מדינה: אירלנד
שפה: אנגלית
מקור: HPRA (Health Products Regulatory Authority)
Mercaptopurine
Fontus Health Limited
L01BB; L01BB02
Mercaptopurine
50 milligram(s)
Tablet
Purine analogues; mercaptopurine
Not marketed
2019-08-19
1 PACKAGE LEAFLET: INFORMATION FOR THE USER HANIXOL 50 MG TABLETS 6-mercaptopurine 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, pharmacist or nurse. - 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Hanixol 50 mg Tablets are and what they are used for 2. What you need to know before you take Hanixol 50 mg Tablets 3. How to take Hanixol 50 mg Tablets 4. Possible side effects 5. How to store Hanixol 50 mg Tablets 6. Contents of the pack and other information 1. WHAT HANIXOL 50 MG TABLETS ARE AND WHAT THEY ARE USED FOR Hanixol 50 mg Tablets contain a medicine called 6-mercaptopurine. This belongs to a group of medicines called cytotoxics (also called chemotherapy). Hanixol 50 mg Tablets are used to treat cancer of the blood (leukaemia) in adults, adolescents and children. It works by reducing the number of new blood cells your body makes. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE HANIXOL 50 MG TABLETS DO NOT TAKE HANIXOL 50 MG TABLETS: If you are allergic to 6-mercaptopurine or any of the other ingredients of this medicine (listed in section 6). WARNINGS AND PRECAUTIONS Talk to your doctor before using Hanixol 50 mg Tablets: - If you have recently received, or are due to receive, a vaccination (vaccine). If you take Hanixol, you should not have a live organism vaccine (for example; flu vaccine, measles vaccine, BCG vaccine, etc.) until advised it is safe to do so by your doctor. This is because some vaccines may give you an infection if you receive them while you are taking Hanixol - If you have a genetic disease called TPMT (thiopurine methyltransfera קרא את המסמך השלם
Health Products Regulatory Authority 16 April 2020 CRN009Q75 Page 1 of 10 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Hanixol 50 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each Tablet contains 50 mg of 6-mercaptopurine. Excipients with known effect: -Lactose anhydrous: 59 mg per tablet For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablets. Round 7.4 mm yellowish tablet, scored 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Hanixol 50 mg tablets is indicated for the treatment of APL (acute promyelocytic leukaemia) and AML M3 (acute myeloid leukaemia M3) in adults, adolescents and children. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology 6-mercaptopurine treatment should be initiated and supervised by a doctor or other healthcare professional experienced in the management of patients with acute leukemia. 6-mercaptopurine may be taken with food or on an empty stomach, but patients should standardise the method of administration. 6-mercaptopurine should not be taken with milk or dairy products (see section 4.5). 6-mercaptopurine should be taken at least 1 hour before or 2 hours after ingestion of milk or dairy products. Populations ADULTS AND CHILDREN For adults and children, the usual dose is 2.5 mg/kg bodyweight per day, or 50 to 75 mg/m 2 body surface area per day, but the dose and duration of administration depend on the nature and dosage of other cytotoxic agents given in conjunction with 6-mercaptopurine. The dosage should be carefully adjusted to suit the individual patient. 6-mercaptopurine has been used in various combination therapy schedules and the literature should be consulted for details. Studies carried out in children with acute lymphoblastic leukaemia suggested that administration of 6-mercaptopurine in the evening lowered the risk of relapse compared with morning administration. ELDERLY It is advisable to monitor renal and hepatic function in these patients, and if there is any impairment, consideration should be given to reducing t קרא את המסמך השלם