País: Irlanda
Língua: inglês
Origem: HPRA (Health Products Regulatory Authority)
OLANZAPINE
Chanelle Medical
N05AH03
OLANZAPINE
5 Milligram
Film Coated Tablet
Product subject to prescription which may not be renewed (A)
Antipsychotics
Authorised
2011-05-06
ID: PL 146M IE VERSION: 07 EFFECTIVE DATE: 15/11/2016 PAGE 1 OF 5 PACKAGE LEAFLET: INFORMATION FOR THE USER OLANZAPINE 2.5 MG FILM-COATED TABLETS OLANZAPINE 5 MG FILM-COATED TABLETS OLANZAPINE 7.5 MG FILM-COATED TABLETS OLANZAPINE 10 MG FILM-COATED TABLETS OLANZAPINE 15 MG FILM-COATED TABLETS OLANZAPINE 20 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, ask your doctor or pharmacist. This medicine has been prescribed for you. 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. IN THIS LEAFLET: 1. What Olanzapine is and what it is used for 2. What you need to know before you take Olanzapine 3. How to take Olanzapine 4. Possible side effects 5. How to store Olanzapine 6. Contents of the pack and other information 1. WHAT OLANZAPINE IS AND WHAT IT IS USED FOR Olanzapine Film-coated Tablets contain the active substance olanzapine. Olanzapine 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such as hearing, seeing or sensing things which are not there, mistaken beliefs, unusual suspiciousness, and becoming withdrawn.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 has been shown to prevent recurrence of Leia o documento completo
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Olanzapine 5 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each coated tablet contains 5 mg olanzapine. _Excipient with known effect: _Each film-coated tablet contains 108.35 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. White to off-white round, film-coated tablets embossed with “5” on one side and plain on the other side. 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 do Leia o documento completo