Երկիր: Մալթա
Լեզու: անգլերեն
Աղբյուրը: Medicines Authority
ITRACONAZOLE
Actavis Group PTC ehf Revkjavikurvegi 76-78, 220 Hafnarfjordur, Iceland
J02AC02
ITRACONAZOLE 100 mg
HARD CAPSULE
ITRACONAZOLE 100 mg
POM
ANTIMYCOTICS FOR SYSTEMIC USE
Withdrawn
2006-08-03
Page 1 of 6 PACKAGE LEAFLET: INFORMATION FOR THE USER ITRACONAZOL ACTAVIS 100 MG, HARD CAPSULES ITRACONAZOLE READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 sign 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 Itraconazol Actavis is and what it is used for 2. What you need to know before you take Itraconazol Actavis 3. How to take Itraconazol Actavis 4. Possible side effects 5. How to store Itraconazol Actavis 6. Contents of the pack and further information 1. WHAT ITRACONAZOL ACTAVIS IS AND WHAT IT IS USED FOR Itraconazol Actavis contains itraconazole which is an anti-fungal agent. It prevents the fungus from building up a normal cell wall. Without a functional cell wall the fungus will die. Itraconazol Actavis is used to treat fungal infections in the vagina, mouth, skin and nails. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ITRACONAZOL ACTAVIS DO NOT TAKE ITRACONAZOL ACTAVIS - if you are allergic (hypersensitive) to itraconazole or any of the other ingredients of this medicine (see section 6) - if you are pregnant. See also under Pregnancy and breast-feeding. - if you are also taking any medicines containing the following ingredients: - terfenadine, astemizole or mizolastine (medicines used in the treatment of allergies) - cisapride (used in treating some digestive d Կարդացեք ամբողջական փաստաթուղթը
Page 1 of 14 S UMMARY OF PRODUCT CHARACTERISTICS 1 N AME OF THE MEDICINAL PRODUCT Itraconazol Actavis 100 mg hard capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule, hard contains 100mg of itraconazole. Excipient with known effect: Each capsule, hard contains 224.31mg sucrose. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Capsule, hard Hard gelatine capsules, opaque green cap and body, containing yellowish-beige spherical microgranules. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Itraconazole is indicated for the treatment of the following fungal infections verified by direct microscopy and /or cultures where systemic treatment is considered necessary: Vulvovaginal candidiasis, oral candidiasis, pityriasis versicolor, dermatomycoses, onychomycoses (caused by dermatophytes and yeasts). Consideration should be given to the official guidelines on the appropriate use of antifungal agents. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Itraconazol Actavis capsules are for oral use The capsules should be taken immediately after meals The capsules should be swallowed whole. _Adults:_ _Vulvovaginal candidiasis. _ 200 mg in the morning and 200 mg in the evening for 1 day. _Oral candidiasis:_ 100 mg once daily for 2 weeks. _Pityriasis versicolor_: 200 mg once daily for 1 week. _ _ _ _ Page 2 of 14 _Tinea corporis/cruris: _ 100 mg once daily for 2 week_S_. _ _ _Tinea pedis/manus: _ 100 mg twice daily for 4 weeks. _ _ _Onychomycoses: _ _Pulse treatment: _ _ _ _Toenail infection with or without fingernail infection: _ 200 mg twice daily for 7 days, followed by a treatment-free_ _interval of 3 weeks, 3 times in t Կարդացեք ամբողջական փաստաթուղթը