Xcopri Titration Pack

Cenobamate is used to treat partial-onset seizures in adults.

Cenobamate may also be used for purposes not listed in this medication guide.

You should not use cenobamate if you are allergic to it, or if you have:

• a genetic heart rhythm disorder called short QT syndrome.

Tell your doctor if you have ever had:

• depression, or a mood disorder;
• suicidal thoughts or actions;
• liver or kidney disease;
• a blood cell disorder; or
• an allergic reaction to a medicine that caused a rash or affected your internal organs or blood cells.

Some people have thoughts about suicide while taking cenobamate. Your doctor will need to 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.

Cenobamate can make birth control pills less effective. Ask your doctor about using a non-oral birth control to prevent pregnancy. This includes injections, implants, skin patches, vaginal rings, condom, diaphragm, cervical cap, or contraceptive sponge.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of cenobamate on the baby.

It may not be safe to breastfeed while using this medicine. Ask your doctor about any risk.

Cenobamate is not approved for use by anyone younger than 18 years old.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

You may take cenobamate with or without food.

Swallow the tablet whole with liquid. Do not crush, chew, or break the tablet.

Do not stop using cenobamate suddenly, even if you feel fine. Stopping suddenly may cause increased seizures or unpleasant withdrawal symptoms. Follow your doctor's instructions about tapering your dose.

Store at room temperature away from moisture and heat.

Call your doctor for instructions if you miss a dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

This medicine may cause blurred vision and may impair your reactions. Avoid driving or hazardous activity until you know how this medicine will affect you.

Drinking alcohol with this medicine can cause side effects.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include: skin rash, fever, swollen glands, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes.

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

Cenobamate can cause serious or life-threatening allergic reactions that can affect your liver, blood cells, or other parts of the body. Call your doctor or get emergency medical help if you have symptoms such as:

• fast or pounding heartbeats, fluttering in your chest, and sudden dizziness (like you might pass out);
• feeling very weak or tired;
• severe muscle pain;
• fever, swollen glands, sore throat;unusual bruising or bleeding;
• painful sores in your mouth or around your eyes;
• swelling in your face, mouth, or throat;
• trouble breathing or swallowing;
• hives or a rash;
• yellowing of your skin or eyes;
• any infection or illness that does not get better; or
• nervous system problems--dizziness, trouble walking, loss of coordination, vision problems, drowsiness, tiredness, problems with thinking or memory.

Common side effects may include:

• feeling tired;
• dizziness, drowsiness;
• double vision; or
• headache.

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.

Tell your doctor about all your other seizure medications.

Using cenobamate with other drugs that make you dizzy or drowsy can worsen this effect. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety.

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Other drugs may affect cenobamate, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Your pharmacist can provide more information about cenobamate.