Страна: Австралія
мова: англійська
Джерело: Department of Health (Therapeutic Goods Administration)
quetiapine fumarate
Apotex Pty Ltd
Quetiapine fumarate
Registered
CHEMMART QUETIAPINE _Quetiapine fumarate_ CONSUMER MEDICINE INFORMATION _FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055_ WHAT IS IN THIS LEAFLET READ THIS LEAFLET CAREFULLY BEFORE TAKING YOUR MEDICINE. This leaflet answers some common questions about quetiapine. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. The information in this leaflet was last updated on the date listed on the last page. More recent information on this medicine may be available. ASK YOUR DOCTOR OR PHARMACIST: • if there is anything you do not understand in this leaflet, • if you are worried about taking your medicine, or • to obtain the most up-to-date information. You can also download the most up to date leaflet from www.apotex.com.au. All medicines have risks and benefits. Your doctor has weighed the risks of you using this medicine against the benefits they expect it will have for you. Pharmaceutical companies cannot give you medical advice or an individual diagnosis. Keep this leaflet with your medicine. You may want to read it again. WHAT THIS MEDICINE IS USED FOR The name of your medicine is Chemmart Quetiapine tablets. It contains the active ingredient quetiapine (as quetiapine fumarate). It is used to treat: • the symptoms of schizophrenia, an illness which affects the way people think, feel and behave. • Bipolar 1 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. Quetiapine may both treat and prevent bipolar disorder from recurring. Ask your doctor if you have any questions about why this medicine has been prescribed for you. Your doctor may have prescribed this medicine for another reason. This medicine is available only with a doctor's prescription. _HOW IT WORKS_ Quetiapine belongs to a gro Прочитайте повний документ
1 AUSTRALIAN PRODUCT INFORMATION CHEMMART QUETIAPINE (QUETIAPINE FUMARATE) TABLETS 1 NAME OF THE MEDICINE Quetiapine fumarate 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 25 mg, 100 mg, 150 mg, 200 mg or 300 mg of quetiapine fumarate. For the full list of excipients see section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM CHEMMART QUETIAPINE TABLETS 25 MG: Peach, round, biconvex, film coated tablet. Engraved “APO” on one side, “QUE” over “25” on the other side. CHEMMART QUETIAPINE TABLETS 100 MG: Yellow, round, biconvex, film coated tablet. Engraved “APO” on one side, “QUE” over “100” on the other side. CHEMMART QUETIAPINE TABLETS 150 MG: Pale yellow, round, biconvex, film coated tablet. Engraved “APO” on one side, “QUE” over “150” on the other side. CHEMMART QUETIAPINE TABLETS 200 MG: White, round, biconvex, film coated tablet. Engraved “APO” on one side, “QUE” over “200” on the other side. CHEMMART QUETIAPINE TABLETS 300 MG: White, capsule shaped, biconvex, film coated tablet. Engraved “APO” on one side, “QUE 300” on the other side. 2 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS 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 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 DOSE AND METHOD OF ADMINISTRATION Chemmart Quetiapine tablets are intended for oral administration DOSAGE Chronic antipsychotic treatment should generally b Прочитайте повний документ