Medication Guide

FELBATOL (Fel-ba-taal)

(felbamate)

Tablets and Oral Suspension

IS-00431-02 Rev. 2/2018
SOV-IS-00431-02 Rev. 2/2018

Read this Medication Guide before you start taking FELBATOL 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 FELBATOL?
Do not stop taking FELBATOL without first talking to your healthcare provider.
Stopping FELBATOL suddenly can cause serious problems.

FELBATOL can cause serious side effects, including:

1. FELBATOL 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, FELBATOL 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 FELBATOL without first talking to a healthcare provider.

Stopping FELBATOL 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 FELBATOL?

FELBATOL 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 FELBATOL?

Do not take FELBATOL if you:

•

are allergic to felbamate, carbamates or any of the ingredients in FELBATOL. See the end of this Medication Guide for a complete list of ingredients in FELBATOL.

•

have or have had blood problems

•

have or have had liver problems

What should I tell my healthcare provider before taking FELBATOL?

Before you take FELBATOL, 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 FELBATOL can harm your unborn baby. Tell your healthcare provider right away if you become pregnant while taking FELBATOL. You and your healthcare provider will decide if you should take FELBATOL while you are pregnant.

•

If you become pregnant while taking FELBATOL, 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. FELBATOL may pass into your breast milk. You and your healthcare provider should decide if you should take FELBATOL while you breastfeed.

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

Taking FELBATOL 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 FELBATOL?

•

Take FELBATOL exactly as your healthcare provider tells you. Your healthcare provider will tell you how much FELBATOL to take and when to take it.

•

Your healthcare provider may change your dose of FELBATOL. Do not change your dose of FELBATOL 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 FELBATOL.

•

If you take too much FELBATOL, call your healthcare provider or local Poison Control Center right away.

•

Do not stop FELBATOL without first talking to your healthcare provider.

What should I avoid while taking FELBATOL?

•

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

What are the possible side effects of FELBATOL?

See “What is the most important information I should know about FELBATOL?”

FELBATOL may cause serious side effects including:

The most common side effects of FELBATOL 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 FELBATOL. 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 FELBATOL?

•

Store FELBATOL at room temperature between 68°F to 77°F (20°C to 25°C).

Keep FELBATOL and all medicines out of the reach of children.

General information about FELBATOL.

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

What are the ingredients in FELBATOL?

Active Ingredient: felbamate

Tablet Inactive Ingredients: starch, microcrystalline cellulose, croscarmellose sodium, lactose, magnesium stearate, FD&C yellow No. 6, D&C Yellow No. 10, and FD&C Red No. 40 (600 mg tablets only).

Suspension Inactive Ingredients: sorbitol, glycerin, microcrystalline cellulose, carboxymethylcellulose sodium, simethicone, polysorbate 80, methylparaben, saccharain sodium, propylparaben, FD&C Yellow No. 6, FD&C Red No. 40, flavorings, and purified water.

For more information, go to www. FELBATOL.com or call 1-800-526-3840.

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

Manufactured for:
MEDA Pharmaceuticals Inc.
Somerset, NJ 08873 U.S.A.

FELBATOL is a registered trademark of Meda Pharmaceuticals Inc., a Mylan company

© 2018 Mylan Specialty LP

Issued 2/2018

IS-00431-02 Rev. 2/2018
SOV-IS-00431-02 Rev. 2/2018

Rx Only