Valsts: Austrālija
Valoda: angļu
Klimata pārmaiņas: Department of Health (Therapeutic Goods Administration)
olanzapine, Quantity: 15 mg
Arrotex Pharmaceuticals Pty Ltd
Olanzapine
Tablet, orally disintegrating
Excipient Ingredients: carmellose calcium; sucralose; mannitol; colloidal anhydrous silica; microcrystalline cellulose; magnesium stearate
Oral
28
(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: Yellow, round, flat, faced radial edge tablets. Engraved "APO" on one side, "OL" over "15" on the other side.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
2009-11-26
APO-OLANZAPINE ORALLY DISINTEGRATING TABLETS _ORALLY DISINTEGRATING TABLETS_ _Olanzapine_ CONSUMER MEDICINE INFORMATION _FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055_ WHAT IS IN THIS LEAFLET This leaflet answers some common questions about this medicine. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking this medicine against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT THIS MEDICINE IS USED FOR The name of your medicine is APO- Olanzapine. It contains the active ingredient olanzapine. Olanzapine belongs to a group of medicines called antipsychotics. It helps to correct chemical imbalances in the brain, which may cause mental illness. It is used: • to treat symptoms of schizophrenia and related psychoses • alone, or in combination with lithium or valproate, for the short- term treatment of acute manic episodes associated with Bipolar I Disorder. • as a mood stabiliser that prevents further occurrences of 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. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed this medicine for another reason. This medicine is available only with a doctor's prescription. This medicine may affect your ability to drive a car or operate machinery. There is no evidence that this medicine is addictive. _USE IN CHILDREN_ Olanzapine is not recommended for use in c Izlasiet visu dokumentu
1 AUSTRALIAN PRODUCT INFORMATION – APO-OLANZAPINE ODT ORALLY DISINTEGRATING TABLETS (OLANZAPINE) 1 NAME OF THE MEDICINE Olanzapine 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each orally disintegrating tablet contains 5mg, 10mg, 15mg or 20mg olanzapine, as the active ingredient. EXCIPIENTS WITH KNOWN EFFECT Not applicable For the full list of excipients see section 6.1 List of Excipients 3 PHARMACEUTICAL FORM 5MG ORALLY DISINTEGRATING TABLETS: Yellow, round, flat face radial-edged tablets. Engraved “APO” on one side, “OL” over “5” on the other side. 10MG ORALLY DISINTEGRATING TABLETS: Yellow, round, flat face radial-edged tablets. Engraved “APO” on one side, “OL” over “10” on the other side. 15MG ORALLY DISINTEGRATING TABLETS: Yellow, round, flat face radial-edged tablets. Engraved “APO” on one side, “OL” over “15” on the other side. 20MG ORALLY DISINTEGRATING TABLETS: Yellow, round, flat face radial-edged tablets. Engraved “APO” on one side, “OL” over “20” on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS 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. 2 4.2 DOSE AND METHOD OF ADMINISTRATION Olanzapine ODT orally disintegrating tablets are intended for oral administration. The orally disintegrating tablet begins disintegrating in the mouth within seconds, allowing its contents to be subsequently swallowed with or without liquid. The orally disintegrating tablet should be handled carefully with dry hands. Direct contact with hands should be avoided if possible. The orally disintegrating tablet may also be stirred into 125mL of water, milk, coffee, orange juice or apple juice and the contents promptly consumed. SCHIZOPHRENIA AND RELATED DISORDERS The recommended starting dose is 5 to 10mg/day, administered as a single d Izlasiet visu dokumentu