Country: Ирска
Језик: Енглески
Извор: HPRA (Health Products Regulatory Authority)
Clozapine
Rowex Ltd
N05AH; N05AH02
Clozapine
100 milligram(s)
Tablet
Product subject to prescription which may not be renewed (A)
Diazepines, oxazepines, thiazepines and oxepines; clozapine
Not marketed
2007-09-14
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT CLOZALUX 25 MG TABLETS CLOZALUX 50 MG TABLETS CLOZALUX 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 Clozalux is and what it is used for 2. What you need to know before you take Clozalux 3. How to take Clozalux 4. Possible side effects 5. How to store Clozalux 6. Contents of the pack and other information 1. WHAT CLOZALUX IS AND WHAT IT IS USED FOR The active ingredient of Clozalux is clozapine which belongs to a group of medicines called antipsychotics (medicines that are used to treat specific mental disorders such as psychosis). Clozalux 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. Clozalux 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 CLOZALUX DO NOT TAKE CLOZALUX IF YOU - are allergic to clozapine or any of the other ingredients of this medicine (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 Прочитајте комплетан документ
Health Products Regulatory Authority 17 June 2020 CRN009QVZ Page 1 of 19 SUMMARY OF PRODUCT CHARACTERISTICS ▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions. CLOZAPINE CAN CAUSE AGRANULOCYTOSIS. ITS USE SHOULD BE LIMITED TO PATIENTS: ● WITH SCHIZOPHRENIA WHO ARE NON-RESPONSIVE TO OR INTOLERANT OF ANTIPSYCHOTIC MEDICATION, OR WITH PSYCHOSIS IN PARKINSON'S DISEASE WHEN OTHER TREATMENT STRATEGIES HAVE FAILED (SEE SECTION 4.1). ● WHO HAVE INITIALLY NORMAL LEUKOCYTE FINDINGS (WHITE BLOOD CELL COUNT ≥3500/MM 3 (≥3.5 X 10 9 /L), AND ANC (ABSOLUTE NEUTROPHIL COUNTS) ≥2000/MM 3 (≥2.0 X 10 9 /L), AND ● IN WHOM REGULAR WHITE BLOOD CELL (WBC) COUNTS AND ABSOLUTE NEUTROPHIL COUNTS (ANC) CAN BE PERFORMED AS FOLLOWS: WEEKLY DURING THE FIRST 18 WEEKS OF TREATMENT, AND AT LEAST EVERY 4 WEEKS THEREAFTER THROUGHOUT TREATMENT. MONITORING MUST CONTINUE THROUGHOUT TREATMENT AND FOR 4 WEEKS AFTER COMPLETE DISCONTINUATION OF CLOZAPINE (SEE SECTION 4.4). PRESCRIBING PHYSICIANS MUST COMPLY FULLY WITH THE REQUIRED SAFETY MEASURES. AT EACH CONSULTATION, A PATIENT RECEIVING CLOZAPINE MUST BE REMINDED TO CONTACT THE TREATING PHYSICIAN IMMEDIATELY IF ANY KIND OF INFECTION BEGINS TO DEVELOP. PARTICULAR ATTENTION MUST BE PAID TO FLU-LIKE COMPLAINTS SUCH AS FEVER OR SORE THROAT AND TO OTHER EVIDENCE OF INFECTION, WHICH MAY BE INDICATIVE OF NEUTROPENIA (SEE SECTION 4.4). CLOZAPINE MUST BE DISPENSED UNDER STRICT MEDICAL SUPERVISION IN ACCORDANCE WITH OFFICIAL RECOMMENDATIONS (SEE SECTION 4.4). MYOCARDITIS CLOZAPINE IS ASSOCIATED WITH AN INCREASED RISK OF MYOCARDITIS WHICH HAS, IN RARE CASES, BEEN FATAL. THE INCREASED RISK OF MYOCARDITIS IS GREATEST IN THE FIRST 2 MONTHS OF TREATMENT. FATAL CASES OF CARDIOMYOPATHY HAVE ALSO BEEN REPORTED RARELY (SEE SECTION 4.4). MYOCARDITIS OR CARDIOMYOPATHY SHOULD BE SUSPECTED IN PATIENTS WHO EX Прочитајте комплетан документ