Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Olanzapine (form-1)
Accord Healthcare Limited
N05AH; N05AH03
Olanzapine (form-1)
5 milligram(s)
Film-coated tablet
Product subject to prescription which may not be renewed (A)
Diazepines, oxazepines, thiazepines and oxepines; olanzapine
Marketed
2011-12-05
PACKAGE LEAFLET: INFORMATION FOR THE USER OLANZAPINE ACCORD 2.5 MG FILM-COATED TABLETS OLANZAPINE ACCORD 5 MG FILM-COATED TABLETS OLANZAPINE ACCORD 7.5 MG FILM-COATED TABLETS OLANZAPINE ACCORD 10 MG FILM-COATED TABLETS OLANZAPINE ACCORD 15 MG FILM-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, please 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 or nurse. This includes any possible side effects not listed in this leaflet. See Section 4. WHAT IS IN THIS LEAFLET 1. What Olanzapine Accord is and what it is used for 2. What you need to know before you take Olanzapine Accord 3. How to take Olanzapine Accord 4. Possible side effects 5. How to store Olanzapine Accord 6. Contents of the pack and other information 1. WHAT OLANZAPINE ACCORD IS AND WHAT IT IS USED FOR Olanzapine Accord contains the active substance olanzapine. Olanzapine tablets 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such as hearing, seeing or sensing things which are not there, mistaken beliefs, unusual suspiciousness, and becoming withdrawn.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 Accord 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 ACCORD DO NOT TAKE OLANZAPINE ACCORD If you are allergic (hypersensitive) to olanzapine or any of the other ingredients of this medicine (listed i Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Olanzapine Accord 5 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 5 mg of Olanzapine. Excipient with known effect: Lactose 56.24 mg For the full list of excipients see section 6.1 3 PHARMACEUTICAL FORM Film-coated tablet White to off white round, biconvex, film-coated tablets of 6.4 mm, debossed with 'O1' on one side and plain on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _Adults_ Olanzapine Accord is indicated for the treatment of schizophrenia. Olanzapine Accord is effective in maintaining the clinical improvement during continuation therapy in patients who have shown an initial treatment response. Olanzapine Accord is indicated for the treatment of moderate to severe manic episode. In patients whose manic episode has responded to Olanzapine Accord treatment, Olanzapine Accord 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 Accord is 10mg/day. Manic episode: The starting dose is 15mg as a single daily dose in monotherapy or 10mg daily in combination therapy (see section 5.1). Preventing recurrence in bipolar disorder: The recommended starting dose is 10mg/day. For patients who have been receiving Olanzapine Accord for treatment of manic episode, continue therapy for preventing recurrence at the same dose. If a new manic, mixed, or depressive episode occurs, Olanzapine Accord treatment should be continued (with dose optimization 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 5-20mg/day. An increase to a dose greater than the recommended starting dose is advised only after app Read the complete document