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DIN (Drug Identification Number)
02369613 BANZEL 100MG TABLET
02369621 BANZEL 200MG TABLET
02369648 BANZEL 400MG TABLET
How does this medication work? What will it do for me?
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.
What form(s) does this medication come in?
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.
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.
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.
How should I use this medication?
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.
Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.
Who should NOT take this medication?
- 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 take this medication if you:
Do not give this medication to children under 4 years of age.
What side effects are possible with this medication?
- decreased appetite
- dry eyes
- dry skin
- flu-like symptoms (sudden lack of energy, fever, cough, sore throat)
- muscle aches
- nose bleeds
- stuffy or runny nose
- balance problems
- changes to menstrual cycle
- difficulty walking
- difficulty speaking
- 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)
- 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)
- 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)
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.
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:
Stop taking the medication and seek immediate medical attention if any of the following occur:
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 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.
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, 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 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 this medication?
- antihistamines (e.g., cetirizine, doxylamine, diphenhydramine, hydroxyzine, loratadine)
- anti-psychotics (e.g., chlorpromazine, clozapine, haloperidol, olanzepine, quetiapine, risperidone)
- barbiturates (e.g., butalbital, phenobarbital)
- benzodiazepines (e.g., clonazepam, diazepam, lorazepam)
- birth control pills
- chloral hydrate
- muscle relaxants (e.g., cyclobenzaprine, methocarbamol, orphenadrine)
- narcotic pain relievers (e.g., codeine, fentanyl, morphine, oxycodone)
- tricyclic antidepressants (e.g., amitriptyline, desipramine, nortriptyline)
- valproic acid
- 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.
There may be an interaction between rufinamide and any of the following:
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:
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.
All material copyright MediResource Inc. 1996 – 2019. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/drug/getdrug/Banzel
All material © 1996-2019 MediResource Inc. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition.
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