Страна: Австралия
Язык: английский
Источник: Department of Health (Therapeutic Goods Administration)
quetiapine fumarate, Quantity: 115.136 mg (Equivalent: quetiapine, Qty 100 mg)
Pharmacor Pty Ltd
Quetiapine fumarate
Tablet, film coated
Excipient Ingredients: macrogol 4000; calcium hydrogen phosphate dihydrate; magnesium stearate; titanium dioxide; microcrystalline cellulose; lactose monohydrate; hypromellose; povidone; sodium starch glycollate type A; iron oxide yellow
Oral
60, 90, 20
(S4) Prescription Only Medicine
Quetiapine is indicated for:,Bipolar disorder,Adults,? 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,Children/adolescents aged 10 to 17 years,? Monotherapy treatment of acute mania associated with bipolar I disorder,Schizophrenia (adults and adolescents aged 13 to 17 years),? Treatment of schizophrenia
Visual Identification: Yellow coloured, film coated, round shape, biconvex tablets, debossed with"261" on one side and plain on other side.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure
Licence status A
2014-02-13
ALKEM QUETIAPINE _Quetiapine (as fumarate) _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some of the common questions people ask about ALKEM QUETIAPINE. 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 ALKEM QUETIAPINE IS USED FOR ALKEM QUETIAPINE helps to correct chemical imbalances in the brain. It is used to treat conditions such as: Schizophrenia, an illness with disturbances in thinking, feelings and behaviour 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. ALKEM QUETIAPINE belongs to a group of medicines called antipsychotics. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY IT HAS BEEN PRESCRIBED FOR YOU. Your doctor may prescribe this medicine for another reason. You may find it helpful to tell a friend or relative that you are suffering from these symptoms, and ask them to read this leaflet. You might ask them to tell you if they think your symptoms are getting worse, or if they are worried about any other changes in your behaviour. It is not addictive. This medicine is available only with a doctor's prescription. BEFORE YOU TAKE IT _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE ALKEM QUETIAPINE IF YOU HAVE AN ALLERGY TO quetiapine, the active ingredient in the medicine any of the other ingredients listed at the end of this leaflet. Some of the symptoms of an allergic reaction may include shortness of breath, wheezing or difficult Прочитать полный документ
_____________________________________________________________________________ ALKEM QUETIAPINE PI (V-05) Page 1 of 45 AUSTRALIAN PRODUCT INFORMATION – ALKEM QUETIAPINE (QUETIAPINE FUMARATE) 1. NAME OF THE MEDICINE Quetiapine fumarate 2. QUALITATIVE AND QUANTITATIVE COMPOSITION ALKEM QUETIAPINE 25 mg, 100 mg, 150 mg, 200 mg and 300 mg contains quetiapine fumarate equivalent to 25 mg, 100 mg, 150 mg, 200 mg and 300 mg quetiapine free base respectively. Excipient(s) with known effect: lactose monohydrate For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS. 3. PHARMACEUTICAL FORM Tablets, film coated ALKEM QUETIAPINE 25 MG TABLETS: peach coloured round, biconvex, film-coated tablet; debossed with “262” on one side and plain on the other side. ALKEM QUETIAPINE 100 MG TABLETS: yellow coloured round, biconvex, film-coated tablet; debossed with “261” on one side and plain on the other side. ALKEM QUETIAPINE 150 MG TABLETS: pale yellow coloured, round, biconvex, film- coated tablet; debossed with “353” on one side and plain on the other side. ALKEM QUETIAPINE 200 MG TABLETS: white coloured round, biconvex, film-coated tablet; debossed with “260” on one side and plain on the other side. ALKEM QUETIAPINE 300 MG TABLETS: white coloured, capsoid, film-coated tablet; debossed with “259” on one side and plain on the other side. _____________________________________________________________________________ ALKEM QUETIAPINE PI (V-05) Page 2 of 45 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS ALKEM QUETIAPINE is indicated for: BIPOLAR DISORDER _ _ _ADULTS _ 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 4.2 DOSE AND METHOD OF ADMINISTRATION) Treatment of acute mania associated with bipolar I disorder as monotherapy or in combination with lithium or sodium v Прочитать полный документ