OLANCOR FC TABLETS 5MG

TABLET, FILM COATED

**4.2. Posology and method of administration** **Schizophrenia:** The recommended starting dose for olanzapine is 10 mg/day. **Manic episode:** The starting dose is 15 mg as a single daily dose in monotherapy or 10 mg daily in combination therapy. (See Section 5.1 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_) **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 both schizophrenia, manic episode and recurrence prevention in bipolar disorder, daily dosage may subsequently be adjusted on the basis of individual clinical status within the range 5–20 mg/day. An increase to a dose greater than the recommended starting dose is advised only after appropriate clinical reassessment and should generally occur at intervals of not less than 24 hours. Olanzapine can be given without regards for meals as absorption is not affected by food. Gradual tapering of the dose should be considered when discontinuing olanzapine. **Children:** Olanzapine has not been studied in subjects under 18 years of age. **Elderly patients:** A lower starting dose (5 mg/day) is not routinely indicated but should be considered for those 65 and over when clinical factors warrant. **Patients with renal and/or hepatic impairment:** A lower starting dose (5 mg) should be considered for such patients. In cases of moderate hepatic insufficiency (cirrhosis, Child-Pugh Class A or B), the starting dose should be 5 mg and only increased with caution. **Gender:** The starting dose and dose range need not be routinely altered for female patients relative to male patients. **Smokers:** The starting dose and dose range need not be routinely altered for non-smoking patients relative to smoking patients. When more than one factor is present which might result in slower metabolism (female gender, geriatric age, non-smoking status), consideration should be given to decreasing the starting dose. Dose escalation, when indicated, should be conservative in such patients. (See also Section 4.5, Interaction with Other Medicaments and Other Forms of Interaction, and Section 5.2, Pharmacokinetic properties – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_)