Banzel

This medicine will not cure LGS and will only work to control seizures for as long as you continue to take it.

This medicine is available only with your doctor`s prescription.

This product is available in the following dosage forms:

• Tablet

Before Using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of rufinamide in children below 4 years of age. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of rufinamide in the elderly. However, elderly patients are more likely to have age-related heart, kidney, or liver problems, which may require an adjustment in the dose in patients receiving rufinamide.

Pregnancy

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Carbamazepine


• Estradiol Cypionate


• Ethinyl Estradiol


• Etonogestrel


• Lamotrigine


• Levonorgestrel


• Medroxyprogesterone


• Mestranol


• Norethindrone


• Norgestrel


• Phenobarbital


• Phenytoin


• Primidone


• Triazolam


• Valproic Acid

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Familial Short QT syndrome (heart rhythm problem)a€”Should not be used in patients with this condition.

• Heart rhythm problems (e.g., shortened QT interval)a€”Use with caution. May make this condition worse.

• Liver diseasea€”Use with caution. The effects may be increased because of slower removal of the medicine from the body .

Proper Use

Take this medicine only as directed by your doctor . Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

It is best to take this medicine with food.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor`s orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  
  
  
  • For seizures:
    
    
    
    • Adultsa€”At first, 400 to 800 milligrams (mg) per day taken in two divided doses. Your doctor may gradually increase your dose if needed. However, the dose is usually not more than 3,200 mg per day.
    
    
    • Children 4 years of age and oldera€”Dose is based on body weight . The usual dose is 10 milligrams (mg) per kilogram (kg) of body weight per day taken in two divided doses. Your doctor may gradually increase your dose if needed. However, the dose is usually not more than 45 mg/kg/day or 3,200 mg per day.
    
    
    • Children below 4 years of agea€”Use and dose must be determined by your doctor .
    
    
    
    
  
  
  
  

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly.

If you develop any unusual or strange thoughts and behavior while taking rufinamide, be sure to discuss it with your doctor . Some changes that have occurred in people taking this medicine are like those seen in people who drink too much alcohol . Other changes might be confusion, worsening of depression, hallucinations (seeing, hearing, or feeling things that are not there), suicidal thoughts, and unusual excitement, nervousness, or irritability.

This medicine may cause some people to become drowsy, dizzy, lightheaded, clumsy, unsteady, or less alert than they are normally. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not alert or able to think or see well .

Rufinamide may cause serious allergic reactions that may affect several parts of the body (e.g., liver or kidney). Check with your doctor right away if you have the following symptoms: fever, dark-colored urine, headache, rash, itching, extra fluid around the face, stomach pain, unusual tiredness, or yellow eyes or skin .

Do not stop taking this medicine without checking with your doctor first. Your doctor may want you to gradually reduce the amount you are using before stopping it completely.

Avoid drinking alcohol while taking this medicine.

Do not take other medicines unless they have been discussed with your doctor . This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention .

Check with your doctor immediately if any of the following side effects occur:

More common

• Dizziness


• Shakiness in the legs, arms, hands, or feet


• Sleepiness or unusual drowsiness


• Trembling or shaking of the hands or feet


• Uncontrolled eye movements

Less common

• Attack, assault, or force


• Chills


• Cough producing mucus


• Diarrhea


• Difficulty breathing


• Dizziness or lightheadedness


• Fear or nervousness


• Feeling of constant movement of self or surroundings


• Fever


• General feeling of discomfort or illness


• Headache


• Joint pain


• Loss of appetite


• Muscle aches and pains


• Nausea


• Pain or tenderness around the eyes and cheekbones


• Rash


• Restlessness


• Runny nose


• Sensation of spinning


• Shakiness and unsteady walk


• Shivering


• Shortness of breath or troubled breathing


• Sore throat


• Stuffy or runny nose


• Sweating


• Tightness in the chest


• Trouble in walking


• Trouble sitting still


• Trouble sleeping


• Unsteadiness, trembling, or other problems with muscle control or coordination


• Unusual tiredness or weakness


• Vomiting


• Wheezing

Rare

• Black, tarry stools


• Bleeding gums


• Blood in urine or stools


• Burning while urinating


• Chest pain


• Difficult or painful urination


• Fainting


• Frequent urination


• Inability to hold urine


• Increased urge to urinate during the night


• Increased volume of pale, dilute urine


• Lower back or side pain


• Pale skin


• Pinpoint red spots on the skin


• Pounding, slow heartbeat


• Sore tongue


• Sores, ulcers, or white spots on the lips or in the mouth


• Swollen glands


• Swollen, painful, or tender lymph glands in the neck, armpit, or groin


• Troubled breathing with exertion


• Unusual bleeding or bruising


• Waking to urinate at night

Some side effects may occur that usually do not need medical attention . These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Blurred vision


• Double vision


• Seeing double

Less common

• Acid or sour stomach


• Back pain


• Belching


• Change in hearing


• Decreased appetite


• Difficulty having a bowel movement (stool)


• Ear drainage


• Earache or pain in the ear


• Heartburn


• Indigestion


• Itching skin


• Stomach discomfort, upset, or pain


• Upper abdominal pain

Rare

• Increased appetite

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional .

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.