APTIOM (Eslicarbazepine Acetate)

What is this medication?

Aptiom is an anticonvulsant. It works by decreasing nerve impulses that cause seizures and pain.
Aptiom is used alone or with other medications to treat partial-onset seizures in adults and children who are at least 4 years old.
Aptiom may also be used for purposes not listed in this medication guide.

How should I take this medication?

Aptiom is usually given once per day. Follow all directions on your prescription label. Your doctor may occasionally change your dose. Do not take this medicine in larger or smaller amounts or for longer than recommended.
You may take Aptiom with or without food. The Aptiom tablet may be crushed or swallowed whole.
Do not stop using Aptiom suddenly, even if you feel fine. Stopping suddenly may cause increased seizures. Get your prescription refilled before you run out of medicine completely.
Eslicarbazepine can cause unusual results with certain medical tests. Tell any doctor who treats you that you are using Aptiom.

What if I miss a dose?

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.

How should I store this medication?

Store at room temperature away from moisture and heat.

What are the possible side effects of using this medication?

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning in your eyes, skin pain, red or purple skin rash that spreads and causes blistering and peeling).

Seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include: skin rash, fever, swollen glands, flu-like symptoms, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes. This reaction may occur several weeks after you began using eslicarbazepine.

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, depression, anxiety, or if you feel agitated, hostile, restless, hyperactive (mentally or physically), 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;
• sudden weakness or ill feeling, fever, chills, sore throat, mouth sores; or
• liver problems - nausea, loss of appetite, upper stomach pain, dark urine, jaundice (yellowing of the skin or eyes).

Common Aptiom 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.

What other drugs will affect Aptiom?

Tell your doctor about all your current medicines and any you start or stop using, especially:

• all other seizure medicines you use;
• omeprazole; or
• rosuvastatin (Crestor) or simvastatin (Zocor).

This list is not complete. Other drugs may interact with eslicarbazepine, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.