Felbatol

Felbamate is an anti-epileptic medicine, also called an anticonvulsant.

Felbamate is used alone or with other medications to treat seizures in adults with epilepsy.

Felbamate is also used with other medications in children with Lennox-Gastaut syndrome, a severe form of childhood epilepsy that also causes developmental and behavior problems.

Felbamate can cause serious side effects that may not be reversible. Felbamate should be used only for conditions that cannot be treated with a safer medicine.

Felbamate may also be used for purposes not listed in this medication guide.

You may be required to read and sign a Patient Acknowledgement form before you get a prescription for felbamate. You must understand the risks and benefits of this medicine.

You should not use felbamate if you are allergic to it, or if you have:

• a history of liver disease; or
• a history of blood cell disorders.

Tell your doctor if you have ever had:

• kidney disease;
• depression;
• a mood disorder; or
• suicidal thoughts or actions.

Some people have thoughts about suicide while taking felbamate. Your doctor will need to check your progress at regular visits. Your family or other caregivers should also be alert to changes in your mood or symptoms.

Do not start or stop taking seizure medication during pregnancy without your doctor's advice. Having a seizure during pregnancy could harm both mother and baby. Tell your doctor right away if you become pregnant.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of felbamate on the baby.

It may not be safe to breastfeed while using this medicine. Ask your doctor about any risk.

Your doctor will perform blood tests to make sure you do not have conditions that would prevent you from safely using felbamate.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

If you switch to felbamate from another seizure medication, carefully follow your doctor's instructions about how much to take and how often. Avoid medication errors by using only the form and strength your doctor prescribes.

Shake the oral suspension (liquid) before you measure a dose. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon).

You will need frequent medical tests, and your next dose may be delayed based on the results.

Felbamate can increase your risk of bleeding or infection. Call your doctor if you have unusual bruising or bleeding, or new signs of infection (fever, sore throat, frequent or recurring illness). These symptoms may first develop even after you have been using the medication for several months.

Store at room temperature away from moisture and heat.

In case of emergency, wear or carry medical identification to let others know you use seizure medication.

Do not stop using felbamate suddenly, even if you feel fine. Stopping suddenly may cause increased seizures. Follow your doctor's instructions about tapering your dose.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Get your prescription refilled before you run out of medicine completely.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Drinking alcohol with this medicine can increase dizziness or drowsiness.

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), depressed, or have thoughts about suicide or hurting yourself.

Felbamate can cause serious or life-threatening side effects on your blood cells or your liver.

Call your doctor at once if you have:

• easy bruising or bleeding (nosebleeds, bleeding gums), purple or red spots under your skin;
• low red blood cells (anemia)--pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet;
• new signs of infection--fever, sore throat, frequent or recurring illness; or
• liver problems--loss of appetite, stomach pain (upper right side), nausea, vomiting, dark urine, jaundice (yellowing of the skin or eyes).

Common side effects may include:

• dizziness, drowsiness;
• headache;
• sleep problems (insomnia);
• weight loss;
• nausea, vomiting;
• double vision; or
• changes in your sense of taste.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Using felbamate with other drugs that make you dizzy or drowsy can worsen this effect. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.

Tell your doctor about all other seizure medicines you take. Some drugs can affect your blood levels of felbamate, which may make this medicine less effective.

Other drugs may affect felbamate, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Your pharmacist can provide more information about felbamate.