देश: ऑस्ट्रेलिया
भाषा: अंग्रेज़ी
स्रोत: Department of Health (Therapeutic Goods Administration)
olanzapine, Quantity: 2.5 mg
Arrotex Pharmaceuticals Pty Ltd
Tablet, uncoated
Excipient Ingredients: microcrystalline cellulose; lactose; hyprolose; magnesium stearate
Oral
28
(S4) Prescription Only Medicine
PRYZEX 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 'O4' 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
2020-07-01
PRYZEX TABLETS 1 PRYZEX TABLETS _Olanzapine _ CONSUMER MEDICINE INFORMATION 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 EXPIRY DATE PRINTED ON THE PACK OR IF THE PACKAGING IS TORN OR SHOWS SIGNS OF पूरा दस्तावेज़ पढ़ें
1 AUSTRALIAN PRODUCT INFORMATION PRYZEX (OLANZAPINE) TABLETS 1 NAME OF THE MEDICINE Olanzapine 2 QUALITATIVE AND QUANTITATIVE COMPOSITION PRYZEX tablets contain olanzapine 2.5 mg, 5 mg, 7.5 mg and 10 mg. Excipients with known effect: sugars as lactose monohydrate. 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. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS PRYZEX 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 PRYZEX 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 meals. Daily dosage may subsequently be adjusted on the 2 basis of individual clinical status within the range of 5 to 20mg daily. An increase to a dose greater than the routine therapeutic dose of 10mg/day is recommended only after appropriate clinical reassessment. ACUTE MANIA ASSOCIATED WITH BIPOLAR DISORDER The recommended starting dose for olanzapine tablets is 10 or 15mg administered once a day as monotherapy or 10 mg administered once daily in combination therapy with lithi पूरा दस्तावेज़ पढ़ें