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CenobamateMedical AlertYour 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). PrecautionsBefore taking cenobamate, tell your doctor or pharmacist if you are allergic to it; 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: kidney problems, liver problems, mental/mood disorders (such as confusion, depression, thoughts of suicide), substance use disorder (such as overuse of or addiction to drugs/alcohol). Cenobamate may cause a condition that affects the heart rhythm (QT shortening). QT shortening can rarely cause serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away. The risk of QT shortening may be increased if you have certain medical conditions or are taking other drugs that may cause QT shortening. Before using cenobamate, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions: certain heart problems (irregular heartbeat, QT shortening in the EKG), family history of certain heart problems (QT shortening in the EKG, sudden cardiac death). This drug may make you dizzy or drowsy or cause blurred 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). During pregnancy, this medication should be used only when clearly needed. However, since untreated seizures are a serious condition that can harm both a pregnant woman and her unborn baby, do not stop taking this medication unless directed by your doctor. If you are planning pregnancy, become pregnant, or think you may be pregnant, discuss with your doctor right away the benefits and risks of using this medication during pregnancy. Since birth control pills, patches, implants, and injections may not work if used with this medication (see also Drug Interactions section), discuss reliable forms of birth control with your doctor. It is unknown if this medication passes into breast milk. Consult your doctor before breastfeeding. Side EffectsDrowsiness, dizziness, tiredness, nausea, vomiting, constipation, decreased appetite, diarrhea, or weakness 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: problems with walking/balance, problems with coordination, vision changes (such as blurred vision, double vision, decreased vision), feeling of spinning (vertigo), trouble reading/speaking/writing, signs of liver disease (such as nausea/vomiting that doesn't stop, stomach/abdominal pain, yellowing eyes/skin, dark urine). Get medical help right away if you have any very serious side effects, including: fast/irregular heartbeat, severe dizziness, 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 problems thinking clearly or paying attention, slowed thinking, confusion, memory problems, 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: fever, swollen lymph nodes, 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. |