Uses of Lacosamide Injection:

• It is used to treat seizures.

What do I need to tell my doctor BEFORE I take Lacosamide Injection?

• If you have an allergy to lacosamide or any other part of lacosamide injection.
• If you are allergic to lacosamide injection; any part of lacosamide injection; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have liver disease.

This is not a list of all drugs or health problems that interact with lacosamide injection.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take lacosamide injection with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Lacosamide Injection?

• Tell all of your health care providers that you take lacosamide injection. This includes your doctors, nurses, pharmacists, and dentists.
• Avoid driving and doing other tasks or actions that call for you to be alert until you see how lacosamide injection affects you.
• To lower the chance of feeling dizzy or passing out, rise slowly if you have been sitting or lying down. Be careful going up and down stairs.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• Talk with your doctor before you drink alcohol or use other drugs and natural products that slow your actions.
• Do not stop taking lacosamide injection all of a sudden without calling your doctor. You may have a greater risk of seizures. If you need to stop this drug, you will want to slowly stop it as ordered by your doctor.
• Abnormal heartbeats have happened with lacosamide injection. Rarely, this has led to severe heart problems and death. If you have questions, talk with the doctor.
• If you are 65 or older, use lacosamide injection with care. You could have more side effects.
• Tell your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding. You will need to talk about the benefits and risks to you and the baby.

How is this medicine (Lacosamide Injection) best taken?

Use lacosamide injection as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• It is given into a vein for a period of time.

What do I do if I miss a dose?

• Call your doctor to find out what to do.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Change in balance.
• Memory problems or loss.
• Very bad dizziness or passing out.
• Fast, slow, or abnormal heartbeat.
• Shakiness.
• Seeing double.
• Shortness of breath.
• Chest pain.
• A burning, numbness, or tingling feeling that is not normal.
• Not able to control eye movements.
• Patients who take lacosamide injection may be at a greater risk of having thoughts or actions of suicide. The risk may be greater in people who have had these thoughts or actions in the past. Call the doctor right away if signs like low mood (depression), nervousness, restlessness, grouchiness, panic attacks, or changes in mood or actions are new or worse. Call the doctor right away if any thoughts or actions of suicide occur.
• A very bad and sometimes deadly effect has happened in people taking drugs for seizures like lacosamide injection. Call your doctor right away if you have swollen glands; fever; rash; chest pain; unable to pass urine or change in the amount of urine passed; or signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.

What are some other side effects of Lacosamide Injection?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Feeling dizzy, sleepy, tired, or weak.
• Headache.
• Blurred eyesight.
• Upset stomach or throwing up.
• Diarrhea.
• Dry mouth.
• Sweating a lot.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If OVERDOSE is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Lacosamide Injection?

• If you need to store lacosamide injection at home, talk with your doctor, nurse, or pharmacist about how to store it.

Consumer Information Use and Disclaimer

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
• This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time lacosamide injection is refilled. If you have any questions about lacosamide injection, please talk with the doctor, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.