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FycompaGeneric Name:? HYPERLINK "" perampanel?(per AM pa nel)Brand Names:?FycompaWhat is Fycompa?Fycompa (perampanel) is an anticonvulsant used to treat seizures in adults and?children?who are at least 12 years old.Fycompa is a prescription medicine that is used with other medications to?treat?partial-onset seizures?with or without secondarily generalized seizures, and to treat primary generalized tonic-clonic (PGTC) seizures, in adults and children who are at least 12 years old.Fycompa may also be used for purposes not listed in this medication guide.Important informationSome people taking Fycompa have had serious psychotic effects, especially when starting this medicine or changing doses. Stay alert to changes in your mood or?symptoms.Before taking this medicineYou should not use Fycompa if you are allergic to perampanel, or if you have severe liver disease.To make sure Fycompa is safe for you, tell your doctor if you have:liver disease;kidney disease;a history of depression or mental illness; ora history of alcoholism or drug addiction.Some people taking Fycompa have had serious psychotic effects such as anger, aggression, feeling hostile or irritable, and thoughts about hurting others. These effects may be more likely to occur when you first start taking Fycompa, or whenever your dose is changed. Your doctor should check your progress at regular visits. Your family or other caregivers should also be alert to changes in your mood or symptoms.Do not start or stop taking seizure medication during pregnancy without your doctor's advice.?Having a seizure during pregnancy could harm both mother and baby.?Tell your doctor right away if you become pregnant.Fycompa can make certain birth control pills less effective. Ask your doctor about using non-hormonal birth control (condom, diaphragm with spermicide) to prevent pregnancy while taking Fycompa.If you are pregnant, your name may be listed on a pregnancy registry. This is to track the outcome of the pregnancy and to evaluate any effects of Fycompa on the baby.It is not known whether perampanel passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this?medicine.Fycompa is not approved for use by anyone?younger?than 12 years old.How should I take Fycompa?Fycompa is usually taken at bedtime. Follow all directions on your prescription label. Your?doctor?may occasionally change your dose to make sure you get the best results. Do not use this medicine in larger or smaller amounts or for longer than recommended.Fycompa may be habit-forming.?Never share Fycompa with another person, especially someone with a history of drug abuse or addiction.?Keep the medication in a place where others cannot get to it. Selling or giving away this medicine is against the law.Shake the oral suspension (liquid) well just before you measure a dose. Measure liquid medicine with the dosing syringe provided, or with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.Do not stop using any other seizure medications suddenly, even if you feel fine. Stopping suddenly may cause increased seizures. Follow your doctor's instructions about tapering your dose.Store Fycompa at room temperature away from moisture and heat.Keep track of the amount of medicine used from each new bottle. Fycompa may be a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.Fycompa dosing informationUsual Adult Dose of Fycompa for Seizures:In the absence of enzyme inducing AEDs:Initial dose: 2 mg orally once daily at bedtime. Dosage may be increased by 2 mg orally daily in increments no more frequently than every week.Maintenance dose: 4 to 12 mg orally once daily at bedtimeMaximum dose: 12 mg orally once daily at bedtimeIn the presence of enzyme inducing AEDs (including phenytoin, carbamazepine, and oxcarbazepine):Initial dose: 4 mg orally once daily at bedtime. Patients should be monitored closely for response. Studies revealed a substantially reduced effect on seizure rates in these patients. When these enzyme-inducing AEDs are introduced or withdrawn from a treatment regimen, the patient should be monitored for clinical response and tolerability. Dose adjustment of perampanel may be necessary.Maximum dose: 12 mg orally once daily at bedtimeApproved indication: Adjunctive therapy for the treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy 12 years of age and older.Usual Pediatric Dose of Fycompa for Seizures:Greater than or equal to 12 years of age:In the absence of enzyme inducing AEDs: Initial dose: 2 mg orally once daily at bedtime. Dosage may be increased by 2 mg orally daily in increments no more frequently than every week. Maintenance dose: 4 to 12 mg orally once daily at bedtime Maximum dose: 12 mg orally once daily at bedtimeIn the presence of enzyme inducing AEDs (including phenytoin, carbamazepine, and oxcarbazepine): Initial dose: 4 mg orally once daily at bedtime. Patients should be monitored closely for response. Studies revealed a substantially reduced effect on seizure rates in these patients. When these enzyme-inducing AEDs are introduced or withdrawn from a treatment regimen, the patient should be monitored for clinical response and tolerability. Dose adjustment of perampanel may be necessary.Maximum dose: 12 mg orally once daily at bedtimeApproved indication: Adjunctive therapy for the treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy 12 years of age and older.What happens if I miss a dose?Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra?medicine?to make up the missed dose.Call your?doctor?for instructions if you miss your Fycompa dose for more than one day.What happens if I overdose?Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.What should I avoid while taking Fycompa?This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.Drinking alcohol can increase certain side effects of Fycompa.Fycompa side effectsGet emergency medical help if you have?signs of an allergic reaction to Fycompa:?hives; difficult breathing; swelling of your face, lips, tongue, or throat.Stop using Fycompa and call your doctor at once if you have a side effect such as:changes in mood, behavior, or personality;anger, aggression, anxiety, trouble sleeping, feeling hostile or irritable;talking more than usual;unusual thoughts, paranoid behavior, panic attacks;thoughts about suicide, or thoughts about hurting someone else;trouble walking, loss of balance or coordination;an accidental fall; orsevere dizziness, spinning sensation, feeling like you might pass out.Accidental falls may occur more often in elderly patients who take Fycompa. Use caution to avoid falling or accidental injury while taking this mon Fycompa side effects may include:dizziness, drowsiness;feeling anxious, tired, or irritable;nausea, vomiting, stomach pain;bruising;weight gain; orheadache, joint pain, back pain.This is not a complete list of side effects and others may occur. Call your doctor for medical?advice?about side effects. You may report side effects to FDA at 1-800-FDA-1088.What other drugs will affect Fycompa?Taking this medicine with other drugs that make you sleepy can worsen this effect. Ask your doctor before taking Fycompa with a sleeping pill, narcotic?pain?medicine, muscle relaxer, or medicine for anxiety or depression.Tell your doctor about all your current medicines and any you start or stop using, especially:birth control pills;rifampin;St. John's wort;other seizure medicine--carbamazepine, oxcarbazepine, phenytoin.This list is not complete. Other drugs may interact with perampanel, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.In Summary: Common side effects of Fycompa include:?dizziness, drowsiness, falling, hostility, equilibrium disturbance, abnormal gait, aggressive behavior, fatigue, ataxia, and irritability.?Other side effects include:anxiety, weight gain, blurred vision, vertigo, and back pain. See below for a comprehensive list of adverse effects.For the Consumer: Applies to perampanel: oral tabletIn addition to its needed effects, some unwanted effects may be caused by perampanel (the active ingredient contained in Fycompa). In the event that any of these side effects do occur, they may require medical attention.Major Side EffectsYou should check with your doctor immediately if any of these side effects occur when taking perampanel:More common:Aggression or angeranxietyclumsiness or unsteadinessdry mouthhyperventilationirregular heartbeatsirritabilityrestlessnessshakiness and unsteady walkshortness of breathsleepiness or unusual drowsinesstrouble sleepingunsteadiness, trembling, or other problems with muscle control or coordinationunusual tiredness or weaknessLess common:Abnormal or decreased touch sensationburning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelingsIncidence not known:Changes in behaviordepressionthoughts of killing oneselfMinor Side EffectsSome of the side effects that can occur with perampanel may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:More common:Dizziness or lightheadednessfeeling of constant movement of self or surroundingsheadachenauseasensation of spinningLess common:Back painbloating or swelling of the face, arms, hands, lower legs, or feetblurred visionbody aches or painbone painchanges in speech patternschillsconfusioncoughdecreased urine outputdifficulty having a?bowel movement?(stool)difficulty with movingdouble visionear congestionfast or irregular heartbeatfeverincreased thirstlack or loss of strengthloss of voicemuscle pain or crampsmuscle stiffnessnasal congestionnausea or vomitingpain in the arms or legspain in the jointsrunny noseslurred speechsneezingsore throattrouble rememberingtrouble with speakingunusual weight gain or lossunusually deep sleepIncidence not known:Unusual drowsiness, dullness, tiredness,?weakness, or feeling of ................
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