Fycompa Film-Coated Tablets 4 mg (Perampanel)

Adult dose

Take this medicine once daily at bedtime, with or without food. Swallow it whole with plenty of water; do not chew, crush, or divide it. Dose adjustment Adjust the dose by 2mg per day at intervals of at least 2 weeks. For patients receiving concomitant medicines that do not decrease the half-life of perampanel, adjust the dose by 2mg per day at intervals of at least 2 weeks. For patients receiving concomitant medicines that decrease the half-life of perampanel (such as phenytoin, carbamazepine, or oxcarbazepine), adjust the dose by 2mg per day at intervals of at least 1 week (see section ‘6. Interactions’). When discontinuing this medicine, reduce the dose gradually (see section ‘5. General precautions’). If a dose of this medicine is missed during treatment, take it as follows, depending on the duration of the interruption. ㆍIf 1 dose is missed: In view of the long half-life of perampanel, do not take an additional dose; take the next dose at the next scheduled dosing time. ㆍIf 2 or more consecutive doses are missed, but the interruption is less than 5 times the half-life: Consider restarting treatment at the last administered dose. ㆍIf doses are missed for 5 times the half-life or longer consecutively: Retitrate the dose starting from the initial dose. A period corresponding to 5 times the half-life is 3 weeks in patients not taking antiepileptic medicines that induce perampanel metabolism, and 1 week in patients taking such medicines. Patients with renal impairment No dose adjustment is necessary for patients with mild renal impairment. Use of this medicine is not recommended in patients with moderate or severe renal impairment or in patients receiving hemodialysis. Patients with hepatic impairment Dose adjustment is necessary in patients with mild or moderate hepatic impairment because the half-life is prolonged and exposure is increased. The initial dose is 2mg per day, and the dose is increased by 2mg per day at intervals of at least 2 weeks. The maximum recommended dose is 6mg per day for patients with mild hepatic impairment and 4mg per day for patients with moderate hepatic impairment. As in other patients, adjust the dose according to the patient's clinical response and tolerability. Use of this medicine is not recommended in patients with severe hepatic impairment.

Child dose

Monotherapy, partial-onset seizures: Age 4 years and older — Start treatment with this medicine at 2mg per day. Increase the dose according to the patient's clinical response and tolerability to a maintenance dose of 4mg to 8mg per day; if necessary, the dose may be increased to a maximum of 8mg per day. Adjunctive therapy, partial-onset seizures: Age 4 years and older — Start treatment with this medicine at 2mg per day. Increase the dose according to the patient's clinical response and tolerability to a maintenance dose of 4mg to 8mg per day; if necessary, the dose may be increased to a maximum of 12mg per day. Adjunctive therapy, primary generalized tonic-clonic seizures: Age 7 years and older — Start treatment with this medicine at 2mg per day. Increase the dose according to the patient's clinical response and tolerability to a maintenance dose of 8mg per day; if necessary, the dose may be increased to a maximum of 12mg per day.

This medication is used for the treatment of epilepsy, and there may be an increased risk of suicidal thoughts or behaviors during treatment. Patients should be closely monitored for changes in mood and behavior. Symptoms such as mental health issues, aggressive behavior, or irritability may occur, and it is important to consult a physician immediately if these changes arise. Patients with a history of allergic reactions to this medication or genetic metabolic disorders such as lactose intolerance should not take this drug. Elderly patients may have an increased risk of falls, and those with a history of substance abuse should be closely monitored for signs of misuse. Drug interactions may occur when taken with other medications, so especially inform the physician if taking specific antiepileptic drugs or contraceptives. Dizziness or drowsiness may occur during treatment, so caution should be taken when driving or operating dangerous machinery. If severe skin rashes or systemic symptoms occur, discontinue use immediately and consult healthcare professionals; regular monitoring may be needed due to possible liver function abnormalities. Pregnant or breastfeeding women should consult their physician thoroughly before using this medication, and additional non-hormonal contraceptive measures are recommended for women of childbearing potential. In cases of overdose, there is no specific antidote, so visit a hospital immediately for vital sign monitoring and appropriate treatment. This medication should be swallowed whole and not chewed or crushed, and should be kept out of reach of children. This drug has potential for abuse, so patients with a history of substance abuse should exercise greater caution, and it is advisable to taper the dosage gradually rather than stopping abruptly.

Suicidal ideation, suicidal behavior, depression, aggression, hostility, irritability, anger, homicidal ideation, threats, confusion, psychotic disorders, dizziness, drowsiness, ataxia, dysarthria, balance disorders, diplopia, blurred vision, vertigo, nausea, drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), Stevens-Johnson syndrome (SJS), back pain, gait disturbance, fatigue, weight gain, falls, memory disturbances, cognitive impairment, flexibility, perceptual disturbances, head tremors, sedation, syncope, sensory loss, psychiatric disorders, psychomotor agitation, bradykinesia, cerebrovascular accident, decreased level of consciousness, attention deficit, orthostatic dizziness, lethargy, encephalopathy, epilepsy, generalized tonic-clonic seizures, hypotonia, benign focal seizures, cluster seizures, suicide attempts, acute psychosis, auditory hallucinations, changes in mental status, sleep disorders, visual hallucinations, delirium, attention deficit hyperactivity disorder, bruxism, drug dependence, echolalia, visual disturbances, mixed hallucinations, inappropriate affect, intermittent explosive disorder, restlessness, schizophrenia, sleep seizures, fever, worsening of condition, illness perception, chest discomfort, edema, warmth, swelling, facial swelling, cold sensation, pain, peripheral edema, abdominal pain, diarrhea, abdominal discomfort, constipation, upper abdominal pain, oral ulcer formation, nausea, dry mouth, gastritis, hypersalivation, alopecia, urticaria, acne, diaphoresis, friction urticaria, ocular pain, increased lacrimation, vision deterioration, eye fatigue, weight loss, elevated liver function tests, decreased platelet count, encephalitis, cellulitis, chronic hepatitis B, erectile dysfunction, menstrual disorders, sexual dysfunction, dyspnea, nasal obstruction, orthostatic hypotension, peripheral coldness, musculoskeletal rigidity, myalgia, palpitations, oral injuries, anemia, spontaneous abortion, lying down for prolonged periods, headache, seizures, hypersomnia, somnolence, tremors, insomnia, vomiting, dyspepsia, rash, pruritus, muscle weakness, changes in mental state, anxiety, aggressive behavior, coma, decreased level of consciousness

This medication should be stored in a tightly sealed container to protect it from air and moisture, and it is safe to store it at room temperature between 1°C and 30°C. Therefore, to maintain the effectiveness of the medication and prevent degradation, it is important to avoid direct sunlight and maintain appropriate storage conditions.

Appearance

Red, biconvex, round film-coated tablet

Package unit

28 tablets (14 tablets/blister × 2)