Land: Schweden
Sprache: Schwedisch
Quelle: Läkemedelsverket (Medical Products Agency)
klozapin
Orifarm AB
N05AH02
clozapine
25 mg
Tablett
laktosmonohydrat Hjälpämne; klozapin 25 mg Aktiv substans
Receptbelagt
Avregistrerad
2017-02-22
1 PACKAGE LEAFLET 2 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT CLOZAPINE ACTAVIS 25 MG TABLETS 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 is Clozapine Actavis and what it is used for 2. What you need to know before you take Clozapine Actavis 3. How to take Clozapine Actavis 4. Possible side effects 5. How to store Clozapine Actavis 6. Contents of the pack and other information 1. WHAT CLOZAPINE ACTAVIS IS AND WHAT IT IS USED FOR The active ingredient of Clozapine Actavis is clozapine which belongs to a group of medicines called antipsychotics (medicines that are used to treat specific mental disorders such as psychosis). Clozapine Actavis 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. Clozapine Actavis 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 CLOZAPINE ACTAVIS DO NOT TAKE CLOZAPINE ACTAVIS 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 Lesen Sie das vollständige Dokument
1 SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Clozapine Actavis 25 mg tablets Clozapine Actavis 100 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 25 mg clozapine. Excipient with known effect: lactose monohydrate 48 mg per tablet Each tablet contains 100 mg clozapine Excipient with known effect: lactose monohydrate 192 mg per tablet For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Clozapine Actavis 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 Clozapine Actavis (see section 4.4.). Prescribing physicians must comply fully with the required safety measures. At each consultation, a patient receiving Clozapine Actavis must be reminded to contact the treating physician immediately if any kind of infection begins to develop. Particular attention must be paid to flulike complaints such as fever or sore throat and to other evidence of infection, which may be indicative of neutropenia (see section 4.4.). Clozapine Actavis 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 rarel Lesen Sie das vollständige Dokument