Brivaracetam Tablet 50 mg (Brivaracetam)

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 relative to seizure reduction. Based on clinical response and tolerability, the dose may be increased or decreased from 50mg per day [25mg per dose, twice daily] to 200mg per day [100mg per dose, twice daily]. Take this film-coated tablet whole with water, with or without food. If you miss 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 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 during 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 per dose, twice daily], and the recommended maximum dose is 150mg per day [75mg per dose, twice daily].

This medication is used for the treatment of epilepsy and may increase the risk of suicidal thoughts or behaviors; therefore, patients and guardians should carefully observe for these signs. Additionally, this medication may produce central nervous system side effects such as drowsiness, fatigue, dizziness, and coordination movements disorders, particularly at the start of treatment or when the dose is increased. Sudden discontinuation of the medication may increase the risk of seizures; therefore, it should be tapered off gradually following a doctor's instructions. Patients with an allergy to the main ingredient or other components of this medication, as well as those with specific genetic issues such as lactose intolerance, should not take it. Patients with liver function issues need dose adjustments, and clinical data for patients with hepatic impairment is limited, so it should be administered cautiously. During the use of this medication, psychiatric symptoms such as depression, anxiety, suicidal thoughts, and serious skin reactions (e.g., Stevens-Johnson syndrome) should be closely monitored, and if any abnormal symptoms appear, medical consultation should be sought immediately. Alcohol consumption may affect cognitive and attention functions, so it is advisable to avoid drinking during the course of this medication. There may be interactions when using this medication in combination with other antiepileptic drugs or specific medications, so any drugs being taken should definitely be reported to healthcare personnel. During pregnancy, the safety for the fetus has not been established; therefore, it should be avoided except in special circumstances, and during breastfeeding, consultation with a physician is necessary because the medication may be excreted in breast milk. The safety and efficacy for pediatric patients under 16 years of age have not been sufficiently confirmed, so caution is needed when using it. This medication may cause drowsiness or dizziness, so it is safest to avoid dangerous activities such as driving or operating machinery during the initial period of use. In case of overdose, symptoms such as drowsiness, dizziness, anxiety, and depression may occur, and there is no specific antidote, so general treatment based on symptoms is required. Finally, this medication should be kept out of the reach of children, and transferring it to another container may lead to degradation of quality or accidents, so caution should be taken.

• suicidal thoughts
• suicidal behavior
• drowsiness
• fatigue
• dizziness
• coordination disorders
• influenza
• type I hypersensitivity reactions
• neutropenia
• decreased appetite

This medication should be stored in a sealed container to protect it from exposure to air or moisture. It is important to maintain a storage temperature between 1°C and 30°C.

Appearance

Pale yellow oval film-coated tablets

Package unit

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