Piconpafil Film-Coated Tablet 10 mg (Perampanel)

Adult dose

This medicine is taken 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 medications 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 medications 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 is missed during treatment, take the medicine as follows, depending on the length of time missed. ㆍIf 1 dose is missed: Given 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 period is less than 5 times the half-life: Consider restarting treatment at the last administered dose. ㆍIf doses are missed consecutively for a period of 5 times the half-life or longer: Retitrate the dose starting from the initial dose. A period equal to 5 times the half-life corresponds to 3 weeks if the patient is not taking antiepileptic drugs that induce perampanel metabolism, and 1 week if the patient is taking such drugs. Patients with renal impairment No dose adjustment is required 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 required 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; adjust the dose according to the patient's clinical response and tolerability, as for other patients. Use of this medicine is not recommended in patients with severe hepatic impairment.

Child dose

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

This medication is used for the treatment of epilepsy. During treatment, there may be an increased risk of suicidal thoughts or behaviors, so it is essential to closely monitor changes in mood or behavior. Mental health may be affected, leading to behavioral changes such as aggression, anger, or irritability. If any of these symptoms arise, it should be reported to a physician immediately. Patients with hypersensitivity to this drug or specific genetic issues such as lactose intolerance should not use it. Caution is needed for elderly patients due to the increased risk of falls, and patients with a history of substance abuse should be closely monitored for signs of drug misuse. When taken alongside other medications, dosage adjustments may be required due to potential interactions, as advised by a physician. Dizziness or drowsiness may occur during treatment, so caution should be exercised during potentially hazardous activities such as driving or operating machinery. Severe skin reactions and liver function abnormalities may rarely occur, so immediate medical attention is needed if skin rashes or systemic symptoms appear. Pregnant or breastfeeding women should be cautious when taking this medication, and women of childbearing age should preferably use non-hormonal contraceptive methods. In the case of overdose, there is no specific antidote, and prompt medical attention should be sought for appropriate treatment. The tablets should be swallowed whole and should not be chewed or crushed. Keep this medication out of reach of children, and do not take expired medication.

suicidal ideation, suicidal behavior, depression, aggression, hostility, irritability, anger, homicidal ideation, threats, confusion, psychotic disorders, dizziness, drowsiness, ataxia, dysarthria, balance disorder, diplopia, blurred vision, vertigo, nausea, drug reaction accompanied by 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, hyperactivity, hypokinesia, cerebrovascular accident, decreased level of consciousness, attention deficit, position-related dizziness, lethargy, encephalopathy, epilepsy, generalized tonic-clonic seizures, muscular hypotonia, tonic-clonic seizures, cluster seizures, suicide attempt, acute psychosis, auditory hallucinations, changes in mental state, sleep disorders, visual hallucinations, delirium, attention deficit hyperactivity disorder, bruxism, drug dependence, echolalia, visual disturbances, mixed hallucinations, inappropriate affect, intermittent explosive disorder, schizophrenia, sleep seizures, fever, worsening condition, malaise, chest discomfort, edema, thermogenesis, 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, sweating, friction urticaria, eye pain, increased tear production, decreased vision, eye fatigue, weight loss, increased liver function tests, decreased platelet count, encephalitis, soft tissue inflammation, chronic hepatitis B, erectile dysfunction, menstrual disorders, sexual dysfunction, shortness of breath, nasal obstruction, orthostatic hypotension, peripheral coldness, musculoskeletal rigidity, myalgia, palpitations, oral injury, anemia, spontaneous abortion, bedridden, headache, seizures, hypersomnia, somnolence, tremors, insomnia, auditory hallucinations, asthenia, strange sensation, adverse drug reaction, vomiting, dyspepsia, rash, pruritus, muscle weakness, changes in mental state, anxiety, aggressive behavior, coma, decreased level of consciousness

This medication must be stored in a tightly closed container to protect it from air and moisture. The suitable storage temperature is between 1 to 30 degrees Celsius. Avoid storing in excessively hot or cold places.

Appearance

Green, biconvex, round film-coated tablet

Package unit

28 tablets (14 tablets/blister × 2)