Phacom Pa Film-Coated Tablets 8 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, partial-onset seizures: Age 4 years and older — Start 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, partial-onset seizures: Age 4 years and older — Start 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, primary generalized tonic-clonic seizures: Age 7 years and older — Start 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.

There is a risk of developing mental health issues such as suicidal thoughts, suicidal behaviors, and depression during the use of this drug, so patients and caregivers must carefully monitor for these symptoms. Changes in mental behavior such as aggression, anger, and irritability may occur, so if these changes are observed, a doctor should be consulted immediately. This drug should not be administered to patients with certain genetic disorders, such as lactase deficiency or galactose intolerance. Caution should be exercised in older adults due to an increased risk of falls, and patients with a history of substance abuse should be closely monitored for signs of misuse of this medication. Interactions may occur when taken with other medications, especially certain antiepileptic drugs, thus dose adjustment and monitoring are necessary. Abrupt discontinuation of this drug may result in seizure recurrence; therefore, it is safe to taper the dosage gradually as directed by a physician. Symptoms such as dizziness or drowsiness may occur, so care should be taken during potentially hazardous activities such as driving or operating machinery. Rarely, serious skin reactions or liver function abnormalities may occur, so if skin rash, systemic symptoms, or signs of liver dysfunction appear, immediate medical attention should be sought. Women who are pregnant or nursing should use this medication with caution, especially since contraceptive efficacy might be reduced, and additional non-hormonal contraception is recommended. Safety and effectiveness in children and the elderly have not been fully established, so caution should be used according to medical judgment. In case of overdose, there is no specific antidote, so go to the hospital immediately for appropriate treatment, and the tablets should be swallowed whole without chewing or crushing. Lastly, this medication should be kept out of the reach of children, and expired products should not be used; transferring to other containers is to be avoided.

suicidal impulse, suicidal behavior, depression, aggression, hostility, irritability, anger, homicidal impulse, threat, state of confusion, psychotic disorder, dizziness, drowsiness, ataxia, speech impairment, equilibrium disorder, diplopia, blurred vision, vertigo, nausea, drug reaction accompanied by eosinophilia and systemic symptoms (DRESS syndrome), Stevens-Johnson syndrome (SJS), back pain, walking disturbance, fatigue, weight gain, falls, memory impairment, cognitive impairment, flexibility, perceptual disturbances, head tremor, sedation, syncope, sensory loss, mental disorder, psychomotor agitation, bradykinesia, cerebrovascular accident, level of consciousness reduction, attention deficit, orthostatic dizziness, stupor, encephalopathy, epilepsy, generalized tonic-clonic seizures, hypotonia, focal muscle contractions, cluster seizures, suicide attempt, acute psychosis, hallucinations, change in mental state, sleep disorders, illusions, delirium, attention deficit hyperactivity disorder, bruxism, drug dependence, echolalia, visual hallucinations, mixed hallucinations, inappropriate affect, intermittent explosive disorder, restlessness, schizophrenia, sleep seizures, fever, worsening condition, malaise, chest discomfort, edema, heat sensation, swelling, facial swelling, sensation of cold, pain, peripheral swelling, abdominal pain, diarrhea, abdominal discomfort, constipation, epigastric pain, oral ulcer formation, nausea, dry mouth, gastritis, excessive salivation, alopecia, urticaria, acne, cold sweat, frictional urticaria, eye pain, increased tear production, diminished vision, eye fatigue, weight loss, elevated liver function tests, decreased platelet count, encephalitis, soft tissue infection, chronic hepatitis B, erectile dysfunction, menstrual disorders, sexual dysfunction, difficulty breathing, nasal obstruction, orthostatic hypotension, peripheral coldness, musculoskeletal rigidity, myalgia, palpitations, oral injuries, anemia, spontaneous abortion, bedridden, headache, seizures, hypersomnia, somnolence, tremors, insomnia, vomiting, indigestion, rash, pruritus, muscle weakness, change in mental state, anxiety, aggressive behavior, coma, level of consciousness reduction

This medication may be sensitive to air and moisture, so it should be stored in a tightly sealed container. It is recommended to maintain storage temperatures between 1 to 30 degrees Celsius. This helps to preserve the effectiveness and safety of the medication for a prolonged period.

Appearance

Purple, double convex, round film-coated tablet

Package unit

28 tablets (14 tablets/blister × 2)