Страна: Велика Британія
мова: англійська
Джерело: 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
PACKAGE LEAFLET: INFORMATION FOR THE USER SPORANOX® 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 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 100 mg Capsules but will be referred to as Sporanox capsules throughout the remainder of the leaflet. WHAT IS IN THIS LEAFLET 1. What Sporanox capsules are and what they are used for 2. What you need to know before you take Sporanox capsules 3. How to take Sporanox capsules 4. Possible side effects 5. How to store Sporanox capsules 6. Contents of the pack and other information 1. WHAT SPORANOX CAPSULES ARE AND WHAT THEY ARE USED FOR Sporanox capsules contain a medicine called itraconazole. This belongs to a group of medicines called ‘antifungals’. Sporanox capsules are used for infections caused by fungi or yeasts in adults. They are 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 capsules. 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 CAPSULES DO NOT TAKE SPORANOX CAPSULES: • If you are allergic to anything in Sporanox capsules (listed in section 6 below) • If you are pregnant or could become pregnant unless your doc Прочитайте повний документ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT SPORANOX™ 100mg Capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Itraconazole 100mg. For excipients, see 6.1. 3. PHARMACEUTICAL FORM Capsule (Size 0): opaque blue cap and pink transparent body containing coated beads. 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. Sporanox 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 and 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. Sporanox 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 Sporanox is for oral administration and must be taken immediately after a meal for maximal absorption. The capsules must be swallowed whole. 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 days Tinea pedis, tinea manuum 100 mg once daily for 30 days Oropharyngeal candidosis 100 mg once daily for 15 days Increase dose to 200 mg once d Прочитайте повний документ