Rufinamide belongs to the class of medications called antiepileptics (anti-seizure medications). It is used along with other seizure medications to help control the seizures associated with Lennox-Gastaut syndrome in adults and children 4 years of age and older. Lennox-Gastaut syndrome is a seizure disorder where the person experiences frequent seizures and different types of seizures. Rufinamide is not used to treat other seizure disorders.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

The recommended starting dose for people who weigh less than 30 kg is 100 mg taken twice a day. The recommended starting dose for people who weigh more than 30 kg is 200 mg taken twice a day.

Depending on your body's response to the medication and side effects, your doctor will gradually increase your daily dose until your seizures are controlled. The maximum daily dose is based on your body weight.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

In order to get the most benefit from each dose, take rufinamide with food.

It is important to take this medication exactly as prescribed by your doctor. If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store this medication at room temperature, protect it from light and moisture, and keep it out of the reach of children.

100 mg
Each pink, oval-shaped, slightly convex, film-coated tablet, with a score on both sides and marked with "€261" on one side, contains 100 mg of rufinamide. Nonmedicinal ingredients: colloidal silicon dioxide, corn starch, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium lauryl sulphate; film coating: hypromellose, iron oxide red, polyethylene glycol, talc, and titanium dioxide.

200 mg
Each pink, oval-shaped, slightly convex, film-coated tablet, with a score on both sides and marked with "€262" on one side, contains 200 mg of rufinamide. Nonmedicinal ingredients: colloidal silicon dioxide, corn starch, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium lauryl sulphate; film coating: hypromellose, iron oxide red, polyethylene glycol, talc, and titanium dioxide.

400 mg
Each pink, oval-shaped, slightly convex, film-coated tablet, with a score on both sides and marked with "€263" on one side, contains 400 mg of rufinamide. Nonmedicinal ingredients: colloidal silicon dioxide, corn starch, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium lauryl sulphate; film coating: hypromellose, iron oxide red, polyethylene glycol, talc, and titanium dioxide.

Do not take this medication if you:

• are allergic to rufinamide or any ingredients of this medication
• are allergic to any of the "azole" antifungal drugs (e.g., fluconazole, ketoconazole)
• have a heart arrhythmia called familial short QT syndrome or have a family history or history of short QT syndrome

Do not give this medication to children under 14 years of age.

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• dizziness
• headache
• nausea
• sleepiness
• tiredness
• vomiting

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• signs of depression (e.g., poor concentration, changes in weight, changes in
• signs of liver problems (e.g., nausea, vomiting, diarrhea, loss of appetite, weight loss, yellowing of the skin or whites of the eyes, dark urine, pale stools)

Stop taking the medication and seek immediate medical attention if any of the following occur:

• thoughts of suicide or harming yourself
• signs of allergic reaction (e.g., rash, facial swelling, fever, swollen lymph nodes)
• signs of an irregular heartbeat (e.g., dizziness, palpitations [pounding or racing heartbeat], fainting or loss of consciousness)
• severe skin rash (e.g., blistering, peeling, or loosening of the skin and mucous membranes)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Abnormal heart rhythms: Rufinamide can cause changes to the normal rhythm of the heart, including an irregular heartbeat called QT shortening. QT shortening is a serious condition that can cause fainting and life-threatening heart rhythm problems.

If you are at risk for heart rhythm problems or are taking medications that cause QT shortening (e.g., digoxin, mexiletine, phenytoin, magnesium sulfate), discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. People who have or have had short QT syndrome or a family history of short QT syndrome should not take rufinamide.

Birth control: As with other anti-seizure medications, rufinamide may reduce the effectiveness of oral contraceptives or other female hormonal treatments. It is advisable to use a non-hormonal form of birth control while you are taking this medication. Contact your doctor immediately if you experience changes in your menstrual pattern such as breakthrough bleeding while taking rufinamide.

Drowsiness/reduced alertness: People with uncontrolled epilepsy should not drive or handle potentially dangerous machinery. Common side effects of rufinamide include dizziness, problems with muscle coordination, drowsiness, double vision, and blurred vision. Do not undertake activities requiring mental alertness or physical coordination until you determine how rufinamide affects you.

Galactose Intolerance/Glucose Malabsorption: This medication contains lactose. If you have lactose intolerance or galactose malabsorption you should not take this medication.

Hypersensitivity (allergic) reactions: Rarely, rufinamide can cause severe allergic reactions called "hypersensitivity syndrome," which may be life-threatening. This reaction involves a number of organs in the body and may be fatal if not treated quickly. Stop taking the medication and get immediate medical attention if you have symptoms of a severe allergic reaction, including fever, swollen glands, yellowing of the skin or eyes, or flu-like symptoms with skin rash or blistering.

Stopping the medication: Suddenly stopping any antiepileptic medication may cause rebound seizures. In general, the medication should be stopped gradually, as directed by your doctor, to minimize this risk. Before stopping rufinamide, contact your doctor for guidance.

Suicidal thoughts or behaviour and depression: Like other antiepileptic medications, rufinamide may cause thoughts of suicide or harming oneself. People with epilepsy may also experience depression.

If you experience agitation, restlessness, anxiety, aggressiveness, irritability, unusual changes in behaviour or mood, not feeling like yourself, or wanting to hurt yourself or others, contact your doctor immediately. If you notice these side effects in a family member who is taking this medication, contact their doctor immediately.

Vision problems: Rufinamide may cause vision changes or problems, including blurred vision, seeing double, dry eyes, and eye infections. Report any changes in your vision to your doctor as soon as possible.

Pregnancy: The effect of rufinamide on a developing baby when taken during pregnancy is unclear. This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.

Do not stop taking the medication until you've consulted your doctor, since doing so can cause rebound seizures that may be harmful to the mother and unborn baby.

Breast-feeding: This medication may pass into breast milk. If you are a breast-feeding mother and are taking rufinamide, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using rufinamide for children under 1 year of age have not been established.

Seniors: The use of rufinamide by people over 65 years of age has not been well studied. Seniors are at increased risk of side effects of many medications and a lower-than normal dose of rufinamide may be appropriate.

There may be an interaction between rufinamide and any of the following:

• alcohol
• antihistamines (e.g., cetirizine, doxylamine, diphenhydramine, hydroxyzine, loratadine)
• anti-psychotics (e.g., cariprazine, chlorpromazine, clozapine, haloperidol, olanzapine, quetiapine, risperidone)
• barbiturates (e.g., butalbital, phenobarbital)
• benzodiazepines (e.g., clonazepam, diazepam, lorazepam, triazolam)
• birth control pills
• brimonidine
• buprenorphine
• chloral hydrate
• clonidine
• dimenhydrinate
• diphenoxylate
• efavirenz
• entacapone
• esketamine
• estrogens (e.g., conjugated estrogen, estradiol, ethinyl estradiol)
• flibanserin
• flunarizine
• general anesthetics (medications used to put people to sleep before surgery)
• guanfacine
• ketotifen
• lemborexant
• methadone
• mirtazapine
• muscle relaxants (e.g., baclofen, cyclobenzaprine, methocarbamol, orphenadrine)
• narcotic pain relievers (e.g., codeine, fentanyl, morphine, oxycodone, tapentadol, tramadol)
• nimodipine
• olopatadine
• perampanel
• pomalidomide
• pregabalin
• progestins (e.g., dienogest, levonorgestrel, medroxyprogesterone, norethindrone)
• scopolamine
• other seizure medications (e.g., carbamazepine, clobazam, levetiracetam, phenobarbital, phenytoin, primidone, topiramate, valproic acid, zonisamide)
• selpercatinib
• sirolimus
• tacrolimus
• tetrabenazine
• tizanidine
• trazodone
• tricyclic antidepressants (e.g., amitriptyline, desipramine, nortriptyline)
• zopiclone
• zolpidem

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.