Brivaracetam 50 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 drug is used for the treatment of epilepsy, and serious mental health issues such as suicidal thoughts or behavior may occur, so patients and caregivers should carefully monitor for these symptoms. CNS symptoms such as drowsiness, fatigue, and dizziness may occur during the use of this medication, especially at the start of treatment or when the dosage is increased. Suddenly stopping the medication could increase the frequency of seizures, thus it is necessary to taper the dosage gradually under a doctor's guidance. Patients with hypersensitivity to the active ingredient or other components of this drug, or with a genetic lactose metabolism disorder, should not take this medication. Patients with impaired liver function may require dose adjustments, so it should be administered with caution. While taking this drug, there may be serious allergic reactions on the skin or severe skin disorders like Stevens-Johnson syndrome, so if skin rashes or other unusual symptoms develop, immediate consultation with a healthcare professional is advised. Alcohol consumption can exacerbate the CNS side effects of this medication, hence it should be avoided. This drug may interact with other antiepileptic medications or certain drugs, so it is essential to inform medical professionals of any other medications being taken. During pregnancy, the safety for the fetus has not been sufficiently confirmed, and it should only be used if necessary. Caution is also required when breastfeeding, as the drug may be excreted in breast milk. Safety and efficacy have not been established for children under 16 years of age, and use is therefore not recommended. This drug may cause symptoms like drowsiness, so caution is advised when driving or operating machinery. It is advisable to avoid such activities when first starting the medication or changing the dosage. In case of overdose, symptoms such as drowsiness, dizziness, anxiety, and aggression may appear, and since there is no specific antidote, immediate medical assistance is needed. This medication should be stored out of the reach of children, and transferring it to another container is not recommended as it may affect quality.

• suicidal ideation
• suicidal behavior
• drowsiness
• fatigue
• dizziness
• coordination impairment
• influenza
• type 1 hypersensitivity reaction
• neutropenia
• decreased appetite

This medication should be stored in a tightly sealed container to prevent exposure to air and moisture. It is advisable to keep it at room temperature between 1°C and 30°C.

Appearance

Yellow oval film-coated tablets

Package unit

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