Страна: Ірландія
мова: англійська
Джерело: HPRA (Health Products Regulatory Authority)
Clozapine
Clonmel Healthcare Ltd
N05AH; N05AH02
Clozapine
50 milligram(s)/millilitre
Oral suspension
Product subject to prescription which may not be renewed (A)
Diazepines, oxazepines, thiazepines and oxepines; clozapine
Marketed
2009-03-06
PACKAGE LEAFLET: INFORMATION FOR THE USER DENZAPINE ® 50 MG/ML ORAL SUSPENSION Clozapine The use of Denzapine is restricted to those patients registered with the Denzapine Monitoring Service. 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 possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Denzapine is and what it is used for 2. What you need to know before you take Denzapine 3. How to take Denzapine 4. Possible side effects 5. How to store Denzapine 6. Contents of the pack and other information 1. WHAT DENZAPINE IS AND WHAT IT IS USED FOR Denzapine contains the active substance clozapine, which belongs to a group of medicines called atypical antipsychotics. Antipsychotics are mainly used to treat schizophrenia. Schizophrenia is a psychiatric disorder that affects the way a person thinks and behaves. Denzapine is used: - to treat schizophrenia when at least two other antipsychotic medicines, including one of the newer atypical antipsychotics, have not worked or have caused severe side effects - to treat psychotic disorders occurring in patients with Parkinson’s disease, when standard treatment has failed. Denzapine is available only with a doctor’s prescription. Ask your doctor if you have any questions about why this medicine has been prescribed for you 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DENZAPINE Denzapine must not be given to anyone who is unconscious or in a coma. DO NOT TAKE DENZAPINE: - if you are allergic to clozapine or to any of the other ingredients of this medicine (listed in section 6). It is important to tell your doctor if y Прочитайте повний документ
Health Products Regulatory Authority 07 November 2023 CRN009K15 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. As a consequence of a recent European regulatory initiative, the Denzapine Summary of Product Characteristics (SmPC) has been harmonised across Europe. The SmPC states that blood monitoring should be carried out in accordance with national-specific official recommendations. These are reproduced below. The Denzapine Monitoring Service (DMS) 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 clozapine is used in conjunction with a Monitoring Service, of 0.01%[2]. The Denzapine Monitoring Service provides centralised monitoring of leucocyte and neutrophil counts which is a mandatory requirement for all patients in the UK and Ireland who are treated with Denzapine. The use of Denzapine is restricted to patients who are registered with the Denzapine Monitoring Service. In addition to registering their patients, prescribing physicians must register themselves and a nominated pharmacist with the Denzapine Monitoring Service. All Denzapine-treated patients must be under the supervision of an appropriate specialist and supply of Denzapine is restricted to hospital and retail pharmacies registered with the Denzapine Monitoring Service. Denzapine is not sold to, or distributed through wholesalers. The patient's 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 blood counts (green ra Прочитайте повний документ