Erata

Citazar is indicated as monotherapy in the treatment of partial-onset seizures with or without secondary generalization in adults and adolescents from 16 years of age with newly diagnosed epilepsy. Citazar is indicated as adjunctive therapy-
in the treatment of partial-onset seizures with or without secondary generalization in adults, adolescents, children and infants from 1 month of age with epilepsy.
... Read more
Citazar is indicated as monotherapy in the treatment of partial-onset seizures with or without secondary generalization in adults and adolescents from 16 years of age with newly diagnosed epilepsy. Citazar is indicated as adjunctive therapy-
in the treatment of partial-onset seizures with or without secondary generalization in adults, adolescents, children and infants from 1 month of age with epilepsy.
in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with Juvenile Myoclonic Epilepsy.
in the treatment of primary generalized tonic-clonic seizures in adults and adolescents from 12 years of age with Idiopathic Generalised Epilepsy.

Most common adverse reactions (incidence ≥ 5% more than placebo) include:
Adult patients: somnolence, asthenia, infection and dizziness
Pediatric patients: fatigue, aggression, nasal congestion, decreased appetite, and irritability

Renal impairment
: The administration of Citazar to patients with renal impairment may require dose adjustment. In patients with severely impaired hepatic function, assessment of renal function is recommended before dose selection.
Acute kidney injury
: The use of Citazar has been very rarely associated with acute kidney injury with a time to onset ranging from a few days to several months.
Blood cell counts
: Rare cases of decreased blood cell counts (neutropenia, agranulocytosis, leucopenia, thrombocytopenia and pancytopenia) have been described in association with Citazar administration, generally at the beginning of the treatment. Complete blood cell counts are advised in patients experiencing important weakness, pyrexia, recurrent infections or coagulation disorders.
Suicide
: Suicide, suicide attempt, suicidal ideation and behaviour have been reported in patients treated with anti-epileptic agents (including Citazar). A meta-analysis of randomized placebo-controlled trials of anti-epileptic medicinal products has shown a small increased risk of suicidal thoughts and behaviour. The mechanism of this risk is not known. Therefore patients should be monitored for signs of depression and/or suicidal ideation and behaviours and appropriate treatment should be considered. Patients (and caregivers of patients) should be advised to seek medical advice should signs of depression and/or suicidal ideation or behaviour emerge.
Paediatric population
: The tablet formulation is not adapted for use in infants and children under the age of 6 years. Available data in children did not suggest an impact on growth and puberty. However, long term effects on learning, intelligence, growth, endocrine function, puberty and childbearing potential in children remain unknown.