Oxcarbazepine (ox-kar-BAZ-e-peen)

Used alone or together with other medicines to treat seizures caused by epilepsy in adults and children 2 years of age and older.

Brand Name(s):

Trileptal

When This Medicine Should Not Be Used:

How to Use This Medicine:

Liquid, Tablet

• Your doctor will tell you how much of this medicine to use and how often. Your dose may need to be changed several times in order to find out what works best for you. Do not use more medicine or use it more often than your doctor tells you to.
• You may take this medicine with or without food.
• Measure the oral liquid medicine with a marked measuring spoon, oral syringe, or medicine cup.
• Shake the oral liquid well just before using. You can take the medicine directly from the oral syringe, or you can mix the medicine in a glass with a small amount of water. If you mix the medicine, drink the mixture right away. Do not save any mixture to use later.
• If you use any type of medicine to control your seizures, keep using it as directed by your doctor. Do not stop taking it without first checking with your doctor. If you will be switching to oxcarbazepine only, your doctor may want you to gradually reduce the amount of the other medicine you are taking for 3 to 6 weeks before stopping it completely.
• This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions. Ask your pharmacist for the Medication Guide if you do not have one. Your doctor might ask you to sign some forms to show that you understand this information.

If a dose is missed:

• If you miss a dose or forget to use your medicine, use it as soon as you can. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up for a missed dose.

How to Store and Dispose of This Medicine:

• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Store the oral liquid in the original container. Use the liquid within 7 weeks after opening the bottle for the first time. Throw away any unused liquid.
• Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any leftover medicine after you have finished your treatment. You will also need to throw away old medicine after the expiration date has passed.
• Keep all medicine away from children and never share your medicine with anyone.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Make sure your doctor knows if you are also using any other medicines to control seizures. Seizure medicine includes carbamazepine (Tegretol®), phenobarbital, phenytoin (Dilantin®), or valproic acid (Depakote®). Tell your doctor if you also use felodipine (Plendil®), verapamil (Calan®, Covera®, Isoptin®), or birth control pills.
• Do not drink alcohol while you are using this medicine.

Warnings While Using This Medicine:

• Make sure your doctor knows if you are pregnant or breastfeeding, or if you have kidney disease, depression, low sodium in the blood, or if you have had an allergic reaction to carbamazepine (Tegretol®).
• Tell your doctor if you become pregnant while taking this medicine. Your doctor may need you to be monitored carefully during your pregnancy and after giving birth. Also, your doctor may want you to join the North American Antiepileptic Drug Pregnancy Registry, which is used by pregnant patients who are taking this medicine.
• Hyponatremia (low sodium in the blood) may occur while you are taking this medicine. Check with your doctor right away if you or your child develop confusion, decreased urine output, dizziness, fast or irregular heartbeat, headache, muscle pain or cramps, nausea or vomiting, weakness, or swelling of the face, ankles, or hands while taking this medicine.
• This medicine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Stop using this medicine and call your doctor right away if you or your child have itching, hives, hoarseness, trouble breathing, trouble swallowing, or any swelling of your face, eyes, lips, or tongue while you are using this medicine.
• This medicine can cause a serious reaction called angioedema. Stop using this medicine and tell your doctor right away if you or your child start to have swelling of your face, lips, tongue, throat, arms, or legs, or if you are having trouble swallowing or breathing.
• Serious skin reactions can occur with this medicine. Stop using this medicine and check with your doctor right away if you or your child 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.
• If you or your child develop any unusual or strange thoughts and behavior while taking this medicine, be sure to discuss it with your doctor. Other changes might be confusion, worsening of depression, hallucinations (seeing, hearing, or feeling things that are not there), suicidal thoughts, and unusual excitement, nervousness, or irritability.
• This medicine may make you dizzy, drowsy, lightheaded, clumsy, unsteady, or less alert. Avoid driving, using machines, or doing anything else that could be dangerous if you are not alert or able to think or see well.
• Do not stop using this medicine suddenly without asking your doctor. You may need to slowly decrease your dose before stopping it completely. Stopping the medicine suddenly may cause your seizures to return or to occur more often.
• This medicine may cause serious allergic reactions that may affect several parts of the body (e.g., liver or kidneys). Check with your doctor right away if you or your child have more than one of the following symptoms: fever, dark-colored urine, headache, rash, itching, extra fluid around the face, stomach pain, unusual tiredness, or yellow eyes or skin.
• This medicine lowers the number of some types of blood cells in your body. Because of this, you may bleed or get infections more easily. To help with these problems, avoid being near people who are sick or have infections. Wash your hands often. Stay away from rough sports or other situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be careful when using sharp objects, including razors and fingernail clippers.
• Birth control pills may not work while you are using oxcarbazepine. To keep from getting pregnant, use another form of birth control. Other forms include condoms, diaphragms, or contraceptive foams or jellies.
• Your doctor will need to check your progress at regular visits while you are using this medicine. Be sure to keep all appointments. Blood tests will also be needed to check for unwanted effects.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blistering, peeling, or red skin rash.
• Blurred vision or any changes in vision.
• Change in how much or how often you urinate.
• Chills, cough, runny or stuffy nose, sore throat, and body aches.
• Confusion, weakness, and muscle twitching.
• Fast, slow, or pounding heartbeat.
• Feeling depressed, irritable, nervous, or restless.
• Fever with rash, or swollen glands in your neck.
• Nausea, vomiting, loss of appetite, or pain in your upper stomach.
• Rapid eye movements (especially in children).
• Seizures or tremors.
• Trouble walking, speaking, or controlling body movements.
• Uncontrollable shaking.
• Unusual behavior or thoughts of hurting oneself.
• Unusual bleeding, bruising, or weakness.
• Yellowing of your skin or the whites of your eyes.

If you notice these less serious side effects, talk with your doctor:

• Feeling of constant movement of self or surroundings.
• Headache or dizziness.
• Joint pain.
• Mild nausea, vomiting, belching, gas, indigestion, or stomach pain.
• Mild skin rash.
• Sleepiness or unusual drowsiness.
• Trouble sleeping.

If you notice other side effects that you think are caused by this medicine, tell your doctor

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