Negara: Irlandia
Bahasa: Inggris
Sumber: HPRA (Health Products Regulatory Authority)
Quetiapine fumarate
McDermott Laboratories Ltd t/a Gerard Laboratories
N05AH; N05AH04
Quetiapine fumarate
300 milligram(s)
Film-coated tablet
Product subject to prescription which may not be renewed (A)
Diazepines, oxazepines, thiazepines and oxepines; quetiapine
Not marketed
2007-10-19
Health Products Regulatory Authority 28 November 2018 CRN008RHR Page 1 of 28 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Geroquel 300 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 300mg of quetiapine as quetiapine fumarate Excipient with known effect: Each tablet contains 54.00 mg of lactose (as lactose monohydrate) and approximately 2.61 mg of sodium For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. White, capsule shaped, biconvex, film-coated tablet engraved ‘Q’ breakline ‘300’ on one side. The tablet can be divided into equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Geroquel 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. Health Products Regulatory Authority 28 November 2018 CRN008RHR Page 2 of 28 _ADULTS_ FOR THE TREATMENT OF SCHIZOPHRENIA For the treatment of schizophrenia, quetiapine 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 should Baca dokumen lengkapnya
Health Products Regulatory Authority 08 January 2019 CRN008T3C Page 1 of 28 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Geroquel 300 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 300mg of quetiapine as quetiapine fumarate Excipient with known effect: Each tablet contains 54.00 mg of lactose (as lactose monohydrate) and approximately 2.61 mg of sodium For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. White, capsule shaped, biconvex, film-coated tablet engraved ‘Q’ breakline ‘300’ on one side. The tablet can be divided into equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Geroquel 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. Health Products Regulatory Authority 08 January 2019 CRN008T3C Page 2 of 28 _ADULTS_ FOR THE TREATMENT OF SCHIZOPHRENIA For the treatment of schizophrenia, quetiapine 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 should be Baca dokumen lengkapnya