Lacosamide (oral/injection)

Lacosamide is used to treat partial onset seizures in adults and children who are at least 1 month old.

Lacosamide is also used to treat primary generalized tonic-clonic seizures in adults and children who are at least 4 years old.

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

Do not stop using lacosamide suddenly or you may have increased seizures.

Some people have thoughts about suicide while taking lacosamide. Tell your doctor right away if you have any sudden changes in mood or behavior, or thoughts about suicide.

You may feel faint while using lacosamide. Call your doctor right away if you have fast or pounding heartbeats, shortness of breath, and sudden dizziness.

You should not use lacosamide if you are allergic to it.

Tell your doctor if you have ever had:

• heart problems;
• depression, a mood disorder, suicidal thoughts or actions;
• drug or alcohol addiction;
• nerve problems caused by diabetes;
• kidney disease; or
• liver disease.

Lacosamide oral solution may contain phenylalanine. Tell your doctor if you have phenylketonuria (PKU).

Some people have thoughts about suicide while using lacosamide. 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 using 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.

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

Ask a doctor before using this medicine if you are breastfeeding. Tell your doctor if you notice severe drowsiness in the nursing baby.

Get emergency medical help if you have signs of an allergic reaction: hives, trouble 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: changes in mood or behavior, depression, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), or have thoughts about suicide or hurting yourself.

Lacosamide may cause serious side effects. Call your doctor right away if you have:

• a light-headed feeling, like you might faint;
• severe dizziness;
• problems with balance or muscle movement;
• chest pain, shortness of breath;
• fast or pounding heartbeats;
• dark urine; or
• very slow heartbeats.

Common side effects of lacosamide may include:

• headache, dizziness;
• drowsiness;
• double vision; or
• nausea.

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.

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.

Lacosamide oral is taken by mouth. Lacosamide injection is given as an infusion into a vein. A healthcare provider will give you this injection if you are unable to take the medicine by mouth.

Doses are based on weight in children. Your child's dose may change if the child gains or loses weight.

Lacosamide may be habit-forming. Misuse can cause addiction, overdose, or death. Keep the medication in a place where others cannot get to it. Selling or giving away lacosamide is against the law.

Lacosamide tablets or oral solution can be taken with or without food.

Swallow the tablet/capsule whole and do not crush, chew, or break it.

Measure the oral solution with the supplied measuring device (not a kitchen spoon).

Call your doctor if your seizures get worse or you have them more often while using lacosamide.

Seizures may increase if you stop using lacosamide suddenly. Ask your doctor before stopping the medicine.

Wear a medical alert tag or carry an ID card to let others know you use lacosamide.

Store at room temperature away from moisture and heat. Do not freeze the liquid form of lacosamide. Throw away any oral solution not used within 7 weeks after opening the bottle.

Keep track of your medicine. You should be aware if anyone is using it improperly or without a prescription.

Use the medicine as soon as you can, but skip the missed dose if it is close to the time for your next dose. Do not use two doses at the same time.

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

Avoid driving or hazardous activity until you know how lacosamide will affect you. Your reactions could be impaired.

Drinking alcohol with this medicine can cause side effects such as drowsiness and dizziness.

Tell your doctor about all your other medicines, especially:

• heart or blood pressure medication.

This list is not complete. Other drugs may affect lacosamide, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.