Country: Armenia
Language: English
Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
fluconazole
REPLEK FARM Ltd. Skopje
J02AC01
fluconazole
150mg
capsules
(1) in blister
Prescription
Registered
2019-06-11
PACKAGE LEAFLET: INFORMATION FOR THE USER DIFLUKONAZOL (fluconazole) 150 MG CAPSULES READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE - 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. - If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. What Diflukonazol capsules are and what they are used for 2. Before you take Diflukonazol 3. How to take Diflukonazol 4. Possible side effects 5. How to store Diflukonazol 6. Further information 1. WHAT DIFLUKONAZOL CAPSULES ARE AND WHAT THEY ARE USED FOR Diflukonazol is one of a group of medicines called “antifungals”. The active substance is fluconazole. Diflukonazol 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 Diflukonazol 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 immune system is weak and not working properly). CHILDREN AND ADOLESCENTS (0 TO 17 YEARS OLD) Y Read the complete document
- 1 - - 1 - SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF MEDICINAL PRODUCT DIFLUKONAZOL fluconazole 150 MG CAPSULES ATC J02A C01 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 150 mg fluconazole, excipients. *For full list of excipients see section 6.1. 3. PHARMACEUTICAL FORM Capsule DIFLUKONAZOL 150 mg capsules are uniform, white, hard, gelatinous capsules. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Fluconazole is indicated in the following fungal infections (see section 5.1). Fluconazole 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. - 2 - - 2 - • 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 section 5.1)). Fluconazole is indicated in term newborn infants, infants, toddlers, children, and adolescents aged from 0 to 17 yea Read the complete document