Important Note

The following information is intended to supplement, not substitute for, the expertise and judgment of your physician, pharmacist or other healthcare professional. It should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. Consult your healthcare professional before using this drug.

FELBAMATE - ORAL SUSPENSION

(FELL-bum-ate)

COMMON BRAND NAME(S): Felbatol

WARNING: Because severe, even fatal, blood disorders (aplastic anemia, pancytopenia) and liver problems have occurred with usage of felbamate, it should be used only in people with severe epilepsy and only after careful consideration. Aplastic anemia may occur even after the drug has been stopped. This drug is not recommended for use in those who have liver problems. Stop using this drug and immediately notify your doctor if you have symptoms of infection such as fever, chills, or persistent sore throat or if you have unusual bleeding or bruising, weakness, fatigue, dark urine, yellowing of the eyes or skin, or persistent stomach/abdominal pain. Your doctor will perform liver function tests before starting felbamate and every 1 to 2 weeks while you use this drug. Blood tests may also be performed.

Uses

This medication is used to treat partial seizures and epilepsy when other treatments have failed.

How To Use

Shake well before using. This medication may be taken with or without food. Take with food or milk if stomach upset occurs. Follow the dosing schedule precisely. Do not stop taking this drug suddenly without consulting your doctor as seizures may occur. It is important to take all doses on time to keep the level of medication in your blood constant. Do this by taking doses at the same time(s) each day. Do not skip doses.

Side Effects

This medication may rarely cause severe anemia and liver damage. Be sure to notify your doctor immediately if you experience any of the following: fever, sore throat or mouth, easy bruising, pale skin, pale fingernails, skin rash, hives, itching, fatigue, loss of appetite, dark urine, pale stools, yellowing of the skin or eyes. Other side effects are relatively mild. The most frequent are nausea, vomiting, constipation, insomnia, headache, anorexia and weight loss. These tend to diminish over time with continued use. Drowsiness has been reported (along with the previously mentioned side effects) when taking other seizure medication concurrently with felbamate. Be sure to tell your doctor if any of these side effects persist. If you notice other effects not listed above, contact your doctor or pharmacist.

Precautions

Tell your doctor if you have: kidney problems, heart disease, liver disease, anemia, allergies (especially drug allergies). This medication is only to be used when other treatments have not been successful and the risk of aplastic anemia is acceptable. This medication may make you more sensitive to the sun. Avoid prolonged sun exposure. Wear protective clothing and use a sunscreen when outdoors. This medication should be used only if clearly needed during pregnancy. Discuss the risks and benefits with your doctor. This medication appears in breast milk. Consult your doctor before breast-feeding.

Drug Interactions

Tell your doctor of all prescription and nonprescription drugs you may use, especially of: other seizure drugs (e.g., carbamazepine, divalproex, phenytoin, valproic acid). Do not start or stop any medicine without doctor or pharmacist approval.

Overdose

If overdose is suspected, contact your local poison control center or emergency room immediately. Symptoms of overdose may include stomach upset and fast heart rate.

Notes

Be sure to let your doctor know you if you are taking any other medication for seizures because the dose may need to be adjusted.

Missed Dose

If you miss a dose, contact your doctor who will help establish a new dosing schedule. Do not "double-up" the dose to catch up.

Storage

Store at room temperature between 59 and 86 degrees F (between 15 and 30 degrees C) away from moisture and sunlight. Do not store in the bathroom.

Medical Alert

Your condition can cause complications in a medical emergency. For enrollment information call MedicAlert at 1-800-854-1166 (USA), or 1-800-668-1507 (Canada).