Country: European Union
Language: English
Source: EMA (European Medicines Agency)
olanzapine
Eli Lilly Nederland B.V.
N05AH03
olanzapine
Psycholeptics
Schizophrenia; Bipolar Disorder
Coated tabletsAdultsOlanzapine 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.InjectionAdultsZyprexa powder for solution for injection is indicated for the rapid control of agitation and disturbed behaviours in patients with schizophrenia or manic episode, when oral therapy is not appropriate. Treatment with Zyprexa powder for solution for injection should be discontinued and the use of oral olanzapine should be initiated as soon as clinically appropriate.
Revision: 42
Authorised
1996-09-27
60 B. PACKAGE LEAFLET 61 PACKAGE LEAFLET: INFORMATION FOR THE USER ZYPREXA 2.5 MG COATED TABLETS ZYPREXA 5 MG COATED TABLETS ZYPREXA 7.5 MG COATED TABLETS ZYPREXA 10 MG COATED TABLETS ZYPREXA 15 MG COATED TABLETS ZYPREXA 20 MG 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 ZYPREXA is and what it is used for 2. What you need to know before you take ZYPREXA 3. How to take ZYPREXA 4. Possible side effects 5. How to store ZYPREXA 6. Contents of the pack and other information 1. WHAT ZYPREXA IS AND WHAT IT IS USED FOR ZYPREXA contains the active substance olanzapine. ZYPREXA 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such as hearing, seeing or sensing things which are not there, mistaken beliefs, unusual suspiciousness, and becoming withdrawn.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 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 _ _ DO NOT TAKE ZYPREXA • 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 Read the complete document
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT ZYPREXA 2.5 mg coated tablets ZYPREXA 5 mg coated tablets ZYPREXA 7.5 mg coated tablets ZYPREXA 10 mg coated tablets ZYPREXA 15 mg coated tablets ZYPREXA 20 mg coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION ZYPREXA 2.5 mg coated tablets Each coated tablet contains 2.5 mg olanzapine. Excipient with known effect: Each coated tablet contains 102 mg lactose monohydrate. ZYPREXA 5 mg coated tablets Each coated tablet contains 5 mg olanzapine. Excipient with known effect: Each coated tablet contains 156 mg lactose monohydrate. ZYPREXA 7.5 mg coated tablets Each coated tablet contains 7.5 mg olanzapine. Excipient with known effect: Each coated tablet contains 234 mg lactose monohydrate. ZYPREXA 10 mg coated tablets Each coated tablet contains 10 mg olanzapine. Excipient with known effect: Each coated tablet contains 312 mg lactose monohydrate. ZYPREXA 15 mg coated tablets Each coated tablet contains 15 mg olanzapine. Excipient with known effect: Each coated tablet contains 178 mg lactose monohydrate. ZYPREXA 20 mg coated tablets Each coated tablet contains 20 mg olanzapine. Excipient with known effect: Each coated tablet conatins 238 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Coated tablet ZYPREXA 2.5 mg coated tablets Round, white, coated tablets _ _ imprinted with “LILLY” and a numeric identicode “4112”. ZYPREXA 5 mg coated tablets Round, white, coated tablets _ _ imprinted with “LILLY” and a numeric identicode “4115”. ZYPREXA 7.5 mg coated tablets Round, white, coated tablets _ _ imprinted with “LILLY” and a numeric identicode “4116”. 3 ZYPREXA 10 mg coated tablets Round, white, coated tablets _ _ imprinted with “LILLY” and a numeric identicode “4117”. ZYPREXA 15 mg coated tablets Elliptical, blue, coated tablets _ _ debossed with “LILLY” and a numeric identicode “4415”. ZYPREXA 20 mg coated tablets Pink, elliptical, coated tablets _ Read the complete document