País: Unió Europea
Idioma: anglès
Font: EMA (European Medicines Agency)
olanzapine
Apotex Europe BV
N05AH03
olanzapine
Psycholeptics
Schizophrenia; Bipolar Disorder
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.
Revision: 13
Authorised
2010-06-10
158 B. PACKAGE LEAFLET 159 PACKAGE LEAFLET: INFORMATION FOR THE USER OLANZAPINE APOTEX 2.5 MG FILM-COATED TABLETS OLANZAPINE APOTEX 5 MG FILM-COATED TABLETS OLANZAPINE APOTEX 7.5 MG FILM-COATED TABLETS OLANZAPINE APOTEX 10 MG FILM-COATED TABLETS Olanzapine READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 Apotex is and what it is used for 2. What you need to know before you take Olanzapine Apotex 3. How to take Olanzapine Apotex 4. Possible side effects 5. How to store Olanzapine Apotex 6. Contents of the pack and other information 1. WHAT OLANZAPINE APOTEX IS AND WHAT IT IS USED FOR Olanzapine Apotex contains the active substance olanzapine. Olanzapine Apotex 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such as hearing, seeing or sensing things which are not there, mistaken beliefs, unusual suspiciousness, and becoming withdrawn.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 Apotex 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 APOTEX DO NOT TAKE OLANZAPINE APOTEX If you are allergic (hypersensitive) to olanzapine or any of the other ingredients of this medicine (listed in section 6). An allergic reaction Llegiu el document complet
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Olanzapine Apotex 2.5 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 2.5 mg olanzapine. Excipient with known effect: Each film-coated tablet contains 63.17 mg lactose. For the full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Film-coated tablet White, round, biconvex film-coated tablets engraved ‘APO’ on one side and ‘OLA’ over ‘2.5’ 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 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 recommended starting dose is advised only after ap Llegiu el document complet