País: Irlanda
Língua: inglês
Origem: HPRA (Health Products Regulatory Authority)
ITRACONAZOLE
Janssen-Cilag Ltd
J02AC02
ITRACONAZOLE
10mg/ml Mg/Ml
Oral Solution
Product subject to prescription which may be renewed (B)
itraconazole
Marketed
1997-09-05
Page 1 PACKAGE LEAFLET: INFORMATION FOR THE USER SPORANOX 10 MG/ML ORAL SOLUTION (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 symptoms 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. WHAT IS IN THIS LEAFLET: 1. WHAT SPORANOX ORAL SOLUTION IS AND WHAT IT IS USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU USE SPORANOX ORAL SOLUTION 3. HOW TO USE SPORANOX ORAL SOLUTION 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE SPORANOX ORAL SOLUTION 6. CONTENTS OF THE PACK AND OTHER INFORMATION 1. WHAT SPORANOX ORAL SOLUTION IS AND WHAT IT IS USED FOR Sporanox is one of a group of medicines called “antifungals”. These medicines are used to treat and stop you from getting infections caused by fungi including yeasts. You may be given Sporanox to: treat yeast infections of the mouth, throat or gullet if you have a poor immune system stop you from getting certain fungal infections if you have a poor immune system due to a major blood disorder or bone marrow transplantation. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE SPORANOX ORAL SOLUTION DO NOT USE SPORANOX ORAL SOLUTION IF YOU ARE: ALLERGIC (hypersensitive) to itraconazole or to any of the ingredients in Sporanox oral solution (listed in Section 6 Contents of the pack and other information) PREGNANT, think you might be pregnant or could become pregnant (see the section on Pregnancy) TAKING ANY OF THE FOLLOWING MEDICINES: o terfenadine or mizolastine (antihistamines for allergies) o bepridil, ivabradine or ranolazine - used to treat angina (crushing chest pain) o nisoldipine, lercanidipine or eplerenone (used for high blood pressure) o Leia o documento completo
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Sporanox 10 mg/ml oral solution. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1ml Sporanox oral solution contains 10mg Itraconazole. Sorbitol E420 (190 microlitre per ml). For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Oral solution. Sporanox oral solution is clear, yellow to slightly amber solution with an odour of cherry. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS SPORANOX Oral Solution is indicated: o for the treatment of oral and/or oesophageal candidosis in HIV-positive or other immunocompromised patients. o as prophylaxis of deep fungal infections anticipated to be susceptible to itraconazole, when standard therapy is considered inappropriate, in patients with haematological malignancy or undergoing bone marrow transplant, and who are expected to become neutropenic (i.e. < 500 cells/µl). At present there are insufficient clinical efficacy data in the prevention of aspergillosis. Consideration should be given to national and/or local guidance regarding the appropriate use of antifungal agents. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For optimal absorption, SPORANOX Oral Solution should be taken without food (patients are advised to refrain from eating for at least 1 hour after intake). For the treatment of oral and/or oesophageal candidosis, the liquid should be swished around the oral cavity (approx. 20 seconds) and swallowed. There should be no rinsing after swallowing. Treatment of oral and/or oesophageal candidosis: 200 mg (2 measuring cups) per day in two intakes, or alternatively in one intake, for 1 week. If there is no response after 1 week, treatment should be continued for another week. Treatment of fluconazole resistant oral and/or oesophageal candidosis: 100 to 200 mg (1-2 measuring cups) twice daily for 2 weeks. If there is no response after 2 weeks, treatment should be continued for another 2 weeks. The 400 mg daily dose should not be used for longer than 14 days if there are no signs of improveme Leia o documento completo