Felbamate (By mouth)

Introduction

Felbamate (fel-BAM-ate)

Used alone or together with other medicines to control partial seizures in patients who have failed other treatments. Also given to children with a type of epilepsy called Lennox-Gastaut syndrome. Belongs to a class of medicines called anticonvulsants.

Brand Name(s)

Felbatol

When This Medicine Should Not Be Used

How to Use This Medicine

Liquid, Tablet

• Your doctor will tell you how much of this medicine to use and how often. Your dose may need to be changed several times in order to find out what works best for you. Do not use more medicine or use it more often than your doctor tells you to.
• This medicine should not be the first medicine you use to treat your condition. It is meant to be used only after you have tried other medicines that have not worked or have caused unwanted side effects.
• It is very important that you understand the risks and benefits before taking this medicine. You may be asked to sign a patient/physician acknowledgment form and read the medication guide to make sure you understand what your doctor has discussed with you. Be sure to ask your doctor about anything you do not understand.
• It is best to take this medicine with food or milk.
• Shake the oral liquid well before using. Measure the oral liquid medicine with a marked measuring spoon, oral syringe, or medicine cup.
• This medicine can be used with other seizure medicines. Keep using all of your seizure medicines unless your doctor tells you to stop.
• This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions. Ask your pharmacist for the Medication Guide if you do not have one.

If a dose is missed:

• If you miss a dose or forget to use your medicine, use it as soon as you can. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up for a missed dose.

How to Store and Dispose of This Medicine

• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.
• Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any outdated medicine or medicine no longer needed.
• Keep all medicine away from children and never share your medicine with anyone.

Drugs and Foods to Avoid

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Make sure your doctor knows about all other medicines you are using to treat or prevent seizures. These includes carbamazepine (Tegretol®), phenobarbital, or phenytoin (Dilantin®).

Warnings While Using This Medicine

• It is important to tell your doctor if you become pregnant. Your doctor may want you to join the North American Antiepileptic Drug Pregnancy Registry, which is used by pregnant patients who are taking this medicine.
• Make sure your doctor knows if you are breastfeeding, or if you have kidney disease, depression, or mental illness.
• Felbamate has caused a few cases of a serious blood disorder called aplastic anemia and a few cases of liver failure. Talk to your doctor about these risks.
• Stop using this medicine and check with your doctor right away if you or your child have pain or tenderness in the upper stomach; pale stools; dark urine; loss of appetite; nausea; unusual tiredness or weakness; or yellow eyes or skin. These could be symptoms of a serious liver problem.
• Tell your doctor right away if you or your child has chest pain; chills; cough; fever; headache; shortness of breath; sores, ulcers, or white spots on lips or in mouth; swollen or painful glands; tightness in chest; unusual bleeding or bruising; unusual tiredness or weakness; or wheezing. These could be symptoms of aplastic anemia.
• Do not stop using this medicine suddenly without asking your doctor. You may need to slowly decrease your dose before stopping it completely..
• If you or your child develop any unusual or strange thoughts and behavior while taking this medicine, be sure to discuss it with your doctor. Other changes might be confusion, worsening of depression, hallucinations (seeing, hearing, or feeling things that are not there), suicidal thoughts, and unusual excitement, nervousness, or irritability.
• This medicine may make you dizzy or drowsy. Avoid driving, using machines, or doing anything else that could be dangerous if you are not alert.
• Your doctor will need to check your progress at regular visits while you are using this medicine. Be sure to keep all appointments. Blood tests may be needed to check for unwanted effects.

Possible Side Effects While Using This Medicine

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Anxiety, confusion, depression, or trouble sleeping.
• Fainting.
• Fast or uneven heartbeat.
• Fever, chills, cough, sore throat, and body aches.
• Loss of seizure control.
• Swelling in your face, throat, or lips.
• Tremors.
• Unusual bleeding or bruising.
• Unusual thoughts or behavior.
• Unusual tiredness or weakness.
• Wheezing or trouble breathing.
• Yellowing of your skin or the whites of your eyes.

If you notice these less serious side effects, talk with your doctor:

• Constipation, diarrhea, nausea, vomiting, heartburn, or stomach pain or upset.
• Dry mouth, hiccups.
• Earache.
• Headache, dizziness, or drowsiness.
• Loss of appetite.
• Skin rash, hives, or itching.
• Sleepiness or unusual drowsiness.
• Stuffy or runny nose.
• Unusual taste in your mouth.

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088