Brivaracetam 25 mg Tablets

Adult dose

This drug is taken twice daily. The recommended initial dose is 25mg or 50mg per dose, based on the healthcare provider's assessment of potential adverse effects in relation 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]. (Tablets) This drug is a film-coated tablet. Swallow it whole with water. It may be taken with or without food. (Oral solution) This drug may be diluted in water immediately before taking and may be taken with or without food. It may also be administered through a nasogastric tube or gastrostomy tube. 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 When discontinuing this drug, 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) No dosage adjustment is required in elderly patients. Clinical experience in elderly patients aged 65 years and older is limited. Renal impairment No dosage adjustment is required in patients with renal impairment. This drug is not recommended for patients with end-stage renal disease receiving hemodialysis. Hepatic impairment Exposure to this drug 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 drug is an anticonvulsant and may increase the risk of suicidal thoughts or behaviors, so careful observation for mood changes or abnormal behaviors is necessary during treatment. It can cause side effects related to the central nervous system such as drowsiness, fatigue, dizziness, and coordination disorders, which may occur frequently during the initial treatment but can arise at any time during the treatment period. Abrupt cessation of the medication may lead to an increased frequency of seizures, so it is essential to gradually reduce the dosage under medical guidance. Those who are allergic to any components of this drug or have certain genetic issues, such as lactose intolerance, should avoid taking it. Patients with impaired liver function may require dosage adjustments, so consultation with a physician is necessary. This medication contains Yellow No. 4 (Tartrazine), and caution should be taken in patients who are sensitive to this ingredient. During use, various psychiatric and neurological symptoms such as infections, depression, anxiety, insomnia, and suicidal thoughts may occur; consult a healthcare provider immediately if any unusual symptoms appear. Severe skin reactions, such as Stevens-Johnson syndrome, may occur, so if symptoms such as skin rash, redness, or blisters appear, discontinue the medication immediately and visit a medical institution. This medication may affect psychomotor function and attention when taken with alcohol, so avoiding alcohol consumption is advisable. There may be interactions with other anticonvulsants or specific medications, so disclose all medications being taken to the healthcare provider. It is generally advised not to use this medication during pregnancy, and women planning to conceive should consult with a physician before taking it. This drug is excreted in breast milk, so the decision to use it while breastfeeding should be made cautiously. Safety and efficacy in children under 16 years have not yet been established, so pediatric use is not recommended. Drowsiness or dizziness may occur at the start of treatment or when there is a change in dosage; therefore, care should be taken when driving or performing hazardous activities. In cases of overdose, symptoms such as drowsiness, dizziness, anxiety, fatigue, and suicidal thoughts may occur, and since there is no specific antidote, supportive treatment according to symptoms is necessary. Store the medication out of reach of children, and it is safer and better for quality maintenance not to transfer it to other containers.

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

This medication must be stored in a well-sealed container to avoid exposure to air and moisture. It is crucial to maintain storage temperatures between 1 and 30 degrees Celsius to preserve the drug's efficacy safely.

Appearance

Gray oval film-coated tablets

Package unit

30 tablets/bottle, 100 tablets/bottle