Pericomp Tablet 10mg (Perampanel (Unrefined))

Adult dose

This medicine is taken once daily before 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 reduce 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 reduce 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 is missed during treatment, take the medicine 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 scheduled 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 of 5 times the half-life corresponds to 3 weeks in patients not taking antiepileptic drugs that induce perampanel metabolism, and 1 week in patients taking such drugs. Patients with renal impairment No dose adjustment is necessary in 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: 4 years of age and older — Treatment with this medicine is initiated at 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; if necessary, it may be increased to a maximum of 8mg once daily. Adjunctive therapy, partial-onset seizures: 4 years of age and older — Treatment with this medicine is initiated at 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; if necessary, it may be increased to a maximum of 12mg once daily. Adjunctive therapy, primary generalized tonic-clonic seizures: 7 years of age and older — Treatment with this medicine is initiated at 2mg once daily. Depending on the patient’s clinical response and tolerability, the dose is increased to the maintenance dose of 8mg once daily; if necessary, it may be increased to a maximum of 12mg once daily.

This medication is used to treat epilepsy, and there may be an increased risk of suicidal thoughts or behaviors during use, so patients and caregivers should closely monitor for mood changes or abnormal behaviors. Symptoms such as mental instability, aggressive behavior, anger, and irritability may occur, and if such changes happen, patients should consult a doctor immediately. Patients with allergies to this medication or specific genetic problems like lactose intolerance should not take this medication. Particularly in elderly patients, there is a heightened risk of falls during use of this medication, and patients with a history of substance abuse should be carefully monitored for signs of misuse of this medication. This medication can interact with other drugs, so dosage adjustments are necessary, especially when taken with specific antiepileptic drugs under the doctor's guidance. Dizziness or drowsiness may occur while taking this medication, so it is advisable to avoid driving or operating hazardous machinery. Rarely, severe allergic reactions can occur with serious skin rashes or systemic symptoms, so if any skin abnormality is noticed, the medication should be discontinued immediately, and a doctor consulted. Use during pregnancy is not recommended, and nursing mothers should carefully consider whether to breastfeed, as this medication may pass into breast milk. There is no specific antidote for overdose, so if overdose occurs, the patient should visit a medical institution immediately for appropriate treatment. This medication should be swallowed whole, without chewing or crushing. Finally, keep this medication out of the reach of children, and do not use expired products.

Suicidal ideation, suicidal behavior, depression, aggression, hostility, irritability, anger, homicidal ideation, threats, dizziness, drowsiness, ataxia, dysarthria, balance disorder, double vision, 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 impairment, cognitive dysfunction, flexibility, perceptual disturbances, head tremors, sedation, syncope, sensory loss, mental disorders, excessive psychomotor activity, bradykinesia, cerebrovascular accident, decreased level of consciousness, attention deficit, orthostatic dizziness, mental confusion, encephalopathy, epilepsy, generalized tonic-clonic seizure, hypotonia, focal muscle spasms, cluster seizures, suicide attempt, confusion state, acute psychosis, auditory hallucinations, altered mental state, sleep disorders, visual hallucinations, delirium, attention deficit hyperactivity disorder, bruxism, substance dependence, echolalia, visual disturbances, mixed hallucinations, inappropriate affect, intermittent explosive disorder, altered mental state, negative thinking, psychotic disorders, restlessness, schizophrenia, sleep attacks, 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, excessive salivation, alopecia, urticaria, acne, diaphoresis, frictional urticaria, eye pain, increased tear secretion, decreased vision, eye fatigue, weight loss, increased liver function tests, decreased platelet count, encephalitis, soft tissue inflammation, chronic hepatitis B, erectile dysfunction, menstrual disturbances, sexual dysfunction, dyspnea, nasal obstruction, orthostatic hypotension, peripheral coldness, musculoskeletal rigidity, myalgia, palpitations, oral injury, anemia, spontaneous abortion, bedridden, headache, seizure, hypersomnia, hypersomnolence, tremors, insomnia, auditory hallucinations, asthenia, strange sensations, adverse drug reactions, vomiting, dyspepsia, rash, pruritus, muscle weakness, altered mental state, anxiety, aggressive behavior, coma, decreased level of consciousness

This medication should be stored in a tightly closed container to protect it from air and moisture, and it is best stored at a temperature between 1 degree and 30 degrees Celsius. Storing it this way will help maintain the effectiveness of the medication for a longer period.

Appearance

Green, double convex, round film-coated tablet

Package unit

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