Kraj: Australia
Język: angielski
Źródło: Department of Health (Therapeutic Goods Administration)
quetiapine fumarate, Quantity: 345.39 mg (Equivalent: quetiapine, Qty 300 mg)
Arrotex Pharmaceuticals Pty Ltd
Quetiapine fumarate
Tablet, modified release
Excipient Ingredients: magnesium stearate; macrogol 400; lactose monohydrate; light magnesium oxide; carrageenan; titanium dioxide; microcrystalline cellulose; iron oxide yellow; povidone
Oral
60
(S4) Prescription Only Medicine
Bipolar disorder - Maintenance treatment of bipolar 1 disorder, as monotherapy or in combination with lithium or sodium valproate, for the prevention of relapse/recurrence of manic, depressive or mixed episodes. Treatment of depressive episodes associated with bipolar disorder (see dosage and administration). Treatment of acute mania associated with bipolar I disorder as monotherapy or incombination with lithium or sodium valproate. Efficacy of quetiapine in the treatment of bipolar disorder indications was established in part, on the basis of extrapolation from the established effectiveness of quetiapine immediate release tablets. Schizophrenia - Treatment of schizophrenia, prevention of relapse and maintenance of clinical improvement during continuation therapy. Major depressive disorder (MDD)- Treatment of recurrent major depressive disorde in patients who are intolerant of, or who have an inadequate response to alternative therapies. Generalised anxiety disorder (GAD). Treatment of generalised anxiety disorder.
Visual Identification: Pale yellow, capsule shaped, biconvex, coated tablet, plain on both sides; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure
Licence status A
2014-01-17
APX-QUETIAPINE XR _contains the active ingredient quetiapine (as fumarate)_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some of the common questions people ask about APX-QUETIAPINE XR. 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 will have weighed the risks of you taking it 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 APX-QUETIAPINE XR IS USED FOR APX-QUETIAPINE XR helps to correct chemical imbalances in the brain. It is used to treat conditions such as: • Bipolar disorder, an illness of in which there are sustained mood swings either up (mania) or down (depression). During mania, patients experience episodes of overactivity, elation or irritability. During depression, patients may feel depressed or guilty, lack energy, lose their appetite and have trouble sleeping. • Recurrent major depressive disorder, an illness where depression is longer lasting and/ or more severe than the "low moods" everyone has from time to time due to the stress of everyday life. It is thought to be caused by a chemical imbalance in parts of the brain. This imbalance affects your whole body and can cause emotional and physical symptoms such as feeling low in spirit, loss of interest in activities, being unable to enjoy life, poor appetite or overeating, disturbed sleep, often waking up early, loss of sex drive, lack of energy and feeling guilty over nothing. • Generalised anxiety disorder, where patients have excessive anxiety and worry. • Schizophrenia, an illness with disturbances in thinking, feelings and behaviour. APX-QUETIAPINE XR belongs to a group of medicines called antipsychotics. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY APX- QUETIAPINE XR HAS BEEN PRESCRIBED FOR YOU. Your doctor may have pre Przeczytaj cały dokument
1 AUSTRALIAN PRODUCT INFORMATION APX-QUETIAPINE XR (Quetiapine fumarate) modified release tablet 1 NAME OF THE MEDICINE Quetiapine fumarate 2 QUALITATIVE AND QUANTITATIVE COMPOSITION APX-QUETIAPINE XR modified release tablets come in five strengths and contain quetiapine fumarate equivalent to 50 mg, 150 mg, 200 mg, 300 mg and 400 mg of quetiapine free base. EXCIPIENTS WITH KNOWN EFFECT: Contains sugars as lactose. The tablets are gluten free. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM _APX-QUETIAPINE XR 50 MG_ Quetiapine (as fumarate) 50 mg modified release tablet; Light pink to pink, capsule shaped, biconvex, coated tablet, plain on both sides. _APX-QUETIAPINE XR 150 MG_ Quetiapine (as fumarate) 150 mg modified release tablet; White to off-white, round, biconvex, coated tablet, plain on both sides. _APX-QUETIAPINE XR 200 MG_ Quetiapine (as fumarate) 200 mg modified release tablet; Yellow, capsule shaped, biconvex, coated tablet, plain on both sides. _APX-QUETIAPINE XR 300 MG_ Quetiapine (as fumarate) 300 mg modified release tablet; Pale yellow, capsule shaped, biconvex, coated tablet, plain on both sides. _APX-QUETIAPINE XR 400 MG_ Quetiapine (as fumarate) 400 mg modified release tablet; White to off-white, capsule shaped, biconvex, coated tablet, plain on both sides. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS APX-QUETIAPINE XR is indicated for: BIPOLAR DISORDER • Maintenance treatment of bipolar I disorder, as monotherapy or in combination with lithium or sodium valproate, for the prevention of relapse/recurrence of manic, depressive or mixed episodes 2 • Treatment of depressive episodes associated with bipolar disorder (see section 4.2 Dose and method of administration). • Treatment of acute mania associated with bipolar I disorder as monotherapy or in combination with lithium or sodium valproate Efficacy of quetiapine modified release tablets in the treatment of bipolar disorder indications was established in part, on the basis of extrapolation f Przeczytaj cały dokument