What is this medication?

ETHOTOIN (ETH oh toyn) is used to control seizures in certain types of epilepsy.

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

COMMON BRAND NAME(S): Peganone

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; a previous suicide attempt by you or a family member

•an unusual or allergic reaction to ethotoin, other medicines, foods, dyes, or preservatives

•pregnant or trying to get pregnant

•breast-feeding

How should I use this medication?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. Take with food. Take your doses at regular intervals. Do not take your medicine more often than directed. Do not stop taking this medicine suddenly.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as 1 year of age for selected conditions, precautions do apply.

Patients over 65 years old may have a stronger reaction and need a smaller dose.

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 your next dose. Do not take double or extra doses.

What may interact with this medication?

• warfarin

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 doctor or health care professional for regular checks on your progress. This medicine needs careful monitoring. Your doctor or health care professional may schedule regular blood tests.

Wear a medical ID bracelet or chain, and carry a card that describes your disease and details of your medicine 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 medicine 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 medicine. Avoid alcoholic drinks.

Birth control pills may not work properly while you are taking this medicine. Talk to your doctor about using an extra method of birth control.

This medicine can cause unusual growth of gum tissues. Visit your dentist regularly. Problems can arise if you need dental work, and in the day to day care of your teeth. Try to avoid damage to your teeth and gums when you brush or floss your teeth.

Do not take antacids at the same time as this medicine. If you get an upset stomach and want to take an antacid or medicine for diarrhea, make sure there is an interval of 2 to 3 hours before or after you take this medicine.

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

Women who become pregnant while using this medicine may enroll in the North American Antiepileptic Drug Pregnancy Registry by calling 1-888-233-2334. This registry collects information about the safety of antiepileptic drug use during pregnancy.

What side effects may I notice from receiving this medication?

Side effects that you should report to your doctor or health care professional as soon as possible:

•allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

•breathing problems

•changes in vision

•chest pain or tightness

•confusion

•dark yellow or brown urine

•fast or irregular heartbeat

•fever, sore throat

•headache

•loss of seizure control

•poor control of body movements or difficulty walking

•redness, blistering, peeling or loosening of the skin, including inside the mouth

•unusual bleeding or bruising, pinpoint red spots on skin

•vomiting

•worsening of mood, thoughts or actions of suicide or dying

•yellowing of the eyes or skin

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

•constipation

•difficulty sleeping

•excessive hair growth on the face or body

•nausea

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 the reach of children.

Store below 25 degrees C (77 degrees F). Protect from light. Keep container tightly closed. Throw away any unused medicine 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.