What Banzel is used for and how to use it
Россия
  • Россия
  • Украина

Banzel - Consumer Medicine Information

Manufacture: Eisai Inc.
Country: Canada
Condition: Epilepsy, Lennox-Gastaut Syndrome, Seizures (Convulsions)
Class: Anticonvulsants
Form: Tablets
Ingredients: rufinamide, colloidal silicon dioxide, corn starch crosscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium lauryl sulphate, iron oxide red, polyethylene glycol, talc, and titanium dioxide.

Rufinamide Tablets

About This Medication

What the Medication is Used For

BANZEL is a prescription medication used with other antiepileptic drugs to treat seizures associated with Lennox-Gastaut syndrome in adults and children 4 years of age and older by decreasing the overall number and severity of seizures, and the number of drop attacks.

What It Does

The exact way in which BANZEL controls seizures is not known.

When It Should not be Used

You should not take BANZEL if:

  • You have a family history of a genetic condition called Familial Short QT syndrome that affects the electrical system of the heart.
  • You are allergic to any of the ingredients in BANZEL or to triazole derivatives.
  • You are breastfeeding.

Do not use BANZEL for a condition for which it was not prescribed. Do not give BANZEL to other people, even if they have the same symptoms as you. It may harm them.

What the Medicinal Ingredient Is

Rufinamide

What the Nonmedicinal Ingredients Are

Colloidal silicon dioxide, corn starch, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium lauryl sulphate.

What Dosage Form It Comes In

Tablets: 100 mg, 200 mg, and 400 mg

Warnings and Precautions

BEFORE you use BANZEL talk to your doctor or pharmacist if you:

  • Have heart problems
  • Have liver problems
  • Have other medical problems
  • Have or have had suicidal thoughts or actions, depression or mood problems
  • Are pregnant, or think you might be pregnant, or intend to become pregnant while taking BANZEL. It is not known if BANZEL can harm your unborn baby. Tell your doctor right away if you become pregnant while taking BANZEL. You and your doctor will decide if you should take BANZEL while you are pregnant.
  • BANZEL may make certain types of birth control (i.e., hormonal contraceptives) less effective. Talk to your doctor about the best birth control methods for you while taking BANZEL.
    • If you become pregnant while taking BANZEL, talk to your doctor about registering with the North American Antiepileptic Drug Pregnancy Registry. You can enroll in this registry by calling 1-888-233-2334. The purpose of this registry is to collect information about the safety of antiepileptic medicines during pregnancy.
  • Are breast-feeding or plan to start breast-feeding while taking BANZEL. BANZEL may pass into your breast milk. You and your doctor should decide if you will take BANZEL or breastfeed. You should not do both.

Like other antiepileptic drugs, BANZEL may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. You should contact your doctor right away or go to the nearest hospital if you have any of these symptoms, especially if they are new, worse, or worry you:

  • Attempt to commit suicide
  • New or worse depression
  • New or worse anxiety
  • Feeling agitated or restless
  • Panic attacks
  • Trouble sleeping (insomnia)
  • New or worse irritability
  • Acting aggressive, being angry, or violent
  • Acting on dangerous impulses
  • An extreme increase in activity and talking (mania)
  • Other unusual changes in behaviour or mood
  • Suicidal thoughts or actions can be caused by things other than medicines. If you have suicidal thoughts or actions, your doctor may check for other causes.

You should pay attention to any changes, especially sudden changes, in mood, behaviours, thoughts or feelings.

You should keep all follow-up visits with your doctor as scheduled and call your doctor between visits as needed, especially if you are worried about symptoms.

Do not stop BANZEL without first talking to your doctor.

  • Stopping BANZEL suddenly can cause serious problems. Stopping a seizure medication suddenly in a patient who has epilepsy can cause seizures that will not stop (status epilepticus).

BANZEL may cause you to feel sleepy, tired, weak, dizzy or have problems with coordination and walking. Do not drive, operate heavy machinery or do other dangerous activities until you know how BANZEL affects you. BANZEL can slow your thinking and motor skills.

Interactions With This Medication

Tell your doctor about all the medications you take, including prescription and non-prescription medicines, vitamins and herbal supplements. Taking BANZEL with certain other medications can cause side effects or affect how well they work.

Do not start or stop other medications without telling your doctor about all other medications you are taking e.g., when adding another antiepileptic drug to your treatment with BANZEL. The other antiepileptic drug may change the concentration of BANZEL. Your doctor will have to adjust the dosage of the new drug.

Know the medications you take. Keep a list of them to show your doctor and pharmacist each time you get a new medication.

Do not drink alcohol or take other medications that make you sleepy or dizzy while taking BANZEL until you talk to your doctor.

Taking BANZEL with alcohol or medications that cause sleepiness or dizziness may make your sleepiness or dizziness worse.

Proper Use of This Medication

Usual Starting Dose

Use in children and adults less than 30 kg:

Treatment initiated at 200 mg/day in two divided doses. Maximum recommended dose not over 1300 mg/day.

Use in adults and children 30 kg or over:

Treatment initiated at 400 mg/day in two divided doses. Maximum recommended dose as per the weight table. Safety of doses above 3200 mg/day has not been established

Your doctor will adjust your dosage until a satisfactory control of seizures is obtained.

Weight Table
Weight range 30.0 to 50.0
kg
50.1 to 70.0
kg
Equal to or
more than
70.1 kg
Maximum recommended dose (mg/day) 1800 2400 3200

Take BANZEL exactly as your doctor tells you.

Do not change your dose of BANZEL without talking to your doctor.

Do not stop BANZEL without first talking to a doctor. Stopping

BANZEL suddenly can cause serious problems. Stopping a seizure medication suddenly in a patient who has epilepsy can cause seizures that will not stop (status epilepticus).

Take BANZEL with food.

BANZEL can be swallowed whole, cut in half or crushed.

Overdose:

In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Missed Dose:

A missed dose should be taken as soon as possible. However, if it is almost time for the next dose skip the missed dose and continue taking BANZEL as normal. Do not take a double dose to make up for a forgotten dose. If you miss more than one dose, seek advice from your doctor.

Side Effects and What to Do About Them

The most common side effects of BANZEL include:

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

BANZEL can also cause allergic reactions or serious problems which may affect organs and other parts of your body like the liver or blood cells. You may or may not have a rash with these types of reactions.

Serious Side Effects, how Often They Happen and What to Do About Them

Symptom / effect Talk with your
doctor or
pharmacist
Seek Emergency Medical Attention
Only if
severe
In all
cases
Rare Thoughts of suicide or hurting yourself
Allergic reaction (symptoms include swelling in the eyes, lips, mouth, tongue, face and throat, itching, rash, hives)
Serious skin reactions that typically present with any combination of rash, redness, blistering of the lips, eyes or mouth, skin peeling, accompanied by fever, chills, headache, cough, body aches or swollen lymph nodes, joint pain, and may be associated with signs and symptoms involving other organs, e.g. liver.
Very Rare Liver disorder (symptoms include: nausea, vomiting, loss of appetite combined with itching, yellowing of the skin or eyes, dark urine)
Cardiac arrhythmias (potential symptoms: irregular pulse, slow pulse, rapid pulse, palpitations, shortness of breath, dizziness)

This is not a complete list of side effects. For any unexpected effects while taking BANZEL, contact your doctor or pharmacist.

How to Store It

Store your BANZEL tablets at room temperature (15o to 30oC) in a dry place. Cap the bottle tightly immediately after use. Keep out of reach and sight of children.

Reporting Suspected Side Effects

You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:

  • Report online at www.healthcanada.gc.ca/medeffect
  • Call toll-free at 1-866-234-2345
  • Complete a Canada Vigilance Reporting Form and:
    • Fax toll-free to 1-866-678-6789, or
    • Mail to: Canada Vigilance Program
            Health Canada
            Postal Locator 0701D
            Ottawa, Ontario
            K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect Canada Web site at www.healthcanada.gc.ca/medeffect.

NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.

More Information

This document plus the full product monograph, prepared for health professionals can be obtained by contacting the sponsor, Eisai Limited, at: 1-877-873-4724.

BANZEL is a trademark of Novartis Pharma AG, used under licence.

Eisai Limited, Mississauga, ON L5N 7K2