Perampanel Tablets

What is this medication?

PERAMPANEL (per AM pa nel) prevents and controls seizures in people with epilepsy. It works by calming overactive nerves in your body.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): FYCOMPA

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Bipolar disorder
• Depression
• Frequently drink alcohol
• Kidney disease
• Liver disease
• Mental health conditions
• Substance use disorder
• Suicidal thoughts, plans, or attempt by you or a family member
• An unusual or allergic reaction to perampanel, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

Take this medication by mouth with a glass of water. Follow the directions on the prescription label. You can take it with or without food. If it upsets your stomach, take it with food. Take your medication at regular intervals. Do not take it more often than directed. Do not stop taking except on your care team's advice.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your care team about the use of this medication in children. While this medication may be prescribed for children as young as 4 years for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medication?

• Alcohol
• Benzodiazepines, such as alprazolam, diazepam, or lorazepam
• Certain antihistamines
• Certain medications for depression, such as amitriptyline or trazodone
• Certain medications for fungal infections, such as ketoconazole
• Certain medications for seizures, such as carbamazepine, eslicarbazepine, oxcarbazepine, phenobarbital, phenytoin, primidone, topiramate
• Levonorgestrel hormones
• Medications that cause drowsiness before a procedure, such as propofol
• Medications that help you fall asleep
• Medications that relax muscles
• Opioids for pain or cough
• Phenothiazines, such as chlorpromazine, prochlorperazine, thioridazine
• Rifampin
• St. John's Wort

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. Tell your care team if your symptoms do not start to get better or if they get worse.

This medication may cause serious skin reactions. They can happen weeks to months after starting the medication. Contact your care team right away if you notice fevers or flu-like symptoms with a rash. The rash may be red or purple and then turn into blisters or peeling of the skin. Or, you might notice a red rash with swelling of the face, lips or lymph nodes in your neck or under your arms.

Wear a medical ID bracelet or chain. Carry a card that describes your condition. List the medications and doses you take on the card.

It is important to take this medication exactly as directed. When first starting treatment, your dose will need to be adjusted slowly. It may take weeks or months before your dose is stable. You should contact your care team if your seizures get worse or if you have any new types of seizures. Do not stop taking this medication unless instructed by your care team. Stopping your medication suddenly can increase your seizures or their severity.

This medication may affect your coordination, reaction time, or judgment. Do not drive or operate machinery until you know how this medication affects you. Sit up or stand slowly to reduce the risk of dizzy or fainting spells. Drinking alcohol with this medication can increase the risk of these side effects.

Estrogen and/or progestin hormones may not work as well while you are taking this medication. If you are using this medication for contraception, talk to your care team about using a second type of contraception. A barrier contraceptive, such as a condom or diaphragm, is recommended.

Watch for new or worsening thoughts of suicide or depression. This includes sudden changes in mood, behaviors, or thoughts. These changes can happen at any time but are more common in the beginning of treatment or after a change in dose. Call your care team right away if you experience these thoughts or worsening depression.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Loss of balance or coordination
• Mood and behavior changes—anxiety, nervousness, confusion, hallucinations, irritability, hostility, thoughts of suicide or self-harm, worsening mood, feelings of depression
• Rash, fever, and swollen lymph nodes

Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):

• Dizziness
• Drowsiness
• Fatigue
• Headache
• Irritability
• Nausea
• Weight gain

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets. This medication can be abused. Keep it in a safe place to protect it from theft. Do not share it with anyone. It is only for you. Selling or giving away this medication is dangerous and against the law.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Get rid of any unused medication after the expiration date.

This medication may cause harm and death if it is taken by other adults, children, or pets. It is important to get rid of the medication as soon as you no longer need it or it is expired. You can do this in two ways:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put it in the trash, take the medication out of the container. Mix the medication with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.