LAMICTAL - lamotrigine tablet
Physicians Total Care, Inc.
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MEDICATION GUIDE
LAMICTAL® (la-MIK-tal)
(lamotrigine)
Tablets and Chewable Dispersible Tablets
LAMICTAL® ODT™
(lamotrigine)
Orally Disintegrating Tablets
Read this Medication Guide before you start taking LAMICTAL and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or treatment. If you have questions about LAMICTAL, ask your healthcare provider or pharmacist.
What is the most important information I should know about LAMICTAL?
1. LAMICTAL 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, 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.
The risk of getting a serious skin rash is higher if you:
Call your healthcare provider right away if you have any of the following:
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.
2. Other serious reactions, including serious blood problems or liver problems. LAMICTAL can also cause other types of 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:
3. 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:
Do not stop LAMICTAL without first talking to a healthcare provider.
How can I watch for early symptoms of suicidal thoughts and actions?
4. LAMICTAL 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:
Meningitis has many causes other than LAMICTAL, which your doctor would check for if you developed meningitis while taking LAMICTAL.
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?”
5. 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:
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.
25 mg, white Imprinted with LAMICTAL 25 |
100 mg, peach Imprinted with LAMICTAL 100 |
150 mg, cream Imprinted with LAMICTAL 150 |
200 mg, blue Imprinted with LAMICTAL 200 |
LAMICTAL (lamotrigine) Chewable Dispersible Tablets
2 mg, white Imprinted with LTG 2 |
5 mg, white Imprinted with GX CL2 |
25 mg, white Imprinted with GX CL5 |
LAMICTAL ODT (lamotrigine) Orally Disintegrating Tablets
25 mg, white to off-white Imprinted with LMT on one side 25 on the other |
50 mg, white to off-white Imprinted with LMT on one side 50 on the other |
100 mg, white to off-white Imprinted with LAMICTAL on one side 100 on the other |
200 mg, white to off-white Imprinted with LAMICTAL on one side 200 on the other |
What is LAMICTAL?
LAMICTAL is a prescription medicine used:
It is not known if LAMICTAL is safe or effective in children or teenagers under the age of 18 with mood disorders such as bipolar disorder or depression.
It is not known if LAMICTAL is safe or effective when used alone as the first treatment of seizures in adults.
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 this leaflet for a complete list of ingredients in LAMICTAL.
What should I tell my healthcare provider before taking LAMICTAL?
Before taking LAMICTAL, tell your healthcare provider about all of your medical conditions, including if you:
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. If you use LAMICTAL with certain other medicines, they can affect each other, causing side effects.
How should I take LAMICTAL?
What should I avoid while taking LAMICTAL?
Do not drive a car or operate complex, hazardous machinery until you know how LAMICTAL affects you.
What are possible side effects of LAMICTAL?
Common side effects of LAMICTAL include:
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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.
How should I store LAMICTAL?
General information about LAMICTAL
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use LAMICTAL for a condition for which it was not prescribed. Do not give LAMICTAL to other people, even if they have the same symptoms you have. It may harm them.
This Medication Guide summarizes the most important information about LAMICTAL. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about LAMICTAL that is written for healthcare professionals.
For more information, go to www.lamictal.com or call 1-888-825-5249.
What are the ingredients in LAMICTAL?
LAMICTAL Tablets
Active ingredient: lamotrigine.
Inactive ingredients: lactose; magnesium stearate, microcrystalline cellulose, povidone, sodium starch glycolate, FD&C Yellow No. 6 Lake (100 mg tablet only), ferric oxide, yellow (150 mg tablet only), and FD&C Blue No. 2 Lake (200 mg tablet only).
LAMICTAL Chewable Dispersible Tablets
Active ingredient: lamotrigine.
Inactive ingredients: blackcurrant flavor, calcium carbonate, low-substituted hydroxypropylcellulose, magnesium aluminum silicate, magnesium stearate, povidone, saccharin sodium, and sodium starch glycolate.
LAMICTAL ODT Orally Disintegrating Tablets
Active ingredient: lamotrigine
Inactive ingredients: artificial cherry flavor, crospovidone, ethylcellulose, magnesium stearate, mannitol, polyethylene, and sucralose.
This Medication Guide has been approved by the U.S. Food and Drug Administration.
LAMICTAL is a registered trademark of GlaxoSmithKline.
DEPAKENE and DEPAKOTE are registered trademarks of Abbott Laboratories.
GlaxoSmithKline
Research Triangle Park, NC 27709
LAMICTAL Tablets and Chewable Dispersible Tablets are manufactured by
DSM Pharmaceuticals, Inc.,
Greenville, NC 27834 or
GlaxoSmithKline
Research Triangle Park, NC 27709
LAMICTAL Orally Disintegrating Tablets are manufactured by
Eurand, Inc., Vandalia, OH 45377
©2011, GlaxoSmithKline. All rights reserved.
December 2011
LMT:7MG