Land: Irland
Språk: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
Quetiapine hemifumarate
KRKA, d.d., Novo mesto
N05AH; N05AH04
Quetiapine hemifumarate
200 milligram(s)
Prolonged-release tablet
Product subject to prescription which may not be renewed (A)
Diazepines, oxazepines, thiazepines and oxepines; quetiapine
Marketed
2015-01-09
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT QUENTIAX SR 50 MG PROLONGED-RELEASE TABLETS QUENTIAX SR 150 MG PROLONGED-RELEASE TABLETS QUENTIAX SR 200 MG PROLONGED-RELEASE TABLETS QUENTIAX SR 300 MG PROLONGED-RELEASE TABLETS QUENTIAX SR 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 Quentiax SR is and what it is used for 2. What you need to know before you take Quentiax SR 3. How to take Quentiax SR 4. Possible side effects 5. How to store Quentiax SR 6. Contents of the pack and other information 1. WHAT QUENTIAX SR IS AND WHAT IT IS USED FOR Quentiax SR contains a substance called quetiapine. This belongs to a group of medicines called anti- psychotics. Quentiax SR 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 Quentiax SR 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 Qu Les hele dokumentet
Health Products Regulatory Authority 24 March 2022 CRN00CMDQ Page 1 of 19 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Quentiax SR 200 mg prolonged-release tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each prolonged-release tablet contains 200 mg quetiapine (as quetiapine hemifumarate). Excipients with known effect Each prolonged-release tablet contains 50.09 mg lactose and 19.38 mg sodium. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Prolonged-release tablet Yellow brown, oval, biconvex, film-coated tablets. Tablet dimensions: length is 16 mm and thickness is 5.6 – 7.1 mm. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Quentiax SR 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 Quentiax SR (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 Quentiax SR 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 within the effective dose range of 400 mg to 800 mg per day, depending on Les hele dokumentet