Briviact Tablets 25 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 medication may cause suicidal thoughts or behaviors in some patients; therefore, it is essential to carefully monitor for these symptoms during treatment. Neurological and psychiatric side effects such as drowsiness, fatigue, dizziness, and coordination disturbances may occur, so caution is especially advised when starting treatment or adjusting the dosage. Discontinuing this medication suddenly may lead to increased seizure frequency, so it should be tapered off according to the physician's instructions. Patients with hypersensitivity to this medication or specific genetic issues like lactose intolerance should not use it. Patients with liver dysfunction may need dosage adjustments, so they should use this medication cautiously after consulting their physician. Various adverse reactions such as influenza, depression, anxiety, insomnia, and suicidal thoughts may occur during treatment; report any worsening symptoms or new symptoms to healthcare professionals immediately. This medication may affect mental and motor functions or attention when taken with alcohol, so it is advisable to avoid alcohol consumption during treatment. Women who are pregnant or planning to become pregnant should consult their physician regarding the use of this medication. Nursing mothers should also carefully consider the use of this medication, as it may be excreted in breast milk. The safety and efficacy of this medication have not been established in pediatric patients under 16 years; its use is not recommended. Drowsiness or dizziness may occur; it is safe to avoid hazardous activities such as driving or operating machinery until patients are accustomed to the effects of the medication. There is no specific antidote for overdose, so if an overdose occurs, seek immediate treatment and recognize that blood dialysis may not be effective in removing the drug. This medication should be kept out of reach of children and should not be transferred to another container; consume within the specified period after opening.

• suicidal ideation
• suicidal behavior
• drowsiness
• fatigue
• dizziness
• akathisia
• influenza
• type I hypersensitivity reaction
• neutropenia
• decreased appetite

This medication should be stored in a tightly sealed container to prevent air or moisture from entering. It is recommended to store it at room temperature between 1°C and 30°C.

Appearance

Gray oval film-coated tablets

Package unit

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