Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
QUETIAPINE FUMARATE
Pfizer Healthcare Ireland
200 Milligram
Film Coated Tablet
2011-09-23
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Quetiapine Pfizer 200mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 200 mg of quetiapine (as quetiapine fumarate). Excipient: 41.333 mg lactose monohydrate per tablet. For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Film-coated tablet White, round, with diameter 11.2 mm, biconvex, film coated tablet imprinted with 'E 55' on one side and plain on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Quetiapine Pfizer is indicated for the treatment of: Schizophrenia. Quetiapine Pfizer is indicated for the 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 in patients with bipolar disorder, in patients whose manic or depressive episode has responded to quetiapine treatment. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Quetiapine Pfizer can be administered with or without food. _Adults:_ FOR THE TREATMENT OF SCHIZOPHRENIA For the treatment of schizophrenia, Quetiapine Pfizer should be administered twice a day. The total daily dose for the first 4 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 Pfizer should be administered twice a day. The total daily dose fo Read the complete document