Eslicarbazepine

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

Symptoms of overdose may include the following:

• dizziness
• nausea
• vomiting
• sleepiness
• abnormal elevated mood
• numbness or tingling in the mouth
• difficulty walking or with coordination
• double vision
• seizures that happen more often or are worse than before
• weakness
• headache
• confusion
• irritability
• muscle weakness or spasms

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Eslicarbazepine can reduce the sodium in your body to dangerously low levels, which can cause a life-threatening electrolyte imbalance. Call your doctor right away if you have nausea, lack of energy, confusion, feeling tired or irritable, severe weakness, muscle pain, or increased seizures.

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

Also call your doctor at once if you have:

• severe dizziness or drowsiness, vision changes, thinking problems, trouble with walking or coordination;
• painful mouth sores or sores around your eyes;
• liver problems--nausea, upper stomach pain, itching, tiredness, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• signs of inflammation in your body--swollen glands, flu symptoms, easy bruising or bleeding, severe tingling or numbness, muscle weakness, chest pain, new or worsening cough with fever, trouble breathing; or
• severe skin reaction--fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common side effects may include:

• dizziness, drowsiness, headache;
• feeling tired;
• nausea, vomiting;
• coordination problems, feeling shaky; or
• double vision.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Eslicarbazepine is usually given once per day. Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger or smaller amounts or for longer than recommended.

You may take this medicine with or without food. The eslicarbazepine tablet may be crushed or swallowed whole.

This medication can cause unusual results with certain medical tests. Tell any doctor who treats you that you are using eslicarbazepine.

Do not stop using eslicarbazepine suddenly, even if you feel fine. Stopping suddenly may cause increased seizures. Follow your doctor's instructions about tapering your dose.

Store at room temperature away from moisture and heat.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Eslicarbazepine may impair your thinking or reactions. Avoid driving or operating machinery until you know how this medicine will affect you.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Confusion
• decreased urine output
• dizziness
• fast or irregular heartbeat
• fever or chills
• increased in seizure frequency or severity
• muscle pain or cramps
• nausea or vomiting
• severe thirst
• shortness of breath
• swelling of the face, ankles, or hands
• swollen, painful, or tender lymph glands in the neck, armpit, or groin
• unusual tiredness or weakness

• Abdominal or stomach pain
• blistering, peeling, or loosening of the skin
• bloating of the abdomen or stomach
• changes in behavior
• discouragement
• difficulty breathing
• difficulty swallowing
• feeling sad or empty
• hives, rash, or itching skin
• joint or muscle pain
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• rapid, shallow breathing
• red skin lesions, often with a purple center
• sores, ulcers, or white spots in the mouth or on the lips
• thoughts or attempts at killing oneself
• upper right abdominal or stomach pain
• yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Blurred vision
• double vision
• sensation of spinning or constant movement
• sleepiness
• unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness

• Changes in patterns and rhythms of speech
• heartburn or indigestion
• irritability
• loss of interest or pleasure
• lower back or side pain
• shakiness and unsteady walk
• shakiness in the legs, arms, hands, or feet
• tingling of the hands or feet
• trembling or shaking of the hands or feet
• trouble concentrating
• unusual weight gain or loss

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time this medicine is refilled. If you have any questions about eslicarbazepine, please talk with the doctor, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about eslicarbazepine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using eslicarbazepine.

Review Date: October 4, 2017

(es li kar BAZ e peen)

• Aptiom

-Mild to moderate liver impairment: No adjustment recommended
-Severe liver impairment: Data not available

Hemodialysis removes metabolites from plasma