Eslicarbazepine tablets

What is this medicine?

ESLICARBAZEPINE (es lye kar bay ze peen) is used to treat people with epilepsy. It helps prevent partial seizures.

How should I use this medicine?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. This medicine may be taken with or without food. Take your doses at regular intervals. Do not take your medicine more often than directed. Do not stop taking except on the advice of your doctor or health care professional.

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 pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as 4 years 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 such as skin rash or itching, hives, swelling of the lips, mouth, tongue, or throat

• changes in vision

• confusion

• dark urine

• fever

• general ill feeling or flu-like symptoms

• increased frequency of seizures

• irritable

• light-colored stools

• loss of appetite, nausea

• loss of balance or coordination

• lump or swelling on the neck

• nausea, vomiting

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

• right upper belly pain

• suicidal thoughts or other mood changes

• 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):

• dizziness

• shakiness

• tiredness

What may interact with this medicine?

Do not take this medicine with any of the following medications:

• oxcarbazepine

• ranolazine

• rilpivirine

This medicine may also interact with the following medications:

• birth control pills

• certain medicines for seizures like carbamazepine, phenobarbital, phenytoin

• clobazam

• omeprazole

• rosuvastatin

• simvastatin

• warfarin

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.

Where should I keep my medicine?

Keep out of the 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

• liver disease

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

• any unusual or allergic reaction to eslicarbazepine, oxcarbazepine, 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 regular checks on your progress. Do not stop taking this medicine suddenly. This increases the risk of seizures.

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

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.

Rarely, serious skin allergic reactions may occur with this medicine. If you develop a skin rash, redness, itching, peeling skin inside your mouth, swollen glands, or a fever while taking this medicine, contact your health care provider immediately.

Tell your doctor or health care professional right away if you have any change in your eyesight.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this drug 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.

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.

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.