Ország: Európai Unió
Nyelv: angol
Forrás: EMA (European Medicines Agency)
olanzapine
Krka
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: 20
Authorised
2007-09-27
78 B. PACKAGE LEAFLET 79 PACKAGE LEAFLET: INFORMATION FOR THE USER ZALASTA 2.5 MG TABLETS ZALASTA 5 MG TABLETS ZALASTA 7.5 MG TABLETS ZALASTA 10 MG TABLETS ZALASTA 15 MG TABLETS ZALASTA 20 MG 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. IN THIS LEAFLET: 1. What Zalasta is and what it is used for 2. What you need to know before you take Zalasta 3. How to take Zalasta 4. Possible side effects 5. How to store Zalasta 6. Contents of the pack and other information 1. WHAT ZALASTA IS AND WHAT IT IS USED FOR Zalasta contains the active substance olanzapine. Zalasta 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such as hearing, seeing or sensing things which are not there, mistaken beliefs, unusual suspiciousness, and becoming withdrawn.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. Zalasta 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 ZALASTA DO NOT TAKE ZALASTA - 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, itching, a swollen face, swollen lips or shortness of breath. If this has happened to you, tell your doctor. - If you have been previ Olvassa el a teljes dokumentumot
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Zalasta 2.5 mg tablets Zalasta 5 mg tablets Zalasta 7.5 mg tablets Zalasta 10 mg tablets Zalasta 15 mg tablets Zalasta 20 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Zalasta 2.5 mg tablets Each tablet contains 2.5 mg olanzapine. Zalasta 5 mg tablets Each tablet contains 5 mg olanzapine. Zalasta 7.5 mg tablets Each tablet contains 7.5 mg olanzapine. Zalasta 10 mg tablets Each tablet contains 10 mg olanzapine. Zalasta 15 mg tablets Each tablet contains 15 mg olanzapine. Zalasta 20 mg tablets Each tablet contains 20 mg olanzapine. Excipient with known effect Zalasta 2.5 mg tablets Each tablet contains 40.4 mg lactose. Zalasta 5 mg tablets Each tablet contains 80.9 mg lactose. Zalasta 7.5 mg tablets Each tablet contains 121.3 mg lactose. Zalasta 10 mg tablets Each tablet contains 161.8 mg lactose. Zalasta 15 mg tablets Each tablet contains 242.7 mg lactose. Zalasta 20 mg tablets Each tablet contains 323.5 mg lactose. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet. 3 Zalasta 2.5 mg tablets Tablets are round, slightly biconvex, slightly yellow tablets with possible individual yellow spots. Zalasta 5 mg tablets Tablets are round, slightly biconvex, slightly yellow tablets with possible individual yellow spots and an inscription “5”. Zalasta 7.5 mg tablets Tablets are round, slightly biconvex, slightly yellow tablets with possible individual yellow spots and an inscription “7.5”. Zalasta 10 mg tablets Tablets are round, slightly biconvex, slightly yellow tablets with possible individual yellow spots and an inscription “10”. Zalasta 15 mg tablets Tablets are round, slightly biconvex, slightly yellow tablets with possible individual yellow spots and an inscription “15”. Zalasta 20 mg tablets Tablets are round, slightly biconvex, slightly yellow tablets with possible individual yellow spots and an inscription “20”. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _Adults_ Olanzap Olvassa el a teljes dokumentumot