国: アイルランド
言語: 英語
ソース: HPRA (Health Products Regulatory Authority)
Quetiapine
Clonmel Healthcare Ltd
N05AH; N05AH04
Quetiapine
150 milligram(s)
Prolonged-release tablet
Oral use
10, 20, 30, 60, 90, 100, 120, 180 and 200 tablets
Product subject to prescription which may not be renewed (A)
Pharmathen S.A, Pharmathen International S.A, STADA Arzneimittel AG, STADA Arzneimittel GmbH, Clonmel Healthcare Ltd
Antipsychotics; Diazepines, oxazepines, thiazepines and oxepines
Diazepines, oxazepines, thiazepines and oxepines; quetiapine
It is indicated for: treatment of Schizophrenia; treatment of bipolar disorder; add-on treatment of major depressive episodes in patients with Major Depressive Disorder (MDD) who have had sub-optimal response to antidepressant monotherapy
Marketed
2015-04-02
Page 1 of 9 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT SEROPIA XR 50 MG PROLONGED-RELEASE TABLETS SEROPIA XR 150 MG PROLONGED-RELEASE TABLETS SEROPIA XR 200 MG PROLONGED-RELEASE TABLETS SEROPIA XR 300 MG PROLONGED-RELEASE TABLETS SEROPIA XR 400 MG PROLONGED-RELEASE TABLETS Quetiapine READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. If you get any side effects, talk to your doctor, or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Seropia XR is and what it is used for 2. What you need to know before you take Seropia XR 3. How to take Seropia XR 4. Possible side effects 5. How to store Seropia XR 6. Contents of the pack and other information 1. WHAT SEROPIA XR IS AND WHAT IT IS USED FOR Seropia XR contains a substance called quetiapine. This belongs to a group of medicines called antipsychotics. Seropia XR can be used to treat several illnesses, such as: Bipolar depression and major depressive episodes in major depressive disorder: where you feel sad. 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 Seropia XR is being taken to treat major depressive episodes in major depressive disorder, it will be taken in addition to another medicine being used to treat this illness. Your doctor may continue 完全なドキュメントを読む
Health Products Regulatory Authority 16 March 2022 CRN00CGW5 Page 1 of 19 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Seropia XR 150 mg prolonged-release tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Seropia XR 150 mg contains 150 mg quetiapine (as quetiapine fumarate) Excipient with known effect: 42 mg lactose per tablet For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Prolonged-release tablet A white to off white, oblong biconvex tablet, 13.6 mm in length, 6.6mm in width and 4.2 mm in thickness,engraved with “150” on one side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Seropia XR is indicated for: • treatment of Schizophrenia. • 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 of manic or depressed episodes in patients with bipolar disorder who previously 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 quetiapine (see Section 4.4). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Different dosing schedules exist for each indication. It must therefore be ensured that patients receive clear information on the appropriate dosage for their condition. _Adults_ _For the treatment of schizophrenia and moderate to severe manic episodes in bipolar disorder_ Seropia XR should be administered at least one hour before a meal. The daily dose at the start of therapy is 300 mg on Day 1 and 600 mg on Day 2. The recommended daily dose is 600 mg, however if clinically justified the dose may be increased to 800 mg daily. The dose should be adjusted within the effective dose range of 400 mg to 800 mg per day, depending on the clinical response and tolerabilit 完全なドキュメントを読む