Pronunciation:

es-li-kar-BAZ-e-peen AS-e-tate

Brand Names:

• Aptiom

Dosage Forms:

• Tablet

Classifications:

Therapeutic—

Anticonvulsant

Chemical—

Dibenzazepine Carboxamide

Uses of This Medicine:

Eslicarbazepine is used alone or together with other medicines to control partial seizures (convulsions) in the treatment of epilepsy.

Eslicarbazepine belongs to a class of medicines called anticonvulsants. It acts in the brain to prevent seizures. However, this medicine cannot cure epilepsy and will only work to control seizures as long as you continue to take it.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of eslicarbazepine in children younger than 4 years of age. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of eslicarbazepine in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require caution and an adjustment in the dose for patients receiving eslicarbazepine.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Alfentanil
• Amiodarone
• Amitriptyline
• Atazanavir
• Atogepant
• Benzhydrocodone
• Buprenorphine
• Calcifediol
• Carisoprodol
• Ceritinib
• Cilostazol
• Citalopram
• Clobazam
• Clomipramine
• Cobicistat
• Codeine
• Cyclophosphamide
• Cyclosporine
• Desogestrel
• Diazepam
• Dienogest
• Dihydrocodeine
• Dolutegravir
• Doxepin
• Drospirenone
• Escitalopram
• Esomeprazole
• Estetrol
• Estradiol
• Ethinyl Estradiol
• Ethynodiol
• Etonogestrel
• Fentanyl
• Fexinidazole
• Fosphenytoin
• Gestodene
• Hydrocodone
• Lacosamide
• Lansoprazole
• Levonorgestrel
• Lumateperone
• Medroxyprogesterone
• Meperidine
• Mephenytoin
• Meprobamate
• Mestranol
• Methadone
• Nelfinavir
• Nilotinib
• Nomegestrol
• Norelgestromin
• Norethindrone
• Norgestimate
• Norgestrel
• Oliceridine
• Omeprazole
• Orlistat
• Ospemifene
• Oxycodone
• Palbociclib
• Pantoprazole
• Pentazocine
• Perampanel
• Phenobarbital
• Phenytoin
• Piperaquine
• Primidone
• Progesterone
• Propranolol
• Rabeprazole
• Rosuvastatin
• Segesterone
• Simvastatin
• Sufentanil
• Tacrolimus
• Tenofovir Alafenamide
• Tramadol
• Ubrogepant
• Ulipristal
• Voriconazole
• Vortioxetine
• Zolpidem
• Zuranolone

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Carbamazepine
• Warfarin

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Depression, history of or
• Hyponatremia (low sodium in the blood) or
• Mental illness, history of—Use with caution. May make these conditions worse.

• Kidney disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

• Liver disease, severe—Use of eslicarbazepine is not recommended.

Proper Use of This Medicine:

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

This medicine comes with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

You may crush the tablets or swallow them whole. You may take this medicine with or without food.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  • For seizures:
    • Adults—At first, 400 milligrams (mg) once per day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 1600 mg once per day.
    • Children 4 to 17 years of age—Dose is based in body weight and must be determined by your doctor.
      • Weighs more than 38 kilograms (kg)—At first, 400 mg once per day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 1200 mg once per day.
      • Weighs 32 to 38 kg—At first, 300 mg once per day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 900 mg once per day.
      • Weighs 22 to 31 kg—At first, 300 mg once per day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 800 mg once per day.
      • Weighs 11 to 21 kg—At first, 200 mg once per day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 600 mg once per day.
    • Children younger than 4 years of age—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Blood and urine tests may be needed to check for unwanted effects.

Eslicarbazepine may cause some people to be agitated, irritable, or display other abnormal behaviors, such as feeling sad or hopeless, getting upset easily, or feeling nervous, restless, or hostile. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. If you notice any of these side effects, tell your doctor right away.

Serious skin reactions can occur with this medicine. Check with your doctor right away if you have blistering, peeling, or loosening of the skin, red skin lesions, severe acne or skin rash, sores or ulcers on the skin, or fever or chills while you are using this medicine.

This medicine may cause serious allergic reactions affecting multiple body organs (eg, liver, kidneys). Check with your doctor right away if you have the following symptoms: a fever, dark urine, headache, rash, stomach pain, swollen, painful, or tender lymph glands in neck, armpit, or groin, unusual tiredness, or yellow eyes or skin.

This medicine may cause serious allergic reactions, including anaphylaxis and angioedema. These can be life-threatening and require immediate medical attention. Call your doctor right away if you have a rash, itching, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.

This medicine may cause hyponatremia (low sodium in the blood). Check with your doctor right away if you have confusion, decreased urine output, dizziness, fast or irregular heartbeat, headache, muscle pain or cramps, nausea, vomiting, swelling of the face, ankles, or hands, or unusual tiredness or weakness while you are using this medicine.

Eslicarbazepine may make you dizzy, drowsy, clumsy, tired, or have vision changes. Do not drive or do anything else that could be dangerous until you or your child know how this medicine affects you. If these reactions are especially bothersome, check with your doctor.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.

Do not suddenly stop taking this medicine without checking first with your doctor. Your doctor may want you to gradually reduce the amount you are using before stopping it completely. This may help decrease your chance of having more seizures.

This medicine may increase your risk of having blood problems (eg, pancytopenia, agranulocytosis, leukopenia). Talk to your doctor about this risk.

Some birth control pills may not work as well while you are using this medicine. You might need additional forms of birth control with your pills to avoid getting pregnant. Talk to your doctor if you have concerns.

Before you have any medical tests, tell the medical doctor in charge that you are taking this medicine. The results of some tests may be affected by this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

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:

Less common

Chills

confusion

decreased urine output

dizziness

fast or irregular heartbeat

fever

increased in seizure frequency or severity

muscle pain or cramps

nausea

severe thirst

swelling of the face, ankles, or hands

swollen, painful, or tender lymph glands in the neck, armpit, or groin

unusual tiredness or weakness

vomiting

Less common

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

stomach pain

thoughts or attempts at killing oneself

upper right abdominal or stomach pain

yellow eyes or skin

Incidence not known

Agitation

black, tarry stools

bleeding gums

blood in the urine or stools

chest pain

cough

hoarseness

decreased awareness or responsiveness

fainting spells

general feeling of tiredness or weakness

headache

high fever

hostility

irregular heartbeat

irritability

loss of consciousness

lower back or side pain

muscle twitching

painful or difficult urination

pale skin

pinpoint red spots on the skin

rapid weight gain

severe sleepiness

sore throat

unusual bleeding or bruising

unusual drowsiness, dullness, or feeling of sluggishness

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:

More common

Blurred vision

double vision

sensation of spinning or constant movement

sleepiness

Less common

Changes in patterns and rhythms of speech

heartburn

indigestion

loss of interest or pleasure

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.