Ország: Izrael
Nyelv: angol
Forrás: Ministry of Health
CLOZAPINE
DEVRIES & CO. LTD
TABLETS
CLOZAPINE 100 MG
PER OS
Required
MYLAN PHARMA GMBH, SWITZERLAND
For treatment in resistant schizoprenic patients who are non-responsive to, or intolerant to classical neuroleptics. Reducing the risk of recurrent suicidal behavior in patients with schizophrenia or schizoaffective disorder who are judged to be at chronic risk for re-experiencing suicidal behavior, based on history and recent clinical state. Suicidal behavior refers to actions by a patient that put him/herself at risk for diath.
2022-04-30
Patient leaflet in accordance with the Pharmacists' Regulations (Preparations) - 1986 This medicine is dispensed with a doctor's prescription only Leponex 25 mg tablets Leponex 100 mg tablets Active ingredient: Each tablet contains: Each tablet contains: Clozapine 25 mg Clozapine 100 mg Inactive ingredients and allergens: See section 6 under ‘Additional information’ and ‘Important information about some of this medicine’s ingredients’ in section 2. Preparation dispensing instructions: During the first 18 weeks: Perform a blood test once a week during the first 18 weeks. The community pharmacy will dispense the medicine for one week of treatment only, according to a doctor's prescription, provided that it carries the stamp: “White blood cell test was performed, and the results are normal”. Starting from week 19 of treatment: A blood test must be performed at least once a month. The community pharmacy will dispense the medicine for one month of treatment only, according to a doctor's prescription, provided that it carries the stamp: “White blood cell test was performed, and the results are normal”. Read the entire leaflet carefully before you start using this medicine. This leaflet contains concise information about this medicine. If you have any further questions, consult your doctor or pharmacist. This medicine has been prescribed to treat your illness. Do not pass it on to others. It may harm them, even if it seems to you that their illness is similar to yours. Before starting treatment with Leponex, blood tests must be performed to make sure that you can take the medicine. 1. What is this medicine intended for? Leponex is used for treatment in resistant schizophrenic patients who are non- responsive to, or intolerant of other antipsychotic medicines. The medicine is also intended for reducing the risk of recurrent suicidal behaviour in patients with schizophrenia or schizoaffective disorder who are at long-term risk due to suicidal behaviour, based on previous history. Therapeutic group: Atypi Olvassa el a teljes dokumentumot
1 1. NAME OF THE MEDICINAL PRODUCT Leponex ® 25 mg tablets Leponex ® 100 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active substance_: _clozapine Excipient with known effect: lactose_. _ For the full list of excipients, see section 6.1. Leponex can cause agranulocytosis. Its use should be limited to patients: • with schizophrenia who are non-responsive to or intolerant of classical antipsychotic agents, or with schizophrenia or schizoaffective disorder who are at risk of recurrent suicidal behaviour (see “Indications”), • who have initially absolute neutrophil counts (ANC) ≥ 2,000 per mm 3 , and at least 1,500 per mm 3 patients with documented Benign Ethnic Neutropenia (BEN). • and in whom regular white blood cell counts and absolute neutrophil counts can be performed as follows: weekly during the first 18 weeks of therapy, and at least every 4 weeks thereafter throughout treatment. Monitoring must continue throughout treatment and for 4 weeks after complete discontinuation of Leponex (see “Warnings and precautions”). 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 p e r s i s t e n t t a c h y c a r d i a a t r e s t , e s p e c i a l l y i n t h e f i r s t 2 m o n t h s o f t r e a t m e n t , a n d / o r 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 who develop clozapine-induced myocarditis or cardiomyopathy should not be re-exposed to clozapine. Increase mortality in elderly patients with dementia related psychosi Olvassa el a teljes dokumentumot