cenobamate 250 mg/day (150 mg x 1 and 100 mg x 1) tablets

Generic name:
Cenobamate - oral

Pronunciation
(SEN-oh-BAM-ate)

Brand name(s)
Xcopri

This medication is used to treat a certain type of seizure disorder (partial onset). It is not known exactly how it works, but it may affect the action of some nerves that cause seizures.

Read the Medication Guide provided by your pharmacist before you start taking cenobamate and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth with or without food as directed by your doctor, usually once daily. The dosage is based on your medical condition and response to treatment.

If needed, you may also crush the tablet(s). Mix the crushed tablet(s) with water (1 ounce or 25 milliliters) in a cup. Swirl to mix and drink the suspension right away. Refill the cup with more water (1 ounce or 25 milliliters) and drink the mixture to make sure you are getting the whole dose. Repeat until there are no more tablet pieces left in the cup. Do not save the mixture for future use.

If you are giving this medication through a feeding tube, ask your health care professional for detailed instructions on how to properly mix and give it.

To reduce your risk of side effects, your doctor may direct you to start this medication at a low dose and gradually increase your dose. Follow your doctor's instructions carefully.

Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day.

Do not stop taking this medication without consulting your doctor. Some conditions (such as seizure) may become worse when this drug is suddenly stopped. Also, suddenly stopping this medication may cause withdrawal, especially if you have used it for a long time or in high doses. To prevent withdrawal, your doctor may lower your dose slowly over at least 2 weeks. Tell your doctor or pharmacist right away if you have any withdrawal symptoms such as decreased appetite or mental/mood changes such as depression, loss of memory, trouble sleeping.

Though it helps many people, this medication may sometimes cause addiction. This risk may be higher if you have a substance use disorder (such as overuse of or addiction to drugs/alcohol). Take this medication exactly as prescribed to lower the risk of addiction. Ask your doctor or pharmacist for more details.

Keep this medicine in a safe place to prevent theft, misuse, or abuse.

Tell your doctor if your condition does not get better or if it gets worse.

Drowsiness, dizziness, tiredness, nausea, vomiting, constipation, decreased appetite, diarrhea, or weakness may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including:

• problems with walking/balance
• problems with coordination
• vision changes (such as blurred vision, double vision, decreased vision)
• feeling of spinning (vertigo)
• trouble reading/speaking/writing
• signs of liver disease (such as nausea/vomiting that doesn't stop, stomach/abdominal pain, yellowing eyes/skin, dark urine)

Get medical help right away if you have any very serious side effects, including:

• fast/irregular heartbeat
• severe dizziness
• fainting

A small number of people who take anticonvulsants for any condition (such as seizure, bipolar disorder, pain) may experience depression, suicidal thoughts/attempts, or other mental/mood problems. Tell your doctor right away if you or your family/caregiver notice any unusual/sudden changes in your mood, thoughts, or behavior such as problems thinking clearly or paying attention, slowed thinking, confusion, memory problems, signs of depression, suicidal thoughts/attempts, thoughts about harming yourself.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• fever
• swollen lymph nodes
• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before taking cenobamate, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• kidney problems
• liver problems
• mental/mood disorders (such as confusion, depression, thoughts of suicide)
• substance use disorder (such as overuse of or addiction to drugs/alcohol)

Cenobamate may cause a condition that affects the heart rhythm (QT shortening). QT shortening can rarely cause serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away.

The risk of QT shortening may be increased if you have certain medical conditions or are taking other drugs that may cause QT shortening. Before using cenobamate, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions:

• certain heart problems (irregular heartbeat, QT shortening in the EKG)
• family history of certain heart problems (QT shortening in the EKG, sudden cardiac death)

This drug may make you dizzy or drowsy or cause blurred vision. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness or clear vision until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. However, since untreated seizures are a serious condition that can harm both a pregnant woman and her unborn baby, do not stop taking this medication unless directed by your doctor. If you are planning pregnancy, become pregnant, or think you may be pregnant, discuss with your doctor right away the benefits and risks of using this medication during pregnancy. Since birth control pills, patches, implants, and injections may not work if used with this medication (see also Drug Interactions section), discuss reliable forms of birth control with your doctor.

It is unknown if this medication passes into breast milk. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Cenobamate can speed up the removal of other drugs from your body, which may affect how they work. Examples of affected drugs include asunaprevir, elacestrant, lonafarnib, mavacamten, ombitasvir/paritaprevir/ritonavir, quizartinib, revumenib, among others.

This medication may decrease the effectiveness of hormonal birth control such as pills, patch, or ring. This could cause pregnancy. Discuss with your doctor or pharmacist if you should use reliable backup birth control methods while taking this medication. Also tell your doctor if you have any new spotting or breakthrough bleeding, because these may be signs that your birth control is not working well.

Tell your doctor or pharmacist if you are using other products that cause drowsiness such as opioid pain or cough relievers (such as codeine, hydrocodone), alcohol, marijuana (cannabis), drugs for sleep or anxiety (such as alprazolam, lorazepam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), or antihistamines (such as cetirizine, diphenhydramine).

Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Do not share this medication with others. Sharing it is against the law.

Lab and/or medical tests (such as liver function, potassium blood level) may be done while you are taking this medication. Keep all medical and lab appointments.

It is important to take each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule. Do not double the dose to catch up.

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.