Levetiracetam extended-release tablets

What is this medicine?

LEVETIRACETAM (lee ve tye RA se tam) is an antiepileptic drug. It is used with other medicines to treat certain types of seizures.

How should I use this medicine?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. Do not cut, crush or chew this medicine. You may take this medicine with or without food. Take your doses at regular intervals. Do not take your medicine more often than directed. Do not stop taking this medicine or any of your seizure medicines unless instructed by your doctor or health care professional. Stopping your medicine suddenly can increase your seizures or their severity.

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.

Contact your pediatrician or health care professional regarding the use of this medication in children. While this drug may be prescribed for children as young as 12 years of age for selected conditions, precautions do apply.

What side effects may I notice from receiving this medicine?

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 emotions or moods

• dark urine

• general ill feeling or flu-like symptoms

• problems with balance, talking, walking

• suicidal thoughts or actions

• unusually weak or tired

• 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):

• diarrhea

• dizzy, drowsy

• headache

• loss of appetite

What may interact with this medicine?

This medicine may interact with the following medications:

• carbamazepine

• colesevelam

• probenecid

• sevelamer

What if I miss a dose?

If you miss a dose and it has only been a few hours, 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.

Where should I keep my medicine?

Keep out of reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Throw away any unused medicine after the expiration date.

What should I tell my health care provider before I take this medicine?

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

• kidney disease

• suicidal thoughts, plans, or attempt; a previous suicide attempt by you or a family member

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

• pregnant or trying to get pregnant

• breast-feeding

What should I watch for while using this medicine?

Visit your doctor or health care professional for a regular check on your progress. Wear a medical identification bracelet or chain to say you have epilepsy, and carry a card that lists all your medications.

It is important to take this medicine exactly as instructed by your health care professional. When first starting treatment, your dose may need to be adjusted. It may take weeks or months before your dose is stable. You should contact your doctor or health care professional if your seizures get worse or if you have any new types of seizures.

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.

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.

The tablet shell for some brands of this medicine does not dissolve. This is normal. The tablet shell may appear in the stool. This is not cause for concern.

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.