Țară: Malta
Limbă: engleză
Sursă: Medicines Authority
Aspen Pharma Trading Limited 3016 Lake Drive City West Businees Campus Dublin 24, Ireland
L01BB02
MERCAPTOPURINE 50 mg
TABLET
MERCAPTOPURINE 50 mg
POM
ANTINEOPLASTIC AGENTS
Licence number in the source country: NOT APPLICAPABLE
Authorised
2022-11-30
PACKAGE LEAFLET: INFORMATION FOR THE USER PURI-NETHOL 50 MG TABLETS mercaptopurine monohydrate 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 effects not listed in this leaflet. See section 4 WHAT IS IN THIS LEAFLET 1. What Puri-Nethol is and what it is used for 2. What you need to know before you take Puri-Nethol 3. How to take Puri-Nethol 4. Possible side effects 5. How to store Puri-Nethol 6. Contents of the pack and other information 1. WHAT PURI-NETHOL IS AND WHAT IT IS USED FOR Puri-Nethol contains the active substance mercaptopurine monohydrate. Mercaptopurine monohydrate belongs to a group of medicines called cytotoxics (also called chemotherapy) and works by reducing the number of new blood cells your body makes. Puri-Nethol is used to treat cancer of the blood (leukaemia) in adults, adolescents and children. This is a fast-growing disease which increases the number of new white blood cells. These new white blood cells are immature (not fully formed) and unable to grow and work properly. They therefore cannot fight infections and may cause bleeding. Ask your doctor if you would like more explanation about this disease. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PURI-NETHOL DO NOT TAKE PURI-NETHOL: If you are allergic to Puri-Nethol (mercaptopurine monohydrate) or any of the other ingredients of this medicine (see section 6). Do not get vaccinated with yellow fever vaccine whilst you are taking Puri-Nethol because it may be fatal. WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist or nurse before taking Puri-Nethol if: • you have been vaccinated with yel Citiți documentul complet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Puri-Nethol 50 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 50 mg of the active substance mercaptopurine monohydrate. Excipients with known effect: Each tablet contains 59mg of the excipient lactose monohydrate. For the full list of excipients, see Section 6.1. 3 PHARMACEUTICAL FORM Tablet. Pale yellow, round tablets, biconvex, scored on one side, engraved PT and 50 on either side of the scoreline and plain on the other side. The scoreline is only to facilitate breaking of the tablets for ease of swallowing and not to divide into equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Mercaptopurine monohydrate is indicated for the treatment of acute leukaemia in adults, adolescents and children. It may be utilised in: • Acute lymphoblastic leukaemia (ALL); • Acute promyelocytic leukaemia (APL)/Acute myeloid leukaemia M3 (AML M3). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Mercaptopurine monohydrate treatment should be supervised by a physician or other healthcare professional experienced in the management of patients with ALL and APL (AML M3). POSOLOGY The dose is governed by cautiously monitored haematotoxicity and the dose should be carefully adjusted to suit the individual patient in accordance with the employed treatment protocol. Depending on phase of treatment, starting or target doses should be lower in patients with reduced or absent Thiopurine Methyl Transferase (TPMT) enzyme activity (see Section 4.4). For adults and children, the usual dose is 2.5 mg/kg bodyweight per day, or 50 to 75mg/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 mercaptopurine monohydrate. The dosage should be carefully adjusted to suit the individual patient. Mercaptopurine monohydrate has been used in various combination therapy schedules for acute leukaemia and the literature and current treatment guidelines _ _ Citiți documentul complet