IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

LACOSAMIDE - ORAL

(la-KOE-sa-mide)

COMMON BRAND NAME(S): Vimpat

USES: Lacosamide is used to prevent and control seizures. It is an anticonvulsant or antiepileptic drug. It works by reducing the spread of seizure activity in the brain.

HOW TO USE: Read the Medication Guide provided by your pharmacist before you start taking lacosamide and each time you get a refill. If you have any questions, consult your doctor or pharmacist. Take this medication by mouth as directed by your doctor, usually twice a day with or without food. If you are using the liquid form of this medication, carefully measure the dose using a special measuring device/spoon. Do not use a household spoon because you may not get the correct dose. Dosage is based on your medical condition and response to treatment. To reduce your risk of side effects, your doctor may direct you to start this medication at a low dose and gradually increase your dose. Follow your doctor's instructions carefully. This medication works best when the amount of drug in your body is kept at a constant level. Therefore, take this drug at evenly spaced intervals. To help you remember, take it at the same times each day. Do not stop taking this medication without consulting your doctor. Seizures may become worse when the drug is suddenly stopped. Your dose may need to be gradually decreased. Consult your doctor or pharmacist for more details. Though it is very unlikely to occur, this medication can result in abnormal drug-seeking behavior (addiction/habit-forming). Do not increase your dose, take it more frequently, or use it for a longer period of time than prescribed. Properly stop this medication when so directed. This will lessen the chances of becoming addicted. Tell your doctor immediately if your seizure control worsens (such as the number of seizures increases).

SIDE EFFECTS: Dizziness, drowsiness, blurred/double vision, nausea, vomiting, tiredness, loss of balance, difficulty walking, shakiness (tremor), or memory problems may occur. These side effects are more common when you first start taking the drug and usually lessen as your body adjusts to the medication. If any of these effects persist or worsen, notify your doctor or pharmacist promptly. Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Seek immediate medical attention if any of these rare but serious side effects occur: fast/slow/pounding heartbeat, shortness of breath, severe dizziness, fainting. A small number of people who take anticonvulsants for any condition (such as seizure, bipolar disorder, pain) may experience depression, suicidal thoughts/attempts, or other mental/mood problems. Tell your doctor immediately if you or your family/caregiver notice any unusual/sudden changes in your mood, thoughts, or behavior including signs of depression, suicidal thoughts/attempts, thoughts about harming yourself. This medication may rarely cause a serious immune system problem (Drug Reaction with Eosinophilia and Systemic Symptoms). Tell your doctor immediately if you experience any of these unlikely but serious side effects: unusual fever, swollen glands, yellowing skin/eyes, unusual tiredness, dark urine, severe stomach/abdominal pain, change in amount of urine, side/back pain (flank pain), bloody/pink urine, chest pain. A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking lacosamide, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: heart problems (such as chest pain, sick sinus syndrome, heart failure, AV block), liver problems, kidney problems (including dialysis treatment), mental/mood problems (such as depression, psychosis). This drug may make you dizzy/drowsy or cause blurred vision. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Avoid alcoholic beverages. The liquid form of this medication may contain aspartame. If you have phenylketonuria (PKU) or any other condition that requires you to limit/avoid aspartame (or phenylalanine) in your diet, ask your doctor or pharmacist about using this medication safely. Before having surgery, tell your doctors or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. It is not known whether this drug passes into breast milk and the effect on a nursing infant is unknown. Discuss the risks and benefits with your doctor before breast-feeding.

DRUG INTERACTIONS: Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first. Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: drugs that can slow the heart rate (such as digoxin, beta blockers including propranolol/metoprolol). Tell your doctor or pharmacist if you are taking other products that cause drowsiness including alcohol, antihistamines (such as cetirizine, diphenhydramine), drugs for sleep or anxiety (such as alprazolam, diazepam, zolpidem), muscle relaxants, and narcotic pain relievers (such as codeine). Check the labels on all your medicines (such as cough-and-cold products) because they may contain drowsiness-causing ingredients. Ask your pharmacist about using those products safely. This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: severe nausea/vomiting, difficulty waking up, very slow breathing.

NOTES: Do not share this medication with others. It is against the law. Laboratory and/or medical tests (such as liver/kidney tests, EKG) may be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store at room temperature between 68-77 degrees F (20-25 degrees C) away from light and moisture. Brief storage between 59-86 degrees F (15-30 degrees C) is permitted. Do not freeze. Do not store in the bathroom. Keep all medications away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. The liquid form should be used/discarded within 7 weeks after opening. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-800-854-1166 (USA) or 1-800-668-1507 (Canada).

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