Felbatol

Felbatol is a medicine that helps prevent seizures, also known as an anticonvulsant.

Felbatol is used by itself or with other medicines to treat seizures in adults with epilepsy.

Felbatol is also used with other medicines in children who have Lennox-Gastaut syndrome, which is a severe type of childhood epilepsy that can also lead to developmental and behavior issues.

Felbatol can cause serious side effects that may not go away. This medicine should only be used for conditions that cannot be treated with a safer medicine.

Felbatol may also be used for other reasons 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 Felbatol.

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

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

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

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

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

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

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

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

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

You should not use Felbatol 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 Felbatol. 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.

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 if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), depressed, or have thoughts about suicide or hurting yourself.

Felbatol can cause serious or life-threatening side effects that affect your blood cells or your liver.

Felbatol 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 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 of Felbatol 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.

Take the medicine as soon as possible, but skip the missed dose if it's nearly time for your next dose. Do not take two doses at once.

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

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

Drinking alcohol with Felbatol can make you feel more dizzy or drowsy.

Using Felbatol with other drugs that cause dizziness or drowsiness can make these effects worse. Talk to your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.

Inform your doctor about all other seizure medicines you are taking. Some drugs can change the levels of felbamate in your blood, which may make this medicine less effective.

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