देश: यूरोपीय संघ
भाषा: अंग्रेज़ी
स्रोत: EMA (European Medicines Agency)
olanzapine
Mylan Pharmaceuticals Limited
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: 19
Authorised
2008-10-06
84 B. PACKAGE LEAFLET 85 PACKAGE LEAFLET: INFORMATION FOR THE USER OLANZAPINE MYLAN 2.5 MG FILM-COATED TABLETS OLANZAPINE MYLAN 5 MG FILM-COATED TABLETS OLANZAPINE MYLAN 7.5 MG FILM-COATED TABLETS OLANZAPINE MYLAN 10 MG FILM-COATED TABLETS OLANZAPINE MYLAN 15 MG FILM-COATED TABLETS OLANZAPINE MYLAN 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 Mylan is and what it is used for 2. What you need to know before you take Olanzapine Mylan 3. How to take Olanzapine Mylan 4. Possible side effects 5. How to store Olanzapine Mylan 6. Contents of the pack and other information _ _ 1. WHAT OLANZAPINE MYLAN IS AND WHAT IT IS USED FOR Olanzapine Mylan contains the active substance olanzapine. Olanzapine 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such as hearing, seeing or sensing things which are not there, mistaken beliefs, unusual suspiciousness, and becoming withdrawn.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 Mylan 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 MYLAN DO NOT TAKE OLANZAPINE MYLAN • if you are allergic (hypersensitive) to olanzapine, peanut or soya or any पूरा दस्तावेज़ पढ़ें
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Olanzapine Mylan 2.5 mg film-coated tablets Olanzapine Mylan 5 mg film-coated tablets Olanzapine Mylan 7.5 mg film-coated tablets Olanzapine Mylan 10 mg film-coated tablets Olanzapine Mylan 15 mg film-coated tablets Olanzapine Mylan 20 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Olanzapine Mylan 2.5 mg film-coated tablets Each film-coated tablet contains 2.5 mg olanzapine. Excipients with known effect Each film-coated tablet contains 76 mg lactose (as monohydrate). The film-coating of each 2.5 mg tablet contains 0.06 mg soya lecithin. Olanzapine Mylan 5 mg film-coated tablets Each film-coated tablet contains 5 mg olanzapine. Excipients with known effect Each film-coated tablet contains 152 mg lactose (as monohydrate). The film-coating of each 5 mg tablet contains 0.12 mg soya lecithin. Olanzapine Mylan 7.5 mg film-coated tablets Each film-coated tablet contains 7.5 mg olanzapine. Excipients with known effect Each film-coated tablet contains 228 mg lactose (as monohydrate). The film-coating of each 7.5 mg tablet contains 0.18 mg soya lecithin. Olanzapine Mylan 10 mg film-coated tablets Each film-coated tablet contains 10 mg olanzapine. Excipients with known effect Each film-coated tablet contains 304 mg lactose (as monohydrate). The film-coating of each 10 mg tablet contains 0.24 mg soya lecithin. Olanzapine Mylan 15 mg film-coated tablets Each film-coated tablet contains 15 mg olanzapine. Excipients with known effect Each film-coated tablet contains 183 mg lactose (as monohydrate). The film-coating of each 15 mg tablet contains 0.15 mg soya lecithin. Olanzapine Mylan 20 mg film-coated tablets Each film-coated tablet contains 20 mg olanzapine. Excipients with known effect Each film-coated tablet contains 244 mg lactose (as monohydrate). The film-coating of each 20 mg tablet contains 0.20 mg soya lecithin. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet). Olanzap पूरा दस्तावेज़ पढ़ें