Rufinamide

Rufinamide is used with other medication(s) to control seizures in people who have Lennox-Gastaut syndrome (a severe form of epilepsy that begins during childhood and causes several types of seizures, behavioral disturbances, and developmental delays). Rufinamide is in a class of medications called anticonvulsants. It works by decreasing abnormal excitement in the brain.

Rufinamide comes as a tablet to take by mouth. It is usually taken with food twice a day. Take rufinamide at around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take rufinamide exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Rufinamide tablets may be swallowed whole, broken in half on the score mark, or crushed. Talk to your doctor or pharmacist about the best way for you to take rufinamide.

Your doctor will probably start you on a low dose of rufinamide and gradually increase your dose, not more than once every other day.

Rufinamide may help to control your condition but will not cure it. Continue to take rufinamide even if you feel well. Do not stop taking rufinamide without talking to your doctor. If you suddenly stop taking rufinamide, your seizures may worsen. Your doctor will probably decrease your dose gradually.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with rufinamide and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (https://www.fda.gov/Drugs) or the manufacturer's website to obtain the Medication Guide.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before taking rufinamide,

• tell your doctor and pharmacist if you are allergic to rufinamide or any other medications.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take while taking rufinamide. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you have or have ever had familial short QT syndrome (an inherited condition that causes irregular heartbeat, dizziness, fainting, or sudden death). Your doctor will probably tell you not to take rufinamide.
• tell your doctor if you are being treated with dialysis (treatment to remove waste from the blood when the kidneys are not working well) and if you have or have ever had liver disease.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking rufinamide, call your doctor.
• you should know that rufinamide may decrease the effectiveness of hormonal contraceptives (birth control pills, patches, rings, implants, and injections). Talk to your doctor about methods of birth control that will work for you while you are taking rufinamide.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking rufinamide.
• you should know that rufinamide may make you drowsy. Do not drive a car or operate machinery until you know how this medication affects you.
• ask your doctor about the safe use of alcoholic beverages while you are taking rufinamide. Alcohol can make the side effects from rufinamide worse.
• you should know that your mental health may change in unexpected ways, and you may become suicidal (think about harming or killing yourself or plan or try to do so) while you are taking rufinamide. A small number of adults and children 5 years of age and older who took anticonvulsants such as rufinamide during clinical studies were found to be twice as likely to become suicidal than people who did not take the medication. This increased risk of suicidal behavior was seen as early as one week after starting the medication. You, your family, or your caregiver should call your doctor right away if you experience any of the following symptoms: difficulty falling asleep or staying asleep, impulsive and dangerous behavior, panic attacks, anxiety, agitation, hostility, mania (frenzied, abnormally excited mood), talking or thinking about wanting to hurt yourself or end your life, withdrawing from friends and family, new or worsening depression, preoccupation with death and dying, or giving away prized possessions. Be sure that your family or caregiver knows which symptoms may be serious so they can call the doctor if you are unable to seek treatment on your own.

Unless your doctor tells you otherwise, continue your normal diet.

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Rufinamide may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• sleepiness
• headache
• loss of coordination
• difficulty walking
• excessive movement or activity
• uncontrollable shaking of a part of the body
• uncontrollable movements of the eyes
• difficulty paying attention
• dizziness
• loss of appetite
• nausea
• vomiting
• back pain
• stomach pain

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:

• fever
• rash
• hives
• itching
• swelling of the face
• decreased ability to respond to others
• seizures
• blurred or double vision
• yellowing of the skin or eyes
• dark-colored urine
• light-colored stool

Rufinamide may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (https://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Keep all appointments with your doctor.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

• Banzel^®