البلد: أيرلندا
اللغة: الإنجليزية
المصدر: HPRA (Health Products Regulatory Authority)
Olanzapine
Actavis Group PTC ehf
N05AH; N05AH03
Olanzapine
15 milligram(s)
Orodispersible tablet
Product subject to prescription which may not be renewed (A)
Diazepines, oxazepines, thiazepines and oxepines; olanzapine
Marketed
2010-08-06
PACKAGE LEAFLET: INFORMATION FOR THE USER OLANZAPINE ACTAVIS 5 MG ORODISPERSIBLE TABLET OLANZAPINE ACTAVIS 10 MG ORODISPERSIBLE TABLET OLANZAPINE ACTAVIS 15 MG ORODISPERSIBLE TABLET OLANZAPINE ACTAVIS 20 MG ORODISPERSIBLE TABLET 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. See section 4. WHAT IS IN THIS LEAFLET: 1 WHAT OLANZAPINE ACTAVIS IS AND WHAT IT IS USED FOR 2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE OLANZAPINE ACTAVIS 3 HOW TO TAKE OLANZAPINE ACTAVIS 4 POSSIBLE SIDE EFFECTS 5 HOW TO STORE OLANZAPINE ACTAVIS 6 CONTENTS OF THE PACK AND OTHER INFORMATION 1 WHAT OLANZAPINE ACTAVIS IS AND WHAT IT IS USED FOR Olanzapine Actavis contains the active substance olanzapine. Olanzapine Actavis 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such as hearing, seeing or sensing things which are not there, mistaken beliefs, unusual suspiciousness and becoming withdrawn.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 Actavis 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 ACTAVIS DO NOT TAKE OLANZAPINE ACTAVIS • if you are allergic (hypersensitive) to olanzapine or any of the other ingredients of this medicine (listed in section 6). An allergic reaction may be recogni اقرأ الوثيقة كاملة
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Olanzapine Actavis 15mg Orodispersible Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each orodispersible tablet contains 15 mg olanzapine. Excipients: aspartame (E951) 8.4 mg For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Orodispersible tablet. A round biconvex, yellow tablet 9 mm in diameter and marked with “O2” on one side, rapid-dispersing preparation to be placed in the mouth or alternatively to be dispersed in water or other suitable beverage for administration. 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 Posology _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. H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ اقرأ الوثيقة كاملة