Important Safety Information About LAMICTAL^® (lamotrigine) Tablets and LAMICTAL^® ODT™ (lamotrigine) Orally Disintegrating Tablets

LAMICTAL may cause a serious skin rash that may cause you to be hospitalized or to stop LAMICTAL; 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, within the first 2-8 weeks of treatment. But it can happen in people who have taken LAMICTAL 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 LAMICTAL.

The risk of getting a rash is higher if taking LAMICTAL while taking valproate [Depakene^* (valproic acid) or Depakote^* (divalproex sodium)], taking a higher starting dose of LAMICTAL than a healthcare provider prescribed or increasing the dose of LAMICTAL faster than prescribed.

LAMICTAL 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 the eyes, swelling of the lips or tongue, yellowing of the 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.

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

LAMICTAL 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).

Attention Healthcare Professionals: Medication errors involving LAMICTAL have occurred. To reduce the potential for medication errors, please write and say "LAMICTAL" and "LAMICTAL ODT" clearly. Attention Patients and Caregivers: Always check that you receive LAMICTAL or LAMICTAL ODT. Patients prescribed LAMICTAL have sometimes been given the wrong medicine in error because many medicines have names similar to LAMICTAL.

Common side effects include dizziness, headache, blurred or double vision, lack of coordination, sleepiness, nausea, vomiting, insomnia, tremor, rash, fever, abdominal pain, back pain, tiredness, and dry mouth. 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 and birth control pills. These are not all the possible side effects of LAMICTAL.