Quốc gia: Malta
Ngôn ngữ: Tiếng Anh
Nguồn: Medicines Authority
ITRACONAZOLE
Syri Pharma Limited Floor 0 1 WML, 1 Windmill Lane Dublin 2, D02 F206, Ireland
J02AC02
ITRACONAZOLE 10 mg
ORAL SOLUTION
ITRACONAZOLE 10 mg
POM
ANTIMYCOTICS FOR SYSTEMIC USE
Authorised
2017-03-16
Page 1 of 7 PACKAGE LEAFLET: INFORMATION FOR THE USER ITRACONAZOLE 10MG/ML SUGAR FREE ORAL SOLUTION 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 Itraconazole 10mg/ml Sugar Free Oral Solution but it will be referred to as ‘Itraconazole’ throughout this leaflet. WHAT IS IN THIS LEAFLET: 1. What Itraconazole is and what it is used for 2. What you need to know before you take Itraconazole 3. How to take Itraconazole 4. Possible side effects 5. How to store Itraconazole 6. Contents of the pack and other information 1. WHAT ITRACONAZOLE IS AND WHAT IT IS USED FOR Itraconazole 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 Itraconazole 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 TAKE ITRACONAZOLE DO NOT USE ITRACONAZOLE ORAL SOLUTION IF YOU ARE: ALLERGIC (hypersensitive) to itraconazole or to any of the ingredients in Itraconazole oral solution (listed in Section 6) PREGNANT , think you might be pregnant or could become pregnant (see the section on Pregnancy) taking any of the following medicines: • terfenadine, astemizole or mizolastine (antihistamine for allergies) • bepridil - used to treat angina (crushing chest Đọc toàn bộ tài liệu
Page 1 of 17 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Itraconazole 10mg/ml Sugar Free Oral Solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of oral solution contains 10mg itraconazole. _Excipient(s) with known effect: _ Each ml of oral solution contains 172mg sorbitol (E420) and 0.7124mg sodium. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Oral solution Itraconazole oral solution is clear, colourless to yellow colour solution with an odour of cherry. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Itraconazole oral solution is indicated: For the treatment of oral and/or oesophageal candidosis in HIV-positive or other immunocompromised patients. 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 (ie < 500 cells/µl). At present there are insufficient clinical efficacy data in the prevention of aspergillosis. Page 2 of 17 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, Itraconazole 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_ : 200mg (20ml) 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 200mg (10- 20ml) twice daily for 2 weeks. If there is no response after 2 weeks, treatment should be continued for anothe Đọc toàn bộ tài liệu