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 Banzel (Rufinamide). If you are concerned about side effects, discuss the risks and benefits of Banzel (Rufinamide) with your doctor.

The following side effects have been reported by at least 1% of people taking Banzel (Rufinamide). 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.

• decreased appetite
• 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:

• balance problems
• difficulty walking
• 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)
• vision changes (e.g., double vision, blurred vision)

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 Banzel (Rufinamide).

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 Banzel (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 Banzel (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 Banzel (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 Banzel (Rufinamide) if you:

• are allergic to Banzel (Rufinamide) or any ingredients of Banzel (Rufinamide)
• 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 Banzel (Rufinamide) to children under 4 years of age.

There may be an interaction between Banzel (Rufinamide) and any of the following:

• alcohol
• antihistamines (e.g., cetirizine, doxylamine, Diphenhydramine, Hydroxyzine, Loratadine)
• anti-psychotics (e.g., Chlorpromazine, Clozapine, Haloperidol, Olanzapine, Quetiapine, Risperidone)
• barbiturates (e.g., butalbital, Phenobarbital)
• benzodiazepines (e.g., Clonazepam, Diazepam, Lorazepam)
• birth control pills
• Buspirone
• chloral hydrate
• Entacapone
• Methadone
• Mirtazapine
• muscle relaxants (e.g., Baclofen, Cyclobenzaprine, methocarbamol, orphenadrine)
• narcotic pain relievers (e.g., Codeine, Fentanyl, Morphine, Oxycodone)
• Olopatadine
• scopolamine
• other seizure medications (e.g.,  Carbamazepine, Clobazam, Levetiracetam, phenobarbital, phenytoin, primidone, Topiramate, Valproic acid, zonisamide)
• Tapentadol
• tolcapone
• Tramadol
• 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 Banzel (Rufinamide). 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.

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 Banzel (Rufinamide).

Abnormal heart rhythms: Banzel (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 Banzel (Rufinamide) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Banzel (Rufinamide), 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 Banzel (Rufinamide).

Birth control: As with other anti-seizure medications, Banzel (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 Banzel (Rufinamide). Contact your doctor immediately if you experience changes in your menstrual pattern such as breakthrough bleeding while taking Banzel (Rufinamide).

Drowsiness/reduced alertness: People with uncontrolled Epilepsy should not drive or handle potentially dangerous machinery. Common side effects of Banzel (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 Banzel (Rufinamide) affects you.

Galactose Intolerance/Glucose Malabsorption: Banzel (Rufinamide) contains lactose. If you have lactose intolerance or galactose malabsorption you should not take Banzel (Rufinamide).

Hypersensitivity (allergic) reactions: Rarely, Banzel (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 Anaphylaxis (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 Banzel (Rufinamide), contact your doctor for guidance.

Suicidal thoughts or behaviour and depression: Like other antiepileptic medications, Banzel (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 Banzel (Rufinamide), contact their doctor immediately.

Vision problems: Banzel (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 Banzel (Rufinamide) on a developing baby when taken during pregnancy is unclear. Banzel (Rufinamide) should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking Banzel (Rufinamide), 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: Banzel (Rufinamide) may pass into breast milk. If you are a breast-feeding mother and are taking Banzel (Rufinamide), it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using Banzel (Rufinamide) for children under 1 year of age have not been established.

Seniors: The use of Banzel (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 Banzel (Rufinamide) may be appropriate.