Country: Ástralía
Tungumál: enska
Heimild: Department of Health (Therapeutic Goods Administration)
olanzapine
Apotex Pty Ltd
Olanzapine
Registered
APO-OLANZAPINE FILM COATED TABLETS 1 APO-OLANZAPINE FILM COATED 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 ch Lestu allt skjalið
1 AUSTRALIAN PRODUCT INFORMATION – APO-OLANZAPINE FILM COATED TABLETS (OLANZAPINE) 1 NAME OF THE MEDICINE Olanzapine 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film coated tablet contains 2.5mg, 5mg, 7.5mg, 10mg, 15mg or 20mg olanzapine, as the active ingredient. EXCIPIENTS WITH KNOWN EFFECT Olanzapine film coated tablets contain lactose monohydrate. For the full list of excipients see section 6.1 LIST OF EXCIPIENTS 3 PHARMACEUTICAL FORM 2.5MG FILM COATED TABLETS: White, round, biconvex film-coated tablet. Engraved “APO” on one side, “OLA” over “2.5” on the other side. 5MG FILM COATED TABLETS: White, round, biconvex film-coated tablet. Engraved “APO” on one side, “OLA” over “5” on the other side. 7.5MG FILM COATED TABLETS: White, round, biconvex film-coated tablet. Engraved “APO” on one side, “OLA” over “7.5” on the other side. 10MG FILM COATED TABLETS: White, round, biconvex film-coated tablet. Engraved “APO” on one side, “OLA” over “10” on the other side. 15MG FILM COATED TABLETS: Light blue, elliptical, biconvex film-coated tablet. Engraved “APO” on one side, “OLA 15” on the other side. 20MG FILM COATED TABLETS: Light pink, elliptical, biconvex film-coated tablet. Engraved “APO” on one side, “OLA 20” on the other side. 2 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. 4.2 DOSE AND METHOD OF ADMINISTRATION Olanzapine film coated tablets are intended for oral administration. SCHIZOPHRENIA AND RELATED DISORDERS The recommended starting dose is 5 to 10mg/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 20mg daily. An increase to a dose greater Lestu allt skjalið