When This Medicine Should Not Be Used:
You should not use this medicine if you have had an allergic reaction to ethotoin, or if you are pregnant. You should not use this medicine if you have liver disease or a blood disease.

How to Use This Medicine:
Tablet

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• It is best to take this medicine with food or milk.
• It is best to plan your doses so they are evenly spaced during the day. Talk with your doctor if you have questions about when to take this medicine.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.

Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Make sure your doctor knows if you are also using a blood thinner such as warfarin (Coumadin®).

Warnings While Using This Medicine:

• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant. Your doctor may want you to join a pregnancy registry for patients taking seizure medicines.
• Make sure your doctor knows if you are breastfeeding, or if you have megaloblastic anemia or depression.
• Call your doctor right away if you or your child have a fever, nosebleeds, skin rash, small red or purple spots on the skin, sore throat, unusual bruising or bleeding, unusual tiredness or weakness, or generally feel ill. These may be signs that you have an infection or a bleeding problem.
• For some children, teenagers, and young adults, this medicine can increase thoughts of suicide. Tell your doctor or your child's doctor right away if you or your child start to feel more depressed and have thoughts about hurting yourself. Report any unusual thoughts or behaviors that trouble you or your child, especially if they are new or get worse quickly. Make sure the doctor knows if you or your child have trouble sleeping, get upset easily, have a big increase in energy, or start to act reckless. Also tell the doctor if you or your child have sudden or strong feelings, such as feeling nervous, angry, restless, violent, or scared. Let the doctor know if you, your child, or anyone in your family has bipolar disorder (manic-depressive) or has tried to commit suicide.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Do not stop using this medicine suddenly. Your doctor will need to slowly decrease your dose before you stop it completely.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blistering, peeling, or red skin rash.
• Blurred vision, dizziness, or headache.
• Changes in behavior, or thoughts of hurting yourself or others.
• Chest pain or shortness of breath.
• Fever, chills, cough, sore throat, or body aches.
• Lumps in your armpits, neck, hands, or thighs.
• Nosebleeds, small red or purple spots on the skin.
• Problems with balance or walking.
• Sores or white patches in your mouth or tongue.
• Swelling in your hands, ankles, or feet.
• Unusual bleeding, bruising, or weakness.
• Yellowing of your skin or the whites of your eyes.

If you notice these less serious side effects, talk with your doctor:

• Jerky eye movements or double vision.
• Mild nausea, vomiting, diarrhea, or stomach pain.
• Mild skin rash.
• Swelling of your gums.
• Trouble with sleeping.

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088