September 18, 2014
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Drug Factsheets

 Health Home >> Medications 

Banzel

(rufinamide)

DIN (Drug Identification Number)

02369613 BANZEL 100MG TABLET
02369621 BANZEL 200MG TABLET
02369648 BANZEL 400MG TABLET

What side effects are possible with Banzel?

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.

  • acne
  • decreased appetite
  • diarrhea
  • dizziness
  • dry eyes
  • dry skin
  • fatigue
  • flu-like symptoms (sudden lack of energy, fever, cough, sore throat)
  • headache
  • muscle aches
  • nausea
  • nose bleeds
  • sleepiness
  • stuffy or runny nose
  • 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
  • changes to menstrual cycle
  • difficulty walking
  • difficulty speaking
  • disorientation
  • fever
  • inability to concentrate or focus
  • involuntary eye movement
  • loss of appetite
  • mood changes
  • rapid or irregular heartbeat
  • reduced coordination
  • ringing in the ears
  • sensation of spinning
  • signs of anemia (low red blood cells; e.g., pale skin, unusual tiredness or weakness)
  • signs of depression (e.g., poor concentration, changes in weight, changes in sleep, decreased interest in activities, thoughts of suicide)
  • signs of eye infection (e.g., red, painful, irritated eyes)
  • signs of infection (symptoms may include fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness)
  • tremor
  • 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
  • seizures lasting longer than 5 minutes
  • signs of allergic reaction (e.g., rash, facial swelling, fever, swollen lymph nodes)

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.





Are there any other precautions or warnings for Banzel?

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.

Hypersensitivity (allergic) reactions: Rarely, rufinamide can cause severe allergic reactions that may be life-threatening. These reactions may involve several organs. If you experience any rash, swelling of the face or lymph nodes around the neck, contact your doctor immediately.

Liver function: If you have reduced liver function or liver disease, 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. The use of rufinamide by people with severe liver impairment is not recommended.

Red blood cells: Rufinamide may cause low levels of red blood cells. If you experience symptoms of reduced red blood cell count (anemia) such as shortness of breath, feeling unusually tired or pale skin, contact your doctor as soon as possible.

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, do not feel like yourself, or if you want 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 4 years 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.

What other drugs could interact with Banzel?

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

  • alcohol
  • birth control pills
  • carbamazepine
  • divalproex
  • lamotrigine
  • phenobarbital
  • phenytoin
  • primidone
  • triazolam
  • valproic acid

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.

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