Valproate

Female patients: • For all female patients aged under 55 years:

For the treatment of generalised, partial or other epilepsy only when there is no other effective or tolerated treatment. • For all female patients aged over 55 years: For the treatment of generalised, partial or other epilepsy. Male patients: • For all male patients aged under 55 years initiating treatment with valproate: For the treatment of generalised, partial or other epilepsy only when there is no other effective or tolerated treatment.

• For all male patients established on treatment with valproate or male patients aged over 55 years: For the treatment of generalised, partial or other epilepsy.

ODAN-VALPROIC ACID (valproic acid) is indicated for: • use as sole or adjunctive therapy in the treatment of simple or complex absence seizures, including petit mal, and is useful in primary generalized seizures with tonic-clonic manifestations.

• use adjunctively in patients with multiple seizure types which include either absence or tonic-clonic seizures. In accordance with the International Classification of Seizures, simple absence is defined as a very brief clouding of the sensorium or loss of consciousness (lasting usually 2 to 15 seconds), accompanied by certain generalized epileptic discharges without other detectable clinical signs.

Complex absence is the term used when other signs are also present. See

1 Epilepsy Valproic acid oral solution is indicated as monotherapy and adjunctive therapy in the treatment of patients with complex partial seizures that occur either in isolation or in association with other types of seizures. Valproic acid oral solution is indicated for use as sole and adjunctive therapy in the treatment of simple and complex absence seizures, and adjunctively in patients with multiple seizure types which include absence seizures.

Simple absence is defined as very brief clouding of the sensorium or loss of consciousness accompanied by certain generalized epileptic discharges without other detectable clinical signs. Complex absence is the term used when other signs are also present.

1 ) for statement regarding fatal hepatic dysfunction. 2 Important Limitations Because of the risk to the fetus of decreased IQ, neurodevelopmental disorders, neural tube defects, and other major congenital malformations, which may occur very early in pregnancy, valproate should not be used to treat women with epilepsy or bipolar disorder who are pregnant or who plan to become pregnant unless other medications have failed to provide adequate symptom control or are otherwise unacceptable.