Pycompa Film-Coated Tablets 6 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 an antiepileptic drug, and the risk of suicidal thoughts or behavior may increase during treatment. Therefore, patients' mood and behavioral changes should be closely monitored. There may be aggressive or hostile behavior, anger, irritability, etc.; if these symptoms occur, it is essential to consult a doctor immediately. Patients with hypersensitivity to this medication or lactose intolerance should not take it. Older adults may have an increased risk of falls, so caution is needed, and patients with a history of substance abuse should be monitored for signs of abuse of this medication. When used in combination with other medications, the effectiveness may change due to interactions, so dosage adjustments may be necessary under the guidance of a physician. Dizziness or drowsiness may occur during treatment, so it is advisable to avoid engaging in hazardous activities such as driving or operating machinery. Severe adverse reactions such as serious skin reactions can occur, so if there are symptoms like a rash or fever, the medication should be stopped immediately, and a doctor should be informed. Pregnant or breastfeeding women should consult a doctor before taking this medication, and women of childbearing age are advised to use reliable contraception concurrently. In case of overdose, since there is no specific antidote, one should seek immediate medical attention for appropriate treatment. This medication should be swallowed whole and must not be chewed or divided. Keep out of reach of children, and do not use expired products.

suicidal thoughts, suicidal behavior, depression, aggression, hostility, irritability, anger, homicidal thoughts, threats, confusion, psychotic disorder, 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 impairment, flexibility, perceptual abnormalities, head tremor, sedation, fainting, sensory loss, mental disorders, hyperactivity, bradykinesia, cerebrovascular accident, level of consciousness decline, attention deficit, orthostatic dizziness, stupor, encephalopathy, epilepsy, generalized tonic-clonic seizure, hypotonia, focal myoclonus, cluster seizures, suicide attempt, acute psychosis, auditory hallucinations, altered mental state, sleep disorders, hallucinations, delirium, attention deficit hyperactivity disorder, bruxism, drug dependence, echolalia, visual hallucinations, mixed hallucinations, inappropriate affect, intermittent explosive disorder, restlessness, schizophrenia, sleep seizures, fever, exacerbation of condition, malaise, chest discomfort, edema, heat sensation, swelling, facial swelling, cold sensation, pain, peripheral swelling, abdominal pain, diarrhea, abdominal discomfort, constipation, upper abdominal pain, oral ulcer formation, nausea, dry mouth, gastritis, excessive salivation, alopecia, urticaria, acne, diaphoresis, friction urticaria, eye pain, increased tear production, vision impairment, eye fatigue, weight loss, elevated liver function tests, decreased platelet count, encephalitis, cellulitis, chronic hepatitis B, erectile dysfunction, menstrual disorders, sexual dysfunction, respiratory distress, nasal obstruction, orthostatic hypotension, peripheral coldness, musculoskeletal rigidity, myalgia, palpitations, oral injury, anemia, spontaneous abortion, bed rest, headache, seizures, hypersomnia, somnolence, tremor, insomnia, vomiting, dyspepsia, rash, pruritus, muscle weakness, altered mental state, anxiety, aggressive behavior, coma, level of consciousness decline

This medication can be sensitive to air and moisture, so it should be stored in a tightly sealed container. It is recommended to maintain room temperature between 1 and 30 degrees Celsius. This will help preserve the medication's effectiveness and safety for an extended period.

Appearance

Pink, double convex, round film-coated tablet

Package unit

28 tablets (14 tablets/blister × 2)