Χώρα: Ηνωμένο Βασίλειο
Γλώσσα: Αγγλικά
Πηγή: MHRA (Medicines & Healthcare Products Regulatory Agency)
Itraconazole
Waymade Healthcare Plc
J02AC02
Itraconazole
100mg
Oral capsule
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 05020100
Itraconazole capsules contain a medicine called itraconazole. This belongs to a group of medicines called ‘antifungals’. Itraconazole capsules are used for infections caused by fungi or yeasts. They are used for: • Infections of the mouth or vagina causing ‘thrush’ • Skin and nail infections Patches of skin may take a few weeks to completely clear up after you have finished your treatment with Itraconazole. Finger and toe nails may take several months to completely clear up. This is because your skin or nail will only look normal after new skin or nail has grown, even though the medicine has killed the fungus that caused the infection. DO NOT TAKE ITRACONAZOLE • if you are ALLERGIC to itraconazole or to any of the other ingredients of this medicine (listed in section 6) • if you are TAKING ANY OF THE FOLLOWING MEDICINES: - medicines that are degraded via the enzyme cytochrome P450 3A4 and which can change the heart rhythm, such as - ASTEMIZOLE, MIZOLASTINE, TERFENADINE, medicines against allergies - BEPRIDIL, a medicine against narrowed heart vessels - QUINIDINE, DOFETILIDE, medicines against disorders in the heart rhythm - CISAPRIDE, a stomach and bowel agent - LEVACETYLMETHADOLE or LEVOMETHADYL, used for the therapy of opiate dependents - PIMOZIDE and SERTINDOLE, used in schizophrenia - certain medicines to lower cholesterol levels, such as ATORVASTATIN, LOVASTATIN and SIMVASTATIN - TRIAZOLAM, a medicine against sleep disturbances - MIDAZOLAM for oral intake, a medicine for sedation before examinations, or operations or in intensive care units - DIHYDROERGOTAMINE, used in case of low blood pressure or certain headaches - ERGOMETRINE or ERGONOVINE, METHYLERGOMETRINE or METHYLERGONOVINE, medicines staunching bleeding used after birth - ERGOTAMINE and ELETRIPTAN, medicines against migraine - NISOLDIPINE a medicine against high blood pressure and narrowed heart vessels • in case of signs of HEART DYSFUNCTION or PREVIOUS HEART FAILURE, except for the treatment of life-threatening or serious fungal Διαβάστε το πλήρες έγγραφο
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Itraconazole 100mg Capsules, hard 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule, hard contains 100 mg of itraconazole. Excipient with known effect: Each hard capsule contains 224.31 mg sucrose. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Capsule, hard. No. 0 hard gelatin capsules, opaque green cap and body, containing yellowish-beige spherical micro-granules 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Vulvovaginal candidiasis, _-_ Oral candidiasis _-_ Dermatophytoses caused by organisms susceptible to itraconazole (Trichophyton spp., Microsporum spp., Epidermophyton floccosum) e.g. tinea pedis, tinea cruris, tinea corporis, tinea manuum, - Pityriasis versicolor, - Onychomycoses caused by dermatophytes and/or yeasts, - Systemic candidiasis, - Cryptococcal infections (including cryptococcal meningitis). In immunosuppressed patients suffering from cryptococcosis and in patients with cryptococcosis of the CNS Itraconazole is indicated only if the usually recommended initial therapy seems to be inappropriate or ineffective - Histoplasmosis. - Aspergillosis. Itraconazole can be used to treat patients suffering from invasive aspergillosis who were found to be refractory or intolerant to Amphotericin B - Maintenance therapy in AIDS patients to prevent relapse of underlying fungal infection who were found to be refractory or intolerant to first-line systemic anti-fungal therapy is inappropriate or has proved ineffective. Due to PK properties, orally administered itraconazole (capsules) should not be used as the initial treatment in patients with severe life-threatening forms of systemic mycoses. Oral forms should be used as a continuation therapy, after initial treatment with i.v. itraconazole (see section 4.4). Consideration should be given to official guidance regarding the appropriate use of antifungal_ _agents. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology. INDICATIONS DOSE DURATION OF TREATMENT Gynecol Διαβάστε το πλήρες έγγραφο