1. 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 to 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 you:

• take LAMICTAL while taking valproate [Depakene* (valproic acid) or Depakote* (divalproex sodium)]
• take a higher starting dose of LAMICTAL than your healthcare provider prescribed
• increase your 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 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
• 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.

*Depakene and Depakote are registered trademarks of Abbott Laboratories.

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2. Like other antiepileptic drugs, 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 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)
• other unusual changes in behavior or mood

Do not stop LAMICTAL without first talking to a healthcare provider.

• Stopping LAMICTAL suddenly can cause serious problems.
• Suicidal thoughts or actions can be caused by things other than medicines. If you have suicidal thoughts or actions, your healthcare provider may check for other causes.

How can I watch for early symptoms of suicidal thoughts and actions?

• Pay attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings.
• Keep all follow-up visits with your healthcare provider as scheduled.
• Call your healthcare provider between visits as needed, especially if you are worried about symptoms

LAMICTAL can have other serious side effects. For more information ask your healthcare provider or pharmacist. Tell your healthcare provider if you have any side effect that bothers you. Be sure to read the section below entitled "What are the possible side effects of LAMICTAL?"

What are the possible side effects of LAMICTAL?

Common side effects of LAMICTAL include:

dizziness headache blurred or double vision lack of coordination sleepiness nausea, vomiting insomnia

tremor rash fever abdominal pain back pain tiredness dry mouth

Tell your healthcare provider about any side effect that bothers you or that does not go away.

These are not all the possible side effects of LAMICTAL. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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3. 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.

Taking the wrong medication can cause serious health problems. When your healthcare provider gives you a prescription for LAMICTAL:

• 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 shown below.

These pictures show the distinct wording, colors, and shapes of the tablets that help to identify the right strength of LAMICTAL Tablets, Chewable Dispersible Tablets, and Orally Disintegrating Tablets. Immediately call your pharmacist if you receive a LAMICTAL tablet that does not look like one of the tablets shown below, as you may have received the wrong medication.

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WHO SHOULD NOT TAKE LAMICTAL?

You should not take LAMICTAL if you have had an allergic reaction to lamotrigine or to any of the inactive ingredients in LAMICTAL. See the end of the Medication Guide for a complete list of ingredients in LAMICTAL.

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WHAT SHOULD I TELL MY HEALTHCARE PROVIDER?

Before taking LAMICTAL, tell your healthcare provider about all of your medical conditions, including if you:

• have had a rash or allergic reaction to another antiseizure medicine.
• have or have had depression, mood problems or suicidal thoughts or behavior
• are taking oral contraceptives (birth control pills) or other female hormonal medicines. Do not start or stop taking birth control pills or other female hormonal medicine until you have talked with your healthcare provider. Tell your healthcare provider if you have any changes in your menstrual pattern such as breakthrough bleeding. Stopping or starting these medicines may cause side effects (such as dizziness, lack of coordination, or double vision) or lessen how well LAMICTAL works.
• are pregnant or plan to become pregnant. It is not known if LAMICTAL will harm your unborn baby. If you become pregnant while taking LAMICTAL, talk to your healthcare provider about registering with the North American Antiepileptic Drug Pregnancy Registry. You can enroll in this registry by calling 1-888-233-2334. The purpose of this registry is to collect information about the safety of antiepileptic drugs during pregnancy.
• are breastfeeding. LAMICTAL can pass into your breast milk. You and your healthcare provider should decide if you should take LAMICTAL or breastfeed. Breastfeeding while taking LAMICTAL is not recommended.

Tell your healthcare provider about all the medicines you take or if you are planning to take a new medicine, including prescription and non-prescription medicines, vitamins, and herbal supplements. Using LAMICTAL with certain other medicines can affect each other, causing side effects.

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WHAT SHOULD I AVOID WHILE TAKING LAMICTAL?

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

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