Perampanel, Oral

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KEY POINTS

• This medicine is taken by mouth to treat certain types of seizures. Take it exactly as directed.
• This medicine may increase suicidal thoughts or actions in some people.
• Keep all appointments for tests to see how this medicine affects you.
• This medicine may cause unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: antiseizure

Generic and brand names: perampanel, oral; Fycompa

What is this medicine used for?

This medicine is taken by mouth to treat partial-onset seizures and primary generalized tonic-clonic seizures. This medicine is usually taken with other medicines.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• Depression, mood problems, or thoughts of suicide
• Kidney or liver problems
• Problems with alcohol or drug abuse

Females of childbearing age: Talk with your healthcare provider if you are pregnant or plan to become pregnant. It is not known whether this medicine will harm an unborn baby. This medicine can make hormonal birth control less effective. Ask your healthcare about using non-hormonal birth control (condom or diaphragm) while taking this medicine and for 1 month after you have stopped taking this medicine. Do not breast-feed while taking this medicine without your healthcare provider's approval.

How do I take it?

Read the Medication Guide that comes in the medicine package when you start taking this medicine and each time you get a refill.

Check the label on the medicine for directions about your specific dose. This medicine may be habit-forming. Take it exactly as directed by your healthcare provider. Do not take more of it or take it more often than directed. Taking too much of this medicine will increase the chances of side effects. Do not stop taking this medicine without your healthcare provider's approval. You may have to gradually reduce your dosage. Seizures may get worse if you suddenly stop taking this medicine.

Check with your healthcare provider before using this medicine in children under age 12.

This medicine is available in tablets and a liquid. If you have the liquid form of this medicine, shake it well before measuring a dose. Use the measuring spoon, cup, dropper, or oral syringe that comes with the medicine, or ask your pharmacist for one. Do not use a kitchen spoon because the dose may not be correct.

This medicine may make you sleepy. It is usually taken at bedtime. You may take this medicine with or without food.

What if I miss a dose?

If you miss a dose, skip the missed dose and take the next one as directed. Do not take double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose may include: dizziness, drowsiness, irregular heartbeat, problems with coordination, confusion, increased seizures, or feeling hostile or agitated.

What should I watch out for?

Antiseizure medicines may increase suicidal thoughts or actions in some people. Call your healthcare provider right away if you or your family notices any disturbing changes in your thoughts or behavior, such as:

• New or worse aggressive behavior, hostility, anger, or irritability
• Confusion
• Hallucinations
• New or worsening depression or suicidal thoughts

This medicine may make you dizzy or cause balance problems and increase your risk of falling.

This medicine may make you dizzy or drowsy. Do not drive or operate machinery until you are fully alert.

Alcohol and other medicines that slow down your nervous system may add to your side effects. Do not drink alcohol while you are taking this medicine without your healthcare provider's approval.

Adults over the age of 65 may be at greater risk for side effects. Talk with your healthcare provider about this.

This medicine is a controlled substance. It is illegal for you to give it to anyone else. This medicine may cause seizures that do not stop in people who do not have a seizure disorder.

You may need to have blood tests regularly to see how this medicine affects you. Keep all appointments for these tests.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine. Carry some form of identification stating that you have seizures and are taking this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): Increase in the number of seizures; fast or irregular heartbeat; unusual weakness; severe drowsiness, dizziness, fainting, or falls; trouble talking or walking; problems with balance; severe confusion; vision changes; new or worsening depression; thoughts of suicide; unusual nervousness or agitation; unusual mood or behavior changes; hallucinations; trouble concentrating or memory problems; trouble sleeping; numbness or tingling in hands or feet.

Other: Dizziness, drowsiness, headache, stomach or back pain, weight gain, nausea, vomiting, constipation.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Antianxiety medicines such as alprazolam (Xanax), clonazepam (Klonopin), clorazepate (Gen-Xene, Tranxene), diazepam (Valium), lorazepam (Ativan), and oxazepam
• Antibiotics such as clarithromycin (Biaxin), erythromycin (E.E.S., Ery-Tab, Erythrocin), nafcillin, rifabutin (Mycobutin), rifampin (Rifadin), rifapentine (Priftin), and telithromycin (Ketek)
• Antidepressants such as amitriptyline, duloxetine (Cymbalta), fluoxetine (Prozac), fluvoxamine (Luvox), imipramine (Tofranil), nefazodone, nortriptyline (Pamelor), sertraline (Zoloft), trazodone, and venlafaxine (Effexor)
• Antifungal medicines such as itraconazole (Sporanox), ketoconazole (Nizoral), posaconazole (Noxafil), and voriconazole (Vfend)
• Antihistamines such as chlorpheniramine (Chlor-Trimeton), diphenhydramine (Benadryl), hydroxyzine (Vistaril), and meclizine (Dramamine)
• Antipsychotic medicines such as chlorpromazine, fluphenazine, olanzapine (Zyprexa), perphenazine, thioridazine, and trifluoperazine
• Antiseizure medicines such as carbamazepine (Carbatrol, Epitol, Equetro, Tegretol), eslicarbazepine (Aptiom), lamotrigine (Lamictal), oxcarbazepine (Trileptal), phenobarbital, phenytoin (Dilantin, Phenytek), primidone (Mysoline), and topiramate (Qudexy, Topamax, Trokendi)
• Antiviral medicines such as ombitasvir/paritaprevir/ritonavir/dasabuvir (Viekira) and ombitasvir/paritaprevir/ritonavir (Technivie)
• Barbiturates such as butabarbital (Butisol), pentobarbital (Nembutal), phenobarbital, and secobarbital (Seconal)
• Bosentan (Tracleer)
• Cancer medicines such as ceritinib (Zykadia), enzalutamide (Xtandi), idelalisib (Zydelig), and mitotane (Lysodren)
• Doxepin (Silenor)
• Flibanserin (Addyi)
• HIV medicines such as atazanavir (Reyataz), cobicistat (Tybost), darunavir (Prezista), delavirdine (Rescriptor), efavirenz (Sustiva), etravirine (Intelence), fosamprenavir (Lexiva), indinavir (Crixivan), lopinavir/ritonavir (Kaletra), nelfinavir (Viracept), ritonavir (Norvir), and saquinavir (Invirase)
• Hormonal birth control implants, IUDs, patches, pills, shots, and vaginal rings (Talk to your healthcare provider if you need birth control.)
• Lumacaftor/ivacaftor (Orkambi)
• Mefloquine
• Mifepristone (Korlym, Mifeprex)
• Muscle relaxants such as baclofen (Gablofen, Lioresal), carisoprodol (Soma), cyclobenzaprine (Amrix), methocarbamol (Robaxin), and tizanidine (Zanaflex)
• Narcotic pain medicines such as codeine, fentanyl (Abstral, Actiq, Duragesic, Fentora, Sublimaze), hydromorphone (Dilaudid, Exalgo), meperidine (Demerol), methadone (Dolophine, Methadose), morphine (Kadian, MS Contin), and oxycodone (OxyContin, Roxicodone)
• Natural remedies such as ginkgo, gotu kola, kava, St. John's wort, and valerian
• Nausea medicines such as prochlorperazine (Compro) and promethazine
• Orlistat (alli, Xenical)
• Paroxetine (Brisdelle, Paxil, Pexeva)
• Sleeping pills such as eszopiclone (Lunesta), flurazepam, suvorexant (Belsomra), temazepam (Restoril), triazolam (Halcion), zaleplon (Sonata), and zolpidem (Ambien, Edluar, Intermezzo)
• Stimulants such as armodafinil (Nuvigil) and modafinil (Provigil)

Do not drink alcohol while you are taking this medicine without your healthcare provider's approval.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and bright light. Do not let it freeze. Discard any unused liquid medicine 90 days after opening the bottle.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.