These highlights do not include all the information needed to use LACOSAMIDE TABLETS safely and effectively. See full prescribing information for LACOSAMIDE TABLETS. LACOSAMIDE tablets, for oral use, CV Initial U.S. Approval: 2008

1 INDICATIONS AND USAGE

Indications & Usage Section

2 DOSAGE AND ADMINISTRATION

Dosage & Administration Section

3 DOSAGE FORMS AND STRENGTHS

Dosage Forms & Strengths Section

Lacosamide tablets, USP 50 mg: light pink, oval, biconvex, film-coated tablets debossed with "918" on one side and plain on other side 100 mg: yellow, oval, biconvex, film-coated tablets debossed with "922" on one side and plain on other side 150 mg: orange, oval, biconvex, film-coated tablets debossed with "943" on one side and plain on other side 200 mg: blue, oval, biconvex, film-coated tablets debossed with "980" on one side and plain on other side

4 CONTRAINDICATIONS

Contraindications Section

None.

5 WARNINGS AND PRECAUTIONS

Warnings And Precautions Section

6 ADVERSE REACTIONS

Adverse Reactions Section

The following serious adverse reactions are described below and elsewhere in the labeling: Suicidal Behavior and Ideation [see Warnings and Precautions (5.1)] Dizziness and Ataxia [see Warnings and Precautions (5.2)] Cardiac Rhythm and Conduction Abnormalities [see Warnings and Precautions (5.3)] Syncope [see Warnings and Precautions (5.4)] Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan Hypersensitivity Reactions [see Warnings and Precautions (5.6)]

7 DRUG INTERACTIONS

Drug Interactions Section

8 USE IN SPECIFIC POPULATIONS

Use In Specific Populations Section

9 DRUG ABUSE AND DEPENDENCE

Drug Abuse And Dependence Section

10 OVERDOSAGE

Overdosage Section

Events reported after an intake of more than 800 mg (twice the maximum recommended daily dosage) of lacosamide include dizziness, nausea, and seizures (generalized tonic-clonic seizures, status epilepticus). Cardiac conduction disorders, confusion, decreased level of consciousness, cardiogenic shock, cardiac arrest, and coma have also been observed. Fatalities have occurred following lacosamide overdoses of several grams. There is no specific antidote for overdose with lacosamide. Standard decontamination procedures should be followed. General supportive care of the patient is indicated including monitoring of vital signs and observation of the clinical status of patient. A Certified Poison Control Center should be contacted for up to date information on the management of overdose with lacosamide. Standard hemodialysis procedures result in significant clearance of lacosamide (reduction of systemic exposure by 50% in 4 hours). Hemodialysis may be indicated based on the patient's clinical state or in patients with significant renal impairment.

11 DESCRIPTION

Description Section

The chemical name of lacosamide, USP, the single (R)-enantiomer, is (R)-2-acetamido-N-benzyl-3­-methoxypropionamide (IUPAC). Lacosamide, USP is a functionalized amino acid. Its molecular formula is C 13 H 18 N 2 O 3 and its molecular weight is 250.29. The chemical structure is: Lacosamide is a white to light yellow powder. It is sparingly soluble in water and slightly soluble in acetonitrile and ethanol.

12 CLINICAL PHARMACOLOGY

Clinical Pharmacology Section

13 NONCLINICAL TOXICOLOGY

Nonclinical Toxicology Section

14 CLINICAL STUDIES

Clinical Studies Section

16 HOW SUPPLIED/STORAGE AND HANDLING

How Supplied Section

17 PATIENT COUNSELING INFORMATION

Information For Patients Section

Advise the patient or caregiver to read the FDA-approved patient labeling (Medication Guide). Suicidal Thinking and Behavior Patients, their caregivers, and families should be counseled that AEDs, including lacosamide tablets, may increase the risk of suicidal thoughts and behavior and should be advised of the need to be alert for the emergence or worsening of symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts about self-harm. Behaviors of concern should be reported immediately to healthcare providers [see Warnings and Precautions (5.1)] . Dizziness and Ataxia Patients should be counseled that lacosamide tablets use may cause dizziness, double vision, abnormal coordination and balance, and somnolence. Patients taking lacosamide tablets should be advised not to drive, operate complex machinery, or engage in other hazardous activities until they have become accustomed to any such effects associated with lacosamide tablets [see Warnings and Precautions (5.2)] . Cardiac Rhythm and Conduction Abnormalities Patients should be counseled that lacosamide tablets are associated with electrocardiographic changes that may predispose to irregular heart beat and syncope. Cardiac arrest has been reported. This risk is increased in patients with underlying cardiovascular disease, with heart conduction problems, or who are taking other medications that affect the heart. Patients should be made aware of and report cardiac signs or symptoms to their healthcare provider right away. Patients who develop syncope should lay down with raised legs and contact their health care provider [see Warnings and Precautions (5.3)] . Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/ Multi-Organ Hypersensitivity Patients should be aware that lacosamide tablets may cause serious hypersensitivity reactions affecting multiple organs such as the liver and kidney. Lacosamide tablets should be discontinued if a serious hypersensitivity reaction is suspected. Patients should also be instructed to report promptly to their physicians any symptoms of liver toxicity (e.g., fatigue, jaundice, dark urine) [see Warnings and Precautions (5.6)] . Pregnancy Registry Advise patients to notify their healthcare provider if they become pregnant or intend to become pregnant during lacosamide tablets therapy. Encourage patients to enroll in the North American Antiepileptic Drug (NAAED) pregnancy registry if they become pregnant. This registry is collecting information about the safety of AEDs during pregnancy [see Use in Specific Populations (8.1)]. Lactation Advise breastfeeding women using lacosamide tablets to monitor infants for excess sleepiness and to seek medical care if they notice this sign [see Use in Specific Populations (8.2)]. Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 Manufactured by: Sun Pharmaceutical Industries Limited Survey No. 1012, Dadra-396 193, U.T. of D & NH and Daman & Diu, India.

MEDICATION GUIDE

SPL MEDGUIDE SECTION

Dispense with Medication Guide available at: https://www.sunpharma.com/usa/products MEDICATION GUIDE Lacosamide (la KOE sa mide) Tablets, USP, for oral use Read this Medication Guide before you start taking lacosamide tablets and each time you get a refill. There may be new information. This Medication Guide describes important safety information about lacosamide tablets. This information does not take the place of talking to your healthcare provider about your medical condition or treatment. 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. Call a healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you: thoughts about suicide or dying attempt to commit suicide new or worse depression new or worse anxiety feeling agitated or restless panic attacks trouble sleeping (insomnia) new or worse irritability acting aggressive, being angry, or violent acting on dangerous impulses an extreme increase in activity and talking (mania) other unusual changes in behavior or mood How can I watch for early symptoms of suicidal thoughts and actions? 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. 3. Lacosamide tablets may cause you to have an irregular heartbeat or may cause you to faint. In rare cases, cardiac arrest has been reported. Call your healthcare provider right away if you: have a fast, slow, or pounding heartbeat or feel your heart skip a beat have shortness of breath have chest pain feel lightheaded fainted or if you feel like you are going to faint If you have fainted or feel like you are going to faint you should lay down with your legs raised. 4. Lacosamide is a federally controlled substance (CV) because it can be abused or lead to drug dependence. Keep your lacosamide tablets in a safe place, to protect it from theft. Never give your lacosamide tablets to anyone else, because it may harm them. Selling or giving away this medicine is against the law. What are lacosamide tablets? Lacosamide tablets are a prescription medicine used: to treat partial-onset seizures in people 1 month of age and older. with other medicines to treat primary generalized tonic-clonic seizures in people 4 years of age and older. It is not known if lacosamide tablets are safe and effective for partial-onset seizures in children under 1 month of age or for primary generalized tonic-clonic seizures in children under 4 years of age. What should I tell my healthcare provider before taking lacosamide tablets? 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. Lacosamide passes into breast milk. o Breastfeeding during treatment with lacosamide tablets may cause your baby to have more sleepiness than normal. If this happens, contact your baby's healthcare provider. o Talk to your healthcare provider about the best way to feed your baby if you take lacosamide tablets. Tell your healthcare provider about all the medicines you take , including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking lacosamide tablets with certain other medicines may cause side effects or affect how well they work. Do not start or stop other medicines without talking to your healthcare provider. Know the medicines you take. Keep a list of them and show it to your healthcare provider and pharmacist each time you get a new medicine. How should I take lacosamide tablets? Take lacosamide tablets exactly as your healthcare provider tells you. Your healthcare provider will tell you how many 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 many lacosamide tablets, call your healthcare provider or local Poison Control Center right away. What should I avoid while taking lacosamide tablets? Do not drive, operate heavy machinery, or do other dangerous activities until you know how lacosamide tablets affects you. Lacosamide tablets may cause you to feel dizzy, have double vision, feel sleepy, or have problems with coordination and walking. 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 fever or swollen glands that do not go away shortness of breath tiredness (fatigue) swelling of the legs yellowing of the skin or whites of the eyes dark urine The most common side effects of lacosamide tablets include: double vision headache dizziness nausea sleepiness These are not all of the possible side effects of lacosamide tablets. For more information ask your healthcare provider or pharmacist. Tell your healthcare provider about any side effect that bothers you or that does not go away. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. How should I store lacosamide tablets? Store lacosamide tablets at 20°C to 25°C (68°F to 77°F). Lacosamide tablets come in a child-resistant package. Keep lacosamide tablets and all medicines out of the reach of children. 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 t...

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL- 50 mg

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 47335-918-86 Lacosamide Tablets, USP CV 50 mg PHARMACIST: Dispense with Medication Guide to each patient. Rx only 60 Tablets SUN PHARMA

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL- 100 mg

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 47335-922-86 Lacosamide Tablets, USP CV 100 mg PHARMACIST: Dispense with Medication Guide to each patient. Rx only 60 Tablets SUN PHARMA

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL- 150 mg

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 47335-943-86 Lacosamide Tablets, USP CV 150 mg PHARMACIST: Dispense with Medication Guide to each patient. Rx only 60 Tablets SUN PHARMA

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL- 200 mg

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 47335-980-86 Lacosamide Tablets, USP CV 200 mg PHARMACIST: Dispense with Medication Guide to each patient. Rx only 60 Tablets SUN PHARMA