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

Prescription LAMICTAL XR Extended-Release Tablets are not for everyone.

LAMICTAL XR may cause a serious skin rash that may cause you to be hospitalized or even cause death. There is no way to tell if a mild rash will become more serious. A serious skin rash can happen at any time during your treatment with LAMICTAL XR, but is more likely to happen within the first 2 to 8 weeks of treatment. Children between 2 to 16 years of age have a higher chance of getting this serious skin rash while taking LAMICTAL XR. LAMICTAL XR is not approved for use in children less than 13 years old.

The risk of getting a serious skin 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.

Call your healthcare provider right away if you have any of the following: a skin rash; blistering or peeling of your skin; hives; or painful sores in your mouth or around your eyes. These symptoms may be the first signs of a serious skin reaction. A healthcare provider should examine you to decide if you should continue taking LAMICTAL XR.

LAMICTAL XR can also cause other types of serious allergic reactions or serious problems that may affect organs and other parts of your body like your 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 these symptoms: fever; frequent infections; severe muscle pain; swelling of your face, eyes, lips, or tongue; swollen lymph glands; unusual bruising or bleeding; weakness, fatigue; or yellowing of your skin or the white part of your eyes.

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 any of these symptoms, especially if they are new, worse, or worry you: thoughts about suicide or dying; attempt to commit suicide; new or worse depression; new or worse anxiety; feeling agitated or restless; panic attacks; trouble sleeping (insomnia); new or worse irritability; acting aggressive, being angry, or violent; acting on dangerous impulses; an extreme increase in activity and talking (mania); or other unusual changes in behavior or mood.

Your healthcare provider should inform your caregivers and family that anti-epileptic drugs increase the risk of suicidal thoughts and behavior, advise them to be alert for any new or worse signs and symptoms listed above, and tell them to report concerning behaviors immediately to healthcare providers.

LAMICTAL XR may rarely cause aseptic meningitis, a serious inflammation of the protective membrane that covers the brain and spinal cord. Call your healthcare provider right away if you have any of the following symptoms: headache, fever, nausea, vomiting, stiff neck, rash, unusual sensitivity to light, muscle pains, chills, confusion, or drowsiness.

Meningitis has many causes other than LAMICTAL XR, which your doctor would check for if you developed meningitis while taking LAMICTAL XR.

Do not stop taking LAMICTAL XR without talking to your healthcare provider. Stopping LAMICTAL XR suddenly may cause serious problems. For example, if you stop taking LAMICTAL XR suddenly, you may get seizures that do not stop. Talk with your healthcare provider about how to stop LAMICTAL XR slowly.

Always check that you receive LAMICTAL XR (lamotrigine) Extended-Release Tablets
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:

• Make sure you can read it clearly.
• Talk to your pharmacist to check that you are given the correct medicine.
• Each time you fill your prescription, check the tablets you receive against the pictures of the tablets in the Medication Guide that comes with your prescription.

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.

Tell your healthcare provider before taking LAMICTAL XR if you:

• have had a rash or allergic reaction to another anti-seizure medicine.
• have had aseptic meningitis after taking LAMICTAL (lamotrigine) or LAMICTAL XR.
• are taking birth control pills or other female hormonal medicines. Do not start or stop these medicines before talking with your healthcare provider. Tell your healthcare provider if you have any changes in your menstrual pattern, such as breakthrough bleeding, while taking these medicines and LAMICTAL XR. Stopping these medicines may cause side effects (such as dizziness, lack of coordination, or double vision). Starting these medicines may lessen how well LAMICTAL XR works.
• are pregnant or plan to become pregnant. It is not known if LAMICTAL XR will harm your unborn baby. If you become pregnant while taking LAMICTAL XR, talk to your healthcare provider about enrolling in a registry that collects information about the safety of seizure medicines during pregnancy. Call 1-888-233-2334 to enroll.
• are breastfeeding. LAMICTAL XR passes into breast milk and may cause side effects in a breastfed baby. If you breastfeed while taking LAMICTAL XR, watch your baby closely for trouble breathing, episodes of temporarily stopping breathing, sleepiness, or poor sucking. Call your baby's healthcare provider right away if you see any of these problems. Talk to your healthcare provider about the best way to feed your baby if you take LAMICTAL XR.

Tell your healthcare provider if your seizures get worse or if you have any new types of seizures.

Do not drive a car or operate complex, hazardous machinery until you know how LAMICTAL XR affects you.

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. 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.