What is the most important information I should know about Trileptal?

• Serious skin reactions have been reported in both children and adults who are taking Trileptal. These skin reactions may be life-threatening. Talk to your doctor immediately if you develop a rash or any kind of skin problem.
• Do not stop taking Trileptal without first talking to your doctor, even if you feel better. It is important to continue taking Trileptal to prevent the seizures from recurring. Stopping Trileptal suddenly may result in increased seizure frequency. If the medication needs to be stopped, your doctor may need to lower the dosage gradually.
• Trileptal may decrease the effectiveness of birth control pills. Use a second method of birth control while taking Trileptal to ensure protection from unintended pregnancy.
• Do not drink alcohol while taking Trileptal. Alcohol may increase drowsiness or dizziness caused by Trileptal. Alcohol may also increase the risk of seizures.
• Trileptal may cause drowsiness, dizziness, blurred vision, or poor coordination. Do not drive, operate dangerous machinery, or perform other hazardous activities until you know how Trileptal affects you. If you experience drowsiness, dizziness, blurred vision, or poor coordination, avoid these activities.

What is Trileptal?

• Trileptal is a drug that affects the nerves and brain. It works by decreasing impulses in nerves that cause seizures.
• Trileptal is used alone and with other drugs to treat seizures.
• Trileptal may also be used for purposes other than those listed in this medication guide.

What should I discuss with my healthcare provider before taking Trileptal?

• Do not take Trileptal without first talking to your doctor if you have ever had an allergic reaction to carbamazepine (Tegretol, others). You may have an allergic reaction to Trileptal.
• Before taking this medication, tell your doctor if you have
  • kidney disease, or
  • liver disease.
• You may not be able to take Trileptal, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.
• Serious skin reactions have been reported in both children and adults who are taking Trileptal. These skin reactions may be life-threatening. Talk to your doctor immediately if you develop a rash or any kind of skin problem.
• Trileptal is in the FDA category C. This means that it is not known whether Trileptal will be harmful to an unborn baby. Do not take this medication without first talking to your doctor if you are pregnant or could become pregnant during treatment.
• Trileptal passes into breast milk and may be harmful to a nursing infant. Do not take this medication without first talking to your doctor if you are breast-feeding a baby.
• If you are over 60 years of age, you may be more likely to experience side effects from Trileptal. Your doctor may prescribe a lower dose or special monitoring during treatment.

How should I take Trileptal?

• Take Trileptal exactly as directed by your doctor. If you do not understand these instructions, ask your pharmacist, nurse, or doctor to explain them to you.
• Take each dose with a full glass of water.
• Trileptal can be taken with or without food.
• Shake the suspension well before measuring a dose. To ensure that you get the correct dose, measure the suspension with a dose-measuring spoon or cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist where you can get one.
• It is important to take Trileptal regularly to get the most benefit.
• Do not stop taking Trileptal without first talking to your doctor, even if you feel better. It is important to continue taking Trileptal to prevent the seizures from recurring. Stopping Trileptal suddenly may result in increased seizure frequency. If the medication needs to be stopped, your doctor may need to lower the dosage gradually.
• If treatment with Trileptal is stopped for any reason, contact your doctor before restarting the medication. A lower dose may be needed to prevent side effects from occurring.
• Your doctor may want you to have blood tests or other medical evaluations during treatment with Trileptal to monitor progress and side effects.
• Carry or wear a medical identification tag to let others know that you are taking this medicine in the case of an emergency.
• Store Trileptal at room temperature away from moisture and heat. The suspension should be used within 7 weeks of first opening the bottle.

What happens if I miss a dose?

• Take the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and take only the next regularly scheduled dose. Do not take a double dose of this medication.

What happens if I overdose?

• Seek emergency medical treatment.
• Symptoms of an Trileptal overdose are not known.

What should I avoid while taking Trileptal?

• Do not drink alcohol while taking Trileptal. Alcohol may increase drowsiness or dizziness caused by Trileptal. Alcohol may also increase the risk of seizures.
• Trileptal may cause drowsiness, dizziness, blurred vision, or poor coordination. Do not drive, operate dangerous machinery, or perform other hazardous activities until you know how Trileptal affects you. If you experience drowsiness, dizziness, blurred vision, or poor coordination, avoid these activities.

What are the possible side effects of Trileptal?

• If you experience any of the following serious side effects, seek emergency medical attention or consult your doctor immediately:
  • an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);
  • symptoms of low blood sodium (nausea, general discomfort, headache, extreme drowsiness, or confusion);
  • central nervous system effects (difficulty with concentration, speech, or language; excessive sleepiness or fatigue; a loss of coordination or trouble walking);
  • double vision, nystagmus (back-and-forth movements of the eyes), blurred vision, or other visual disturbances; or
  • increasing frequency or worsening of seizures.
• Other, less serious side effects may be more likely to occur. Continue to take Trileptal and talk to your doctor if you experience
  • headache;
  • mild sleepiness or fatigue;
  • nausea, vomiting, or stomach pain;
  • tremor;
  • dizziness;
  • rash;
  • diarrhea, constipation, or decreased appetite;
  • weight gain; or
  • dry mouth.
• Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

What other drugs will affect Trileptal?

• Trileptal interacts with many of the other drugs used to treat seizures. Before taking Trileptal, tell your doctor about all other medications you are taking. You may require a dosage adjustment or special monitoring during treatment if you are taking a combination of medications to treat seizures. Continue to take all medications prescribed to treat seizures exactly as directed.
• Trileptal may decrease the effectiveness of birth control pills. Use a second method of birth control while taking Trileptal to ensure protection from unintended pregnancy.
• Trileptal may increase the effects of other drugs that cause drowsiness, including antidepressants, alcohol, antihistamines, sedatives (used to treat insomnia), pain relievers, anxiety medicines, and muscle relaxants. Dangerous sedation, dizziness, or drowsiness may occur if Trileptal is taken with any of these medications.
• Drugs other than those listed here may also interact with Trileptal or affect your condition. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including herbal products.