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Felbamate

Medical Alert

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Warning

Severe (sometimes fatal) blood/bone marrow problems (such as low red/white blood cells and platelets) and liver problems have occurred with felbamate. Felbamate should be used only by people with severe seizures (epilepsy) that cannot be controlled with other medications. Do not use this drug if you have liver problems. Discuss the risks and benefits with your doctor before starting felbamate.

Tell your doctor right away if you have signs of infection (such as sore throat that doesn't go away, fever, chills), signs of anemia (such as unusual tiredness), easy bruising/bleeding, or signs of liver problems (such as nausea/vomiting that doesn't stop, stomach/abdominal pain, yellowing eyes/skin, dark urine). Usually, people who have liver problems while taking this drug should not start taking it again.

Your doctor will check certain blood tests (liver function, complete blood count) and may have you see a doctor who treats blood/bone marrow problems before you start felbamate and while you use this drug. Blood/bone marrow problems may also occur after you stop taking the drug. Blood tests may be needed for some time after you stop taking felbamate. Keep all medical and lab appointments.

Precautions

Before taking felbamate, tell your doctor or pharmacist if you are allergic to it; or to meprobamate; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood/bone marrow disorders (such as anemia, bleeding problems, low white blood cell count), liver disease, kidney disease, mental/mood disorders (such as depression, suicidal thoughts).

This drug may make you dizzy or drowsy or blur your vision. It may also cause double vision. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness or clear vision until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Older adults may be more sensitive to the side effects of this drug, especially dizziness, loss of coordination, or fainting. These side effects can increase the risk of falling.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

This medication passes into breast milk. Because of the possible risk to the infant, breastfeeding is not recommended while using this medication. Consult your doctor before breastfeeding.

Side Effects

See also Warning section.

Drowsiness, dizziness, nausea, vomiting, diarrhea, constipation, trouble sleeping, loss of coordination, headache, blurred/double vision, hiccups, or loss of appetite may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: fainting.

A small number of people who take anticonvulsants for any condition (such as seizure, bipolar disorder, pain) may experience depression, suicidal thoughts/attempts, or other mental/mood problems. Tell your doctor right away if you or your family/caregiver notice any unusual/sudden changes in your mood, thoughts, or behavior such as signs of depression, suicidal thoughts/attempts, thoughts about harming yourself.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

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Drug information is selected from data included with permission and copyrighted by First DataBank, Inc. This is a summary and does not contain all possible information about this product. For complete information about this product or your specific health needs, ask your healthcare professional. Always seek the advice of your healthcare professional if you have any questions about this product or your medical condition. This information is not intended as individual medical advice and does not substitute for the knowledge and judgment of your healthcare professional. This information does not contain any assurances that this product is safe, effective or appropriate for you.

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