국가: 영국
언어: 영어
출처: MHRA (Medicines & Healthcare Products Regulatory Agency)
Itraconazole
Sigma Pharmaceuticals Plc
J02AC02
Itraconazole
100mg
Oral capsule
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 05020100
* Please note that ONLY Artwork Studio is permitted to make changes to the above artwork. No changes are permitted by any 3rd party other than added notes and mark ups for required changes. approved for print/date PROOF ROUND UK-Eire-Artwork-Support@Actavis.com Technical Approval NON PRINTING COLOURS COLOURS DATE SENT: DATE RECEIVED: Item no: ORIGINATOR: ORIGINATION DATE: REVISION DATE: REVISED BY: DIMENSIONS: MIN BODY TEXT SIZE: SUPPLIER: 1. 2. 3. 4. 5. 6. 1. 2. 3. ITRACONAZOLE 100MG 15 & 60 TABLETS PIL - UK Black Profile BBBA1065 C.Grant 19/07/17 24/07/17 C.Grant 140x540 9pt 8pt in the table Linconsa 19/07/17 24/07/17 02 ITRACONAZOLE 100MG CAPSULES, HARD PACKAGE LEAFLET: INFORMATION FOR THE USER BBBA1065 _continued top of next column_ _continued over page_ 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 or pharmacist. • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. • If you get any of the 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 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 1 WHAT ITRACONAZOLE CAPSULES ARE AND WHAT THEY ARE USED FOR Itraconazole capsules are indicated for the treatment of fungal infections of the vagina, skin, mouth, eyes, nails and internal organs. The active substance is itraconazole, a member of the following pharmaco- therapeutic class of drugs: Antimycotic for systemic use, triazole derivatives. Itraconazole is very effective against a variety of infections caused by yeasts and 전체 문서 읽기
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 전체 문서 읽기