Felbamate Tablets

What is this medication?

FELBAMATE (fel BAM ate) prevents and controls seizures in people with epilepsy. It works by calming overactive nerves in your body.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Felbatol

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Blood disorders or disease
• Liver disease
• Suicidal thoughts, plans, or attempt by you or a family member
• An unusual or allergic reaction to felbamate, carbamates, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

Take this medication by mouth with a glass of water. Follow the directions on the prescription label. This medication may be taken with or without food. Take your doses at regular intervals. Do not take your medication more often than directed. Do not stop taking this medication suddenly. This increases the risk of seizures. Your care team will tell you how much medication to take. If your care team wants you to stop the medication, the dose will be slowly lowered over time to avoid any side effects.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your care team about the use of this medication in children. While this medication may be prescribed for children for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medication?

• Carbamazepine
• Female hormones, including contraceptive or birth control pills
• Phenobarbital
• Phenytoin
• Sevelamer
• Valproic acid

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress.

Wear a medical ID bracelet or chain, and carry a card that describes your disease and details of your medication and dosage times.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medication affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Alcohol may interfere with the effect of this medication. Avoid alcoholic drinks.

This medication can make you more sensitive to the sun. Keep out of the sun. If you cannot avoid being in the sun, wear protective clothing and use sunscreen. Do not use sun lamps or tanning beds/booths.

The use of this medication may increase the chance of suicidal thoughts or actions. Pay special attention to how you are responding while on this medication. Any worsening of mood, or thoughts of suicide or dying should be reported to your care team right away.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Aplastic anemia—unusual weakness or fatigue, dizziness, headache, trouble breathing, increased bleeding or bruising
• Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
• Thoughts of suicide or self-harm, worsening mood, or feelings of depression

Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):

• Change in taste
• Dizziness
• Drowsiness
• Headache
• Loss of appetite with weight loss
• Nausea
• Trouble sleeping

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of reach of children and pets.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Keep container tightly closed. Throw away any unused medication after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.