Land: Storbritannien
Språk: engelska
Källa: MHRA (Medicines & Healthcare Products Regulatory Agency)
Fluconazole
Sigma Pharmaceuticals Plc
J02AC01
Fluconazole
150mg
Oral capsule
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 05020100
PACKAGE LEAFLET: INFORMATION FOR THE USER Fluconazole 150mg 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 IN THIS LEAFLET: 1. What Fluconazole 150 mg Capsules are and what they are used for 2. What you need to know before you take Fluconazole 150 mg Capsules 3. How to take Fluconazole 150 mg Capsules 4. Possible side effects 5. How to store Fluconazole 150 mg Capsules 6. Contents of the pack and other information 1. WHAT FLUCONAZOLE 150 MG 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 Läs hela dokumentet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Fluconazole 150 mg Capsule 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 150 mg fluconazole. Excipients with known effect: Also contains Lactose Monohydrate and Sunset Yellow E110. For full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Capsules, hard. Fluconazole 150 mg Capsules are yellow capsules_._ 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Fluconazole 150mg capsule is indicated for the treatment of candidal vaginitis, acute or recurrent. It should also be used for treatment of partners with associated candidal balanitis. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION Fluconazole is administered orally. ADULTS (16 TO 60 YEARS): One capsule should be swallowed whole. CHILDREN (UNDER 16 YEARS): Paediatric use is not recommended. ELDERLY: Not recommended in patients over 60 years. RENAL IMPAIRMENT: There is no separate dosage schedule in patients with renal impairment for single dose therapy. 4.3 CONTRAINDICATIONS Fluconazole should not be used in patients with known hypersensitivity to the drug, any of the inert ingredients listed in section 6.1 or to related azole compounds. Coadministration of terfenadine is contraindicated in patients receiving fluconazole at multiple doses of 400mg per day or higher based upon results of a multiple dose interaction study. Coadministration of other medicinal products known to prolong the QT interval and which are metabolised via the cytochrome P450 (CYP) 3A4 such as cisapride, astemizole, pimozide, quinidine and erythromycin are contraindicated in patients receiving fluconazole (see section 4.4 and 4.5). Fluconazole should not be used in patients with porphyria. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Renal system Fluconazole should be administered with caution to patients with renal dysfunction (see section 4.2). Adrenal insufficiency Ketoconazole is known to cause adrenal insufficiency, and this could also, although rarely seen, be applicable to fluconazole. Adrenal Läs hela dokumentet