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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Useful Web Sites

For additional information, please visit these sites or contact these organizations. The Web sites listed are external to GlaxoSmithKline. GlaxoSmithKline does not have control over the content of the information provided on these Web sites and therefore does not warrant their accuracy and completeness.

Be sure to discuss all information related to your epilepsy and treatment with your healthcare professional.

Epilepsy Foundation
8301 Professional Place
Landover, MD 20785
800-332-1000
301-577-2684 (Fax)
www.epilepsyfoundation.org

American Epilepsy Society (AES)
342 North Main Street
West Hartford, CT 06117
860-586-7505
860-586-7550 (Fax)
www.aesnet.org

American Academy of Neurology (AAN)
1080 Montreal Avenue
St. Paul, MN 55116
800-879-1960
651-695-2791 (Fax)
www.aan.com

Child Neurology Society (CNS)
1000 West County Road E, Suite 290
St. Paul, MN 55126
651-486-9447
651-486-9436 (Fax)
www.childneurologysociety.org

Healthfinder
(Department of Health and Human Services Web site)
PO Box 1133
Washington, DC 20013-1133
www.healthfinder.gov

Citizens United for Research in Epilepsy (CURE)
730 North Franklin Street, Suite 404
Chicago, IL 60654
800-765-7118
312-255-1809 (Fax)
www.CUREepilepsy.org

National Association of Epilepsy Centers (NAEC)
5775 Wayzata Boulevard, Suite 200
Minneapolis, MN 55416
888-525-6232
952-525-1560 (Fax)
www.naecepilepsy.org

National Council on Patient Information and Education (NCPIE)
4915 Saint Elmo Avenue, Suite 505
Bethesda, MD 20814-6082
301-656-8565
301-656-4464 (Fax)
www.talkaboutrx.org

Family Caregiver Alliance (FCA)
180 Montgomery Street, Suite 1100
San Francisco, CA 94104
800-445-8106
415-434-3508 (Fax)
www.caregiver.org

National Family Caregivers Association (NFCA)
10400 Connecticut Avenue, #500
Kensington, MD 20895-3944
800-896-3650
301-942-2302 (Fax)
www.nfcacares.org

Society for Neuroscience (SFN)
1121 14th Street NW, Suite 1010
Washington, DC 20005
202-962-4000
202-962-4941 (Fax)
www.sfn.org

National Institute of Neurological Disorders and Stroke (NINDS)
PO Box 5801
Bethesda, MD 20824
800-352-9424
www.ninds.nih.gov

American Therapeutic Recreation Association (ATRA)
629 North Main St.
Hattiesburg, MS 39401
601-450-2872
601-582-3354 (Fax)
www.atra-tr.org

Seizures & Epilepsy Education (SEE)
2122 Rock Hollar Road
Stanley, NC 28164
800-397-3605
www.theseeprogram.com


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.