Neopat tablet 100mg (Lacosamide)

Adult dose

This medicine should be taken twice daily. The recommended initial dose is 50mg twice daily, which should be increased after 1 week to 100mg twice daily. Depending on clinical response and tolerability, the maintenance dose may be increased by 50mg per dose twice daily each week; the maximum recommended dose is 400mg per day (200mg per dose twice daily). If treatment with this medicine is to be discontinued, gradual dose reduction is recommended. (e.g., gradually reduce the daily dose by 200mg each week) This medicine may be taken with or without food. 1. Patients with renal impairment No dose adjustment is necessary in patients with mild or moderate renal impairment (CLCR>30mL/min). A maximum dose of 300mg per day is recommended for patients with severe renal impairment (CLCR≤30mL/min) and end-stage renal disease. As this medicine is removed from plasma by hemodialysis, patients receiving hemodialysis are recommended to receive an additional dose of up to 50% of a single dose immediately after hemodialysis. Use caution when treating patients with end-stage renal disease because clinical experience is limited and metabolites (whose pharmacological activity is unknown) may accumulate. Dose adjustment should be made cautiously in all patients with renal impairment. 2. Patients with hepatic impairment The dose should be determined cautiously in patients with hepatic impairment. A maximum dose of 300mg per day is recommended for patients with mild or moderate hepatic impairment. Use is not recommended in patients with severe hepatic impairment. 3. Elderly patients Dose reduction is not necessary in elderly patients. Although experience with lacosamide use in elderly patients with epilepsy is limited, reduced renal clearance and increased AUC are associated with age and should be taken into consideration in elderly patients. (See the section “Patients with renal impairment”)

Child dose

4. Children Use of this medicine is not recommended in children and adolescents under 16 years of age because data on its safety and efficacy in these age groups are unavailable.

This medication may increase the risk of suicidal thoughts or behavior, so mood changes, symptoms of depression, and unusual behavior changes should be carefully monitored during treatment. Patients who are allergic to any ingredient contained in this medication should not use it. Dizziness may occur, so caution should be taken to prevent falls or injuries during the initial dosing or when adjusting doses. Patients with heart disease or abnormal electrocardiograms should check their heart condition before taking this medication and regularly monitor their heart function during treatment. If symptoms such as slow or irregular heartbeat, dizziness, fainting, palpitations occur during treatment, inform your healthcare provider immediately. This medication can cause psychiatric symptoms such as depression, suicidal thoughts, suicidal behavior, and abnormal mood changes, so patients and caregivers should promptly report these symptoms to healthcare professionals. During treatment, multi-organ hypersensitivity reactions such as rash, fever, eosinophilia, hepatitis, nephritis may occur, so if any unusual symptoms arise, discontinue the medication and consult a healthcare provider immediately. Common side effects of this medication include dizziness, headache, nausea, double vision, cognitive impairment, tremor of the eye, balance disorders, coordination impairment, memory loss, drowsiness, speech disturbance, attention deficit, sensory loss, sensory disturbance, cerebellar syndrome, blurred vision, vertigo, tinnitus, vomiting, constipation, abdominal distension, indigestion, dry mouth, diarrhea, muscle spasms, itching, gait disturbances, weakness, fatigue, irritability, a feeling of drunkenness, fever, falls, skin lacerations, bruises, and neutropenia. It is advisable to avoid driving or operating hazardous machinery until symptoms of dizziness or blurred vision have resolved after taking this medication. Care should be taken when taking this medication with other medications that affect the heart, especially if there are heart-related conditions, it is advisable to consult a healthcare professional. Elderly patients can take this medication without special dosage adjustment; however, caution should be exercised considering their overall physical condition. The safety and efficacy of this medication for children under 16 years old have not been established, and it is not recommended for use in this age group. During pregnancy, there may be a risk to the fetus, so the necessity and risks of using this medication should be carefully considered; during breastfeeding, it is recommended to stop breastfeeding as the medication can be transmitted through breast milk. In case of overdose, symptoms such as dizziness, nausea, vomiting, and cardiac abnormalities may occur, and since there is no specific antidote, appropriate treatment should be sought immediately at a medical institution. This medication can cause psychological dependence, such as a feeling of happiness, so it should be used according to the doctor’s instructions.

suicidal thoughts, suicidal behavior, depression, dizziness, ataxia, prolonged PR interval, second-degree or higher atrioventricular block, atrial fibrillation, atrial flutter, multi-organ hypersensitivity reaction, headache, nausea, diplopia, confusion, insomnia, mood changes, depressed mood, cognitive impairment, eye twitching, balance disorder, coordination disorder, memory impairment, tremors, drowsiness, speech disorder, attention deficit, sensory loss, paresthesia, cerebellar syndrome, blurred vision, vertigo, tinnitus, vomiting, constipation, gastric distension, dyspepsia, dry mouth, diarrhea, oral sensation reduction, muscle cramps, itching, gait disorder, asthenia, fatigue, hypersensitivity, feeling intoxicated, fever, falls, skin laceration, contusion, neutropenia, anemia, palpitations, atrioventricular block, syncope, bradycardia, atrial fibrillation, atrial flutter, abnormal liver function tests, agranulocytosis, drug hypersensitivity reaction, well-being, suicide attempt, aggression, anxiety, psychotic disorder, hallucinations, bradycardia, cardiac asystole, cardiac arrest, death, toxic epidermal necrolysis, Stevens-Johnson syndrome, rash, angioedema, urticaria, seizures, psychogenic seizures, ataxia, sedation, hair loss, blisters, early satiety, weight gain, decreased appetite, urinary incontinence, hiccups

This medication should be stored in a tightly sealed container to prevent air or moisture from entering, ideally at a temperature between 1 degree and 30 degrees Celsius. Storing it this way helps maintain the effectiveness of the medication and prevents degradation.

Appearance

Oval-shaped film-coated tablet of pale yellow color

Package unit

100 tablets (10 tablets/PTP x 10), 30 tablets/bottle, 100 tablets/bottle For export: 30 tablets (10 tablets/PTP x 3)