País: Austrália
Língua: inglês
Origem: Department of Health (Therapeutic Goods Administration)
quetiapine fumarate, Quantity: 460.5 mg (Equivalent: quetiapine, Qty 400 mg)
Luye Pharma Australia Pty Ltd
Quetiapine fumarate
Tablet, modified release
Excipient Ingredients: lactose monohydrate; microcrystalline cellulose; sodium citrate dihydrate; hypromellose; magnesium stearate; macrogol 400; titanium dioxide
Oral
60
(S4) Prescription Only Medicine
SEQUASE 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 - Treatment of depressive episodes associated with bipolar disorder (see DOSAGE AND ADMINISTRATION) - Treatment of acute mania associated with bipolar I disorder as monotherapy or in combination with lithium or sodium valproate. Efficacy of SEQUASE XR in the treatment of bipolar disorder indications was established in part, on the basis of extrapolation from the established effectiveness of quetiapine IR. Schizophrenia: Treatment of schizophrenia, prevention of relapse and maintenance of clinical improvement during continuation therapy. Major depressive disorder: Treatment of recurrent major depressive disorder (MDD) in patients who are intolerant of, or who have an inadequate response to alternative therapies. Generalised anxiety disorder: Treatment of generalised anxiety disorder (GAD).
Visual Identification: white film coated capsule shaped biconvex intagliated tablet with "XR 400" on 1 side & plain on the other; Container Type: Blister Pack; Container Material: PVC/PCTFE (Aclar)/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius
Licence status A
2014-07-03
SEQUASE XR ® 1 SEQUASE XR ® _Quetiapine fumarate _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some of the common questions people ask about SEQUASE 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 SEQUASE XR IS USED FOR SEQUASE 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. SEQUASE XR belongs to a group of medicines called antipsychotics. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY SEQUASE XR HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed this medicine for another reason. This medicine is o Leia o documento completo
1 of 41 Australian PRODUCT INFORMATION SEQUASE XR ® (QUETIAPINE FUMARATE) MODIFIED RELEASE TABLETS 1 NAME OF THE MEDICINE Quetiapine fumarate 2 QUALITATIVE AND QUANTITATIVE COMPOSITION SEQUASE XR 50 mg, 150 mg, 200 mg, 300 mg and 400 mg tablets contain quetiapine fumarate equivalent to 50 mg, 150 mg, 200 mg, 300 mg or 400 mg of quetiapine free base. _Excipient(s) with known effect:_ lactose monohydrate For the full list of excipients, see Section 6.1. 3 PHARMACEUTICAL FORM Tablet, modified release. SEQUASE XR 50 mg, 150 mg, 200 mg, 300 mg and 400 mg are capsule shaped modified release tablets which are peach (50 mg), white (150 mg), yellow (200 mg), pale yellow (300 mg) or white (400 mg) in colour. All tablets are embossed with “XR” and the strength on one side, while the other side is plain. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS SEQUASE 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 Treatment of depressive episodes associated with bipolar disorder (see Section 4.4) Treatment of acute mania associated with bipolar I disorder as monotherapy or in combination with lithium or sodium valproate Efficacy of SEQUASE XR in the treatment of bipolar disorder indications was established in part, on the basis of extrapolation from the established effectiveness of quetiapine immediate release. SCHIZOPHRENIA Treatment of schizophrenia, prevention of relapse and maintenance of clinical improvement during continuation therapy. MAJOR DEPRESSIVE DISORDER Treatment of recurrent major depressive disorder (MDD) in patients who are intolerant of, or who have an inadequate response to alternative therapies. 2 of 41 GENERALISED ANXIETY DISORDER Treatment of generalised anxiety disorder (GAD). 4.2 DOSE AND METHOD OF ADMINISTRATION Chronic antipsychotic treatment should generally be reserved for patients who appear to suffer Leia o documento completo