MEDICATION GUIDE

What is the most important information I should know about lacosamide tablets?

Do not stop taking lacosamide tablets without first talking to your healthcare provider. Stopping lacosamide tablets suddenly can cause serious problems. Stopping seizure medicine suddenly in a patient who has epilepsy can cause seizures that will not stop (status epilepticus).

Lacosamide tablets can cause serious side effects, including:

1. Like other antiepileptic drugs, lacosamide tablets may cause suicidal thoughts or actions in a very small number of people, about 1 in 500.

• thoughts about suicide or dying

• trouble sleeping (insomnia)

• attempt to commit suicide

• new or worse irritability

• new or worse depression

• acting aggressive, being angry, or violent

• new or worse anxiety

• acting on dangerous impulses

• feeling agitated or restless

• an extreme increase in activity and talking (mania)

• panic attacks

• other unusual changes in behavior or mood

• Pay attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings.
• Keep all follow-up visits with your healthcare provider as scheduled.
• Call your healthcare provider between visits as needed, especially if you are worried about symptoms.
• Suicidal thoughts or actions can be caused by things other than medicines. If you have suicidal thoughts or actions, your healthcare provider may check for other causes.

2. Lacosamide tablets may cause you to feel dizzy, have double vision, feel sleepy, or have problems with coordination and walking. Do not drive, operate heavy machinery, or do other dangerous activities until you know how lacosamide tablets affects you.

• have a fast, slow, or pounding heartbeat or feel your heart skip a beat

• feel lightheaded

• have shortness of breath

• fainted or if you feel like you are going to faint

• have chest pain

If you have fainted or feel like you are going to faint you should lay down with your legs raised.

What are lacosamide tablets?

Lacosamide tablets are a prescription medicine used in people 4 years of age and older:

• to treat partial-onset seizures.

It is not known if lacosamide tablets are safe and effective in children under 1 month of age.

Before you take lacosamide tablets, tell your healthcare provider about all of your medical conditions, including if you:

• have or have had depression, mood problems or suicidal thoughts or behavior.
• have heart problems.
• have kidney problems.
• have liver problems.
• have abused prescription medicines, street drugs or alcohol in the past.
• are pregnant or plan to become pregnant. It is not known if lacosamide tablets can harm your unborn baby. Tell your healthcare provider right away if you become pregnant while taking lacosamide tablets. You and your healthcare provider will decide if you should take lacosamide tablets while you are pregnant.

• If you become pregnant while taking lacosamide tablets, talk to your healthcare provider about registering with the North American Antiepileptic Drug Pregnancy Registry. You can enroll in this registry by calling 1-888-233-2334. The purpose of this registry is to collect information about the safety of antiepileptic medicine during pregnancy.

• are breastfeeding or plan to breastfeed. It is not known if lacosamide passes into your breast milk or if it can harm your baby. Talk to your healthcare provider about the best way to feed your baby if you take lacosamide tablets.

How should I take lacosamide tablets?

• Take lacosamide tablets exactly as your healthcare provider tells you.
• Your healthcare provider will tell you how much lacosamide tablets to take and when to take it.
• Your healthcare provider may change your dose if needed.
• Do not stop lacosamide tablets without first talking to a healthcare provider. Stopping lacosamide tablets suddenly in a patient who has epilepsy can cause seizures that will not stop (status epilepticus).
• Lacosamide tablets may be taken with or without food.
• Swallow lacosamide tablets whole with liquid. Do not cut lacosamide tablets.
• If you take too much lacosamide tablets, call your healthcare provider or local Poison Control Center right away.
  

What are the possible side effects of lacosamide tablets?

• See “What is the most important information I should know about lacosamide tablets?”

Lacosamide tablets may cause other serious side effects including:

• A serious allergic reaction that may affect your skin or other parts of your body such as your liver or blood cells. Call your healthcare provider right away if you have:
  

• a skin rash, hives

• swelling of the legs

• fever or swollen glands that do not go away o shortness of breath

• yellowing of the skin or whites of the eyes

• tiredness (fatigue)

• dark urine

• double vision

• nausea

• headache

• sleepiness

• dizziness

How should I store lacosamide tablets?

• Store lacosamide tablets at room temperature between 68ºF to 77ºF (20ºC to 25ºC).

General Information about the safe and effective use of lacosamide tablets.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use lacosamide tablets for a condition for which it was not prescribed. Do not give lacosamide tablets to other people, even if they have the same symptoms that you have. It may harm them.

What are the ingredients in lacosamide tablets?

Active ingredient: lacosamide, USP

Tablet inactive ingredients: colloidal silicon dioxide, crospovidone, hydroxypropylcellulose, magnesium stearate, microcrystalline cellulose and additional ingredients listed below:

• 50 mg tablets: FD&C Blue #2, iron oxide black, iron oxide red, macrogol, polyvinyl alcohol, talc and titanium dioxide
• 100 mg tablets: iron oxide yellow, macrogol, polyvinyl alcohol, talc and titanium dioxide
• 150 mg tablets: iron oxide red, iron oxide yellow, macrogol, polyvinyl alcohol, talc and titanium dioxide
• 200 mg tablets: FD&C Blue #2, macrogol, polyvinyl alcohol, talc and titanium dioxide

Additional pediatric use information is approved for UCB, Inc.’s VIMPAT ® (lacosamide) tablets. However, due to UCB, Inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.

For more information, go to www.avkare.com or call 1-855-361-3993.

Manufactured for:

AvKARE

Pulaski, TN 38478

Manufactured by:
Amneal Pharmaceuticals of New York, LLC
Brookhaven, NY 11719

Mfg. Rev. 03-2022-05 AV 05/22