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The starting dose must not exceed 12.5 mg/daytaken in the eveningSubsequent dose increases must be by 12.5 mg incrementswith a maximum of two increments a week up to a maximum of 50 mga dose that cannot be reached until the end of the second weekThe total daily amount should preferably be given as a single dose in the evening.

Patients with a history of epilepsy should be closely observed during Clozaril therapy since dose-related convulsions have been reportedIn such casesthe dose should be reducedsee section 4.2andif necessaryan anti-convulsant treatment should be initiated.

No paediatric studies have been performedThe safety and efficacy of Clozaril in children and adolescents under the age of 16 years have not yet been establishedIt should not be used in this group until further data become available.

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