LAMICTAL XR

IMPORTANT SAFETY INFORMATION
LAMICTAL XR may cause a serious skin rash that may cause you to be hospitalized or to stop LAMICTAL XR; it may rarely cause death (See Boxed Warning). CONTINUED BELOW

Prescribing Information, including Boxed Warning and Medication Guide.

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Seizure Triggers

A seizure is the result of a shift in the normal balance of electrical energy flow in the brain. A seizure may be dramatic, causing uncontrollable shaking. Or, it may go unnoticed by everyone except the person experiencing it. After a dramatic seizure, you may feel tired or dazed, and may not remember what happened prior to and during the seizure.

What causes seizures?

There is no single cause of seizures. Anything that disturbs the normal pattern of electrical activity in the brain—including illness, brain damage, and abnormal brain development—can lead to seizures.

In people with epilepsy, seizures can be caused by a variety of things. These "triggers" vary from person to person. Some common seizure triggers include:

  • Missed medicines (discontinuing your medicine is a major cause of new seizures)
  • Illness (such as a cold, infection, or high fever)
  • Lack of sleep
  • Flashing bright lights
  • Drinking too much alcohol
  • Over-the-counter medicines, other prescription medicines, supplements, or herbal remedies
  • Use of illegal drugs
  • Physical or emotional stress
  • Hormonal fluctuations associated with ovulation and menstruation, menopause, or pregnancy
  • Poor eating habits
  • Too much caffeine
  • Smoking cigarettes

Many people discover their particular seizure triggers with experience—and plan ahead to avoid or manage those triggers whenever possible. An Events Calendar (PDF) can help you track your seizure patterns and pinpoint your triggers.

Why do seizure disorders occur?

Epilepsy may develop because of abnormal brain function, imbalance of brain chemicals, or a combination of factors. In most cases, the reason a person develops epilepsy is unknown. But there are some known causes of seizures, including:

  • Genetic factors
  • Head injury, brain tumor, or infection of the nervous system
  • Strokes or other conditions causing brain injury
  • Developmental disorders

Important Safety Information About LAMICTAL XR (lamotrigine) Extended-Release Tablets

LAMICTAL XR may cause a serious skin rash that may cause you to be hospitalized or to stop LAMICTAL XR; it may rarely cause death. There is no way to tell if a mild rash will develop into a more serious reaction. These serious skin reactions are more likely to happen when you begin taking LAMICTAL XR, within the first 2 to 8 weeks of treatment. But it can happen in people who have taken LAMICTAL XR for any period of time. Children between 2 to 16 years of age have a higher chance of getting this serious skin reaction while taking lamotrigine. LAMICTAL XR is not approved for use in children less than 13 years old.

The risk of getting a rash is higher if you: take LAMICTAL XR while taking valproate [Depakene* (valproic acid) or Depakote* (divalproex sodium)], take a higher starting dose of LAMICTAL XR than your healthcare provider prescribed, or increase your dose of LAMICTAL XR faster than prescribed.

LAMICTAL XR can also cause other types of allergic reactions or serious problems which may affect organs and other parts of your body like the liver or blood cells. You may or may not have a rash with these types of reactions.

Call your healthcare provider right away if you have any of the following: a skin rash, hives, fever, swollen lymph glands, painful sores in the mouth or around your eyes, swelling of your lips or tongue, yellowing of your skin or eyes, unusual bruising or bleeding, severe fatigue or weakness, severe muscle pain or frequent infections. These symptoms may be the first signs of a serious reaction. A healthcare provider should examine you to decide if you should continue taking LAMICTAL XR.

You should not take LAMICTAL XR if you have had an allergic reaction to lamotrigine or to any of the inactive ingredients in LAMICTAL XR.

Like other antiepileptic drugs, LAMICTAL XR may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. Call a healthcare provider right away if you have worsening depression, any unusual changes in mood or behavior, or thoughts or actions about suicide or self-harm, especially if they are new, worse, or worry you
(see Medication Guide).

Patients prescribed LAMICTAL have sometimes been given the wrong medicine because many medicines have names similar to LAMICTAL, so always check that you receive LAMICTAL XR.
Taking the wrong medication can cause serious health problems. When your healthcare provider gives you a prescription for LAMICTAL XR:

Common side effects include dizziness, tremor, double vision, nausea, vomiting, trouble with balance and coordination, and anxiety. Other common side effects that have been reported with another form of LAMICTAL include headache, sleepiness, blurred vision, runny nose, and rash. Tell your healthcare provider about any side effect that bothers you or does not go away. Also, tell your healthcare provider if you have any changes in your menstrual pattern, such as breakthrough bleeding, while taking LAMICTAL XR and birth control pills. These are not all the possible side effects of LAMICTAL XR. For more information, ask your healthcare provider or pharmacist.

*Depakene and Depakote are registered trademarks of Abbott Laboratories.

Next: Living With a Seizure Disorder