Krajina: Írsko
Jazyk: angličtina
Zdroj: HPRA (Health Products Regulatory Authority)
Clozapine
Mylan IRE Healthcare Limited
N05AH; N05AH02
Clozapine
25 milligram(s)
Tablet
Product subject to prescription which may not be renewed (A)
Diazepines, oxazepines, thiazepines and oxepines; clozapine
Marketed
1992-05-14
1 PACKAGE LEAFLET: INFORMATION FOR THE USER CLOZARIL 25 MG TABLETS CLOZARIL 100 MG TABLETS_ _ clozapine 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 Clozaril is and what it is used for 2. What you need to know before you take Clozaril 3. How to take Clozaril 4. Possible side effects 5. How to store Clozaril 6. Contents of the pack and other information 1. WHAT CLOZARIL IS AND WHAT IT IS USED FOR The active ingredient of Clozaril is clozapine which belongs to a group of medicines called antipsychotics (medicines that are used to treat specific mental disorders such as psychosis). Clozaril is used to treat people with schizophrenia in whom other medicines have not worked. Schizophrenia is a mental illness which affects how you think, feel and behave. You should only use this medicine if you have already tried at least two other antipsychotic medicines, including one of the newer atypical antipsychotics, to treat schizophrenia, and these medicines did not work, or caused severe side effects that cannot be treated. Clozaril is also used to treat severe disturbances in the thoughts, emotions and behaviour of people with Parkinson’s disease in whom other medicines have not worked. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CLOZARIL DO NOT TAKE CLOZARIL IF YOU: - are allergic (hypersensitive) to clozapine or any of the other ingredients of Clozaril (listed in section 6). - are not able to have regular blood tests. - have ever been told you have a low white blood cell count (e.g. leucopenia or agra Prečítajte si celý dokument
Health Products Regulatory Authority 14 April 2021 CRN00C61G Page 1 of 20 SUMMARY OF PRODUCT CHARACTERISTICS IRELAND - CLOZARIL OFFICIAL RECOMMENDATIONS The UK/IRL Clozaril Patient Monitoring Service (CPMS) was developed in order to manage the risk of agranulocytosis associated with clozapine. It is available 24 hours a day. When a monitoring service is not used, evidence suggests a mortality rate from agranulocytosis of 0.3% 1 . This is compared to a mortality rate when Clozaril is used in conjunction with the Clozaril Patient Monitoring Service, of 0.01% 2 . The Clozaril Patient Monitoring Service provides for the centralised monitoring of leucocyte and neutrophil counts which is a mandatory requirement for all patients in the UK and Ireland who are treated with Clozaril. The use of Clozaril is restricted to patients who are registered with the Clozaril Patient Monitoring Service. In addition to registering their patients, prescribing physicians must register themselves and a nominated pharmacist with the Clozaril Patient Monitoring Service. All Clozaril-treated patients must be under the supervision of an appropriate specialist and supply of Clozaril is restricted in Ireland to hospital and retail pharmacies registered with the Clozaril Patient Monitoring Service. Clozaril may only be supplied by way of wholesale dealing by wholesalers which have been specifically qualified by the Marketing Authorisation Holder to supply the product and which have adequate controls in place to assure that only authorised Clozaril customers receive consignments of the product. The Marketing Authorisation Holder has agreed in advance with the HPRA the use of any wholesaler in the supply chain of Clozaril. In the UK and Ireland, a white cell count with a differential count must be monitored: At least weekly for the first 18 weeks of treatment. At least at 2 week intervals between weeks 18 and 52. After 1 year of treatment with stable neutrophil counts, patients may be monitored at least at 4 week intervals. Monito Prečítajte si celý dokument