Land: Europäische Union
Sprache: Englisch
Quelle: EMA (European Medicines Agency)
olanzapine
Eli Lilly Nederland B.V.
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: 31
Authorised
2000-02-03
39 B. PACKAGE LEAFLET 40 PACKAGE LEAFLET: INFORMATION FOR THE USER ZYPREXA VELOTAB 5 MG ORODISPERSIBLE TABLETS ZYPREXA VELOTAB 10 MG ORODISPERSIBLE TABLETS ZYPREXA VELOTAB 15 MG ORODISPERSIBLE TABLETS ZYPREXA VELOTAB 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 ZYPREXA VELOTAB is and what it is used for 2. What you need to know before you take ZYPREXA VELOTAB 3. How to take ZYPREXA VELOTAB 4. Possible side effects 5. How to store ZYPREXA VELOTAB 6. Contents of the pack and other information 1. WHAT ZYPREXA VELOTAB IS AND WHAT IT IS USED FOR ZYPREXA VELOTAB contains the active substance olanzapine. ZYPREXA VELOTAB 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such as hearing, seeing or sensing things which are not there, mistaken beliefs, unusual suspiciousness, and becoming withdrawn.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. ZYPREXA VELOTAB 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 ZYPREXA VELOTAB _ _ DO NOT TAKE ZYPREXA VELOTAB • 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 Lesen Sie das vollständige Dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT ZYPREXA VELOTAB 5 mg orodispersible tablets ZYPREXA VELOTAB 10 mg orodispersible tablets ZYPREXA VELOTAB 15 mg orodispersible tablets ZYPREXA VELOTAB 20 mg orodispersible tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION ZYPREXA VELOTAB 5 mg orodispersible tablets Each orodispersible tablet contains 5 mg olanzapine. Excipients with known effect: Each orodispersible tablet contains 0.60 mg aspartame (E951), 0.1125 mg sodium methyl parahydroxybenzoate (E219), 0.0375 mg sodium propyl parahydroxybenzoate (E217). ZYPREXA VELOTAB 10 mg orodispersible tablets Each orodispersible tablet contains 10 mg olanzapine. Excipients with known effect: Each orodispersible tablet contains 0.80 mg aspartame (E951), 0.15 mg sodium methyl parahydroxybenzoate (E219), 0.05 mg sodium propyl parahydroxybenzoate (E217). ZYPREXA VELOTAB 15 mg orodispersible tablets Each orodispersible tablet contains 15 mg olanzapine. Excipients with known effect: Each orodispersible tablet contains 1.20 mg aspartame (E951), 0.225 mg sodium methyl parahydroxybenzoate (E219), 0.075 mg sodium propyl parahydroxybenzoate (E217) . ZYPREXA VELOTAB 20 mg orodispersible tablets Each orodispersible tablet contains 20 mg olanzapine. Excipients with known effect: Each orodispersible tablet contains 1.60 mg aspartame (E951), 0.30 mg sodium methyl parahydroxybenzoate (E219), 0.10 mg sodium propyl parahydroxybenzoate (E217). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Orodispersible tablet Yellow, round, freeze dried, rapid-dispersing preparation to be placed in the mouth or alternatively to be dispersed in water or other suitable beverage for administration. _ _ _ _ 3 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 fo Lesen Sie das vollständige Dokument