Faranell Tablets 8mg (Perampanel, Unrefined)

Adult dose

Take this medicine 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 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 (e.g., phenytoin, carbamazepine, 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: 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 less than 5 half-lives: Consider restarting treatment at the last dose administered. ㆍIf doses are missed for 5 or more consecutive half-lives: Retitrate the dose starting from the initial dose. A period equivalent to 5 half-lives is 3 weeks for patients not taking antiepileptic drugs that induce perampanel metabolism, and 1 week for patients 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. 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

1. Monotherapy 1) Partial-onset seizures: 4 years of age and older Treatment with this medicine is started at 2mg per day. Increase the dose to the maintenance dose of 4mg to 8mg per day according to the patient's clinical response and tolerability; if needed, the dose may be increased to a maximum of 8mg per day. 2. Adjunctive therapy 1) Partial-onset seizures: 4 years of age and older Treatment with this medicine is started at 2mg per day. Increase the dose to the maintenance dose of 4mg to 8mg per day according to the patient's clinical response and tolerability; if needed, the dose may be increased to a maximum of 12mg per day. 2) Primary generalized tonic-clonic seizures: 7 years of age and older Treatment with this medicine is started at 2mg per day. Increase the dose to the maintenance dose of 8mg per day according to the patient's clinical response and tolerability; if needed, the dose may be increased to a maximum of 12mg per day.

This medication may increase the risk of suicidal thoughts or behaviors, so careful monitoring for mood changes or unusual behaviors is necessary during use. Also, mental changes such as aggression, anger, or irritability may occur, and if such symptoms arise, immediate consultation with a physician is recommended. This medication should not be taken if there is an allergy to any of its components or if there are specific genetic disorders such as lactose intolerance. Elderly patients may be at increased risk of falls when taking this medication, so caution is needed, and patients with a history of substance abuse should closely monitor for signs of drug abuse. There may be interactions when taken with other medications, so dosage adjustments should be made per physician’s instructions, especially when taken with certain antiepileptic drugs. While on this medication, dizziness or drowsiness may occur, so it is advisable to avoid driving or operating hazardous machinery. If a severe rash or allergic reaction occurs, the medication should be discontinued immediately, and a physician should be consulted. Women who are pregnant or breastfeeding should consult a doctor before taking this medication, and fertile women are recommended to use reliable contraception.

suicidal ideation, suicidal behavior, depression, aggression, hostility, irritability, anger, homicidal ideation, threats, dizziness, drowsiness, ataxia, dysarthria, balance disorders, 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 disturbances, head tremor, sedation, syncope, sensory loss, mental disturbances, psychomotor agitation, bradykinesia, cerebrovascular accident, decreased level of consciousness, attention deficit, postural dizziness, delirious state, encephalopathy, epilepsy, generalized tonic-clonic seizure, hypotonia, myoclonic jerks, cluster seizures, suicide attempts, confusional state, 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, changes in mental state, negative thinking, psychotic disorder, restlessness, schizophrenia, sleep seizures, fever, deterioration of condition, malaise, chest discomfort, edema, warmth, swelling, facial swelling, cold sensation, pain, peripheral swelling, abdominal pain, diarrhea, abdominal discomfort, constipation, upper abdominal pain, oral ulcer formation, nausea, dry mouth, gastritis, hypersalivation, alopecia, urticaria, acne, cold sweats, friction urticaria, eye pain, increased tearing, decreased vision, eye strain, weight loss, elevated liver function tests, reduced 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, lying down, headache, seizures, hypersomnia, somnolence, tremor, insomnia, auditory hallucinations, asthenia, strange sensations, adverse drug reactions, vomiting, dyspepsia, rash, pruritus, muscle weakness, changes in mental state, anxiety, aggressive behavior, coma, decreased level of consciousness

This medication should be stored in a tightly sealed container, protected from light and air, at room temperature between 1 to 30 degrees Celsius. By storing it this way, the medication's efficacy can be maintained and deterioration prevented.

Appearance

Purple round film-coated tablet

Package unit

30 tablets/bottle, 90 tablets/bottle