Country: Ástralía
Tungumál: enska
Heimild: Department of Health (Therapeutic Goods Administration)
quetiapine fumarate, Quantity: 345.36 mg (Equivalent: quetiapine, Qty 300 mg)
Accord Healthcare Pty Ltd
Quetiapine fumarate
Tablet, film coated
Excipient Ingredients: magnesium stearate; calcium hydrogen phosphate dihydrate; lactose monohydrate; microcrystalline cellulose; sodium starch glycollate type A; hypromellose; titanium dioxide; macrogol 400; povidone
Oral
60 tablets, 20 tablets, 100 tablets
(S4) Prescription Only Medicine
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: White to off white, capsule shaped, biconvex, film-coated tablet, with '300' debossed on one side and plain on other side.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 48 Months; Container Temperature: Store below 25 degrees Celsius
Licence status A
2014-04-02
SYQUET 1 SYQUET _Quetiapine fumarate_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some of the common questions people ask about SYQUET. 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 YOUR MEDICINE. You may need to read it again. WHAT SYQUET IS USED FOR SYQUET 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. SYQUET 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. 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 SYQUET 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 difficulty breathing; swelling of the face, lips, tongue or other parts of the body; rash, itching or hives on the skin or you may feel faint. DO NOT GIVE SYQUET TO CHILDREN OR ADOLESCENTS UNLESS RECOMMENDED BY YOUR DOCTOR. The effects of SYQUET have only been studied in children aged between 10 and 17 years with mania and in children aged Lestu allt skjalið
1 AUSTRALIAN PRODUCT INFORMATION SYQUET (QUETIAPINE FUMARATE) TABLETS 1 NAME OF THE MEDICINE Quetiapine fumarate 2 QUALITATIVE AND QUANTITATIVE COMPOSITION SYQUET tablets contain quetiapine fumarate equivalent to 25 mg, 100 mg, 200 mg and 300 mg quetiapine free base respectively. Excipients with known effect Lactose monohydrate For the full list of excipients see section 6.1 List of Excipients 3 PHARMACEUTICAL FORM SYQUET 25mg are presented as a pink coloured, round, biconvex, film-coated tablets plain on both side; each tablet contains 25 mg of quetiapine (as fumarate) SYQUET 100mg are presented as a yellow coloured, round, biconvex, film-coated tablet plain on both sides; each tablet contains 100 mg of quetiapine (as fumarate). SYQUET 200mg are presented as a white to off white, round, biconvex, film-coated tablet, plain on both sides; each tablet contains 200 mg of quetiapine (as fumarate). SYQUET 300mg are presented as a white to off white, capsule shaped, biconvex, film-coated tablet, with ‘300’ debossed on one side and plain on other side; each tablet contains 300 mg of quetiapine (as fumarate). 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS SYQUET tablets are 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 valproate Children/adolescents aged 10 to 17 years Monotherapy treatment of acute mania associated with bipolar I disorder 2 Schizophrenia (adults and adolescents aged 13 to 17 years) Treatment of schizophrenia 4.2 DOSE AND METHOD OF ADMINISTRATION Dosage Chronic antipsychotic treatment should generally be reserved for patients who appear to suffer from a chronic illn Lestu allt skjalið