Ország: Írország
Nyelv: angol
Forrás: HPRA (Health Products Regulatory Authority)
Quetiapine
Rowex Ltd
N05AH; N05AH04
Quetiapine
300 milligram(s)
Prolonged-release tablet
Product subject to prescription which may not be renewed (A)
Diazepines, oxazepines, thiazepines and oxepines; quetiapine
Not marketed
2012-10-05
PACKAGE LEAFLET: INFORMATION FOR THE USER QUETIAPINE ROWEX 200 MG PROLONGED-RELEASE TABLETS QUETIAPINE ROWEX 300 MG PROLONGED-RELEASE TABLETS QUETIAPINE ROWEX 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, 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Quetiapine Rowex is and what it is used for 2. What you need to know before you take Quetiapine Rowex 3. How to take Quetiapine Rowex 4. Possible side effects 5. How to store Quetiapine Rowex 6. Contents of the pack and other information 1. WHAT QUETIAPINE ROWEX IS AND WHAT IT IS USED FOR Quetiapine Rowex contains the active substance quetiapine. This belongs to a group of medicines called anti-psychotics. Quetiapine Rowex 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 Quetiapine Rowex is being taken to treat major depressive episodes in major depressive disorder, it will be taken in addition to another drug being used to treat this illness. Your doctor may continue to prescribe Quetiapine Rowex ev Olvassa el a teljes dokumentumot
Health Products Regulatory Authority 31 May 2019 CRN008QGS Page 1 of 19 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Quetiapine Rowex 300 mg Prolonged-Release Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each Prolonged Release Tablet contains 300 mg Quetiapine (as Quetiapine fumarate) Excipients with known effects: 61.05 mg Lactose monohydrate per tablet For the full list of Excipients, see section 6.1. 3 PHARMACEUTICAL FORM Prolonged-Release Tablet. Light yellow coloured, round shaped, biconvex film coated tablets, debossed with ‘Q300’ on one side and plain on other. Diameter of the tablet 11.20 ± 0.2 mm. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Quetiapine prolonged release 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 prolonged release (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 dose for their condition. ADULTS: FOR THE TREATMENT OF SCHIZOPHRENIA AND MODERATE TO SEVERE MANIC EPISODES IN BIPOLAR DISORDER Quetiapine prolonged release 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 may be increased to 800 mg daily. The dose should be adjusted withi Olvassa el a teljes dokumentumot