Krajina: Spojené kráľovstvo
Jazyk: angličtina
Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)
Itraconazole
Teva UK Ltd
J02AC02
Itraconazole
100mg
Oral capsule
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 05020100; GTIN: 5017007035794 5017007035817 5017007035831
ITRACONAZOLE 100 MG CAPSULES (ITRACONAZOLE) 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 of the side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. 1. WHAT ITRACONAZOLE CAPSULES ARE AND WHAT THEY ARE USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ITRACONAZOLE CAPSULES 3. HOW TO TAKE ITRACONAZOLE CAPSULES 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE ITRACONAZOLE CAPSULES 6. CONTENTS OF THE PACK AND OTHER INFORMATION WHAT ITRACONAZOLE CAPSULES ARE AND WHAT THEY ARE USED FOR Itraconazole Capsules belong to a group of medicines called antimycotics for systemic use, also known as "antifungals", which are used to treat infections caused by fungi including yeasts. • Itraconazole Capsules are used to treat fungal infections of the: • vagina • skin • lungs • mouth • nails • internal organs. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ITRACONAZOLE CAPSULES DO NOT TAKE ITRACONAZOLE IF YOU ARE: • allergic to itraconazole or any of the other ingredients of this medicine (listed in section 6) • taking any hay fever antihistamine products containing terfenadine, astemizole or mizolastine • taking certain medicines used to treat angina (chest pain) and high blood pressure, such as bepridil and nisoldipine • taking cisapride (a drug used for certain digestive problems) • taking midazolam (by mouth) or triazolam, medicines taken for anxiety or to help you to sleep (tranquillisers) • taking certain cholesterol lowering drugs, for example, atorvastatin, lovastatin or simvastatin • taking pimozide or sertindole (drugs for certain conditions affecting th Prečítajte si celý dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT ITRACONAZOLE 100mg Capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 100 mg itraconazole. Excipient(s) with known effect: Sucrose 224.31 mg per capsule. For the full list excipients, see section 6.1. 3 PHARMACEUTICAL FORM Capsules, hard Hard gelatin capsules (size 0) with a green opaque cap and body containing yellowish-beige spherical microgranules 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS 1. Vulvovaginal candidosis. 2. Pityriasis versicolor. 3. Dermatophytoses caused by organisms susceptible to itraconazole _(Trichophyton spp._, _Microsporum spp._, _Epidermophyton floccosum_) e.g. tinea pedis, tinea cruris, tinea corporis, tinea manuum. 4. Oropharyngeal candidosis. 5. Onychomycosis caused by dermatophytes and/or yeasts. 6. The treatment of histoplasmosis. 7. Itraconazole is indicated in the following systemic fungal conditions when first-line systemic anti-fungal therapy is inappropriate or has proved ineffective. This may be due to underlying pathology, insensitivity of the pathogen or drug toxicity. - Treatment of aspergillosis, candidosis - Treatment of cryptococcosis (including cryptococcal meningitis) : in immunocompromised patients with cryptococcosis and in all patients with cryptococcosis of the central nervous system. - Maintenance therapy in AIDS patients to prevent relapse of underlying fungal infection. Itraconazole is also indicated in the prevention of fungal infection during prolonged neutropenia when standard therapy is considered inappropriate. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Method of administration Itraconazole is for oral administration and must be taken immediately after a meal for maximal absorption. Treatment schedules in adults for each indication are as follows: _INDICATION_ _DOSE_ _REMARKS_ Vulvovaginal candidosis 200 mg twice daily for 1 day Pityriasis versicolor 200 mg once daily for 7 days Tinea corporis, tinea cruris 100 mg once daily for 15 days or 200 mg once daily for 7 Prečítajte si celý dokument