Šalis: Airija
kalba: anglų
Šaltinis: HPRA (Health Products Regulatory Authority)
QUETIAPINE FUMARATE
PCO Manufacturing
QUETIAPINE FUMARATE
400 Milligram
Tablet Prolonged Release
Product subject to prescription which may not be renewed (A)
Authorised
0000-00-00
PACKAGE LEAFLET: INFORMATION FOR THE USER SEROQUEL ® XR 50 MG, 200 MG, 300 MG, 400 MG PROLONGED-RELEASE TABLETS quetiapine READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. What Seroquel XR is and what it is used for 2. Before you take Seroquel XR 3. How to take Seroquel XR 4. Possible side effects 5. How to store Seroquel XR 6. Further information 1. WHAT SEROQUEL XR IS AND WHAT IT IS USED FOR Seroquel XR contains a substance called quetiapine. This belongs to a group of medicines called anti-psychotics. Seroquel XR can be used to treat several illnesses, such as: Bipolar depression and major depressive episodes in major depressive disorder: where you may feel sad or you may find that you feel depressed, feel guilty, lack energy, lose your appetite or can’t sleep. Mania: where you may feel very excited, elated, agitated, enthusiastic or hyperactive or have poor judgement including being aggressive or disruptive. Schizophrenia: where you may hear or feel things that are not there, believe things that are not true or feel unusually suspicious, anxious, confused, guilty, tense or depressed. When Seroquel XR is being taken to treat major depressive episodes in major depressive disorder, it will be taken in addition to another drug b Perskaitykite visą dokumentą
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Seroquel XR 400mg prolonged-release tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Seroquel XR 400mg contains 400mg quetiapine (as quetiapine fumarate) Excipient: contains lactose monohydrate For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Prolonged-Release Tablet _Product imported from Italy:_ The tablets are white and engraved with “XR 400” on one side 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Seroquel XR is indicated for : • Treatment of schizophrenia, including • preventing relapse in stable schizophrenic patients who have been maintained on Seroquel XR. • treatment of bipolar disorder : • For the treatment of moderate to severe manic episodes in bipolar disorder • For the treatment of major depressive episodes in bipolar disorder • For the prevention of recurrence in patients with bipolar disorder, in patients whose manic or depressive episode has responded to quetiapine treatment. • add-on treatment of major depressive episodes in patients with Major Depressive Disorder (MDD) who have had sub- optimal response to antidepressant monotherapy (see section 5.1). Prior to initiating treatment, clinicians should consider the safety profile of Seroquel XR (see section 4.4). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Different dosing schedules exist for each indication. It must therefore be ensured that patients receive clear information on the appropriate dosage for their condition. Seroquel XR should be administered once daily, without food. The tablets should be swallowed whole and not split, chewed or crushed. _ADULTS:_ FOR THE TREATMENT OF SCHIZOPHRENIA AND MODERATE TO SEVERE MANIC EPISODES IN BIPOLAR DISORDER Seroquel XR should be administrated at least one hou Perskaitykite visą dokumentą