Before prescribing felbamate tablets, the physician should be thoroughly familiar with the details of this prescribing information.

FELBAMATE SHOULD NOT BE USED BY PATIENTS UNTIL THERE HAS BEEN A COMPLETE DISCUSSION OF THE RISKS AND THE PATIENT, PARENT, OR GUARDIAN HAS BEEN PROVIDED THE FELBAMATE WRITTEN ACKNOWLEDGMENT (SEE PATIENT/PHYSICIAN ACKNOWLEDGMENT FORM).

DESCRIPTION

Felbamate is an antiepileptic available as 400 mg and 600 mg tablets for oral administration. Its chemical name is 2-phenyl-1,3-propanediol dicarbamate.

Felbamate, USP is white to off-white powder. It is freely soluble in dimethyl sulfoxide, sparingly soluble in methanol, slightly soluble in acetonitrile and very slightly soluble in water.

Felbamate's molecular weight is 238.24, its molecular formula is C11H14N2O4 and its structural formula is:

Each felbamate tablet, USP contains felbamate, USP 400 mg or 600 mg and following inactive ingredients: colloidal silicon dioxide, ferric oxide yellow, FD & C red no. 40 aluminum lake, lactose monohydrate, microcrystalline cellulose, magnesium stearate, povidone K 30, pregelatinised starch (botanical source: corn) and sodium starch glycolate type A (botanical source: potato). Apart from this felbamate tablets USP, 600 mg also contain D & C yellow no. 10 aluminum lake.

CLINICAL PHARMACOLOGY

CLINICAL STUDIES

The results of controlled clinical trials established the efficacy of felbamate as monotherapy and adjunctive therapy in adults with partial-onset seizures with or without secondary generalization and in partial and generalized seizures associated with Lennox-Gastaut syndrome in children.

INDICATIONS AND USAGE

Felbamate tablets, USP are not indicated as a first line antiepileptic treatment (see Warnings). Felbamate tablets, USP are recommended for use only in those patients who respond inadequately to alternative treatments and whose epilepsy is so severe that a substantial risk of aplastic anemia and/or liver failure is deemed acceptable in light of the benefits conferred by its use.

If these criteria are met and the patient has been fully advised of the risk, and has provided written acknowledgment, felbamate can be considered for either monotherapy or adjunctive therapy in the treatment of partial seizures, with and without generalization, in adults with epilepsy and as adjunctive therapy in the treatment of partial and generalized seizures associated with Lennox-Gastaut syndrome in children.

CONTRAINDICATIONS

Felbamate is contraindicated in patients with known hypersensitivity to felbamate, its ingredients, or known sensitivity to other carbamates. It should not be used in patients with a history of any blood dyscrasia or hepatic dysfunction.

WARNINGS

See Boxed Warning regarding aplastic anemia and hepatic failure.

Antiepileptic drugs should not be suddenly discontinued because of the possibility of increasing seizure frequency.

PRECAUTIONS

ADVERSE REACTIONS

To report SUSPECTED ADVERSE REACTIONS, contact Viona Pharmaceuticals Inc. at 1-888-304-5011 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

The most common adverse reactions seen in association with felbamate in adults during monotherapy are anorexia, vomiting, insomnia, nausea, and headache. The most common adverse reactions seen in association with felbamate in adults during adjunctive therapy are anorexia, vomiting, insomnia, nausea, dizziness, somnolence, and headache.

The most common adverse reactions seen in association with felbamate in children during adjunctive therapy are anorexia, vomiting, insomnia, headache, and somnolence.

The dropout rate because of adverse experiences or intercurrent illnesses among adult felbamate patients was 12 percent (120/977). The dropout rate because of adverse experiences or intercurrent illnesses among pediatric felbamate patients was six percent (22/357). In adults, the body systems associated with causing these withdrawals in order of frequency were: digestive (4.3%), psychological (2.2%), whole body (1.7%), neurological (1.5%), and dermatological (1.5%). In children, the body systems associated with causing these withdrawals in order of frequency were: digestive (1.7%), neurological (1.4%), dermatological (1.4%), psychological (1.1%), and whole body (1%). In adults, specific events with an incidence of 1% or greater associated with causing these withdrawals, in order of frequency were: anorexia (1.6%), nausea (1.4%), rash (1.2%), and weight decrease (1.1%). In children, specific events with an incidence of 1% or greater associated with causing these withdrawals, in order of frequency was rash (1.1%).

Incidence in Clinical Trials:

The prescriber should be aware that the figures cited in the following table cannot be used to predict the incidence of side effects in the course of usual medical practice where patient characteristics and other factors differ from those which prevailed in the clinical trials. Similarly, the cited frequencies cannot be compared with figures obtained from other clinical investigations involving different investigators, treatments, and uses including the use of felbamate (felbamate) as adjunctive therapy where the incidence of adverse events may be higher due to drug interactions. The cited figures, however, do provide the prescribing physician with some basis for estimating the relative contribution of drug and nondrug factors to the side effect incidence rate in the population studied.

Adults

Incidence in Controlled Clinical Trials--Monotherapy Studies in Adults:

The table that follows enumerates adverse events that occurred at an incidence of 2% or more among 58 adult patients who received felbamate monotherapy at dosages of 3,600 mg/day in double-blind controlled trials. Table 3 presents reported adverse events that were classified using standard WHO-based dictionary terminology.

Table 3Adults Treatment-Emergent Adverse Event Incidence in Controlled Monotherapy Trials

*3,600 mg/day; **15 mg/kg/day
	Felbamate*  (N=58)	Low Dose Valproate** (N=50)
Body System Event	%	%
Body as a Whole
Fatigue	6.9	4
Weight Decrease	3.4	0
Face Edema	3.4	0
Central Nervous System
Insomnia	8.6	4
Headache	6.9	18
Anxiety	5.2	2
Dermatological
Acne	3.4	0
Rash	3.4	0
Digestive
Dyspepsia	8.6	2
Vomiting	8.6	2
Constipation	6.9	2
Diarrhea	5.2	0
SGPT Increased	5.2	2
Metabolic/Nutritional
Hypophosphatemia	3.4	0
Respiratory
Upper Respiratory Tract Infection	8.6	4
Rhinitis	6.9	0
Special Senses
Diplopia	3.4	4
Otitis Media	3.4	0
Urogenital
Intramenstrual Bleeding	3.4	0
Urinary Tract Infection	3.4	2

Incidence in Controlled Add-On Clinical Studies in Adults:

Table 4 enumerates adverse events that occurred at an incidence of 2% or more among 114 adult patients who received felbamate adjunctive therapy in add-on controlled trials at dosages up to 3,600 mg/day. Reported adverse events were classified using standard WHO-based dictionary terminology.

Many adverse experiences that occurred during adjunctive therapy may be a result of drug interactions. Adverse experiences during adjunctive therapy typically resolved with conversion to monotherapy, or with adjustment of the dosage of other antiepileptic drugs.

Table 4Adults Treatment-Emergent Adverse Event Incidence in Controlled Add-On Trials

	Felbamate (N=114)	Placebo (N=43)
Body System/Event	%	%
Body as a Whole
Fatigue	16.8	7
Fever	2.6	4.7
Chest Pain	2.6	0
Central Nervous System
Headache	36.8	9.3
Somnolence	19.3	7
Dizziness	18.4	14
Insomnia	17.5	7
Nervousness	7	2.3
Tremor	6.1	2.3
Anxiety	5.3	4.7
Gait Abnormal	5.3	0
Depression	5.3	0
Paraesthesia	3.5	2.3
Ataxia	3.5	0
Mouth Dry	2.6	0
Stupor	2.6	0
Dermatological
Rash	3.5	4.7
Digestive
Nausea	34.2	2.3
Anorexia	19.3	2.3
Vomiting	16.7	4.7
Dyspepsia	12.3	7
Constipation	11.4	2.3
Diarrhea	5.3	2.3
Abdominal Pain	5.3	0
SGPT Increased	3.5	0
Musculoskeletal
Myalgia	2.6	0
Respiratory
Upper Respiratory Tract Infection	5.3	7
Sinusitis	3.5	0
Pharyngitis	2.6	0
Special Senses
Diplopia	6.1	0
Taste Perversion	6.1	0
Vision Abnormal	5.3	2.3

Children

Incidence in a Controlled Add-On Trial in Children with Lennox-Gastaut Syndrome:

Table 5 enumerates adverse events that occurred more than once among 31 pediatric patients who received felbamate up to 45 mg/kg/day or a maximum of 3,600 mg/day. Reported adverse events were classified using standard WHO-based dictionary terminology.

Table 5Children Treatment-Emergent Adverse Event Incidence in Controlled Add-On Lennox-Gastaut Trials

	Felbamate (N=31)	Placebo (N=27)
Body System /Event	%	%
Body as a Whole
Fever	22.6	11.1
Fatigue	9.7	3.7
Weight Decrease	6.5	0
Pain	6.5	0
Central Nervous System
Somnolence	48.4	11.1
Insomnia	16.1	14.8
Nervousness	16.1	18.5
Gait Abnormal	9.7	0
Headache	6.5	18.5
Thinking Abnormal	6.5	3.7
Ataxia	6.5	3.7
Urinary Incontinence	6.5	7.4
Emotional Lability	6.5	0
Miosis	6.5	0
Dermatological
Rash	9.7	7.4
Digestive
Anorexia	54.8	14.8
Vomiting	38.7	14.8
Constipation	12.9	0
Hiccup	9.7	3.7
Nausea	6.5	0
Dyspepsia	6.5	3.7
Hematologic
Purpura	12.9	7.4
Leukopenia	6.5	0
Respiratory
Upper Respiratory Tract Infection	45.2	25.9
Pharyngitis	9.7	3.7
Coughing	6.5	0
Special Senses
Otitis Media	9.7	0

Other Events Observed in Association with the Administration of Felbamate:

In the paragraphs that follow, the adverse clinical events, other than those in the preceding tables, that occurred in a total of 977 adults and 357 children exposed to felbamate and that are reasonably associated with its use are presented. They are listed in order of decreasing frequency. Because the reports cite events observed in open-label and uncontrolled studies, the role of felbamate in their causation cannot be reliably determined.

Events are classified within body system categories and enumerated in order of decreasing frequency using the following definitions: frequent adverse events are defined as those occurring on one or more occasions in at least 1/100 patients; infrequent adverse events are those occurring in 1/100 to 1/1000 patients; and rare events are those occurring in fewer than 1/1000 patients.

Event frequencies are calculated as the number of patients reporting an event divided by the total number of patients (N=1334) exposed to felbamate.

Body as a Whole

Frequent: Weight increase, asthenia, malaise, influenza-like symptoms

Rare: anaphylactoid reaction, chest pain substernal

Cardiovascular

Frequent: Palpitation, tachycardia

Rare: supraventricular tachycardia

Central Nervous System

Frequent: Agitation, psychological disturbance, aggressive reaction

Infrequent: hallucination, euphoria, suicide attempt, migraine

Digestive 

Frequent: SGOT increased

Infrequent: esophagitis, appetite increased

Rare: GGT elevated

Hematologic

Infrequent: Lymphadenopathy, leukopenia, leukocytosis, thrombocytopenia, granulocytopenia

Rare: antinuclear factor test positive, qualitative platelet disorder, agranulocytosis

Metabolic/Nutritional

Infrequent: Hypokalemia, hyponatremia, LDH increased, alkaline phosphatase increased, hypophosphatemia

Rare: creatinine phosphokinase increased

Musculoskeletal

Infrequent: Dystonia

Dermatological

Frequent: Pruritus

Infrequent: urticaria, bullous eruption

Rare: buccal mucous membrane swelling, Stevens-Johnson syndrome

Special Senses

Rare: Photosensitivity allergic reaction

Postmarketing Adverse Event Reports:

Voluntary reports of adverse events in patients taking felbamate (usually in conjunction with other drugs) have been received since market introduction and may have no causal relationship with the drug(s). These include the following by body system:

Body as a Whole: neoplasm, sepsis, L.E. syndrome, SIDS, sudden death, edema, hypothermia, rigors, hyperpyrexia.

Cardiovascular: atrial fibrillation, atrial arrhythmia, cardiac arrest, torsade de pointes, cardiac failure, hypotension, hypertension, flushing, thrombophlebitis, ischemic necrosis, gangrene, peripheral ischemia, bradycardia, Henoch-SchÖnlein purpura (vasculitis).

Central & Peripheral Nervous System: delusion, paralysis, mononeuritis, cerebrovascular disorder, cerebral edema, coma, manic reaction, encephalopathy, paranoid reaction, nystagmus, choreoathetosis, extrapyramidal disorder, confusion, psychosis, status epilepticus, dyskinesia, dysarthria, respiratory depression, apathy, concentration impaired.

Dermatological: abnormal body odor, sweating, lichen planus, livedo reticularis, alopecia, toxic epidermal necrolysis.

Digestive: (Refer to WARNINGS) hepatitis, hepatic failure, G.I. hemorrhage, hyperammonemia, pancreatitis, hematemesis, gastritis, rectal hemorrhage, flatulence, gingival bleeding, acquired megacolon, ileus, intestinal obstruction, enteritis, ulcerative stomatitis, glossitis, dysphagia, jaundice, gastric ulcer, gastric dilatation, gastroesophageal reflux.

Fetal Disorders: fetal death, microcephaly, genital malformation, anencephaly, encephalocele.

Hematologic: (Refer to WARNINGS) increased and decreased prothrombin time, anemia, hypochromic anemia, aplastic anemia, pancytopenia, hemolytic uremic syndrome, increased mean corpuscular volume (mcv) with and without anemia, coagulation disorder, embolism-limb, disseminated intravascular coagulation, eosinophilia, hemolytic anemia, leukemia, including myelogenous leukemia, and lymphoma, including T-cell and B-cell lymphoproliferative disorders.

Metabolic/Nutritional: hypernatremia, hypoglycemia, SIADH, hypomagnesemia, dehydration, hyperglycemia, hypocalcemia.

Musculoskeletal: arthralgia, muscle weakness, involuntary muscle contraction, rhabdomyolysis.

Respiratory: dyspnea, pneumonia, pneumonitis, hypoxia, epistaxis, pleural effusion, respiratory insufficiency, pulmonary hemorrhage, asthma.

Special Senses: hemianopsia, decreased hearing, conjunctivitis.

Urogenital: menstrual disorder, acute renal failure, hepatorenal syndrome, hematuria, urinary retention, nephrosis, vaginal hemorrhage, abnormal renal function, dysuria, placental disorder.

DRUG ABUSE AND DEPENDENCE

Abuse:

Abuse potential was not evaluated in human studies.

Dependence:

Rats administered felbamate orally at doses 8.3 times the recommended human dose 6 days each week for 5 consecutive weeks demonstrated no signs of physical dependence as measured by weight loss following drug withdrawal on day 7 of each week.

OVERDOSAGE

Four subjects inadvertently received felbamate as adjunctive therapy in dosages ranging from 5,400 to 7,200 mg/day for durations between 6 and 51 days. One subject who received 5,400 mg/day as monotherapy for 1 week reported no adverse experiences. Another subject attempted suicide by ingesting 12,000 mg of felbamate in a 12-hour period. The only adverse experiences reported were mild gastric distress and a resting heart rate of 100 bpm. No serious adverse reactions have been reported. General supportive measures should be employed if overdosage occurs. It is not known if felbamate is dialyzable.

DOSAGE AND ADMINISTRATION

Felbamate has been studied as monotherapy and adjunctive therapy in adults and as adjunctive therapy in children with seizures associated with Lennox-Gastaut syndrome. As felbamate is added to or substituted for existing AEDs, it is strongly recommended to reduce the dosage of those AEDs in the range of 20 to 33% to minimize side effects (see Drug Interactions subsection).

Dosage Adjustment in the Renally Impaired:

felbamate should be used with caution in patients with renal dysfunction. In the renally impaired, starting and maintenance doses should be reduced by one-half (see CLINICAL PHARMACOLOGY / Pharmacokinetics and PRECAUTIONS). Adjunctive therapy with medications which affect felbamate plasma concentrations, especially AEDs, may warrant further  reductions in felbamate daily doses in patients with renal dysfunction.

Adults (14 years of age and over)

The majority of patients received 3,600 mg/day in clinical trials evaluating its use as both monotherapy and adjunctive therapy.

Monotherapy: (Initial therapy)

Felbamate has not been systematically evaluated as initial monotherapy. Initiate felbamate at 1,200 mg/day in divided doses three or four times daily. The prescriber is advised to titrate previously untreated patients under close clinical supervision, increasing the dosage in 600 mg increments every 2 weeks to 2,400 mg/day based on clinical response and thereafter to 3,600 mg/day if clinically indicated.

Conversion to Monotherapy:

Initiate felbamate at 1,200 mg/day in divided doses three or four times daily. Reduce the dosage of concomitant AEDs by one-third at initiation of felbamate therapy. At week 2, increase the felbamate dosage to 2,400 mg/day while reducing the dosage of other AEDs up to an additional one-third of their original dosage. At week 3, increase the felbamate dosage up to 3,600 mg/day and continue to reduce the dosage of other AEDs as clinically indicated.

Adjunctive Therapy:

Felbamate should be added at 1,200 mg/day in divided doses three or four times daily while reducing present AEDs by 20% in order to control plasma concentrations of concurrent phenytoin, valproic acid, phenobarbital, and carbamazepine and its metabolites. Further reductions of the concomitant AEDs dosage may be necessary to minimize side effects due to drug interactions. Increase the dosage of felbamate by 1,200 mg/day increments at weekly intervals to 3,600 mg/day. Most side effects seen during felbamate adjunctive therapy resolve as the dosage of concomitant AEDs is decreased.

Table 6Dosage Table (adults)

	WEEK 1	WEEK 2	WEEK 3
Dosage reduction of Concomitant AEDs	REDUCE original dose by 20 to 33%*	REDUCE original dose by up to an additional 1/3*	REDUCE as clinically indicated
Felbamate Dosage	1,200 mg/day Initial dose	2,400 mg/day Therapeutic dosage range	3,600 mg/day Therapeutic dosage range
*See Adjunctive and Conversion to Monotherapy sections.

While the above felbamate conversion guidelines may result in a felbamate 3600 mg/day dose within 3 weeks, in some patients titration to a 3600 mg/day felbamate dose has been achieved in as little as 3 days with appropriate adjustment of other AEDs.

Children with Lennox-Gastaut Syndrome (Ages 2 to 14 years)

Adjunctive Therapy: Felbamate should be added at 15 mg/kg/day in divided doses three or four times daily while reducing present AEDs by 20% in order to control plasma levels of concurrent phenytoin, valproic acid, phenobarbital, and carbamazepine and its metabolites. Further reductions of the concomitant AEDs dosage may be necessary to minimize side effects due to drug interactions. Increase the dosage of felbamate by 15 mg/kg/day increments at weekly intervals to 45 mg/kg/day. Most side effects seen during felbamate adjunctive therapy resolve as the dosage of concomitant AEDs is decreased.

HOW SUPPLIED

Felbamate Tablets USP, 400 mg are off-white to pale yellow colored, capsule shaped biconvex tablets, debossed with "10" and "53" separated by breakline on one side and plain on other and are supplied as:

NDC 72578-056-06 in bottles of 30 tablets with child-resistant closures

NDC 72578-056-16 in bottles of 90 tablets with child-resistant closures

NDC 72578-056-01 in bottles of 100 tablets with child-resistant closures

NDC 72578-056-05 in bottles of 500 tablets

NDC 72578-056-77 in cartons of 100 tablets (10 x 10 unit-dose)

Felbamate Tablets USP, 600 mg are light pink to pink colored, capsule shaped biconvex tablets debossed with "10" and "54" separated by breakline on one side and plain on other and are supplied as:

NDC 72578-057-06 in bottles of 30 tablets with child-resistant closures

NDC 72578-057-16 in bottles of 90 tablets with child-resistant closures

NDC 72578-057-01 in bottles of 100 tablets with child-resistant closures

NDC 72578-057-28 in bottles of 180 tablets

NDC 72578-057-05 in bottles of 500 tablets

NDC 72578-057-77 in cartons of 100 tablets (10 x 10 unit-dose)

Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature].

Dispense in tight container.

PATIENT/PHYSICIAN ACKNOWLEDGEMENT FORM

FELBAMATE SHOULD NOT BE USED BY PATIENTS UNTIL THERE HAS BEEN A COMPLETE DISCUSSION OF THE RISKS.

All patients treated with felbamate should acknowledge that they understand the risks and other information about felbamate discussed below, and physicians should acknowledge this discussion.

IMPORTANT INFORMATION AND WARNING:

Felbamate, taken by itself or with other prescription and/or non-prescription drugs, can result in a severe, potentially fatal blood abnormality ("aplastic anemia") and/or severe, potentially fatal liver damage.

PATIENT ACKNOWLEDGEMENT:

Do not sign this form if there is anything you do not understand about the information you have received. Ask your doctor about anything you do not understand before you initial any of the items below or sign this form.

My [My son, daughter, ward ______________________________________________'s] treatment with felbamate tablets has been personally explained to me by Dr.________________________________.

The following points of information, among others, have been specifically discussed and made clear and I have had the opportunity to ask any questions concerning this information:

1. I, ______________________________________________________________ (Patient's Name), understand that felbamate is used to treat certain types of seizures and my physician has told me that I have this type(s) of seizures;
2. INITIALS: __________________________
3. I understand that felbamate is being used because my seizures have not been satisfactorily treated with other antiepileptic drugs;
4. INITIALS: __________________________
5. I understand that there is a serious risk that I could develop aplastic anemia and/or liver failure, both of which are potentially fatal, by using felbamate;
6. INITIALS: __________________________
7. I understand that there are no laboratory tests which will predict if I am at an increased risk for one of the potentially fatal conditions;
8. INITIALS: __________________________
9. I understand that I should have the recommended blood work before my treatment with felbamate is begun (baseline) and periodically thereafter as clinical judgement warrants. I understand that although this blood work may help detect if I develop one of these conditions, it may do so only after significant, irreversible and potentially fatal damage has already occurred;
10. INITIALS: __________________________
11. If I am currently taking other antiepileptic drugs, I understand that the manufacturer of felbamate recommends that the dosage of these other drugs be decreased by a certain amount when felbamate is started; if my physician determines that this should not be done in my case, he/she has explained the reason(s) for this decision;
12. INITIALS: __________________________
13. I understand that I must immediately report any unusual symptoms to Dr. _______________________ and be especially aware of any rashes, easy bruising, bleeding, sore throats, fever, and/or dark urine;
14. INITIALS: __________________________
15. I understand that antiepileptic drugs such as felbamate may increase the risk of suicidal thoughts and behavior. I understand that I must immediately report any unusual changes in mood or behavior, symptoms of depression or thoughts about self-harm to Dr. ____________________.
16. INITIALS: __________________________

___________________________________________

Patient, Parent, or Guardian

___________________________________________

Address

___________________________________________

Telephone

PHYSICIAN STATEMENT:

I have fully explained to the patient, __________________________________________, the nature and purpose of the treatment with felbamate and the potential risks associated with that treatment.

I have asked the patient if he/she has any questions regarding this treatment or the risks and have answered those questions to the best of my ability. I also acknowledge that I have read and understand the prescribing information.

________________________________________________________________________

Physician                                                                                                         Date

NOTE TO PHYSICIAN:

It is strongly recommended that you retain a signed copy of the Patient/Physician Acknowledgment Form with the patient's medical records.

SUPPLY OF PATIENT/PHYSICIAN ACKNOWLEDGMENT FORMS:

A supply of "Patient/Physician Acknowledgment" Forms as printed above is available, free of charge, on our website, http://vionausa.com/products/felbamate-tablets-usp/, or may be obtained by calling 1-888-304-5011. Permission to use the above Patient/Physician Acknowledgment Form by photocopy reproduction is also hereby granted by Viona Pharmaceuticals Inc.

Manufactured by:

Zydus Lifesciences Ltd.

Matoda, Ahmedabad, India.

Distributed by:

Viona Pharmaceuticals Inc.

Cranford, NJ 07016

Rev.: 07/22

MEDICATION GUIDE

Felbamate

(fel bam' ate)

Felbamate Tablets, USP

Read this Medication Guide before you start taking felbamate tablets and each time you get a refill. There may be new information. 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 felbamate tablets?

Do not stop taking felbamate tablets without first talking to your healthcare provider.

Stopping felbamate tablets suddenly can cause serious problems.

Felbamate tablets can cause serious side effects, including:

1. Felbamate tablets may cause serious blood problems that may be life-threatening.

Call your healthcare provider right away if you have any of the following symptoms:

• Fever, sore throat or other infections that come and go or do not go away
• Frequent infections or an infection that does not go away
• Easy bruising
• Red or purple spots on your body
• Bleeding gums or nose bleeds
• Severe fatigue or weakness

2. Liver problems that may be life-threatening. Call your healthcare provider right away if you have any of these symptoms:

• yellowing of your skin or the whites of your eyes (jaundice)
• dark urine
• nausea or vomiting
• loss of appetite
• pain on the right side of your stomach (abdomen)

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

Call your 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
• attempts 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.

Do not stop felbamate tablets without first talking to a healthcare provider.

Stopping felbamate tablets suddenly can cause serious problems. You should talk to your healthcare provider before stopping. Stopping a seizure medicine suddenly in a patient who has epilepsy can cause seizures.

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.

What are felbamate tablets?

Felbamate tablets are a prescription medicine used when other treatments have failed in:

• adults alone or with other medicines to treat:
  • partial seizures with and without generalization
• children with other medicines to treat:
  • seizures associated with Lennox-Gastaut syndrome

Who should not take felbamate tablets?

Do not take felbamate tablets if you:

• are allergic to felbamate, carbamates or any of the ingredients in felbamate tablets. See the end of this Medication Guide for a complete list of ingredients in felbamate tablets.
• have or have had blood problems
• have or have had liver problems

What should I tell my healthcare provider before taking felbamate tablets?

Before you take felbamate tablets, tell your healthcare provider if you:

• have kidney problems
• have or have had depression, mood problems, or suicidal thoughts or behavior
• have any other medical conditions
• are pregnant or plan to become pregnant. It is not known if felbamate tablets can harm your unborn baby. Tell your healthcare provider right away if you become pregnant while taking felbamate tablets. You and your healthcare provider will decide if you should take felbamate tablets while you are pregnant.
  • If you become pregnant while taking felbamate tablets, talk to your healthcare provider about registering with the North American Antiepileptic Drug (NAAED) Pregnancy Registry. The purpose of this registry is to collect information about the safety of antiepileptic medicine during pregnancy. You can enroll in this registry by calling 1-888-233-2334.
• are breastfeeding or plan to breastfeed. Felbamate may pass into your breast milk. You and your healthcare provider should decide if you should take felbamate tablets while you breastfeed.

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Taking felbamate tablets with certain other medicines can 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 when you get a new medicine.

How should I take felbamate tablets?

• Take felbamate exactly as your healthcare provider tells you. Your healthcare provider will tell you how much felbamate to take and when to take it.
• Your healthcare provider may change your dose of felbamate. Do not change your dose of felbamate without talking to your healthcare provider.
• Because of the risk of serious blood and liver problems, your healthcare provider may do blood tests before you start and while you take felbamate tablets.
• If you take too much felbamate, call your healthcare provider or local Poison Control Center right away.
• Do not stop felbamate tablets without first talking to your healthcare provider.

What should I avoid while taking felbamate tablets?

• Felbamate tablets can cause drowsiness and dizziness. Do not drink alcohol or take other medicines that make you sleepy or dizzy while taking felbamate tablets, until you talk with your doctor. Taking felbamate tablets with alcohol or drugs that cause sleepiness or dizziness may make your sleepiness or dizziness worse.

What are the possible side effects of felbamate tablets?

See "What is the most important information I should know about felbamate tablets?" Felbamate tablets may cause serious side effects including:

The most common side effects of felbamate tablets include:

• weight loss
• vomiting
• trouble sleeping
• nausea
• dizziness
• sleepiness
• headache
• double-vision
• changes in the way that food tastes

These are not all the possible side effects of felbamate tablets. For more information, ask your healthcare provider or pharmacist.

Tell your healthcare provider if you have 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 Viona Pharmaceuticals Inc. at 1-888-304-5011 or FDA at 1-800-FDA-1088.

How should I store felbamate tablets?

• Store felbamate tablets between 68°F to 77°F (20°C to 25°C).

Keep felbamate tablets and all medicines out of the reach of children.

General information about felbamate tablets

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

This Medication Guide summarizes the most important information about felbamate tablets. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about felbamate tablets that is written for health professionals.

What are the ingredients in felbamate tablets?

Active Ingredient: Felbamate, USP

Inactive Ingredients: colloidal silicon dioxide, ferric oxide yellow, FD & C red no. 40 aluminum lake, lactose monohydrate, microcrystalline cellulose, magnesium stearate, povidone K 30, pregelatinised starch (botanical source: corn) and sodium starch glycolate type A (botanical source: potato). Apart from this felbamate tablets USP, 600 mg also contain D & C yellow no. 10 aluminum lake.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 72578-056-01

Felbamate tablets USP, 400 mg

100 Tablets

Rx only

NDC 72578-057-01

Felbamate tablets USP, 600 mg

100 Tablets

Rx only