Ülke: Avustralya
Dil: İngilizce
Kaynak: Department of Health (Therapeutic Goods Administration)
quetiapine fumarate
Medis Pharma Pty Ltd
Quetiapine fumarate
Registered
QUETIAPINE- AS XR QUETIAPINE FUMARATE CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some of the common questions people ask about QUETIAPINE-AS 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 QUETIAPINE- AS XR IS USED FOR QUETIAPINE-AS XR helps to correct chemical imbalances in the brain. It is used to treat conditions such as: • Bipolar disorder, an illness 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. QUETIAPINE-AS XR belongs to a group of medicines called antipsychotics. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY QUETIAPINE-AS XR HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed this medicine for another reason. This Belgenin tamamını okuyun
1 AUSTRALIAN PRODUCT INFORMATION - QUETIAPINE-AS XR (QUETIAPINE FUMARATE) MODIFIED RELEASE TABLETS 1. NAME OF THE MEDICINE Quetiapine fumarate 2. QUANTITATIVE AND QUALITATIVE COMPOSITION Each modified release tablet contains quetiapine fumarate equivalent to 50 mg, 200 mg, 300 mg or 400 mg of quetiapine free base. Excipients with known effect: contains sugars (as lactose). 3. PHARMACEUTICAL FORM QUETIAPINE-AS XR 50 MG MODIFIED RELEASE TABLETS: Peach coloured, round shaped, biconvex film coated tablets, debossed with ‘Q50’ on one side and plain on other. QUETIAPINE-AS XR 200MG MODIFIED RELEASE TABLETS: Yellow coloured, round shaped, biconvex film coated tablets, debossed with ‘I2’ on one side and plain on other. QUETIAPINE-AS XR 300MG MODIFIED RELEASE TABLETS: Light yellow coloured, round shaped, biconvex film coated tablets, debossed with ‘Q300’ on one side and plain on other. QUETIAPINE-AS XR 400MG MODIFIED RELEASE TABLETS: White coloured, round shaped, biconvex, film coated tablets, debossed with ‘I4’ on one side and plain on other. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Quetiapine modified release tablets are 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 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 Treatment of recurre Belgenin tamamını okuyun