Felbatol

Felbamate acts on the central nervous system (CNS) to make it more difficult for seizures to start or to continue. This medicine cannot cure epilepsy and will only work to control seizures for as long as you continue to use it.

Felbamate is available only with your doctor`s prescription.

This product is available in the following dosage forms:

• Tablet


• Suspension

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

This medicine has some very serious unwanted effects. Children may not be able to tell their parent or guardian or their doctor if they have symptoms of these effects, such as chills or stomach pain. Felbamate should be used in children only if other medicines have not controlled their seizures.

Geriatric

Many medicines have not been studied specifically in older people . Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people . There is no specific information comparing use of felbamate in the elderly with use in other age groups. However, older people are more likely to have other illnesses and to use other medicines that may affect the way felbamate works. Your doctor may start with a lower felbamate dose or may increase the dose more slowly.

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 is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Clopidogrel


• Ethinyl Estradiol


• Gestodene

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


• Clobazam


• Fosphenytoin


• Ginkgo


• Methsuximide


• Phenytoin


• Valproic Acid


• Warfarin

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:

• Anemia or other blood problems (or history of) or


• Liver problems (or history of)a€”Felbamate may make the condition worse

Proper Use

Take this medicine only as directed by your doctor, to benefit your condition as much as possible. 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.

For patients taking the oral liquid form of this medicine:

• Shake the bottle well before measuring the dose .


• Use a specially marked measuring spoon, a plastic syringe, or a small marked measuring cup to measure each dose accurately. The average household teaspoon may not hold the right amount of liquid .

To lessen stomach upset, felbamate may be taken with food, unless your doctor has told you to take it on an empty stomach.

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 forms (suspension or tablets):
  
  
  
  • For epilepsy:
    
    
    
    • Adults and teenagers 14 years of age and oldera€”At first, usually 1200 milligrams (mg) a day, divided into three or four smaller doses. Your doctor may increase the dose gradually over several weeks if needed. However, the dose is usually not more than 3600 mg a day.
    
    
    • Children 2 to 14 years of agea€”At first, usually 15 mg per kilogram (kg) [6.8 mg per pound] of body weight per day, divided into smaller doses that are given three or four times during the day. Your doctor may increase the dose gradually over a few weeks if needed. However, the dose is usually not more than 45 mg per kg [20.5 mg per pound] or 3600 mg per day, whichever is less .
    
    
    
    
  
  
  
  

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.

Precautions

It is important that your doctor check your progress at regular visits. This is necessary to allow dose adjustments and to test for serious unwanted effects.

Do not stop taking felbamate without first checking with your doctor . Your doctor may want you to gradually reduce the amount you are taking before stopping completely. Stopping the medicine suddenly may cause your seizures to return or to occur more often.

Felbamate may cause blurred vision, double vision, or other changes in vision . It may also cause some people to become dizzy or drowsy. 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 see well . If these reactions are especially bothersome, check with your doctor .

Side Effects

Felbamate may cause some serious side effects, including blood problems and liver problems . You and your doctor should discuss the good this medicine will do as well as the risks of receiving it.

Along with its needed effects, a medicine may cause some unwanted effects. Some side effects will have signs or symptoms that you can see or feel. Your doctor may watch for others by doing certain tests. 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

• Fever


• Purple or red spots on skin

Rare

• Black or tarry stools


• Blood in urine or stools


• Chills


• Continuing headache


• Continuing stomach pain


• Continuing vomiting


• Dark-colored urine


• General feeling of tiredness or weakness


• Light-colored stools


• Nosebleeds or other unusual bruising or bleeding


• Shortness of breath, trouble in breathing, wheezing, or tightness in chest


• Sore throat


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


• Swelling of face


• Swollen or painful glands


• Yellow eyes or skin

Check with your doctor as soon as possible if any of the following side effects occur:

More common

• Walking in unusual manner

Less common

• Agitation, aggression, or other mood or mental changes


• Clumsiness or unsteadiness


• Skin rash


• Trembling or shaking

Rare

• Chest pain


• Hives or itching


• Muscle cramps


• Nasal congestion


• Pain


• Sensitivity of skin to sunlight


• Swollen lymph nodes

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

• Change in your sense of taste


• Constipation


• Difficulty in sleeping


• Dizziness


• Headache


• Indigestion


• Loss of appetite


• Nausea


• Stomach pain


• Vomiting

Less common

• Blurred or double vision


• Coughing


• Diarrhea


• Drowsiness


• Ear congestion or pain


• Runny nose


• Sneezing


• Weight loss

This medicine may also cause the following side effects that your doctor will watch for:

Rare

• Blood problems

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.