Felbamate

Felbamate is a medicine that helps control epilepsy, and it is also known as an anticonvulsant.

Felbamate can be used by itself or with other medicines to treat seizures in adults who have epilepsy.

In children with Lennox-Gastaut syndrome, a severe type of childhood epilepsy that can lead to developmental and behavior issues, felbamate is used along with other medications.

Felbamate can lead to serious side effects that might not go away. You should only use felbamate for conditions that cannot be treated with a safer medicine.

Felbamate may also be used for other reasons that are not mentioned in this medication guide.

Your doctor will do blood tests to ensure you do not have conditions that would make it unsafe for you to use felbamate.

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

If you switch to felbamate from another seizure medication, carefully follow your doctor's instructions regarding the amount to take and how often. To avoid medication errors, use only the form and strength your doctor prescribes.

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

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

Felbamate can increase your risk of bleeding or infection. Call your doctor if you notice unusual bruising or bleeding, or if you have new signs of infection (fever, sore throat, frequent or recurring illness). These symptoms may appear 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 inform others that you use seizure medication.

Do not stop using felbamate suddenly, even if you feel well. Stopping suddenly may lead to more seizures. Follow your doctor's instructions about gradually reducing your dose.

Felbamate can lead to serious or life-threatening side effects affecting your blood cells or liver.

Contact your doctor if you notice unusual bruising or bleeding, new signs of infection (such as fever, sore throat, or frequent or recurring illnesses), or signs of liver issues (including loss of appetite, upper stomach pain, dark urine, or yellowing of your skin or eyes).

You should not take felbamate if you have a history of liver disease or blood cell disorders.

You may need to read and sign a Patient Acknowledgement form before you receive a prescription for felbamate. You must understand the risks and benefits of felbamate.

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 during regular visits. Your family or other caregivers should also be aware of 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 included in a pregnancy registry to monitor the effects of felbamate on the baby.

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

Get emergency medical help if you have signs of an allergic reaction (hives, trouble 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: changes in mood or behavior, anxiety, panic attacks, trouble sleeping, or feelings of impulsiveness, irritability, agitation, hostility, aggression, restlessness, hyperactivity (mentally or physically), depression, or thoughts about suicide or hurting yourself.

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

Felbamate may cause serious side effects. Call your doctor right away 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 illnesses; 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 of felbamate 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 can report side effects to the FDA at 1-800-FDA-1088.

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 felbamate can increase dizziness or drowsiness.

Using felbamate with other medications that cause dizziness or drowsiness can make these effects worse. Consult your doctor before taking opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.

Inform your doctor about all other seizure medications you are taking. Some drugs can change your blood levels of felbamate, which may reduce how well this medicine works.

Other medications may also affect felbamate, including prescription and over-the-counter medicines, vitamins, and herbal products. Let your doctor know about all your current medications and any new medicines you begin or stop using.