Nazione: Irlanda
Lingua: inglese
Fonte: HPRA (Health Products Regulatory Authority)
Mercaptopurine
Silver Pharma S.L.
L01BB02
Mercaptopurine
50 milligram(s)
Tablet
mercaptopurine
2021-07-02
2 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT MERCAPTOPURINE SILVER PHARMA 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 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. WHAT IS IN THIS LEAFLET 1. What Mercaptopurine Silver Pharma is and what it is used for 2. What you need to know before you take Mercaptopurine Silver Pharma 3. How to take Mercaptopurine Silver Pharma 4. Possible side effects 5. How to store Mercaptopurine Silver Pharma 6. Contents of the pack and other information 1. WHAT MERCAPTOPURINE SILVER PHARMA IS AND WHAT IT IS USED FOR This medicine contains the active substance mercaptopurine monohydrate which belongs to a group of medicines called cytotoxics (also called chemotherapy). Mercaptopurine is used to treat leukaemia (cancer of the blood) and works by reducing the number of new blood cells your body makes. Mercaptopurine is used for: - Acute promyelocytic leukaemia (APL)/Acute myeloid leukaemia M3 (AML M3) - a fast growing disease that increases the number of white blood cells produced by the bone marrow. This can cause infections and bleeding. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE Mercaptopurine Silver Pharma DO NOT TAKE MERCAPTOPURINE SILVER PHARMA : - if you are allergic (hypersensitive) to mercaptopurine or any of the other ingredients of this medicine (listed in section 6). - if you are just giving the vaccine of the yellow fever while taking mercaptopurine, because it may be fatal.. WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking Mercaptopurine Silver Pharma if: • you have Leggi il documento completo
Health Products Regulatory Authority 04 October 2022 CRN00D3V6 Page 1 of 11 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Mercaptopurine Silver Pharma 50 mg tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 50 mg of the active substance mercaptopurine (as monohydrate). Excipient with known effect: Each tablet contains 46.13 mg lactose (as monohydrate). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. Pale yellow 6 mm round tablets. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Mercaptopurine is indicated for the treatment of acute leukaemia in adults, adolescents and children.. It may be utilised in: - Acute promyelocytic leukaemia (APL)/Acute myeloid leukaemia M3 (AML M3). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION 6-mercaptopurine treatment should be supervised by a physician or other healthcare professional experienced in the management of patients with APL (AML M3). Posology _ _ _Adults and paediatric population_ _ _ For adults and children the usual recommended 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 6-mercaptopurine. Daily dose intake in the evening is recommended (see Method of administration in this section). The dosage should be carefully adjusted to suit each individual patient. In overweight children, dose may be close to the maximum daily dose. Therefore, close monitoring of the response to treatment is recommended (see section 5.2). 6-mercaptopurine has been used in various combination therapy schedules for acute leukaemia and the literature and applicable treatment guidelines should be consulted for details. _ _ _ _ _ _ _Elderly_ It is advisable to monitor renal and hepatic function in these patients, and if impaired function is observed, reduction of the 6-mercaptopurine dosage should be considered. _Renal impairment_ Consideration should be given to red Leggi il documento completo