Država: Malezija
Jezik: angleščina
Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
QUETIAPINE FUMARATE
ASTRAZENECA SDN. BHD.
QUETIAPINE FUMARATE
60Tablet Tablets
AstraZeneca Pharmaceutical Co. Ltd.
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ SEROQUEL TABLET Quetiapine Fumarate (25mg, 100mg, 200mg, 300mg) 1 WHAT IS IN THIS LEAFLET 1. What Seroquel is used for 2. How Seroquel works 3. Before you use Seroquel 4. How to use Seroquel 5. While you are using it 6. Side effects 7. Storage and Disposal of Seroquel 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision 11. Serial Number WHAT SEROQUEL IS USED FOR Seroquel can be used to treat schizophrenia in people 13 years of age or older with symptoms, such as hallucinations (for example unexplained voices), strange and frightening thoughts, changes in behaviour, feeling alone and confused. Seroquel can also be used to treat adults with Bipolar Disorder, either in a manic or in a depressed state. In a manic state people may find they are more talkative and have racing thoughts or ideas whereby they feel 'high' or excited. They may also feel unusually irritable. In a depressed state individuals with this condition may feel sad or depressed, feel guilty, lack energy, lose their appetite and/or can’t sleep. Seroquel can also be used to treat manic episodes associated with bipolar disorder in children ages 10 to 17 years old. Your doctor may continue to give you Seroquel even when you are feeling better to prevent your symptoms of bipolar disorder from returning. HOW SEROQUEL WORKS Seroquel contains quetiapine fumarate. Seroquel belongs to a group of medicines called antipsychotics. It helps to correct chemical imbalances in the brain. BEFORE YOU USE SEROQUEL - _When you must not use it _ Do not take Seroquel if you have ever had an allergic reaction to Seroquel or to any of its ingredients (see section PRODUCT DESCRIPTION ). Do not take Seroquel if you are taking any of the following medicines: • HIV-protease inhibitor for Human Immunodeficiency Virus (HIV) • azole medicines (for fungal infections) • erythromycin or clarithromycin (for infections) • nefazodone (for depression) If you are not sure, talk to your docto Preberite celoten dokument
Page 1 of 23 Issued to the Medical Profession Only PACKAGE LEAFLET TEXT ‘SEROQUEL’ quetiapine fumarate Trademark Presentation 25 mg tablet: round, 6 mm, peach coloured, biconvex, film -coated tablet containing quetiapine fumarate delivering a dose of 25 mg of quetia pine free base. 100 mg tablet: round, 8.5 mm, yellow coloured, biconvex, film -coated tablet containing quetiapine fumarate delivering a dose of 100 mg of quetiapine free base. 200 mg tablet: round, 11 mm, white, biconvex, film -coated tablet containing quet iapine fumarate delivering a dose of 200 mg of quetiapine free base. 300 mg tablet: capsule shaped, 19 mm x 7.62 mm, white, film -coated tablet containing quetiapine fumarate delivering a dose of 300 mg of quetiapine free base. For excipients see ‘Pharmace utical Particulars ’. Clinical Particulars Indications Treatment of schizophrenia The antipsychotic efficacy of Seroquel was established in short -term (6 weeks) controlled trials of adults and one 6 -week trial in adolescents (13 -17 years) schizophrenic in patients. The effectiveness of Seroquel in long -term use, that is, for more than 6 weeks, has not been systematically evaluated in controlled trials. Therefore, the physician who elects to use Seroquel for extended periods should periodically re -evaluate the long -term useful ness of the drug for the individual patient . Treatment of acute manic episodes associated with bipolar I disorder, as either monotherapy or adjunct to lithium or divalproex The efficacy of Seroquel in acute bipolar mania was establish ed in two 12 -week monotherapy trials in adults, in one 3 -week adjunct ive trial in adults, and in one 3-week monotherapy trial in p aediatric patients (10 -17 years) . Treatment of depressive episodes associated with bipolar disorder The efficacy of Seroquel was established in two identical 8 -week randomised, placebo - controlled double -blind clinical studies that included either bipolar I or bipolar II patients with and without rapid cycling courses (See ‘ Pharmacodynamic Preberite celoten dokument