Država: Irska
Jezik: angleščina
Source: HPRA (Health Products Regulatory Authority)
OLANZAPINE
Ranbaxy Ireland Limited
2.5 Milligram
Tablets
2010-03-05
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Olanzapine Ranbaxy 2.5mg tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 2.5mg olanzapine. Each tablet also contains 65.5mg lactose For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM TABLET Olanzapine Ranbaxy 2.5 mg tablets: Light yellow to yellow coloured, slightly mottled, round, biconvex tablets, debossed with ‘O4’ on one side and plain on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Adults Olanzapine is indicated for the treatment of schizophrenia. Olanzapine is effective in maintaining the clinical improvement during continuation therapy in patients who have shown an initial treatment response. Olanzapine is indicated for the treatment of moderate to severe manic episode. In patients whose manic episode has responded to olanzapine treatment, olanzapine is indicated for the prevention of recurrence in patients with bipolar disorder (see section 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults Schizophrenia: The recommended starting dose for olanzapine is 10mg/day. Manic episode: The starting dose is 15mg as a single daily dose in monotherapy or 10mg daily in combination therapy (see section 5.1). Preventing recurrence in bipolar disorder: The recommended starting dose is 10mg/day. For patients who have been receiving olanzapine for treatment of manic episode, continue therapy for preventing recurrence at the same dose. If a new manic, mixed, or depressive episode occurs, olanzapine treatment should be continued (with dose optimisation as needed), with supplementary therapy to treat mood symptoms, as clinically indicated. During treatment for schizophrenia, manic episode, and recurrence prevention in bipolar disorder, daily dosage may subsequently Preberite celoten dokument