Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Fluconazole
DE Pharmaceuticals
J02AC01
Fluconazole
50mg
Oral capsule
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 05020100
1 PACKAGE LEAFLET: INFORMATION FOR THE USER FLUCONAZOLE 50MG CAPSULES FLUCONAZOLE 200MG 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, pharmacist or nurse. 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, pharmacist or nurse. This includes any possible side effects not listed in this Leaflet. See section 4. WHAT IS I N THIS LEAFLET : 1. What Fluconazole Capsules are and what they are used for 2. What you need to know before you take Fluconazole Capsules 3. How to take Fluconazole Capsules 4. Possible side effects 5. How to store Fluconazole Capsules 6. Contents of the pack and other information 1. WHAT FLUCONAZOLE CAPSULES ARE AND WHAT THEY ARE USED FOR Fluconazole belongs to a group of medicines called “antifungals”. The active substance is fluconazole Fluconazole 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 infection 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 Fluconazole capsules to: - stop cryptococcal meningitis from coming back - stop mucosal thrush from coming back - reduce recurrence of Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Fluconazole 50mg capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One capsule contains 50 mg of fluconazole. Excipients with known effect: Contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) and 50mg of anhydrous lactose For the full list of excipients: see section 6.1 3 PHARMACEUTICAL FORM Capsules for oral administration. White to off white powder filled in blue/white coloured hard gelatin capsules of size ‘4’. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Fluconazole is indicated in the following fungal infections (see section 5.1). Fluconazole 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 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 Hematopoietic Stem Cell Transplantation (see sectio Read the complete document