国: オーストラリア
言語: 英語
ソース: Department of Health (Therapeutic Goods Administration)
olanzapine, Quantity: 5 mg
Dr Reddys Laboratories Australia Pty Ltd
Olanzapine
Tablet, film coated
Excipient Ingredients: lactose monohydrate; microcrystalline cellulose; crospovidone; magnesium stearate; hyprolose; titanium dioxide; hypromellose; macrogol 400
Oral
28 tablet
(S4) Prescription Only Medicine
Treatment of schizophrenia and related psychoses. Short-term treatment, alone or in combination with lithium or valproate, of acute manic episodes associated with bipolar I disorder. Preventing recurrence of manic, mixed or depressive episodes in bipolar I disorder.
Visual Identification: White to off-white, film coated, oval, biconvex tablets, debossed "OLZ" on one side and "5" on the other side; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius
Licence status A
2011-02-17
OLANZAPINE-DRLA _Olanzapine _ _ _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet is designed to provide you with answers to some common questions about this medicine. It does not contain all the available information and does not take the place of talking with your doctor. The information in this leaflet was last updated on the date shown on the final page. More recent information about this medicine may be available. Make sure you speak to your pharmacist or doctor to obtain the most up to date information on this medicine. The updated leaflet may contain important information about Olanzapine- DRLA and its use that you should be aware of. All medicines have risks and benefits. Your doctor has more information about this medicine than is contained in this leaflet. Also, your doctor has had the benefit of taking a full and detailed history from you and is in the best position to make an expert judgement to meet your individual needs. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, TALK TO YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THIS MEDICINE. You may need to read it again. WHAT OLANZAPINE- DRLA IS USED FOR Olanzapine-DRLA belongs to a group of medicines called antipsychotics. It helps to correct chemical imbalances in the brain, which may cause mental illness. Olanzapine-DRLA is used to treat symptoms of schizophrenia and related psychoses. Schizophrenia is a mental illness with disturbances in thinking, feelings and behaviour. Olanzapine-DRLA alone, or in combination with lithium or valproate, is used for the short- term treatment of acute manic episodes associated with Bipolar I Disorder. Olanzapine- DRLA is also a mood stabiliser that prevents further occurrences of the disabling high and low (depressed) extremes of mood associated with Bipolar I Disorder. Bipolar I Disorder is a mental illness with symptoms such as feeling "high", having excessive amounts of energy, needing much less sleep than usual, talking very quickly with racing ideas and sometimes severe irritability. 完全なドキュメントを読む
AUSTRALIAN PRODUCT INFORMATION – OLANZAPINE-DRLA (OLANZAPINE) TABLETS 1 NAME OF THE MEDICINE Olanzapine 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Olanzapine 2.5 mg, 5 mg, 7.5 mg and 10 mg tablets. The active ingredient in OLANZAPINE-DRLA tablets is olanzapine. OLANZAPINE-DRLA tablets also contain excipients: Lactose monohydrate, –microcrystalline cellulose, crospovidone, hyprolose, magnesium stearate, Opadry complete film coating system OY-58900 WHITE(2.5 mg tablets) PI no.3446 , Opadry complete film coating system 06B580002 WHITE (5 mg, 7.5 mg and 10 mg tablets) PI no. 107258. 3 PHARMACEUTICAL FORM OLANZAPINE-DRLA TABLETS 2.5 mg tablet: White to off-white, film coated, oval, biconvex tablets, debossed “OLZ” on one side and “2.5” on other side. 5 mg tablet: White to off-white, film coated, oval, biconvex tablets, debossed “OLZ” on one side and “5” on other side. 7.5 mg tablet: White to off-white, film coated, oval, biconvex tablets, debossed “OLZ” on one side and “7.5” on other side. 10 mg tablet: White to off-white, film coated, oval, biconvex tablets, debossed “OLZ” on one side and “10” on other side. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS • Treatment of schizophrenia and related psychoses. • Alone or in combination with lithium or valproate is indicated for short-term treatment, of acute manic episodes associated with bipolar I disorder. • Preventing recurrence of manic, mixed or depressive episodes in bipolar I disorder. 4.2 D OSE AND METHOD OF ADMINISTRATION SCHIZOPHRENIA AND RELATED DISORDERS. The recommended starting dose for Olanzapine-DRLA is 5 to 10 mg/day, administered as a single daily dose without regard to meals. Daily dosage may subsequently be adjusted on the basis of individual clinical status within the range of 5 to 20 mg daily. An increase to a dose greater than 1 the routine therapeutic dose of 10 mg/day is recommended only after appropriate clinical reassessment. ACUTE MANIA ASSOCIATED WITH BIPOLAR DISORDER. The recommended starting dos 完全なドキュメントを読む