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    Felbatol

    GENERIC NAME(S): FELBAMATE

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    WARNINGS:

    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.

    Who should not take Felbatol?
    See More

    Uses

    Felbamate is used to treat severe seizures. This medication should be used only when you cannot take other medications or when other medications have not been able to control your seizures. Felbamate is known as an anticonvulsant or anti-epileptic drug.

    How to use Felbatol

    Read and sign the Informed Consent form provided by your doctor. Read the Medication Guide provided by your pharmacist before you start taking felbamate and each time you get a refill. If you have any questions, ask your doctor or pharmacist before starting felbamate.

    Take this medication by mouth with or without food as directed by your doctor, usually 3 to 4 times a day. Take with food or milk if stomach upset occurs.

    If you are using the liquid form of this medication, shake the bottle well before each dose. Carefully measure the dose using a special measuring device/spoon. Do not use a household spoon because you may not get the correct dose.

    The dosage is based on your medical condition and response to treatment. For children, the dosage is also based on weight. To reduce your risk of side effects, your doctor may direct you to start this medication at a low dose and gradually increase your dose.

    Take this medication regularly to get the most benefit from it. To help you remember, take it at the same times each day.

    Do not stop taking this medication without consulting your doctor. Seizures may become worse when this drug is suddenly stopped. Your dose may need to be gradually decreased.

    If you are already taking other anti-seizure medications, carefully follow your doctor's directions for adjusting the dose of these other medications when you start taking felbamate.

    Tell your doctor if your seizures get worse.

    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 your doctor has prescribed this medication because he or she 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.

    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, drowsy, or cause blurred/double vision. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

    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, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

    Interactions

    Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

    A product that may interact with this drug is: clopidogrel.

    This medication may decrease the effectiveness of hormonal birth control such as pills, patch, or ring. This could cause pregnancy. Discuss with your doctor or pharmacist if you should use reliable backup birth control methods while using this medication. Also tell your doctor if you have any new spotting or breakthrough bleeding, because these may be signs that your birth control is not working well.

    Tell your doctor or pharmacist if you are taking other products that cause drowsiness including alcohol, antihistamines (such as cetirizine, diphenhydramine), drugs for sleep or anxiety (such as alprazolam, diazepam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), and narcotic pain relievers (such as codeine, hydrocodone).

    Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.

    Overdose

    If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

    Notes

    Do not share this medication with others.

    Lab and/or medical tests (such as complete blood count, kidney/liver tests) should be done before, during, and after treatment with this medication. See also Warning section.

    Missed Dose

    If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

    Storage

    Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

    Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

    MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

    Information last revised July 2016. Copyright(c) 2016 First Databank, Inc.

    Images

    FELBATOL 400 MG TABLET
    FELBATOL 400 MG TABLET
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    FELBATOL 400, 0430
    FELBATOL 600 MG TABLET
    FELBATOL 600 MG TABLET
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    04 31, Felbatol 600
    FELBATOL 400 MG TABLET
    FELBATOL 400 MG TABLET

    Identification

    color
    yellow
    shape
    oblong
    imprint
    FELBATOL 400, 0430
    This medicine is a yellow, oblong, scored tablet imprinted with "FELBATOL 400" and "0430".
    FELBATOL 600 MG TABLET
    FELBATOL 600 MG TABLET

    Identification

    color
    peach
    shape
    oblong
    imprint
    04 31, Felbatol 600
    This medicine is a peach, oblong, scored tablet imprinted with "04 31" and "Felbatol 600".

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    Selected from data included with permission and copyrighted by First Databank, Inc. This copyrighted material has been downloaded from a licensed data provider and is not for distribution, expect as may be authorized by the applicable terms of use.

    CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.

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