Land: Den europeiske union
Språk: engelsk
Kilde: EMA (European Medicines Agency)
olanzapine
Teva 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: 30
Authorised
2007-12-12
82 B. PACKAGE LEAFLET 83 PACKAGE LEAFLET: INFORMATION FOR THE USER OLANZAPINE TEVA 2.5 MG FILM-COATED TABLETS OLANZAPINE TEVA 5 MG FILM-COATED TABLETS OLANZAPINE TEVA 7.5 MG FILM-COATED TABLETS OLANZAPINE TEVA 10 MG FILM-COATED TABLETS OLANZAPINE TEVA 15 MG FILM-COATED TABLETS OLANZAPINE TEVA 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 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 Teva is and what it is used for 2. What you need to know before you take Olanzapine Teva 3. How to take Olanzapine Teva 4. Possible side effects 5. How to store Olanzapine Teva 6. Contents of the pack and other information 1. WHAT OLANZAPINE TEVA IS AND WHAT IT IS USED FOR Olanzapine Teva contains the active substance olanzapine. Olanzapine Teva 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such as hearing, seeing or sensing things which are not there, mistaken beliefs, unusual suspiciousness, and becoming withdrawn.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 Teva 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 TEVA _ _ DO NOT TAKE OLANZAPINE TEVA - if you are allergic to olanzapine or any of the other ingredients of this medicine (listed in sect Les hele dokumentet
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Olanzapine Teva 2.5 mg film-coated tablets Olanzapine Teva 5 mg film-coated tablets Olanzapine Teva 7.5 mg film-coated tablets Olanzapine Teva 10 mg film-coated tablets Olanzapine Teva 15 mg film-coated tablets Olanzapine Teva 20 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Olanzapine Teva 2.5 mg film-coated tablets Each film-coated tablet contains 2.5 mg olanzapine. _Excipient with known effect _ Each film-coated tablet contains 71.3 mg lactose. Olanzapine Teva 5 mg film-coated tablets Each film-coated tablet contains 5 mg olanzapine. _Excipient with known effect _ Each film-coated tablet contains 68.9 mg lactose. Olanzapine Teva 7.5 mg film-coated tablets Each film-coated tablet contains 7.5 mg olanzapine. _Excipient with known effect _ Each film-coated tablet contains 103.3 mg lactose. Olanzapine Teva 10 mg film-coated tablets Each film-coated tablet contains 10 mg olanzapine. _Excipient with known effect _ Each film-coated tablet contains 137.8 mg lactose. Olanzapine Teva 15 mg film-coated tablets Each film-coated tablet contains 15 mg olanzapine. _Excipient with known effect _ Each film-coated tablet contains 206.7 mg lactose. Olanzapine Teva 20 mg film-coated tablets Each film-coated tablet contains 20 mg olanzapine. _Excipient with known effect _ Each film-coated tablet contains 275.5 mg lactose. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet Olanzapine Teva 2.5 mg film-coated tablets White, biconvex, round film-coated tablets, debossed ”OL 2.5” on one side and plain on the other. Olanzapine Teva 5 mg film-coated tablets White, biconvex, round film-coated tablets, debossed ”OL 5” on one side and plain on the other. Olanzapine Teva 7.5 mg film-coated tablets White, biconvex, round film-coated tablets, debossed ”OL 7.5” on one side and plain on the other. 3 Olanzapine Teva 10 mg film-coated tablets White, biconvex, round film-coated tablets, debossed Les hele dokumentet