Страна: Европейский союз
Язык: английский
Источник: EMA (European Medicines Agency)
olanzapine
Glenmark Pharmaceuticals s.r.o.
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
Authorised
2009-12-10
83 B. PACKAGE LEAFLET 84 PACKAGE LEAFLET: INFORMATION FOR THE USER Olazax Disperzi 5 mg orodispersible tablets Olazax Disperzi 10 mg orodispersible tablets Olazax Disperzi 15 mg orodispersible tablets Olazax Disperzi 20 mg orodispersible 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. See section 4. WHAT IS IN THIS LEAFLET 1. What Olazax Disperzi is and what it is used for 2. What you need to know before you take Olazax Disperzi 3. How to take Olazax Disperzi 4. Possible side effects 5. How to store Olazax Disperzi 6. Contents of the pack and other information 1. WHAT OLAZAX DISPERZI IS AND WHAT IT IS USED FOR Olazax Disperzi contains the active substance olanzapine. Olazax Disperzi 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such as hearing, seeing or sensing things which are not there, mistaken beliefs, unusual suspiciousness, and becoming withdrawn.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. Olazax Disperzi 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 OLAZAX DISPERZI DO NOT TAKE OLAZAX DISPERZI - 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 recognised as a rash, Прочитать полный документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Olazax Disperzi 5 mg orodispersible tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each orodispersible tablet contains 5 mg olanzapine. Excipient with known effect: Each orodispersible tablet contains 0.23 mg aspartame For the full list of excipients see section 6.1 3. PHARMACEUTICAL FORM Orodispersible tablet Yellow coloured circular flat bevelled edge orodispersible tablets with ‘B’ debossed on one 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 appropriate clinica Прочитать полный документ