Eslicarbazepine Acetate

How to take:

Take Aptiom exactly as your health care provider prescribes it. Do not change the dose without talking to your provider first. Stopping a seizure medicine suddenly can cause seizures that do not stop (status epilepticus).

• Check the number of tablets and strength of pills you get from the pharmacy. If your provider changes your dose, the strength of the pills may be different.
• Aptiom can be taken with or without food. It’s best to take it the same way every day.
• It's usually taken once a day in the evening.
• Tablets can be swallowed whole or crushed and taken with food.
• If you take an extra dose by mistake, call your provider for advice. If you take a larger number of pills or overdose, call the poison control center (800-222-1222) or call your hospital emergency room.  

How to store:

• Store Aptiom at room temperature 68 to 77 degrees F (20 to 25 degrees C).
• Keep in a closed container away from moisture, heat, and direct light.
• Keep out of reach of children. 

Taking the right amount of seizure medicine on time every single day is the most important step in preventing seizures. Try these steps to help you remember when to take seizure medicine.

• Take your medication at the same time each day or try pairing it with another routine such as brushing teeth, after meals, or bedtime.
• If you miss a dose, take it as soon as you remember it. Since Aptiom is usually taken once a day, talk to your provider about when to make up a dose. If it is almost time for the next dose, you may be asked to skip the missed dose and go back to your usual schedule.
• Avoid taking 2 doses at the same time or taking extra doses. 
• If you're not sure about what to do, call the doctor's office for advice. Do your best to follow the doctor's directions.
• To avoid missed doses, get a special pillbox or to set an alarm on your watch or on phone.
• Use an online seizure diary that can remind you when to take medicines. 
• If you are having trouble remembering medicines on your own, ask your pharmacist if pre-filled blisterpaks can be used. 
• Write down any missed doses in your seizure calendar. Share this with the doctor or nurse at each visit.

How the body absorbs, digests, and breaks down or gets rid of a medicine or food is called metabolism. The way your body metabolizes seizure medicine affects how often is must be taken. This process can also affect if it will interact with other medicines. 

• Aptiom or eslicarbazepine acetate is metabolized or broken down in the liver into eslicarbazepine, which works to prevent seizures. 
• The medicine is cleared from the body by the kidneys.  

The most common side effects include:

• Clumsy, problems with coordination
• Dizziness
• Double vision or blurry vision
• Headache
• Nause or upset stomach
• Problems with thinking, memory or attention (cognitive problems)
• Sleepiness
• Tremors of feeling shakey
• Vomiting

Side effects may happen at anytime, but are more likely in the first week of starting it or after a dose increase.

Some side effects may improve and go away over time or when the dose of medicine is changed. If a side effect is hard to manage or doesn’t go away within a few weeks, talk to your health care provider. 

Allergic Reactions/Angioedema: If you have signs of an allergic reaction - such as a rash, hives, itchiness, swelling, closing of the throat, or diffiulty breathing - call your doctor immediately or go to an emergency room.  

Severe Skin Reactions: Aptiom may cause a rare but serious skin reaction, such as Stevens-Johnson Syndrome and toxic epidemeral necrolysis (TEN). These conditions may start with a fever and flu-like symptoms. Then a rash develops. Ulcers or lesions of the mucous membranes may be seen and develop into painful blisters.

• Report any fever or rash to a health care provider, as this can be a life-threatening condition. 
• These types of skin reactions happen most commonly in the 2nd or 3rd week after starting the medicine, but it can happen at any time. 
• People who have had this type of reaction to oxcarbazepine should not take Aptiom. 

Hyponatremia: Low sodium or salt in the blood stream is called hyponatremia. This may be seen in the first few months of taking the medicine or happen at any time. You may need to have blood tests done to check the sodium in your blood. 

Symptoms of hyponatremia may include:

• Confusion
• Cramps
• Dizziness
• Decreased urination
• Headaches
• More seizures
• Nausea
• Swelling
• Tired, lack of energy
• Vomiting

Some of these symptoms may occur and not be related to low blood sodium. Or it may be related to another medical problem. Call or provider if any of these problems are seen.

• increases in a type of white blood cell called eosinophils,
• extreme confusion,
• staggering walk,
• suicidal thoughts or behaviors.

Suicidal Thoughts and Behavior:

Suicidal thoughts or actions may occur in a very small number of people, about 1 in 500. It is important to notify your provider if you experience any of the following symptoms

• Suicidal thoughts
• New or worsening depression or anxiety
• Panic attacks
• New or worsening irritability
• Acting aggressive, being angry, or violent
• Other unusual changes in mood or behavior

Rashes: Not all rashes are caused by eslicarbazepine acetate, but all rashes should be immediately reported to your doctor and checked out as soon as possible. Serious rashes usually begin in the first few weeks but can appear any time while you are taking the drug. Serious rashes may have the following symptoms and require you to be checked out immediately:

• Blisters or sores in mouth, eyes, ears, nose, and genital area
• Swelling of eyelids or eyes
• Red spots or patches on skin
• Fever or flu-like symptoms that do not go away

 

Call your doctor right away if any side effects are severe or cause problems in your ability to function.

Do not stop the medicine without talking to your doctor first. 

Eslicarbazepine acetate can interact with many medications and many medications can also affect how eslicarbazepine acetate works.

Caution should be taken in patients who are also taking:

• Oral hormonal contraceptives,
• Phenytoin,
• Carbamazepine,
• Primidone, 
• Phenobarbital.

Eslicarbazepine acetate should not be taken with oxcarbazepine.

Talk with your health care provider to be sure that your medications, including over the counter products or supplements,  are safe to take with eslicarbazepine acetate. 

• While eslicarbazepine acetate is not known to cause bone health problems, some other  medications are known to cause thinning of the bones, called osteopenia or osteoporosis.
• All people taking seizure medications should take calcium and vitamin D supplements daily and maintain a healthy diet with regular exercise. Talk with your health care provider about how to check the health of your bones and to see if any additional steps need to be taken. 

Eslicarbazepine acetate has an FDA pregnancy category of “C,” meaning it should only be used if the potential benefit outweighs the potential risk to the fetus.

• If you find or suspect that you may be pregnant, continue taking the medication and contact your health care provider right away to decide if eslicarbazepine acetate should be continued. Seizures can be harmful to the mother and developing baby, but seizures can be lessened with proper care and monitoring.

All women who could possibly get pregnant should take at least 0.4 milligrams (mg) of folic acid or folate daily.

• Health care providers may recommend that women with epilepsy taking seizure medication take a higher dose of folic acid, up to 4 mg each day.
• Folic acid is also found in leafy, dark, green vegetables, fruits and juices, and lentils.
• Speak to your health care provider for specific instructions.

 If you were exposed to eslicarbazepine acetate during pregnancy, you are encouraged to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry by calling 1-888-233-2334. Additional information is available at www.aedpregnancyregistry.org.

Breastfeeding:

• There is limited information available on the effects of breastfeeding while taking eslcarbazepine acetate.  It is not expected to cause any side effects in infants, especially those over 2 months of age.
•  If you breastfeed while taking this medication i monitor your infant for drowsiness, adequate weight gain, and developmental milestones. ,

Birth control: This medicine may interfere with hormonal birth control, increasing the risk of pregnancy.

• Talk to your health care provider if you start this medicine while taking hormonal birth control
• A different form of birth control or also using a barrier method of contraception may be recommended.
• Tell your health care provider immediately if you have any signs of breakthrough bleeding or symptoms or pregnancy. 

In the United States, companies that manufacture medicines are required to publish certain kinds of information about each product. This document is commonly known as a “package insert” because it is usually included with each package of the medicine. You can also read these documents (also called “prescribing information”) online. The U.S. package insert for Aptiom (Eslicarbazepine acetate) is found at:

• http://www.aptiom.com/Aptiom-Prescribing-Information.pdf

Some of the information may differ in other countries.

To learn how to read and understand a package insert, see "How to read a package insert."

• The exact way that eslicarbazepine acetate works is unknown. Eslicarbazepine acetate is broken down by the body into the eslicarbazepine, which is the form that helps to prevent seizures.
• During a seizure, electrical activity in the brain may be too fast in some areas. Eslicarbazepine works to slow down this electrical activity to prevent or stop seizures. 

• Eslicarbazepine is a relatively new medication that is typically used with other seizure medications.
• Studies have shown that eslicarbazepine acetate was clearly more effective in reducing seizure frequency than a placebo medication when 800 mg was given each day. A dose of 1200 mg was just as helpful at ontrolling seizures, but was more likely to produce side effects. 

Eslicarbazepine acetate is approved for use in treating partial epilepsy. 

• Eslicarbazepine acetate should not be taken if you are allergic or sensitive to eslicarbazepine acetate, carbamazepine, or oxcarbazepine.
• Eslicarbazepine acetate should not be used at the same time as oxcarbazepine because they have not been studied together.
• Caution should be taken in patients with kidney problems. Talk with your health care provider to see if a dosing adjustment needs to be made.

• There is  limited information on the use of eslicarbazepine acetate in children. One study showed that the safety and side effects were similar to adults when doses ranged from 5 to 30 mg/kg/day.
• It is currently approved for use in patients 18 years of age and older.

• Eslicarbazepine acetate is generally well tolerated in the elderly.
• Since this medicine is removed from the body by the kidney and kidney function can decrease with age, it is important to check your kidney function regularly.
• The dose of eslicarbazepine acetate may need to be changed or lower in older persons or people with kidney problems. 

• When stopping eslicarbazepine acetate, make sure to lower it slowly. Stopping this medication quickly can increase the risk of having a seizure.
• Although eslicarbazepine acetate is not affected by liver impairment, it can increase the values of liver laboratory tests. Checking blood tests for liver function is recommended for a person taking this medication. 
• Low sodium levels in the blood can happen with this medication.  Checking sodium levels is recommended for people taking this medicine.