Felbamate

Felbamate may cause a serious blood condition called aplastic anemia. Symptoms of aplastic anemia can start any time you are taking felbamate or for a period of time after you stop taking felbamate. Tell your doctor if you have or have ever had blood problems. Your doctor will probably tell you not to take felbamate. If you experience any of the following symptoms while taking felbamate or after you stop taking felbamate, call your doctor immediately: fever, sore throat, chills, other signs of infection, bleeding, easy bruising, extreme tiredness, weakness, or lack of energy.

Felbamate may cause liver damage. Tell your doctor if you have or have ever had liver disease. Your doctor will probably tell you not to take felbamate. If you experience any of the following symptoms, call your doctor immediately: nausea, extreme tiredness, unusual bleeding or bruising, lack of energy, loss of appetite, pain in the upper right part of the stomach, yellowing of the skin or eyes, or flu-like symptoms.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain tests before, during, and after treatment to check your body's response to felbamate.

Talk to your doctor about the risks of taking felbamate. You will have to sign an informed consent form before you start taking felbamate.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with felbamate and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (https://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer's website to obtain the Medication Guide.

Felbamate is used to treat certain seizures in adults and children with epilepsy whose seizures have not improved with other treatments. It is used alone or in combination with other medications to treat partial seizures in adults. It is used in combination with other medications to treat partial and generalized seizures in children with Lennox-Gastaut syndrome (a disorder that causes seizures and developmental delays). Felbamate is in a class of medications called anticonvulsants. It works by decreasing abnormal activity in the brain.

Felbamate comes as a tablet and a suspension (liquid) to take by mouth. It is usually taken with or without food three or four times a day. Take felbamate at around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take felbamate exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Shake the liquid well before each use to mix the medication evenly.

Your doctor will probably start you on a low dose of felbamate and gradually increase your dose every one or two weeks.

Felbamate controls seizures but does not cure them. Continue to take felbamate even if you feel well. Do not stop taking felbamate without talking to your doctor, even if you experience side effects such as unusual changes in behavior or mood. If you suddenly stop taking felbamate, your seizures may become worse. Your doctor will probably decrease your dose gradually.

This medication should not be prescribed for other uses; ask your doctor or pharmacist for more information.

Before taking felbamate,

• tell your doctor and pharmacist if you are allergic to felbamate; carbamate medications such as meprobamate (Miltown), methocarbamol (Robaxin), and rivastigmine (Exelon); or any other medications.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take while taking felbamate. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you have or have ever had any of the conditions listed in the IMPORTANT WARNINGS section or kidney disease.
• tell your doctor if you are pregnant or plan to become pregnant. If you become pregnant while taking felbamate, call your doctor.
• tell your doctor if you are breastfeeding. Do not breastfeed while taking felbamate.
• you should know that felbamate may make you drowsy. Do not drive a car or operate machinery until you know how this medication affects you.
• remember that alcohol can add to the drowsiness caused by this medication.
• you should know that your mental health may change in unexpected ways and you may become suicidal (thinking about harming or killing yourself or planning or trying to do so) while you are taking felbamate for the treatment of epilepsy, mental illness, or other conditions. A small number of adults and children 5 years of age and older (about 1 in 500 people) who took anticonvulsants such as felbamate to treat various conditions during clinical studies became suicidal during their treatment. Some of these people developed suicidal thoughts and behavior as early as one week after they started taking the medication. There is a risk that you may experience changes in your mental health if you take an anticonvulsant medication such as felbamate, but there may also be a risk that you will experience changes in your mental health if your condition is not treated. You and your doctor will decide whether the risks of taking an anticonvulsant medication are greater than the risks of not taking the medication. You, your family, or your caregiver should call your doctor right away if you experience any of the following symptoms: panic attacks; agitation or restlessness; new or worsening irritability, anxiety, or depression; acting on dangerous impulses; difficulty falling or staying asleep; aggressive, angry, or violent behavior; mania (frenzied, abnormally excited mood); talking or thinking about wanting to hurt yourself or end your life; withdrawing from friends and family; preoccupation with death and dying; giving away prized possessions; or any other unusual changes in behavior or mood. Be sure that your family or caregiver knows which symptoms may be serious so they can call the doctor if you are unable to seek treatment on your own.

Unless your doctor tells you otherwise, continue your normal diet.

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Felbamate may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• heartburn
• vomiting
• constipation
• diarrhea
• weight loss
• difficulty falling asleep or staying asleep
• nervousness
• drowsiness
• swelling of the face
• runny nose
• differences in menstrual bleeding

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately:

• hives
• rash
• itching
• difficulty breathing or swallowing
• rapid or pounding heartbeat

Felbamate may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location — one that is up and away and out of their sight and reach. https://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (https://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include:

• nausea
• rapid heartbeat

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

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