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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How You Can Help

Knowledge is power. From counseling to government aid, there's a wealth of information available to help those living with epilepsy.

You can research online, visit the bookstore or local library, or ask your doctor or local government chapters about support groups and programs. You also can find a support group through the Epilepsy Foundation, the American Epilepsy Society, or Epilepsy.com.

What to do for a seizure

If you see someone having a seizure with convulsions and/or loss of consciousness, here's how you may be able to help:

  • Call for medical help immediately.
  • Stay with the person until the seizure ends.
  • Do not restrict the person from moving unless he or she is in danger.
  • Do not put anything into the person's mouth, not even medicine or liquid. These can cause choking or damage to the person's jaw, tongue, or teeth. Contrary to widespread belief, people cannot swallow their tongues during a seizure or any other time.
  • Gently roll the person on his or her side to prevent choking on any fluids or vomit.
  • Cushion the person's head.
  • Loosen any tight clothing around the neck.
  • Keep the person's airway open. If necessary, grip the person's jaw gently and tilt his or her head back.
  • Remove any sharp or solid objects that the person might hit during the seizure.
  • Note how long the seizure lasts and what symptoms occurred so you can tell a doctor or emergency personnel if necessary.

Understand the challenges

It may help to understand some of the general issues that a person with epilepsy may face:

  • Unpredictability of seizures
  • Feelings of anxiety about having a seizure in an embarrassing or difficult situation
  • Over-focusing on "warning signs" in an attempt to predict when a seizure might occur
  • Job discrimination
  • Financial concerns
  • Concerns about driving restrictions
  • Interference with enjoyable activities due to safety concerns
  • Fear of injury or death during a seizure
  • Worry about the effect that seizures may have on intelligence, memory, and learning
  • Increased risk of depression or anxiety
  • Worry about side effects of antiseizure medicines and how they may interfere with lifestyle goals

Epilepsy affects the whole family

It's not uncommon for people with epilepsy, especially adolescents, to develop behavioral and emotional problems. Sometimes these problems are caused by epilepsy itself, or embarrassment, frustration, or fear of having another seizure.

You can help by encouraging a positive outlook and independence. Don't reward negative behavior with unusual amounts of attention, and try to stay tuned to the person's needs and feelings. Learn to accept and live with the seizure disorder without placing blame or encouraging resentment.

 

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.

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