Country: United Kingdom
Bahasa: Inggeris
Sumber: MHRA (Medicines & Healthcare Products Regulatory Agency)
Clozapine
Britannia Pharmaceuticals Ltd
N05AH02
Clozapine
200mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04020100; GTIN: 5055962500131
will be performed every 4 weeks for as long as you continue to take Denzapine. Tests will also be performed for one month after stopping the medicine. These tests will tell the doctor if there is any problem with the number of white cells in your blood. There are some situations where you may need to have blood tests more often (e.g. twice a week). Your doctor will talk to you about this. If the number of your white blood cells falls below a critical level, Denzapine must be stopped immediately and you must never take any medicines containing clozapine again. You will need to have blood tests for another 4 weeks after the end of Denzapine treatment. Your doctor will also do a physical examination before starting treatment. Your doctor may do an electrocardiogram (ECG) to check your heart, but only if this is necessary for you, or if you have any special concerns. Denzapine may cause alteration in blood lipids (fats), and may cause weight gain. Your doctor may monitor your weight and blood lipid level. If you have a liver disorder you will need regular liver function tests for as long as you continue to take Denzapine. If Denzapine makes you feel light-headed, dizzy or faint, or if you already suffer from these feelings, be careful when getting up from a sitting or lying position as this may increase the possibility of falling. If you have to undergo surgery or if for some reason you are unable to walk around for a long time, discuss with your doctor the fact that you are taking Denzapine. You may be at risk of thrombosis (blood clotting within a vein). Be careful when drinking alcohol or when taking antihistamines (medicines used for hay fever, allergies or colds), sleeping tablets or tablets to relieve pain while taking this medicine. Denzapine can increase drowsiness caused by alcohol and by medicines affecting your nervous system. Denzapine may affect the way your body controls temperature, and it may prevent sweating even in very hot weather. Exercise, hot baths or saunas may make you feel dizzy or faint whil Baca dokumen lengkap
SUMMARY OF PRODUCT CHARACTERISTICS 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 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 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 range), patients may be monitored at least at 4 week intervals • Monitoring must continue throughout treatment and for at least 4 weeks after discontinuation If the blood result of a patient taking Denzapine is below the normal range (See Section 4.4), Britannia will contact the physician and pharmacist registered to the pat Baca dokumen lengkap