国家: 英国
语言: 英文
来源: MHRA (Medicines & Healthcare Products Regulatory Agency)
Itraconazole
Dowelhurst Ltd
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 阅读完整的文件
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Itraconazole 100mg Capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One capsule contains 100 mg itraconazole. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Capsule, hard Opaque green capsule, containing yellowish-beige beads. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Itraconazole is indicated for the treatment of the following fungal infections when thought likely to be susceptible: • Vulvovaginal candidiasis. • Pityriasis versicolor. • Dermatophytoses caused by organisms susceptible to itraconazole (Trichophyton spp. Microsporum spp. Epidermophyton floccosum) e.g. tinea pedis, tinea cruris, tinea corporis, tinea manuum. • Oral candidiasis. • Onychomycosis caused by dermatophytes and/or yeasts. Consideration should be given to official guidance regarding the appropriate use of antifungal agents. For further information please refer to section 5.1. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Treatment schedules in adults for each indication are as follows: INDICATION DOSE Vulvovaginal candidiasis 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 Tinea pedis, tinea manuum 100 mg once daily for 30 days Oral candidiasis 100 mg once daily for 14 days Onychomycosis 200 mg once daily for 3 months For skin infections, optimal clinical and mycological effects are reached at 1 - 4 weeks after cessation of treatment and for nail infections at 6 - 9 months after the cessation of treatment. This is because elimination of itraconazole from skin and nails is slower than from plasma. In Acquired Immune Deficiency Syndrome and neutropenic patients: for the treatment of oral candidiasis 200 mg once daily for 14 days is recommended due to the impaired absorption of itraconazole in these patient groups. The length of treatment for systemic fungal infections should be dictated by the mycological and clinical response to ther 阅读完整的文件