Ferranel Tablet 10 mg (Perampanel (unpurified))

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 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, and 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 following action according to 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 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 most recent dose. ㆍIf treatment has been interrupted for 5 times the half-life or longer: Retitrate the dose from the initial dose. A period equivalent to 5 times the half-life is 3 weeks for patients not taking antiepileptic medicines that induce perampanel metabolism, and 1 week for those 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 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 clinical response and tolerability, as in 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 per day. Increase to a maintenance dose of 4mg to 8mg per day based on the patient's clinical response and tolerability; if needed, the dose may be increased to a maximum of 8mg per day. Adjunctive therapy for partial-onset seizures: Age 4 years and older — Start treatment with this medicine at 2mg per day. Increase to a maintenance dose of 4mg to 8mg per day based on the patient's clinical response and tolerability; if needed, the dose may be increased to a maximum of 12mg per day. Adjunctive therapy for primary generalized tonic-clonic seizures: Age 7 years and older — Start treatment with this medicine at 2mg per day. Increase to a maintenance dose of 8mg per day based on the patient's clinical response and tolerability; if needed, the dose may be increased to a maximum of 12mg per day.

This medication is used for the treatment of epilepsy and may increase the risk of suicidal thoughts or behaviors during treatment; therefore, the patient's mental state should be monitored closely. Changes in mental and behavioral state, such as aggression, anger, and irritability, may occur during or after discontinuation of treatment, and if such symptoms arise, immediate consultation with a physician is necessary. Patients with allergies to this medication or its components, or with lactose intolerance, should not take it. Elderly patients are at a higher risk for falls, and patients with a history of substance abuse should be monitored for signs of misuse of this medication. When taken in conjunction with other medications, interactions may occur, so dosage adjustments and monitoring are required, especially when used in combination with certain antiepileptic drugs. This medication may cause dizziness and drowsiness, so caution is advised when driving or operating hazardous machinery. Serious side effects, such as severe skin reactions and liver dysfunction, may occur; therefore, if symptoms like skin rash or fever arise, discontinue use immediately and consult medical personnel. Use during pregnancy is not recommended, and for breastfeeding mothers, the decision to use should consider the effects on the baby. This medication's safety and efficacy have not been established in certain age ranges for children; therefore, there are age-related usage restrictions. In case of overdose, there is no specific antidote; supportive treatment with monitoring of vital signs and symptoms in a hospital is necessary. Do not chew or crush the tablet; swallow it whole, keep it out of 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 disorders, diplopia, blurred vision, vertigo, nausea, drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), Stevens-Johnson syndrome (SJS), back pain, walking disorders, fatigue, weight gain, falls, memory impairment, cognitive impairment, flexibility, perceptual disturbances, head tremor, sedation, syncope, sensory deterioration, mental disturbances, excessive psychomotor activity, bradykinesia, cerebrovascular accident, reduced level of consciousness, attention deficit, postural dizziness, stupor, encephalopathy, epilepsy, generalized tonic-clonic seizure, hypotonia, myoclonus, cluster seizures, suicide attempts, confusion 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 thoughts, psychotic disorder, restlessness, schizophrenia, sleep seizures, fever, worsening condition, malaise, chest discomfort, edema, heat sensation, swelling, facial swelling, chill sensation, pain, peripheral edema, abdominal pain, diarrhea, abdominal discomfort, constipation, epigastric pain, oral ulcer formation, nausea, dry mouth, gastritis, excessive salivation, alopecia, urticaria, acne, cold sweat, friction urticaria, eye pain, increased tear secretion, visual impairment, eye fatigue, weight loss, elevated liver function tests, decreased 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 injury, anemia, spontaneous abortion, bedridden, headache, seizures, hypersomnia, drowsiness, tremor, insomnia, auditory hallucinations, weakness, strange sensations, adverse drug reactions, vomiting, indigestion, rash, pruritus, muscle weakness, changes in mental state, anxiety, aggressive behavior, coma, reduced level of consciousness

This medication should be stored in a closed container to protect it from air and moisture. It is also important to store the medication at room temperature, which should not be too hot or too cold, specifically between 1 to 30 degrees Celsius.

Appearance

Green round film-coated tablet

Package unit

30 tablets/bottle, 90 tablets/bottle