País: Irlanda
Idioma: anglès
Font: HPRA (Health Products Regulatory Authority)
OLANZAPINE
Ranbaxy Ireland Limited
OLANZAPINE
20 Milligram
Orodispersible Tablet
Product subject to prescription which may not be renewed (A)
Withdrawn
2013-01-31
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Olanzapine Ranbaxy 20mg orodispersible tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each orodispersible tablet conatins 20mg olanzapine Excipient with known effect: Each orodispersible also contains 6.0mg aspartame For the full list of excipients, see Section 6.1. 3 PHARMACEUTICAL FORM Orodispersible tablet. Light yellow to yellow colored, slightly mottled, round tablets debossed with ‘OV4’ on one side and plain on 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, Llegiu el document complet