国家: 爱尔兰
语言: 英文
来源: HPRA (Health Products Regulatory Authority)
Quetiapine fumarate; Quetiapine fumarate
Accord Healthcare Limited
N05AH; N05AH04
Quetiapine fumarate; Quetiapine fumarate
50 milligram(s)
Prolonged-release tablet
Product subject to prescription which may not be renewed (A)
Diazepines, oxazepines, thiazepines and oxepines; quetiapine
Marketed
2013-09-13
PACKAGE LEAFLET: INFROMATION FOR THE USER NOTIABOLFEN XL 50 MG PROLONGED-RELEASE TABLET NOTIABOLFEN XL 200 MG PROLONGED-RELEASE TABLET NOTIABOLFEN XL 300 MG PROLONGED-RELEASE TABLET NOTIABOLFEN XL 400 MG PROLONGED-RELEASE TABLET 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 or nurse. - 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 or nurse. This includes any possible side effects not listed in this leaflet. See section 4 WHAT IS IN THIS LEAFLET: 1. What Notiabolfen XL Prolonged-release Tablet is and what it is used for 2. What you need to know before you take Notiabolfen XL Prolonged-release Tablets 3. How to take Notiabolfen XL Prolonged-release Tablets 4. Possible side effects 5. How to store Notiabolfen XL Prolonged-release Tablets 6. Contents of the pack and other information 1. WHAT NOTIABOLFEN XL PROLONGED-RELEASE TABLET IS AND WHAT IT IS USED FOR Notiabolfen XL Prolonged-release Tablet contains a substance called quetiapine. This belongs to a group of medicines called anti-psychotics. Notiabolfen XL Prolonged-release Tablet can be used to treat several illnesses, such as: • 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. • Mania: where you may feel very excited, elated, agitated, enthusiastic or hyperactive or have poor judgment including being aggressive or disruptive. • 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. When Notiabolfen XL Prolonged-relea 阅读完整的文件
Health Products Regulatory Authority 14 September 2018 CRN008L6D Page 1 of 30 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Notiabolfen XL 50 mg prolonged-release tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 50 mg prolonged release tablet contains 50 mg quetiapine (as quetiapine fumarate) Excipient(s) with known effect: 140.925 mg Lactose monohydrate per tablet For the full list of Excipients, see section 6.1. 3 PHARMACEUTICAL FORM Prolonged-release Tablets Peach colored, round shaped, biconvex film coated tablets, debossed with ‘Q50’ on one side and plain on the other. Note: Diameter of the tablet 11.2 ± 0.2 mm 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Notiabolfen XL 50 mg 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 Notiabolfen XL 50 mg (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 Health Products Regulatory Authority 14 September 2018 CRN008L6D Page 2 of 30 ADULTS FOR THE TREATMENT OF SCHIZOPHRENIA AND MODERATE TO SEVERE MANIC EPISODES IN BIPOLAR DISORDER Notiabolfen XL 50 mg should be administrated 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 阅读完整的文件