Country: New Zealand
Language: English
Source: Medsafe (Medicines Safety Authority)
Olanzapine 7.5mg
Apotex NZ Ltd
Olanzapine 7.5 mg
7.5 mg
Film coated tablet
Active: Olanzapine 7.5mg Excipient: Hyprolose Hypromellose Lactose monohydrate Macrogol 8000 Magnesium stearate Maize starch Microcrystalline cellulose Purified water Titanium dioxide
Blister pack, Al/Al blister, 28 tablets
Prescription
Prescription
Apotex Pharmachem Inc
Olanzapine is indicated for the treatment of schizophrenia and related psychoses.
Package - Contents - Shelf Life: Blister pack, Al/Al blister - 28 tablets - 24 months from date of manufacture stored at or below 25°C - Bottle, plastic, HDPE - 100 tablets - 24 months from date of manufacture stored at or below 25°C - Bottle, plastic, HDPE - 500 tablets - 24 months from date of manufacture stored at or below 25°C
2010-03-29
1 New Zealand Consumer Medicine Information APO-OLANZAPINE _OLANZAPINE _ 2.5mg, 5mg, 7.5mg 10mg, 15mg and 20mg film coated tablets and 5mg, 10mg, 15mg and 20mg orally disintegrating tablets WHAT IS IN THIS LEAFLET Please read this leaflet carefully before you start using Apo-Olanzapine. This leaflet answers some common questions about Apo-Olanzapine. 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 using Apo-Olanzapine against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. Keep this leaflet with the medicine. You may need to read it again. WHAT APO-OLANZAPINE 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. Apo-Olanzapine is used: • to treat symptoms of schizophrenia and related psychoses. Schizophrenia is a mental illness with disturbances in thinking, feelings and behaviour. • alone or in combination with lithium or valproate is indicated for the short-term treatment of acute manic episodes associated with Bipolar I Disorder. • As a mood stabiliser that prevents further occurrences of the disabling high and low (depressed) extremes of mood associated with Bipolar I Disorder. 2 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 Apo-Olanzapine for another reason. Ask your doctor if you have any questions about why Apo-Olanzapine has been prescribed for you. This medicine is available only with a doctor's prescription. Apo-Olanzapine is not recommended for use in children u Read the complete document
NEW ZEALAND DATA SHEET APO-OLANZAPINE Please refer to Medsafe website (www.medsafe.govt.nz) for the most recent datasheet Page 1 1. APO-OLANZAPINE (2.5MG, 5MG, 7.5MG, 10MG, 15MG & 20MG FILM COATED TABLETS) and APO-OLANZAPINE ODT (5MG, 10MG, 15MG & 20MG ORALLY DISINTEGRATING TABLETS) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Olanzapine 2.5mg, 5mg, 7.5mg, 10mg, 15mg or 20mg per film coated tablet or Olanzapine 5mg, 10mg, 15mg or 20mg per orally disintegrating tablet EXCIPIENT(S) OF KNOWN EFFECT APO-OLANZAPINE contains lactose. APO-OLANZAPINE ODT contains sucralose. APO-OLANZAPINE and APO-OLANZAPINE ODT do not contain gluten. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM APO-OLANZAPINE 2.5mg film coated tablet: White, round, biconvex film-coated tablet. Engraved “APO’ on one side, “OLA” over “2.5” on the other side. APO-OLANZAPINE 5mg film coated tablet: White, round, biconvex film-coated tablet. Engraved “APO’ on one side, “OLA” over “5” on the other side. APO-OLANZAPINE 7.5mg film coated tablet: White, round, biconvex film-coated tablet. Engraved “APO’ on one side, “OLA” over “7.5” on the other side. APO-OLANZAPINE 10mg film coated tablet: White, round, biconvex film-coated tablet. Engraved “APO’ on one side, “OLA” over “10” on the other side. APO-OLANZAPINE 15mg film coated tablet: Light blue, elliptical, biconvex film-coated tablet. Engraved “APO’ on one side, “OLA 15” on the other side. APO-OLANZAPINE 20mg film coated tablet: Light pink, elliptical, biconvex film-coated tablet. Engraved “APO’ on one side, “OLA 20” on the other side. Film coated tablet cannot be halved. APO-OLANZAPINE ODT 5mg orally disintegrating tablet: Yellow, round, flat faced radial edge tablet. Engraved “APO’ on one side, “OL” over “5” on the other side. APO-OLANZAPINE ODT 10mg orally disintegrating tablet: Yellow, round, flat faced radial edge tablet. Engraved “APO’ on one side, “OL” over “10” on the other side. APO-OLANZAPIN Read the complete document