Land: Irland
Sprache: Englisch
Quelle: HPRA (Health Products Regulatory Authority)
Quetiapine
KRKA, d.d., Novo mesto
N05AH; N05AH04
Quetiapine
300 milligram(s)
Film-coated tablet
Product subject to prescription which may not be renewed (A)
Diazepines, oxazepines, thiazepines and oxepines; quetiapine
Marketed
2013-06-21
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT QUETIAPINE KRKA 25 MG FILM-COATED TABLETS QUETIAPINE KRKA 100 MG FILM-COATED TABLETS QUETIAPINE KRKA 200 MG FILM-COATED TABLETS QUETIAPINE KRKA 300 MG FILM-COATED 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 Quetiapine Krka is and what it is used for 2. What you need to know before you take Quetiapine Krka 3. How to take Quetiapine Krka 4. Possible side effects 5. How to store Quetiapine Krka 6. Contents of the pack and other information 1. WHAT QUETIAPINE KRKA IS AND WHAT IT IS USED FOR Quetiapine Krka contains a substance called quetiapine. This belongs to a group of medicines called antipsychotics. Quetiapine Krka can be used to treat several illnesses such as: Bipolar depression: 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 judgment 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. Your doctor may continue to prescribe Quetiapine Krka even when you are feeling better. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE QUETIAPINE KRKA DO NOT TAKE QUETIAPINE KRKA if you are allergic to quetiapine or any of the other ingredients of this medicine (listed in section 6). if you are Lesen Sie das vollständige Dokument
Health Products Regulatory Authority 10 December 2021 CRN00CMDN Page 1 of 17 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Quetiapine Krka 300mg Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 300 mg quetiapine (as quetiapine hemifumarate). Excipient(s) with known effect 300 mg Lactose monohydrate 54 mg Sodium < 23 mg For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet Tablets are capsule-shaped (length 18 mm, width 8 mm), white film-coated tablets. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Quetiapine Krka 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. 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 For the treatment of schizophrenia, Quetiapine Krka should be administered twice a day. The total daily dose for the first four days of therapy is 50 mg (Day 1), 100 mg (Day 2), 200 mg (Day 3) and 300 mg (Day 4). From Day 4 onwards, the dose should be titrated to the usual effective dose of 300 to 450 mg/day. Depending on the clinical response and tolerability of the individual patient, the dose may be adjusted within the range 150 to 750 mg/day. FOR THE TREATMENT OF MODERATE TO SEVERE MANIC EPISODES IN BIPOLAR DISORDER For the treatment of manic episodes associated with bipolar disorder, Quetiapine Krka should be administered twice a day. The total daily dose for the first four days of therapy is 100 mg (Day 1), 200 mg (Day 2), 300 mg (Day 3) and 400 mg (D Lesen Sie das vollständige Dokument