Maa: Australia
Kieli: englanti
Lähde: Department of Health (Therapeutic Goods Administration)
olanzapine, Quantity: 15 mg
Sandoz Pty Ltd
Olanzapine
Tablet, orally disintegrating
Excipient Ingredients: purified talc; crospovidone; colloidal anhydrous silica; lactose monohydrate; magnesium stearate; hyprolose; Flavour
Oral
28, 60, 30, 50, 14, 21, 20, 7, 40, 10
(S4) Prescription Only Medicine
For the treatment of schizophrenia and related psychoses. ,Alone or in combination with lithium or valproate, it is indicated for the short-term treatment of acute manic episodes associated with Bipolar I Disorder. ,For preventing recurrence of manic, mixed or depressive episodes in Bipolar I Disorder.
Visual Identification: Yellow, round biconvex tablets; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 18 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure
Registered
2011-08-12
OLANZAPINE SANDOZ ® ODT 1 OLANZAPINE SANDOZ ® ODT _olanzapine orally dispersible tablets _ 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 to your doctor. 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 SANDOZ ODT IS USED FOR OLANZAPINE SANDOZ ODT belongs to a group of medicines called antipsychotics. It helps to correct chemical imbalances in the brain, which may cause mental illness. OLANZAPINE SANDOZ ODT is used to treat symptoms of schizophrenia and related psychoses. OLANZAPINE SANDOZ ODT 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 SANDOZ ODT is also a mood stabiliser that prevents further occurrences of the disabling high and low (depressed) extremes of mood associated with Bipolar I Disorder. Schizophrenia is a mental illness with disturbances in thinking, feelings and behaviour. 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. Your doctor may have prescribed OLANZAPINE SANDOZ ODT for another reason. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY OLANZAPINE SANDOZ ODT HAS BEEN PRESCRIBED FOR YOU. This medicine is available only with a doctor's prescription. OLANZAPINE SANDOZ ODT is not recommended for use in Lue koko asiakirja
191219-olanzapine-sandoz-odt-pi Page 1 of 23 AUSTRALIAN PRODUCT INFORMATION OLANZAPINE SANDOZ ® ODT (OLANZAPINE) ORALLY DISINTEGRATING TABLETS 1. NAME OF THE MEDICINE Olanzapine 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each Olanzapine Sandoz ® ODT 5 contains 5 mg olanzapine. Each Olanzapine Sandoz ® ODT 10 contains 10 mg olanzapine. Each Olanzapine Sandoz ® ODT 15 contains 15 mg olanzapine. Each Olanzapine Sandoz ® ODT 20 contains 20 mg olanzapine _Excipient with known effect:_ Lactose monohydrate. For the full list of excipients, see Section 6.1 List of excipients. 3. PHARMACEUTICAL FORM Olanzapine Sandoz ® ODT are for oral administration only. Olanzapine Sandoz ® ODT 5 are yellow, round, biconvex orally disintegrating tablets. Olanzapine Sandoz ® ODT 10 are yellow, round, flat orally disintegrating tablets. Olanzapine Sandoz ® ODT 15 are yellow, round, biconvex orally disintegrating tablets. Olanzapine Sandoz ® ODT 20 are yellow, round, flat orally disintegrating tablets. 4. CLINICAL PARTICULARS 4.1. T HERAPEUTIC INDICATIONS For the treatment of schizophrenia and related psychoses. For the short term treatment of acute manic episodes associated with Bipolar I Disorder, when used alone or in combination with lithium or valproate. For preventing recurrence of manic, mixed or depressive episodes in Bipolar I Disorder. 4.2. D OSE AND METHOD OF ADMINISTRATION DOSAGE _SCHIZOPHRENIA AND RELATED DISORDERS _ The recommended starting dose for olanzapine is 5-10 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 5-20 mg daily. An increase to a dose greater than the routine therapeutic dose of 10 mg/day is recommended only after appropriate clinical reassessment. 191219-olanzapine-sandoz-odt-pi Page 2 of 23 _ACUTE MANIA ASSOCIATED WITH BIPOLAR DISORDER _ The recommended starting dose for olanzapine is 10 or 15 mg administered once a day as monotherapy or 10 mg administered once daily in co Lue koko asiakirja