Felbamate Oral Suspension

Felbamate Oral Suspension USP, 600 mg/5 mL, is a pink-colored, cherry flavored suspension; available in:

8 fl oz bottles (NDC 51672-4172-1) and 16 fl oz bottles (NDC 51672-4172-9).

Shake suspension well before using. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Dispense in a tight container.

To report SUSPECTED ADVERSE REACTIONS, contact Taro at 1-866-923-4914 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Mfd by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761
Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532
Issued: December 2016
20568-1216-1

Felbamate (fel bam' ate)
Oral Suspension, USP

Read this Medication Guide before you start taking Felbamate Oral Suspension, USP 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 Oral Suspension, USP?

Do not stop taking Felbamate Oral Suspension without first talking to your healthcare provider.

Stopping Felbamate Oral Suspension suddenly can cause serious problems.

Felbamate Oral Suspension can cause serious side effects, including:

1. Felbamate Oral Suspension 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 Oral Suspension 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 Oral Suspension without first talking to a healthcare provider.

Stopping Felbamate Oral Suspension suddenly can cause serious problems. You should talk to your health care 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 is Felbamate Oral Suspension, USP?

Felbamate Oral Suspension is 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 Oral Suspension, USP?

Do not take Felbamate Oral Suspension if you:

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

What should I tell my healthcare provider before taking Felbamate Oral Suspension, USP? Before you take Felbamate Oral Suspension, 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 Oral Suspension can harm your unborn baby. Tell your healthcare provider right away if you become pregnant while taking Felbamate Oral Suspension. You and your healthcare provider will decide if you should take Felbamate Oral Suspension while you are pregnant.
  • If you become pregnant while taking Felbamate Oral Suspension, 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 Oral Suspension may pass into your breast milk. You and your healthcare provider should decide if you should take Felbamate Oral Suspension 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 Oral Suspension 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 Oral Suspension, USP?

• Take Felbamate Oral Suspension exactly as your healthcare provider tells you. Your healthcare provider will tell you how much Felbamate Oral Suspension to take and when to take it.
• Your healthcare provider may change your dose of Felbamate Oral Suspension. Do not change your dose of Felbamate Oral Suspension 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 Oral Suspension.
• If you take too much Felbamate Oral Suspension, call your healthcare provider or local Poison Control Center right away.
• Do not stop Felbamate Oral Suspension without first talking to your healthcare provider.

What should I avoid while taking Felbamate Oral Suspension, USP?

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

What are the possible side effects of Felbamate Oral Suspension, USP?

See "What is the most important information I should know about Felbamate Oral Suspension, USP?"

Felbamate Oral Suspension may cause serious side effects including:

The most common side effects of Felbamate Oral Suspension 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 Oral Suspension. 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 FDA at 1-800-FDA-1088.

How should I store Felbamate Oral Suspension, USP?

• Store Felbamate Oral Suspension at room temperature between 68°F to 77°F (20°C to 25°C).

Keep Felbamate Oral Suspension and all medicines out of the reach of children.

General information about Felbamate Oral Suspension.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Felbamate Oral Suspension for a condition for which it was not prescribed. Do not give Felbamate Oral Suspension 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 Oral Suspension. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about Felbamate Oral Suspension that is written for health professionals.

For more information call Taro at 1-866-923-4914.

What are the ingredients in Felbamate Oral Suspension, USP?

Active Ingredient: felbamate

Inactive Ingredients: carboxymethylcellulose sodium, citric acid monohydrate, FD&C Yellow No. 6, FD&C Red No.40, flavor (cherry), glycerin, methylparaben, microcrystalline cellulose, polysorbate 80, propylparaben, simethicone emulsion, sorbitol, sucralose and water.

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

Mfd by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761
Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532
Issued: December 2016        20568-1216-1

PATIENT/PHYSICIAN ACKNOWLEDGMENT FORM

Felbamate Oral Suspension, USP SHOULD NOT BE USED BY PATIENTS UNTIL THERE HAS BEEN A COMPLETE DISCUSSION OF THE RISKS.

All patients treated with Felbamate Oral Suspension 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 Oral Suspension, 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 ACKNOWLEDGMENT:

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 Oral Suspension 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 Oral Suspension is used to treat certain types of seizures and my physician has told me that I have this type(s) of seizures;
   INITIALS: ______________________
2. I understand that Felbamate Oral Suspension is being used because my seizures have not been satisfactorily treated with other antiepileptic drugs;
   INITIALS: ______________________
3. 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 Oral Suspension;
   INITIALS: ______________________
4. 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;
   INITIALS: ______________________
5. I understand that I should have the recommended blood work before my treatment with Felbamate Oral Suspension 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;
   INITIALS: ______________________
6. If I am currently taking other antiepileptic drugs, I understand that the manufacturer of Felbamate Oral Suspension recommends that the dosage of these other drugs be decreased by a certain amount when Felbamate Oral Suspension 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;
   INITIALS: ______________________
7. 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;
   INITIALS: ______________________
8. I understand that antiepileptic drugs such as Felbamate Oral Suspension 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. ________________________________________________________________.
   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 Oral Suspension 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

Revised: 10/2016

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 Acknowledgement" Forms as printed above is available, free of charge, from your local Taro Pharmaceuticals U.S.A., Inc.'s representative, or may be obtained by calling customer service at 1-800-544-1449 or via download from Taro's website at www.tarousa.com. Permission to use the above Patient/Physician Acknowledgment Form by photocopy reproduction is also hereby granted by Taro Pharmaceuticals U.S.A., Inc.

Mfd by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761
Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532
Issued: December 2016
20568-1216-1

FELBAMATE (fel BAM ate) is used to control seizures in certain types of epilepsy. This medicine is only for people who have not responded to other therapy.

This drug also comes in other forms, including Oral tablet

This drug can cause serious side effects. See which side effects you should report to your doctor right away.

Know how to use your medication, and learn what might happen if you miss a dose.

Talk to your healthcare provider if you have any of these conditions.

Know what to watch for and get tips for reducing your risks while taking this drug.