দেশ: আয়ার্লণ্ড
ভাষা: ইংরেজি
সূত্র: HPRA (Health Products Regulatory Authority)
Fluconazole
Actavis Group PTC ehf
J02AC; J02AC01
Fluconazole
200 milligram(s)
Capsule, hard
Product subject to prescription which may be renewed (B)
Triazole derivatives; fluconazole
Marketed
2011-04-15
* Please note that ONLY Artwork Studio is permitted to make changes to the above artwork. No changes are permitted by any 3rd party other than added notes and mark ups for required changes. approved for print/date PROOF ROUND UK-Eire-Artwork-Support@accord-healthcare.com Technical Approval NON PRINTING COLOURS COLOURS DATE SENT: DATE RECEIVED: Item number: ORIGINATOR: ORIGINATION DATE: REVISION DATE: REVISED BY: DIMENSIONS: MIN BODY TEXT SIZE: SUPPLIER: 1. 2. 3. 4. 5. 6. 1. 2. 3. FMD info NA (not a carton) £ No £ Yes £ Details FLUCONAZOLE 50, 150, 200MG CAPSULES, HARD PIL - IRELAND Black Text Free Area BBBA2887 T. Hull 07.09.2018 13.09.2018 T. Hull 170x320 7pt Specifar S.A. n/a 2 Version 2 01.11.2017 FLUCONAZOLE 50 MG CAPSULES, HARD FLUCONAZOLE 150 MG CAPSULES, HARD FLUCONAZOLE 200 MG CAPSULES, HARD fluconazole PACKAGE LEAFLET: INFORMATION FOR THE USER 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. WHAT IS IN THIS LEAFLET 1 WHAT FLUCONAZOLE IS AND WHAT IT IS USED FOR 2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE FLUCONAZOLE 3 HOW TO TAKE FLUCONAZOLE 4 POSSIBLE SIDE EFFECTS 5 HOW TO STORE FLUCONAZOLE 6 CONTENTS OF THE PACK AND OTHER INFORMATION 1 WHAT FLUCONAZOLE IS AND WHAT IT IS USED FOR Fluconazole is one of 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 infections is a yeast called _Candida_. ADULTS You might be given this medicine by your doc সম্পূর্ণ নথি পড়ুন
Health Products Regulatory Authority 29 March 2019 CRN008N41 Page 1 of 17 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Fluconazole 200 mg capsules, hard 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 200 mg fluconazole. Excipient with known effect: Each hard capsule contains 164 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Capsule, hard. Fluconazole 200 mg consists of blue cap and white body, size “0” hard gelatine capsules, filled with white powder. 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 সম্পূর্ণ নথি পড়ুন