Brivaracetam 10 mg (Brivaracetam)

Adult dose

Take this medicine twice daily. The recommended initial dose is 25mg or 50mg per dose, based on the healthcare provider’s assessment of the potential side effects in relation to 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]. This medicine is a film-coated tablet. Swallow it whole with water. It may be taken 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 dose time. When discontinuing treatment If you wish to stop taking 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) Dose adjustment is not required for elderly patients. Clinical experience in elderly patients aged 65 years and older is limited. Renal impairment Dose adjustment is not required in patients with renal impairment. This medicine is not recommended for patients with end-stage renal disease who are 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 is used in the treatment of epilepsy, and during treatment, mental changes such as suicidal thoughts or behaviors may occur, so careful observation is necessary. CNS-related side effects such as drowsiness, fatigue, dizziness, and coordination disorders may occur commonly during the early stages of treatment, and these symptoms can appear at any time throughout the treatment period. Suddenly discontinuing this medication may increase the risk of seizure frequency, so the dosage should be gradually reduced according to the physician’s instructions. Patients allergic to the main ingredient or excipients of this medication, as well as those with certain genetic lactose intolerance, should not take this medication. Patients with impaired liver function should have their dosage adjusted, and since clinical data on patients with liver dysfunction is limited, careful administration is necessary. During treatment, psychiatric symptoms such as depression, anxiety, insomnia, and suicidal thoughts may appear, so patients and caregivers need to observe these symptoms closely. Rarely, severe skin adverse reactions such as Stevens-Johnson syndrome have been reported; if any skin abnormalities occur, consult a doctor immediately. This medication may negatively impact mental and motor skills and attention when taken with alcohol, so it is recommended to avoid alcohol consumption. There may be interactions with other antiepileptic drugs or certain medications, so all medications being taken should be disclosed to healthcare professionals, and dosage adjustments may be necessary. During pregnancy, the safety of this medication for the fetus has not been established; therefore, it is recommended not to take it except in special cases, and caution is also needed during breastfeeding as the medication may be excreted in breast milk. The safety and efficacy in children under 16 years of age have not been confirmed, so it should not be administered to them. Drowsiness or dizziness may occur while taking this medication, so caution should be exercised during activities requiring attention such as driving or operating machinery. In case of overdose, symptoms such as drowsiness, dizziness, anxiety, and aggression may occur, and since there is no specific antidote, general treatment according to the symptoms is required. This medication should be kept out of reach of children and should not be transferred to another container, as this is important for ensuring safety and quality.

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

This medication may be sensitive to air and moisture, so it should be stored in a sealed container. The recommended storage temperature is room temperature between 1°C to 30°C. This will help maintain the medication's efficacy for a long time.

Appearance

White or off-white round film-coated tablets

Package unit

60 tablets/box [10 tablets/PTP x 6]