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Dating relating emc 10n  directory

Adults Schizophrenia The recommended starting dose for Olanzapine Accord 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).Dose escalation, when indicated, should be conservative in such patients. Paediatric population Olanzapine is not recommended for use in children and adolescents below 18 years of age due to a lack of data on safety and efficacy.A greater magnitude of weight gain, lipid and prolactin alterations has been reported in short-term studies of adolescent patients than in studies of adult patients (see sections 4.4, 4.8, 5.1 and 5.2).

Special populations Elderly patients A lower starting dose (5mg/day) is not routinely indicated but should be considered for those 65 and over when clinical factors warrant (see section 4.4).

Clinical monitoring is recommended and an increase of olanzapine dose may be considered if necessary (see section 4.5).

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.

Patients with renal and/or hepatic impairment A lower starting dose (5mg) should be considered for such patients.

In cases of moderate hepatic insufficiency (cirrhosis, Child-Pugh class A or B), the starting dose should be 5mg and only increased with caution.

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