Страна: Австралия
Язык: английский
Источник: Department of Health (Therapeutic Goods Administration)
quetiapine fumarate, Quantity: 115.12 mg (Equivalent: quetiapine, Qty 100 mg)
Arrotex Pharmaceuticals Pty Ltd
Quetiapine fumarate
Tablet, film coated
Excipient Ingredients: microcrystalline cellulose; calcium hydrogen phosphate dihydrate; povidone; lactose monohydrate; sodium starch glycollate type A; magnesium stearate; titanium dioxide; hypromellose; iron oxide yellow; macrogol 400
Oral
90 Tablets, 20 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: Yellow coloured, round, biconvex, film-coated tablet, plain on both sides.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 48 Months; Container Temperature: Store below 25 degrees Celsius
Registered
2014-04-02
QUETIA TABLETS _QUETIAPINE FUMARATE _ CONSUMER MEDICINE INFORMATION (CMI) WHAT IS IN THIS LEAFLET This leaflet answers some of the common questions people ask about Quetia tablets. 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 Quetia 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 QUETIA ARE USED FOR Quetia belongs to a group of medicines called antipsychotics. It helps to correct chemical imbalances in the brain and 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 irritability. During depression, patients may feel depressed or guilty, lack energy, lose their appetite and have trouble sleeping. 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 QUETIA IF YOU HAVE AN ALLERGY TO: • quetiapine, the active ingredient in Quetia tablets • 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 t Прочитать полный документ
1 AUSTRALIAN PRODUCT INFORMATION – QUETIA (QUETIAPINE FUMARATE) TABLETS 1 NAME OF THE MEDICINE Quetiapine fumarate. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION QUETIA 25, 100, 200 and 300 tablets contain quetiapine fumarate equivalent to 25 mg, 100 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 QUETIA 25 is a pink coloured, round, biconvex, film-coated tablet plain on both sides. QUETIA 100 is a yellow coloured, round, biconvex, film-coated tablet plain on both sides. QUETIA 200 is a white to off white, round, biconvex, film-coated tablet plain on both sides. QUETIA 300 is a white to off white, capsule shaped, biconvex, film-coated tablet with ‘300’ debossed on one side and plain on other side. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS QUETIA 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) 2 • 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 4.2 D OSE AND METHOD OF ADMINISTRATION Chronic antipsychotic treatment should generally be reserved for patients who appear to suffer from a chronic illness that (1) is known to respond to antipsychotic drugs, and (2) for whom alternative equally effective but potentially less harmful treatments are not available or appropriate. In patients who do require chronic treatment, the smallest dose and the s Прочитать полный документ