK Page 1 of 18 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Flucol 200 mg Hard capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 200 mg of fluconazole. Excipient(s) with known effects: Each hard capsule also contains 185 mg of lactose and 0.058 mg of Ponceau 4R (E124). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Capsule, hard Flucol 200 mg hard capsule has a white body and a purple cap. It has “FC 200” printed on it. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Flucol is indicated in the following fungal infections (see section 5.1). Flucol 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. Flucol 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 infections in patients with prolonged neutropenia (such as patients with haematological malignancies receiving chemotherapy or patients receiving Haematopoietic Stem Cell Transplant Read the complete document