Brand Banzel

Rufinamide is used with other medications to prevent or control seizures (epilepsy) associated with Lennox-Gastaut syndrome (LGS) in people aged 4 and older. This medication is an anticonvulsant. Rufinamide is thought to work by acting on the sodium channels in the brain that carry excessive electrical charges that may cause seizures.

Read the Medication Guide provided by your pharmacist before you start using rufinamide and each time you get a refill. If you have any questions, consult your doctor or pharmacist. Take this medication by mouth with food, usually twice daily or as directed by your doctor. If you are using the suspension form of this medication, shake the bottle well before each dose. Measure each dose carefully with the provided oral dosing syringe. Do not use a household spoon because you may not get the correct dose. Rinse the syringe with tap water after each use. 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. It is very important to follow your doctor's dosing instructions exactly. It may take several weeks to reach the best dose for you and to get the full benefit from this medication. Take this medication regularly in order to get the most benefit from it. To help you remember, take it at the same times each day. This drug works best when the amount of medicine in your body is kept at a constant level. Therefore, it is best to take rufinamide at evenly spaced intervals throughout the day and night. Do not stop taking this medication without consulting your doctor. Some conditions (such as seizures) may become worse when the drug is suddenly stopped. Your dose may need to be gradually decreased. Tell your doctor if your condition does not improve or worsens.

Before taking rufinamide, 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. This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: family history of a certain heart problem (QT shortening in the EKG). Before using this medication, tell your doctor or pharmacist your medical history, especially of: severe kidney disease (including dialysis), liver disease, mental/mood disorders (such as depression, thoughts of suicide). This drug may make you dizzy or drowsy or cause blurred/double vision. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Limit alcoholic beverages. During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. This medication may pass into breast milk. Consult your doctor before breast-feeding.

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 and resume your usual dosing schedule. Do not double the dose to catch up.

Your healthcare professionals (e.g., doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring you for it. Do not start, stop or change the dosage of any medicine before checking with them first. Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: valproate. 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 additional reliable 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 diazepam, triazolam, zolpidem), muscle relaxants, and narcotic pain relievers (such as codeine). 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. This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

Drowsiness, dizziness, loss of coordination, trouble walking, tiredness, headache, nausea, vomiting, loss of appetite, or blurred/double vision may occur. If any of these effects persist or worsen, 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. 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 immediately if you or your family/caregiver notice any unusual/sudden changes in your mood, thoughts, or behavior including signs of depression, suicidal thoughts/attempts, thoughts about harming yourself. Tell your doctor immediately if any of these rare but very serious side effects occur: stomach/abdominal pain, yellowing eyes/skin, dark urine, bloody urine, swollen glands. A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, fever, 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. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Store at room temperature away from light and moisture. If using the suspension, store the bottle upright. Do not store in the bathroom. Keep all medicines 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.