Valsts: Austrālija
Valoda: angļu
Klimata pārmaiņas: Department of Health (Therapeutic Goods Administration)
olanzapine, Quantity: 7.5 mg
Arrotex Pharmaceuticals Pty Ltd
Tablet, uncoated
Excipient Ingredients: hyprolose; lactose; microcrystalline cellulose; magnesium stearate
Oral
28
(S4) Prescription Only Medicine
APO-OLANZAPINE tablets are indicated for ? 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 1 disorder.
Visual Identification: Light yellow to yellow coloured, slightly mottled, round, biconvex tablets, debossed with 'O6' on one side and plain on the other side.; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure
Registered
2018-08-29
OLANZAPINE APOTEX TABLETS 1 OLANZAPINE APOTEX 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 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 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 want to read it again. WHAT THIS MEDICINE IS USED FOR Olanzapine belongs to a group of medicines called antipsychotics. Olanzapine 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 the disabling high and low extremes of mood associated Bipolar I Disorder _HOW IT WORKS _ Olanzapine helps to correct chemical imbalances in the brain, which may cause mental illness. 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 is not addictive. There is not enough information to recommend using olanzapine in children under the age of 18 years. BEFORE YOU TAKE THIS MEDICINE _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE THIS MEDICINE IF YOU HAVE AN ALLERGY TO: • olanzapine • any of the ingredients listed at the end of this leaflet. Some of the symptoms of an allergic reaction may include: • shortness of breath • wheezing or difficulty breathing • swelling of the face, lips, tongue, throat or other parts of the body • rash, itching or hives on the skin; DO NOT TAKE THIS MEDICINE AFTER THE EX Izlasiet visu dokumentu
1 AUSTRALIAN PRODUCT INFORMATION OLANZAPINE APOTEX (OLANZAPINE) TABLETS 1 NAME OF THE MEDICINE Olanzapine 2 QUALITATIVE AND QUANTITATIVE COMPOSITION OLANZAPINE APOTEX 2.5 mg uncoated tablet contains olanzapine 2.5 mg. Excipient with known effects: Each 2.5 mg tablet contains 65.5 mg of lactose. OLANZAPINE APOTEX 5 mg uncoated tablet contains olanzapine 5 mg. Excipient with known effects: Each 5 mg tablet contains 131 mg of lactose. OLANZAPINE APOTEX 7.5 mg uncoated tablet contains olanzapine 7.5 mg. Excipient with known effects: Each 7.5 mg tablet contains 196.5 mg of lactose. OLANZAPINE APOTEX 10 mg uncoated tablet contains olanzapine 10 mg. Excipient with known effects: Each 10 mg tablet contains 262 mg of lactose. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Tablet. 2.5 mg: Light yellow to yellow coloured, slightly mottled, round, biconvex tablets debossed with ‘O4’ on one side and plain on the other side. 5 mg: Light yellow to yellow coloured, slightly mottled, round, biconvex tablets debossed with ‘O5’ on one side and plain on the other side. 7.5 mg: Light yellow to yellow coloured, slightly mottled, round, biconvex tablets debossed with ‘O6’ on one side and plain on the other side. 10 mg: light yellow to yellow coloured, slightly mottled, round, biconvex tablets debossed with ‘O7’ on one side and plain on the other side. 2 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS OLANZAPINE APOTEX tablets are indicated for • 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 1 disorder. 4.2 DOSE AND METHOD OF ADMINISTRATION OLANZAPINE APOTEX tablets are intended for oral administration SCHIZOPHRENIA AND RELATED DISORDERS The recommended starting dose for olanzapine tablets is 5 to 10mg/day, administered as a single daily dose without regard to Izlasiet visu dokumentu