Briviact Tablets 100 mg (Brivaracetam)

Adult dose

Take this medicine twice daily. The recommended initial dose is 25 mg or 50 mg per dose, based on the healthcare provider's assessment of potential adverse effects versus seizure reduction. Based on clinical response and tolerability, the dose may be increased or decreased from 50 mg/day [25 mg twice daily] to 200 mg/day [100 mg twice daily]. (Tablets) This medicine is a film-coated tablet. Swallow it whole with water. It may be taken with or without food. (Oral solution) This medicine may be diluted with water immediately before taking. It may be taken with or without food. It may also be administered through a nasogastric tube or gastrostomy tube. If you miss a dose If you miss one or more doses, take one dose as soon as you remember, then take the next dose at the next scheduled morning or evening time. When discontinuing treatment When discontinuing this medicine, gradually reduce the dose by 50 mg/day at 1-week intervals. After 1 week at 50 mg/day, a dose of 20 mg/day is recommended during the final week (see section ‘2. Warnings’). Elderly patients (65 years and older) Dose adjustment is not required in elderly patients. Clinical experience in elderly patients aged 65 years and older is limited (see section ‘12. Information for healthcare professionals’).. Renal impairment Dose adjustment is not required in patients with renal impairment. This medicine is not recommended for patients with end-stage renal disease receiving hemodialysis. Hepatic impairment Exposure to this medicine is increased in patients with hepatic impairment. The recommended initial dose for patients with hepatic impairment is 50 mg/day [25 mg twice daily], and a maximum dose of 150 mg/day [75 mg twice daily] is recommended.

This drug is used in the treatment of epilepsy and may present serious mental health issues such as suicidal thoughts or behaviors in some patients, therefore careful monitoring is necessary. Neurological side effects such as drowsiness, fatigue, and dizziness may occur at the beginning of treatment or at any time during treatment, so caution is needed when driving or operating machinery. Abruptly stopping this medication can increase the risk of more frequent seizures; therefore, the dosage should be gradually reduced according to the physician's instructions. Patients with allergies to the active ingredient or any of the components in this medication, or those with specific hereditary lactose intolerance, should not take this drug. Patients with liver dysfunction need to adjust the dosage of this drug, and clinical data for patients with liver disorders is limited, so it should be used with caution. During the use of this medication, psychiatric symptoms such as depression, anxiety, irritability, and insomnia can occur, and in severe cases, symptoms such as suicidal thoughts or aggression have been reported, thus changes in symptoms should be monitored closely. Severe skin reactions (such as Stevens-Johnson syndrome) can occur, so if a skin rash or any other unusual signs develop, immediate consultation with a physician is advised. Taking this medication with alcohol may further impair psychomotor function, attention, and memory, so it is advisable to avoid alcohol consumption. Interactions may occur with other antiepileptic drugs that can change drug concentrations, so it is essential to discuss interactions with other medications being taken with your physician. Safety for the fetus has not been established during pregnancy, so if planning to become pregnant or if pregnant, careful consideration should be given to whether to take it. Women who are breastfeeding should note that this medication is excreted in breast milk, and whether to continue breastfeeding should be decided in consultation with a physician. Safety and efficacy in children under 16 years have not been sufficiently confirmed; therefore, use in this age group is not recommended. In case of overdose, symptoms such as drowsiness, dizziness, anxiety, and aggression may occur; since there is no specific antidote, appropriate medical treatment should be sought immediately. This medication should be stored out of reach of children and must be taken within the prescribed period after opening.

• suicidal thoughts
• suicidal behavior
• drowsiness
• fatigue
• dizziness
• coordination movement disorder
• influenza
• type I hypersensitivity
• neutropenia
• decreased appetite

This medication should be stored in a tightly closed container to prevent air exposure, ideally at room temperature between 1 degree and 30 degrees Celsius. By doing so, the effectiveness of the medication can be maintained for a longer period.

Appearance

Olive green oval film-coated tablet

Package unit

56 tablets/box [14 tablets/ blisters * 4]