Country: Malta
Language: English
Source: Medicines Authority
CLOZAPINE
Novartis Pharmaceuticals UK Limited Frimley Business Park, Frimley Camberley, Surrey GU16 7SR, United Kingdom
N05AH02
CLOZAPINE 100 mg
TABLET
CLOZAPINE 100 mg
POM
PSYCHOLEPTICS
Withdrawn
2006-08-10
Page 1 of 12 PACKAGE LEAFLET: INFORMATION FOR THE USER LEPONEX® LEPONEX 25 MG TABLETS LEPONEX 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, pharmacist or healthcare provider. - This medicine has been prescribed for you only. Do not use it for any other illnesses. 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 Leponex is and what it is used for 2. What you need to know before you take Leponex 3. How to take Leponex 4. Possible side effects 5. How to store Leponex 6. Contents of the pack and other information 1. WHAT LEPONEX IS AND WHAT IT IS USED FOR Leponex tablets contain an active substance called clozapine. This medicine belongs to a group of medicines called antipsychotics (medicines that are used to treat specific mental disorders such as psychosis). Leponex 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 tried at least two other medicines to treat schizophrenia before, and these medicines did not work, or caused severe side effects that cannot be treated. Leponex 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. HOW LEPONEX WORKS Leponex predominantly works by binding to and blocking the D4 receptor (or dopamine receptor) in the brain. Leponex also has weak binding and blocking activity on the D1, D2, D3 and D5 receptors in the brain as well as other receptors that potentially have some contribution to Read the complete document
Page 1 of 32 SUMMARY OF PRODUCT CHARACTERISTICS LEPONEX 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 (3.5X10 9 /L), AND ANC ≥ 2000/MM 3 (2.0X10 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 LEPONEX. PRESCRIBING PHYSICIANS MUST COMPLY FULLY WITH THE REQUIRED SAFETY MEASURES. AT EACH CONSULTATION, A PATIENT RECEIVING LEPONEX 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. LEPONEX MUST BE DISPENSED UNDER STRICT MEDICAL SUPERVISION IN ACCORDANCE WITH OFFICIAL RECOMMENDATIONS. 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. MYOCARDITIS OR CARDIOMYOPATHY SHOULD BE SUSPECTED IN PATIENTS WHO EXPERIENCE PERSISTENT TACHYCARDIA AT REST, ESPECIALLY IN THE FIRST 2 MONTHS OF TREATMENT, AND/OR PALPITATIONS, ARRHYTHMIAS, CHEST PAIN AND OTHER SIGNS AND SYMPTOMS OF HEART FAILURE (E.G. UNEXPLAINED FATIGUE, DYSPNOEA, TACHYPNOEA) OR SYMPTOMS THAT MIMIC MYOCARDIAL INFARCTION. IF MYOCARDITIS OR CARDIOMYOPATHY ARE SUSPECTED, LEPONEX TREATMENT SHOULD BE PROMPTLY STOPPED AND THE PATIENT IMMEDIATELY REFERRED TO A CARDIOLOGIST. PATIENTS WH Read the complete document