Briviact 10 mg Tablets (Brivaracetam)

Adult dose

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

This medication is used for the treatment of epilepsy and may increase the risk of suicidal thoughts or behavior; thus, patients and guardians should closely monitor for signs of these. This drug may cause central nervous system-related side effects such as drowsiness, fatigue, and dizziness, which are common in the early stages of treatment but may occur at any time during therapy. Stopping the medication abruptly may worsen seizures, so it is essential to taper the dosage gradually according to the physician's instructions. Individuals with hypersensitivity to the active ingredient or other components of this medication, as well as those with specific genetic disorders such as lactase deficiency, should not take it. Patients with impaired liver function may need dosage adjustments, and caution is necessary due to limited clinical data on patients with liver disorders. This drug may cause various adverse reactions, with drowsiness and dizziness being particularly common. Some patients may experience psychiatric symptoms, including depression, anxiety, and suicidal thoughts. Severe skin reactions, such as Stevens-Johnson syndrome, have been reported; patients should consult healthcare providers immediately if any unusual skin symptoms occur. Taking this medication with alcohol may significantly impair psychomotor functions, so it is advisable to avoid alcohol consumption. Drug interactions are possible, particularly with antiepileptic drugs or drugs affecting liver metabolism, so inform your doctor or pharmacist if you are taking any such medications. During pregnancy, there may be potential risks to the fetus, so women of childbearing potential should have careful consultations before taking it, and nursing mothers should also be cautious, as the drug can be excreted in breast milk. Safety and effectiveness in children under 16 years have not been established, so caution is advised. This medication can cause drowsiness and dizziness; therefore, it is advisable to avoid hazardous activities such as driving or operating machinery during the initial stages of treatment. In cases of overdose, symptoms such as drowsiness, dizziness, anxiety, and depression may occur, and as there is no specific antidote, appropriate medical treatment should be obtained immediately. Store this medication out of the reach of children, and it is recommended to use it within 5 months after opening without transferring it to another container.

• suicidal ideation
• suicidal behavior
• drowsiness
• fatigue
• dizziness
• psychomotor agitation
• influenza
• Type I hypersensitivity reaction
• neutropenia
• decreased appetite

Store this medication in a tightly closed container to prevent exposure to light and air. It is advisable to keep it at room temperature between 1 degree Celsius and 30 degrees Celsius.

Appearance

White or off-white round film-coated tablet

Package unit

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