Briviact Special Precautions

Suicidal ideation and behaviour: Suicidal ideation and behaviour have been reported in patients treated with anti-epileptic drugs (AEDs), including brivaracetam, in several indications. A meta-analysis of randomized placebo-controlled clinical studies of AEDs has also shown a small increased risk of suicidal ideation and behaviour. The mechanism of this risk is not known and the available data do not exclude the possibility of an increased risk for brivaracetam.
Patients should be monitored for signs of suicidal ideation and behaviours and appropriate treatment should be considered. Patients (and caregivers of patients) should be advised to seek medical advice should any signs of suicidal ideation or behaviour emerge. See also Paediatric population under Adverse Reactions.
Hepatic impairment: There are limited clinical data on the use of brivaracetam in patients with pre-existing hepatic impairment. Dose adjustments are recommended for patients with hepatic impairment (see Dosage & Administration).
Effects on ability to drive and use machines: Brivaracetam has minor or moderate influence on the ability to drive and use machines.
Due to possible differences in individual sensitivity some patients might experience somnolence, dizziness, and other central nervous system (CNS) related symptoms. Patients should be advised not to drive a car or to operate other potentially hazardous machines until they are familiar with the effects of brivaracetam on their ability to perform such activities.
Film-coated tablet: Excipients: Lactose intolerance: Brivaracetam film-coated tablets contain lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Sodium content: Brivaracetam film-coated tablets contain less than 1 mmol sodium (23 mg) per tablet, that is to say essentially 'sodium free'.
Oral solution: Excipients: Sodium content: Brivaracetam oral solution contains less than 1 mmol sodium (23 mg) per ml, that is to say essentially 'sodium free'.
Fructose intolerance: This medicine contains 168 mg sorbitol (E420) in each ml. Patients with hereditary fructose intolerance (HFI) should not take this medicinal product.
Excipients which may cause intolerance: The oral solution contains methyl parahydroxybenzoate (E218), which may cause allergic reactions (possibly delayed).
Brivaracetam oral solution contains propylene glycol (E1520).
Solution for injection/infusion: Excipients: This medicinal product contains 19.1 mg sodium per vial, equivalent to 1% of the WHO recommended maximum daily intake of 2 g sodium for an adult.