Lacosamide (By mouth)

Introduction

Lacosamide (la-KOE-sa-mide)

Used with other medicines to treat partial seizures in patients who have epilepsy.

Brand Name(s)

Vimpat

When This Medicine Should Not Be Used

How to Use This Medicine

Liquid, Tablet

• Your doctor will tell you how much of this medicine to use and how often. Your dose may need to be changed several times in order to find out what works best for you. Do not use more medicine or use it more often than your doctor tells you to.
• You may take this medicine with or without food.
• Measure the oral liquid medicine with a marked measuring spoon, oral syringe, or medicine cup.
• Lacosamide may be used together with other seizure medicines. Keep using all of your medicines unless your doctor tells you to stop.
• This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions. Ask your pharmacist for the Medication Guide if you do not have one.

If a dose is missed:

• If you miss a dose or forget to use your medicine, use it as soon as you can. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up for a missed dose.

How to Store and Dispose of This Medicine

• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Do not freeze the oral liquid. Throw away any unused medicine after 7 weeks of first opening the bottle.
• Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any outdated medicine or medicine no longer needed.
• Keep all medicine away from children and never share your medicine with anyone.

Drugs and Foods to Avoid

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

Warnings While Using This Medicine

• Make sure your doctor knows if you are pregnant or planning to become pregnant. Your doctor may want you to join the North American Antiepileptic Drug Pregnancy Registry and UCB AED Pregnancy Registry. These registries are used by pregnant patients who are taking this medicine.
• Make sure your doctor knows if you breastfeeding, or if you have kidney disease, liver disease, nerve problem (such as diabetic neuropathy), or a history of depression or mental illness. Tell your doctor if you also have heart problems such as heart attack, heart block, heart failure, or heart rhythm problems (such as prolonged PR interval, sick sinus syndrome).
• If you develop any unusual or strange thoughts and behavior while taking lacosamide, be sure to discuss it with your doctor. Some changes that have occurred in people taking this medicine are like those seen in people who drink too much alcohol. Other changes might be confusion, worsening of depression, hallucinations (seeing, hearing, or feeling things that are not there), suicidal thoughts, and unusual excitement, nervousness, or irritability.
• This medicine may make you dizzy, drowsy, clumsy, or trouble thinking or seeing clearly. Avoid driving, using machines, or doing anything else that could be dangerous if you are not alert, well-coordinated, or able to think or see well.
• This medicine can cause changes in heart rhythms, such as a condition called PR prolongation. It may change the way your heart beats and cause lightheadedness, fainting, or serious side effects in some patients. Contact your doctor right away if you have any symptoms of heart rhythm problems, such as fast, slow, or uneven heartbeats.
• Lacosamide may cause serious allergic reactions affecting multiple body organs, such as the liver or kidney. Stop using this medicine and check with your doctor right away if you have the following symptoms: fever; dark urine; headache; rash; stomach pain; swollen, painful, or tender lymph glands in the neck, armpit, or groin; tiredness; or yellow eyes or skin.
• The oral liquid contains aspartame (a source of phenylalanine). If you have phenylketonuria (PKU), talk to your doctor before using this medicine.
• This medicine may be habit-forming. If you feel that the medicine is not working as well, do not use more than your prescribed dose. Call your doctor for instructions.
• Do not stop using this medicine suddenly without asking your doctor. You may need to slowly decrease your dose before stopping it completely. Stopping the medicine suddenly may cause your seizures to return or to occur more often.
• Your doctor will need to check your progress at regular visits while you are using this medicine. Be sure to keep all appointments. Blood tests may be needed to check for unwanted effects.

Possible Side Effects While Using This Medicine

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Confusion, depression, unusual behavior, or thoughts of hurting yourself.
• Dark-colored urine or pale stools.
• Fast, slow, pounding, or uneven heartbeat.
• Fever, chills, cough, sore throat, and body aches.
• Lightheadedness, dizziness, or fainting.
• Nausea, vomiting, loss of appetite, or pain in your upper stomach.
• Problems with walking or balance control.
• Seizures.
• Shortness of breath.
• Sleepiness or unusual drowsiness.
• Tremors or muscle cramps.
• Uncontrolled eye movements.
• Unsteadiness (having a hard time standing up).
• Yellowing of your skin or the whites of your eyes.

If you notice these less serious side effects, talk with your doctor:

• Blurred or double vision.
• Diarrhea.
• Dry mouth.
• Feeling of constant movement of self or surroundings.
• Headache.
• Itching skin.
• Memory loss.
• Tiredness or weakness.
• Trouble concentrating.

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088