Generic Name: felbamate (fel-BAM-ate)
Brand Name: Felbatol
Because severe, even fatal, blood disorders (aplastic anemia, pancytopenia) and liver problems have occurred with the use of Felbatol, it should be used only in people with severe epilepsy and only after careful consideration. Aplastic anemia may occur even after the drug has been stopped. Felbatol is not recommended for use in patients who have liver problems. Stop using Felbatol and immediately notify your doctor if you have symptoms of infection such as fever, chills, or persistent sore throat, or if you have unusual bleeding or bruising, weakness, fatigue, dark urine, yellowing of the eyes or skin, or persistent stomach/abdominal pain. Your doctor will perform liver function tests before starting Felbatol and every 1 to 2 weeks while you are using Felbatol.
Felbatol is used for:
Treating certain types of seizures. It may be used alone or with other medicines.
Felbatol is an anticonvulsant. It works by controlling nerve impulses in the brain, which prevents or reduces some types of seizures.
Do NOT use Felbatol if:
- you are allergic to any ingredient in Felbatol or other carbamates
- you have a history of blood disorders, bone marrow depression, or liver problems
Contact your doctor or health care provider right away if any of these apply to you.
Before using Felbatol:
Some medical conditions may interact with Felbatol. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have kidney or liver problems
- if you have a history of mental or mood problems (eg, depression), or suicidal thoughts or actions
Some MEDICINES MAY INTERACT with Felbatol. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Gabapentin because the actions and side effects of Felbatol may be increased
- Carbamazepine, hydantoins (eg, phenytoin), or phenobarbital because the effectiveness of Felbatol may be decreased
- Anticoagulants (eg, warfarin), hydantoins (eg, phenytoin), phenobarbital, or valproic acid because the actions and side effects of these medicines may be increased
- Hormonal contraceptives (eg, birth control pills) because their effectiveness may be decreased by Felbatol
This may not be a complete list of all interactions that may occur. Ask your health care provider if Felbatol may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use Felbatol:
Use Felbatol as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- After discussing this medication with your health care provider, you must read, initial, and sign a patient information/consent form before taking Felbatol. Do not sign the consent form if there is anything you do not understand.
- Felbatol may be taken with food if it upsets your stomach.
- Do not suddenly stop taking Felbatol. You may have an increased risk of side effects (eg, seizures). If you need to stop taking Felbatol or add a new medicine, your doctor will gradually lower your dose.
- Continue to use Felbatol even if you feel well. Do not miss any doses.
- If you miss a dose of Felbatol, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Felbatol.
Important safety information:
- Felbatol may cause drowsiness, dizziness, or double vision. These effects may be worse if you take it with alcohol or certain medicines. Use Felbatol with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Patients who take Felbatol may be at increased risk for suicidal thoughts or actions. The risk may be greater in patients who have had suicidal thoughts or actions in the past. Watch patients who take Felbatol closely. Contact the doctor at once if new, worsened, or sudden symptoms such as depressed mood; anxious, restless, or irritable behavior; panic attacks; or any unusual changes in mood or behavior occur. Contact the doctor right away if any signs of suicidal thoughts or actions occur.
- Hormonal birth control (eg, birth control pills) may not work as well while you are using Felbatol. To prevent pregnancy, use an extra form of birth control (eg, condoms).
- Lab tests, including liver function tests and complete blood cell counts, may be performed while you use Felbatol. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Use Felbatol with caution in the ELDERLY; they may be more sensitive to its effects.
- Felbatol should be used with extreme caution in certain CHILDREN; safety and effectiveness in these children have not been confirmed. Discuss with your doctor the risks and benefits of giving Felbatol to your child.
- PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Felbatol while you are pregnant. Felbatol is found in breast milk. If you are or will be breast-feeding while you are using Felbatol, check with your doctor. Discuss any possible risks to your baby.
Possible side effects of Felbatol:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Seek medical attention right away if any of these SEVERE side effects occur:
Constipation; diarrhea; dizziness; drowsiness; fatigue; headache; indigestion; loss of appetite; mild stomach pain; nausea; trouble sleeping; vomiting; weight changes.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); agitation; chest pain; dark urine; fast or irregular heartbeat; fever, chills, or persistent sore throat; loss of coordination; mouth sores; muscle pain; nervousness; new or worsening mental or mood changes (eg, anxiety, depression, restlessness, irritability, panic attacks, behavior changes); new or worsening seizures; red, swollen, blistered, or peeling skin; severe or persistent stomach pain; suicidal thoughts or actions; unusual bruising or bleeding; vision changes; weakness; yellowing of the eyes or skin.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include fast heartbeat; upset stomach.Proper storage of Felbatol:
Store Felbatol at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Felbatol out of the reach of children and away from pets.
- If you have any questions about Felbatol, please talk with your doctor, pharmacist, or other health care provider.
- Felbatol is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
- Check with your pharmacist about how to dispose of unused medicine.
This information should not be used to decide whether or not to take Felbatol or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Felbatol. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Felbatol. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Felbatol.
Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.