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.