Brivaracetam 100 mg Tablets

Adult dose

This medicine is taken twice daily. The recommended initial dose is 25mg or 50mg per dose, based on the healthcare professional’s assessment of potential adverse effects versus seizure reduction. Based on clinical response and tolerability, the dose may be increased or decreased from 50mg per day [25mg twice daily] to 200mg per day [100mg twice daily]. (Tablets) This medicine is a film-coated tablet. Swallow it whole with water. It may be taken with or without food. Missed doses 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. Discontinuation If you wish to discontinue this medicine, gradually reduce the dose by 50mg per day at 1-week intervals. After taking 50mg per day for 1 week, a dose of 20mg per day is recommended for the final week (see section ‘1. Warnings’). Elderly patients (65 years and older) No dose adjustment is necessary in elderly patients. Clinical experience in elderly patients aged 65 years and older is limited. Renal impairment No dose adjustment is necessary 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 50mg per day [25mg twice daily], and the recommended maximum dose is 150mg per day [75mg twice daily].

This medication may increase the risk of suicidal thoughts or behaviors. Therefore, if mood changes or abnormal behaviors occur during treatment, consult a doctor immediately. Also, central nervous system symptoms such as drowsiness, fatigue, and dizziness may occur, so caution is necessary when driving or operating machinery. Discontinuing the medication suddenly may increase the frequency of seizures, so it should be tapered off gradually according to the doctor's instructions. Do not take this medication if you have a hypersensitivity to it or are allergic to the active ingredient or lactose. Patients with poor liver function may need dosage adjustments, so consult your doctor. This medication contains yellow pigments, so patients who are sensitive to them should exercise caution. During treatment, psychiatric symptoms such as depression, anxiety, and insomnia may occasionally occur, so changes in condition should be monitored. Severe skin reactions such as Stevens-Johnson syndrome may occur; if there are signs of abnormal skin changes, inform your doctor immediately. Taking with alcohol can impair psychomotor functions, so it is advisable to avoid alcohol consumption. There may be interactions with other medications, so be sure to inform your doctor or pharmacist of any other medications you are taking. Women who are pregnant or breastfeeding should carefully consider taking this medication and consult a specialist if necessary. The safety for children under 16 years old has not been established, so it is advisable not to administer it to pediatric patients. In case of overdose, symptoms such as drowsiness, dizziness, and anxiety may occur. As there is no specific antidote, seek medical attention immediately. This medication should be kept out of reach of children and should not be transferred to another container for safety.

• suicidal ideation
• suicidal behavior
• drowsiness
• fatigue
• dizziness
• coordination impairment
• influenza
• Type 1 hypersensitivity reaction
• neutropenia
• loss of appetite

This medication is sensitive to air and moisture, so it must be stored in a tightly closed container. The storage temperature should be maintained between 1 and 30 degrees Celsius to preserve the effectiveness of the medication.

Appearance

Pale green oval film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle