Pericomp Tablet 4 mg (Perampanel (micronized))

Adult dose

This medicine is taken once daily at bedtime, with or without food. Swallow the tablet whole with plenty of water; do not chew, crush, or divide it. Dose adjustment The dose is adjusted in increments of 2mg per day at intervals of at least 2 weeks. For patients receiving concomitant medications that do not reduce the half-life of perampanel, the dose is adjusted in increments of 2mg per day at intervals of at least 2 weeks. For patients receiving concomitant medications that reduce the half-life of perampanel (such as phenytoin, carbamazepine, or oxcarbazepine), the dose is adjusted in increments of 2mg per day at intervals of at least 1 week (see “6. Drug Interactions”). When discontinuing this medicine, reduce the dose gradually (see “5. General Precautions”). If a dose is missed during treatment, take the medicine as follows, depending on the duration of the interruption. ㆍIf 1 dose is missed: Considering the long half-life of perampanel, do not take an additional dose; take the next dose at the scheduled time. ㆍIf 2 or more consecutive doses are missed, but the interruption is shorter 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 from the initial dose. The period corresponding to 5 times the half-life is 3 weeks in patients not taking antiepileptic drugs that induce the metabolism of perampanel, and 1 week in patients taking such drugs. 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, with increases of 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: Treatment with this medicine is initiated at a dose of 2mg once daily. Depending on the patient’s clinical response and tolerability, the dose is increased to the maintenance dose of 4mg to 8mg once daily and, if necessary, may be increased to a maximum of 8mg once daily. Adjunctive therapy — Partial-onset seizures: Age 4 years and older: Treatment with this medicine is initiated at a dose of 2mg once daily. Depending on the patient’s clinical response and tolerability, the dose is increased to the maintenance dose of 4mg to 8mg once daily and, if necessary, may be increased to a maximum of 12mg once daily. Adjunctive therapy — Primary generalized tonic-clonic seizures: Age 7 years and older: Treatment with this medicine is initiated at a dose of 2mg once daily. Depending on the patient’s clinical response and tolerability, the dose is increased to the maintenance dose of up to 8mg once daily and, if necessary, may be increased to a maximum of 12mg once daily.

This drug is used for the treatment of epilepsy, and there is an increased risk of suicidal thoughts or behaviors during use, requiring careful monitoring of mood changes and behavioral abnormalities in patients. Moreover, psychiatric and behavioral disorders such as aggression, anger, and irritability may occur in patients taking this medication, and any signs of these symptoms should be discussed with a doctor immediately. This medication should not be administered to patients with certain genetic issues, such as lactose intolerance. Caution is needed for elderly patients due to the risk of falls, and patients with a history of substance abuse should be monitored for signs of abuse of this medication. There may be interactions when used in combination with other drugs, especially those that induce or inhibit enzymes involved in drug metabolism in the liver, requiring close observation of the patient's condition. Dizziness or drowsiness may occur during use, thus caution should be taken when driving or operating dangerous machinery. Additionally, this medication may cause severe skin adverse reactions, such as Stevens-Johnson syndrome or DRESS syndrome, so if symptoms like skin rash or fever occur, the medication should be discontinued immediately and consulting a doctor is necessary. Its use is not recommended during pregnancy, and for those who are breastfeeding, the effects on the newborn should be considered when deciding whether to continue usage. In case of an overdose, immediate medical support and symptom monitoring are needed as there is no specific antidote available. Lastly, this medication should be swallowed whole without chewing, crushing, or splitting, and kept out of reach of children.

suicidal thoughts, suicidal behavior, depression, aggression, hostility, irritability, anger, homicidal impulses, threats, 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 disturbances, fatigue, weight gain, falls, memory disturbances, cognitive impairment, flexibility, perceptual disturbances, head tremors, sedation, fainting, sensory loss, mental disturbances, excessive psychomotor activity, bradykinesia, cerebrovascular accident, decreased consciousness level, attention deficit, postural dizziness, somnolence, encephalopathy, epilepsy, generalized tonic-clonic seizure, hypotonia, focal seizures, cluster seizures, suicide attempts, confusion, acute psychosis, hallucinations, changes in mental state, sleep disorders, illusions, delirium, attention deficit hyperactivity disorder, bruxism, drug dependence, echolalia, visual hallucinations, mixed hallucinations, inappropriate affect, intermittent explosive disorder, changes in mental state, negative thinking, psychotic disorder, restlessness, schizophrenia, sleep seizures, fever, worsening condition, malaise, chest discomfort, edema, heat sensation, 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, cold sweat, friction urticaria, ocular pain, increased tear secretion, decreased vision, eye fatigue, weight loss, increased liver function tests, decreased platelet count, encephalitis, soft tissue infection, 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, bedridden, headache, seizures, hypersomnia, somnolence, tremors, insomnia, auditory hallucinations, asthenia, strange sensations, adverse drug reactions, vomiting, dyspepsia, rash, pruritus, muscle weakness, changes in mental state, anxiety, aggressive behavior, coma, decreased consciousness level

Store this medication in a tightly closed container to prevent exposure to air or moisture. It is advised to keep the storage temperature between 1 degree and 30 degrees Celsius at room temperature to maintain the efficacy and safety of the drug for a longer time.

Appearance

Red, biconvex, round film-coated tablet

Package unit

30 tablets/box [10 tablets/PTP x 3], 30 tablets/bottle, 100 tablets/bottle