Brivlact Tablet 25 mg (Brivaracetam)

Adult dose

This product 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 daily [25mg twice daily] to 200mg daily [100mg twice daily]. Take this product as a whole film-coated tablet 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, then take the next dose at the next scheduled morning or evening time. Discontinuation If you wish to discontinue this product, gradually reduce the dose by 50mg daily at 1-week intervals. After taking 50mg daily for 1 week, a dose of 20mg daily is recommended during the final week (see section '1. Warnings'). Older adults (65 years or older) No dosage adjustment is necessary for older adults. Clinical experience in older patients aged 65 years or older is limited Renal impairment No dosage adjustment is necessary for patients with renal impairment. This product is not recommended for patients with end-stage renal disease undergoing hemodialysis. Hepatic impairment Exposure to this product is increased in patients with hepatic impairment. An initial dose of 50mg daily [25mg twice daily] is recommended for patients with hepatic impairment, and a maximum dose of 150mg daily [75mg twice daily] is recommended.

This medication is used for the treatment of epilepsy, and there may be an increased risk of suicidal thoughts or behaviors in patients taking it, so careful observation is necessary. Common central nervous system-related side effects, such as drowsiness, fatigue, dizziness, and coordination disorders, may occur and can appear at any time during the initial treatment or ongoing therapy. Abrupt discontinuation may increase the frequency of seizures, so dosage should be gradually reduced under the direction of a physician. It should not be used in patients with a known allergy to its ingredients or those with specific genetic lactose intolerance. Patients with impaired liver function need dosage adjustments, and there is limited clinical data for patients with liver disorders; thus, it should be administered cautiously. During treatment, psychiatric symptoms such as depression, anxiety, and suicidal thoughts may present, so changes in symptoms should be closely monitored. Severe skin reactions may occur rarely, so if any symptoms such as rash, blisters, or redness appear, immediate consultation with a physician is necessary. Taking this medication with alcohol can impair psychomotor skills and attention, so it is advisable to avoid alcohol consumption. There may be interactions with some other medications, so patients should inform their healthcare provider or pharmacist about any other medications they are taking. The safety of this medication during pregnancy has not been established, and it should be avoided unless special circumstances warrant its use. Breastfeeding mothers should carefully decide about usage as the drug can be transferred through breast milk. In children under 16 years, the safety and efficacy have not been fully established, so caution is advised. This medication can cause drowsiness or dizziness; avoiding dangerous activities such as driving or operating machinery until symptoms stabilize is recommended. In case of overdose, symptoms such as drowsiness, dizziness, anxiety, insomnia, and depression may occur, and immediate medical attention is necessary as there is no specific antidote. This medication should be stored out of reach of children, and transferring it to another container may cause a decrease in quality or lead to accidents.

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

This medication should be stored in a tightly closed container to protect it from air and moisture. It is also important to store it at room temperature, avoiding extreme heat or cold, ideally between 1 to 30 degrees Celsius.

Appearance

Gray oval film-coated tablet

Package unit

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