Revised SPC: Frisium (clobazam) 10mg Tablets

SPC warns some epidemiological studies suggest an increased incidence of suicidal ideation, suicide attempt and suicide in patients with or without depression and treated with benzodiazepines and other hypnotics, including clobazam; a causal relationship has not been established.

SPS commentary:

SPC also advises extreme caution when prescribing benzodiazepines to patients with personality disorders.

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