Banzel

Rufinamide Oral Suspension

(roo FIN a mide)

Banzel

It is used to help control certain kinds of seizures.

If you are allergic to this drug; any part of this drug; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had. If you have Familial Short QT syndrome. If you have liver disease. This is not a list of all drugs or health problems that interact with this drug. Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this drug with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

Tell all of your health care providers that you take this drug. This includes your doctors, nurses, pharmacists, and dentists. Avoid driving and doing other tasks or actions that call for you to be alert until you see how this drug affects you. Do not stop taking this drug all of a sudden without calling your doctor. You may have a greater risk of seizures. If you need to stop this drug, you will want to slowly stop it as ordered by your doctor. Have blood work checked as you have been told by the doctor. Talk with the doctor. Talk with your doctor before you drink alcohol or use other drugs and natural products that slow your actions. Birth control pills and other hormone-based birth control may not work as well to prevent pregnancy. Use some other kind of birth control also like a condom when taking this drug. Tell your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding. You will need to talk about the benefits and risks to you and the baby.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect: Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat. Shortness of breath, a big weight gain, or swelling in the arms or legs. Any unexplained bruising or bleeding. Very bad muscle pain or weakness. Change in balance. Trouble walking. Shakiness. Change in eyesight. Not able to control eye movements. If seizures are worse or not the same after starting this drug. Like other drugs that may be used for seizures, this drug may rarely raise the risk of suicidal thoughts or actions. The risk may be higher in people who have had suicidal thoughts or actions in the past. Call the doctor right away about any new or worse signs like depression; feeling nervous, restless, or grouchy; panic attacks; or other changes in mood or behavior. Call the doctor right away if any suicidal thoughts or actions occur. A very bad and sometimes deadly effect has happened in people taking drugs for seizures like this drug. Call your doctor right away if you have swollen glands; fever; rash; chest pain; unable to pass urine or change in the amount of urine passed; or signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes. Low white blood cell counts have happened with this drug. This may lead to a higher chance of getting an infection. Call your doctor right away if you have signs of infection like fever, chills, or sore throat.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away: Feeling dizzy, sleepy, tired, or weak. Headache. Upset stomach or throwing up. Flu-like signs. Nose or throat irritation. Not hungry. These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

Use this drug as ordered by your doctor. Read all information given to you. Follow all instructions closely. Take this drug with food. If the adapter has not been put in the bottle when you get it, follow how to prepare the bottle as you have been told or read the package insert. Shake well before use. Only use the measuring device that comes with this liquid drug. Keep taking this drug as you have been told by your doctor or other health care provider, even if you feel well. Do not change the dose or stop this drug. This could cause seizures. Talk with your doctor.

Take a missed dose as soon as you think about it. If it is close to the time for your next dose, skip the missed dose and go back to your normal time. Do not take 2 doses at the same time or extra doses.

Store at room temperature in a dry place. Do not store in a bathroom. Throw away any part not used 90 days after opening. Store upright with the cap on. Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets. Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

If your symptoms or health problems do not get better or if they become worse, call your doctor. Do not share your drugs with others and do not take anyone else's drugs. This drug comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time this drug is refilled. If you have any questions about this drug, please talk with the doctor, pharmacist, or other health care provider. If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.