Maa: Yhdistynyt kuningaskunta
Kieli: englanti
Lähde: MHRA (Medicines & Healthcare Products Regulatory Agency)
Itraconazole
Crescent Pharma Ltd
J02AC02
Itraconazole
100mg
Oral capsule
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 05020100; GTIN: 5017123113406
PACKAGE LEAFLET: INFORMATION FOR THE USER SPORANOX ® 100MG CAPSULES (itraconazole) Sporanox is a registered trademark 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 signs 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. See section 4. The name of your medicine is Sporanox 100mg capsules but will be referred to as Sporanox throughout this leaflet. WHAT IS IN THIS LEAFLET 1. WHAT SPORANOX IS AND WHAT IT IS USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE SPORANOX 3. HOW TO TAKE SPORANOX 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE SPORANOX 6. CONTENTS OF THE PACK AND OTHER INFORMATION 1. WHAT SPORANOX IS AND WHAT IT IS USED FOR Sporanox contains a medicine called itraconazole. This belongs to a group of medicines called ‘antifungals’. Sporanox is used for infections caused by fungi or yeasts in adults. It is used for: Infections of the mouth or vagina causing ‘thrush’ Skin infections Infections affecting other parts of the body Patches of skin may take a few weeks to completely clear up after you have finished your treatment with Sporanox. 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. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE SPORANOX DO NOT TAKE SPORANOX: If you are allergic to anything in Sporanox (listed in section 6 overleaf) If you are pregnant or could become pregnant unless your doctor has told you to (see ‘Pregnancy and breast-feeding’ below) Do not take this medicine if any of the above applies to you. If Lue koko asiakirja
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 Lue koko asiakirja