Quốc gia: Liên Minh Châu Âu
Ngôn ngữ: Tiếng Anh
Nguồn: EMA (European Medicines Agency)
olanzapine
Cipla (EU) Limited
N05AH03
olanzapine
Psycholeptics
Schizophrenia; Bipolar Disorder
AdultsOlanzapine is indicated for the treatment of schizophrenia.Olanzapine is effective in maintaining the clinical improvement during continuation therapy in patients who have shown an initial treatment response.Olanzapine is indicated for the treatment of moderate to severe manic episode.In patients whose manic episode has responded to olanzapine treatment, olanzapine is indicated for the prevention of recurrence in patients with bipolar disorder.
Revision: 12
Withdrawn
2007-11-14
Medicinal product no longer authorised 101 B. PACKAGE LEAFLET Medicinal product no longer authorised 102 PACKAGE LEAFLET: INFORMATION FOR THE USER OLANZAPINE CIPLA 2.5 MG COATED TABLETS OLANZAPINE CIPLA 5 MG COATED TABLETS OLANZAPINE CIPLA 7.5 MG COATED TABLETS OLANZAPINE CIPLA 10 MG COATED TABLETS OLANZAPINE CIPLA 15 MG COATED TABLETS olanzapine 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. What is in this leaflet 1. What OLANZAPINE CIPLA is and what it is used for 2. What you need to know before you take OLANZAPINE CIPLA 3. How to take OLANZAPINE CIPLA 4. Possible side effects 5. How to store OLANZAPINE CIPLA 6. Contents of the pack and other information 1. WHAT OLANZAPINE CIPLA IS AND WHAT IT IS USED FOR OLANZAPINE CIPLA belongs to a group of medicines called antipsychotics and is used to treat the following conditions: Schizophrenia, a disease with symptoms such as hearing, seeing or sensing things which are not there, mistaken beliefs, unusual suspiciousness, and becoming withdrawn. People with this disease may also feel depressed, anxious or tense. Moderate to severe manic episodes, a condition with symptoms of excitement or euphoria. OLANZAPINE CIPLA has been shown to prevent recurrence of these symptoms in patients with bipolar disorder whose manic episode has responded to olanzapine treatment. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE OLANZAPINE CIPLA _ _ DO NOT TAKE OLANZAPINE CIPLA iIf you are allergic (hypersensitive) to olanzapine or any of the other ingredients of this medicine (listed in section 6). An allergic re Đọc toàn bộ tài liệu
Medicinal product no longer authorised 1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Medicinal product no longer authorised 2 1. NAME OF THE MEDICINAL PRODUCT Olanzapine Cipla 2.5 mg coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each coated tablet contains 2.5 mg olanzapine. Excipient with known effect: Each coated tablet contains 80.7 mg lactose monohydrate For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Coated tablet White, round, biconvex, coated tablets with ‘2.5’ debossing on one side and ‘OLZ’ on the other. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _Adults _ Olanzapine is indicated for the treatment of schizophrenia. Olanzapine is effective in maintaining the clinical improvement during continuation therapy in patients who have shown an initial treatment response. Olanzapine is indicated for the treatment of moderate to severe manic episode. In patients whose manic episode has responded to olanzapine treatment, olanzapine is indicated for the prevention of recurrence in patients with bipolar disorder (see section 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Adults _ Schizophrenia: The recommended starting dose for olanzapine is 10 mg/day. Manic episode: The starting dose is 15 mg as a single daily dose in monotherapy or 10 mg daily in combination therapy (see section 5.1). Preventing recurrence in bipolar disorder: The recommended starting dose is 10 mg/day. For patients who have been receiving olanzapine for treatment of manic episode, continue therapy for preventing recurrence at the same dose. If a new manic, mixed, or depressive episode occurs, olanzapine treatment should be continued (with dose optimisation as needed), with supplementary therapy to treat mood symptoms, as clinically indicated. During treatment for schizophrenia, manic episode and recurrence prevention in bipolar disorder, daily dosage may subsequently be adjusted on the basis of individual clinical status within the range 5-20 mg/day. An increase to a dose greater than the reco Đọc toàn bộ tài liệu