Brivatol Tablets 10 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 cause mental health issues such as suicidal thoughts or behaviors; therefore, careful observation for such symptoms is necessary during treatment. Taking this medication may lead to central nervous system side effects, such as drowsiness, fatigue, dizziness, and coordination disorders, especially when first starting the medication. Suddenly stopping the medication may lead to an increase in the frequency of seizures, so dosages should be reduced gradually according to the physician's instructions. Patients with allergies to any ingredients in this medication or with genetic conditions that hinder lactose digestion should not take this medication. Patients with liver dysfunction may require dosage adjustments, noting that clinical data on patients with liver impairment is limited. The most common side effects during treatment are drowsiness and dizziness, which can interfere with daily life, so caution is advised. This medication may interact with other antiepileptic drugs, and especially when taken with certain medications, blood concentrations may change; therefore, consulting a doctor or pharmacist is recommended. Consuming alcohol while taking this medication may further impair psychomotor functions and attention, so it is advisable to avoid alcohol. The effects of this medication on the fetus during pregnancy are not fully understood, so a consultation with a physician is necessary to determine whether to take it. During breastfeeding, this medication may be secreted in breast milk, so it is recommended to discuss whether to continue or stop nursing with a doctor. For children under 16 years old, safety and efficacy have not been sufficiently confirmed, so caution is needed in usage. During treatment with this medication, it is advisable to avoid hazardous activities like driving or operating machinery due to potential symptoms such as drowsiness or dizziness. In case of overdose, symptoms may include drowsiness, dizziness, anxiety, aggression, and depression; there is no specific antidote, so immediate medical treatment should be obtained.

• suicidal thoughts
• suicidal behavior
• drowsiness
• fatigue
• dizziness
• coordination disorders
• influenza
• type 1 hypersensitivity reactions
• neutropenia
• decreased appetite

This medication should be stored in a tightly closed container to prevent exposure to air, and it is best kept at room temperature between 1 and 30 degrees Celsius to maintain its efficacy for an extended period.

Appearance

White or off-white round film-coated tablets

Package unit

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