Pays: Arménie
Langue: anglais
Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
fluconazole
Denk Pharma GmbH & Co. KG
J02AC01
fluconazole
100mg
capsules hard
(10/1x10/) in blister
Prescription
Registered
2018-12-05
_Flucona-Denk 100_ Hard capsule – oral use Antimycotic Active substance: Fluconazole Package leaflet: Information for the user READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAK- ING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT IN- FORMATION 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 FLUCONA-DENK 100 IS AND WHAT IT IS USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE FLUCONA- DENK 100 3. HOW TO TAKE FLUCONA-DENK 100 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE FLUCONA-DENK 100 6. CONTENTS OF THE PACK AND OTHER INFORMATION 1. What Flucona-Denk 100 is and what it is used for Flucona-Denk 100 is one of a group of medicines called “antifungals”. The active substance is fluconazole. Fluco- na-Denk 100 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 bronchopulmona- ry 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 Flucona-Denk 100 to: • stop cryptococcal meningitis from coming back • stop mucosal thrush from coming bac Lire le document complet
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Flucona-Denk 100 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active substance: fluconazole Each hard capsule contains 100 mg fluconazole. Excipient with known effect: Each hard capsule contains 33.2 mg of lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Hard capsule. Flucona-Denk 100 hard capsule is buff. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Flucona-Denk 100 is indicated in the following fungal infections (see section 5.1). Flucona-Denk 100 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. Flucona-Denk 100 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 section 5.1)). 2 Fluconazole is indicated in term newborn infants, infants, toddlers, children Lire le document complet