Pericompa Tablet 12 Milligrams (Perampanel (Non-Crystalline))

Adult dose

This medicine should be 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 Adjust the dose by 2 mg per day at intervals of at least 2 weeks. For patients receiving concomitant medications that do not decrease the half-life of perampanel, adjust the dose by 2 mg per day at intervals of at least 2 weeks. For patients receiving concomitant medications that decrease the half-life of perampanel (such as phenytoin, carbamazepine, or oxcarbazepine), adjust the dose by 2 mg per day at intervals of at least 1 week (see section ‘6. Drug 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 extra dose; take the next dose at the next scheduled administration 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 a consecutive period of 5 times the half-life or longer: Retitrate the dose starting from the initial dose. A period equivalent 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 undergoing 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 2 mg per day, and the dose is increased by 2 mg per day at intervals of at least 2 weeks. The maximum recommended dose is 6 mg per day for patients with mild hepatic impairment and 4 mg per day for patients with moderate hepatic impairment. As with 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 per day. Depending on the patient's clinical response and tolerability, the dose is increased to the maintenance dose of 4mg to 8mg per day; if needed, it may be increased to a maximum of 8mg per day. Adjunctive therapy, partial-onset seizures: 4 years of age and older — Treatment with this medicine is initiated at 2mg per day. Depending on the patient's clinical response and tolerability, the dose is increased to the maintenance dose of 4mg to 8mg per day; if needed, it may be increased to a maximum of 12mg per day. Adjunctive therapy, primary generalized tonic-clonic seizures: 7 years of age and older — Treatment with this medicine is initiated at 2mg per day. Depending on the patient's clinical response and tolerability, the dose is increased to the maintenance dose of up to 8mg per day; if needed, it may be increased to a maximum of 12mg per day.

This medication is used for the treatment of epilepsy, and there is a risk of increased suicidal thoughts or behaviors while taking it, so if there are any changes in mood or behavior, consult a doctor immediately. Behavioral changes such as aggressive behavior, anger, or irritability may occur, and caregivers or guardians need to closely observe the patient and inform a doctor if these symptoms arise. This medication should not be used in patients with certain genetic disorders or allergies to its components, especially patients with lactose intolerance should not take it. Elderly patients should be careful as the risk of falls may increase, and patients with a history of substance abuse should be closely monitored for signs of misuse of this medication. There may be interactions when taken with other medications, so particularly when taking medications that induce or inhibit certain liver enzymes, dosage should be adjusted according to the doctor’s instructions. Dizziness or drowsiness may occur while taking it, so it is recommended to avoid driving or operating dangerous machinery until the influence of the drug is confirmed. Rarely, serious skin reactions or liver function abnormalities may occur, so if a rash, red spots, or itching appears on the skin, notify medical personnel immediately. Women who are pregnant or breastfeeding should be cautious when taking this medication, especially breastfeeding women should consult a doctor before deciding, as it may affect the newborn. In case of overdose, changes in mental state, agitation, aggression, and coma may occur, so emergency treatment should be sought immediately, and it is advisable to gradually discontinue this medication. This medication should not be chewed or crushed but swallowed whole, kept out of reach of children, and expired products should not be used.

suicidal thoughts, suicidal behavior, depression, aggression, hostility, irritability, anger, homicidal thoughts, 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 impairment, flexibility, perceptual abnormalities, head tremor, sedation, fainting, sensory loss, mental disturbances, psychomotor agitation, bradykinesia, cerebrovascular accident, decreased level of consciousness, attention deficit, orthostatic dizziness, hazy state, encephalopathy, epilepsy, generalized tonic-clonic seizures, hypotonia, focal muscle spasms, cluster seizures, suicide attempts, confusional state, acute psychosis, hallucinations, altered mental state, sleep disorders, illusions, delirium, attention deficit hyperactivity disorder, bruxism, drug dependence, echolalia, visual hallucinations, mixed hallucinations, inappropriate affect, intermittent explosive disorder, altered mental state, negative thoughts, 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, excessive salivation, alopecia, urticaria, acne, cold sweat, frictional urticaria, eye pain, increased tear secretion, decreased vision, eye fatigue, weight loss, elevated liver function tests, reduced platelet count, encephalitis, soft tissue infection, chronic hepatitis B, erectile dysfunction, menstrual disorders, sexual dysfunction, respiratory distress, nasal obstruction, orthostatic hypotension, peripheral coldness, musculoskeletal stiffness, myalgia, palpitations, oral injury, anemia, spontaneous abortion, bedridden, headache, seizures, hypersomnia, somnolence, tremors, insomnia, 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 sealed container to prevent exposure to air or moisture. It is best to maintain a storage temperature of between 1 degree to 30 degrees at room temperature.

Appearance

Blue, double convex, round film-coated tablet

Package unit

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