LAMOTRIGINE- lamotrigine tablet 
Taro Pharmaceuticals U.S.A., Inc.

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MEDICATION GUIDE

Lamotrigine
(la moe' tri jeen) Tablets, USP

What is the most important information I should know about lamotrigine tablets?

1. Lamotrigine tablets 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 lamotrigine, but is more likely to happen within the first 2 to 8 weeks of treatment. Children and teenagers aged between 2 and 17 years have a higher chance of getting this serious skin rash while taking lamotrigine.

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 lamotrigine.

2. Other serious reactions, including serious blood problems or liver problems. Lamotrigine 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, lamotrigine tablets 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 lamotrigine tablets without first talking to a healthcare provider.

How can I watch for early symptoms of suicidal thoughts and actions in myself or a family member?

4. Lamotrigine tablets may 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 lamotrigine, which your doctor would check for if you developed meningitis while taking lamotrigine.

Lamotrigine tablets can cause 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 lamotrigine tablets?"

5. People prescribed lamotrigine tablets have sometimes been given the wrong medicine because many medicines have names similar to lamotrigine tablets, so always check that you receive lamotrigine tablets.

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

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

Lamotrigine Tablets, USP
25 mg Tablet 100 mg Tablet 150 mg Tablet 200 mg Tablet
Lamotrigine
Tablets USP 25 mg:

Round, white, scored tablets. One side engraved with "TARO". Other side scored and engraved with "LMT" above the score and "25" below the score.
Lamotrigine
Tablets USP 100 mg:

Round, light peach, scored tablets. One side engraved with "TARO". Other side scored and engraved with "LMT" above the score and "100" below the score.
Lamotrigine
Tablets USP 150 mg:

Round, cream, scored tablets. One side engraved with "TARO". Other side scored and engraved with "LMT" above the score and "150" below the score.
Lamotrigine
Tablets USP 200 mg:

Round, light blue, scored tablets. One side engraved with "TARO". Other side scored and engraved with "LMT" above the score and "200" below the score.

What are lamotrigine tablets?

Lamotrigine is a prescription medicine used:

It is not known if lamotrigine is safe or effective in people younger than 18 years with mood episodes such as bipolar disorder or depression.

It is not known if lamotrigine is safe or effective when used alone as the first treatment of seizures.

It is not known if lamotrigine is safe or effective for people with mood episodes who have not already been treated with other medicines.

Lamotrigine should not be used for acute treatment of manic or mixed mood episodes.

Who should not take lamotrigine tablets?

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

What should I tell my healthcare provider before taking lamotrigine tablets?

Before taking lamotrigine, 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 over-the-counter medicines, vitamins, and herbal supplements.

If you use lamotrigine with certain other medicines, they can affect each other, causing side effects.

How should I take lamotrigine tablets?

What should I avoid while taking lamotrigine tablets?

Do not drive, operate machinery, or do other dangerous activities until you know how lamotrigine affects you.

What are the possible side effects of lamotrigine tablets?

Lamotrigine tablets can cause serious side effects.

See "What is the most important information I should know about lamotrigine tablets?"

Common side effects of lamotrigine include:

  • dizziness
  • tremor
  • headache
  • rash
  • blurred or double vision
  • fever
  • lack of coordination
  • abdominal pain
  • infections, including seasonal flu
  • sleepiness
  • back pain
  • nausea, vomiting
  • diarrhea
  • tiredness
  • insomnia
  • dry mouth
  • stuffy nose
  • sore throat

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 lamotrigine. 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 lamotrigine tablets?

General information about the safe and effective use of lamotrigine tablets.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use lamotrigine for a condition for which it was not prescribed. Do not give lamotrigine to other people, even if they have the same symptoms you have. It may harm them.

If you take a urine drug screening test, lamotrigine may make the test result positive for another drug. If you require a urine drug screening test, tell the healthcare professional administering the test that you are taking lamotrigine.

This Medication Guide summarizes the most important information about lamotrigine. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about lamotrigine that is written for healthcare professionals.

For more information about lamotrigine, call 1-866-923-4914.

What are the ingredients in lamotrigine tablets?

Lamotrigine Tablets, USP

Active ingredient: lamotrigine.

Inactive ingredients: croscarmellose sodium, crospovidone, FD&C Blue #2 Aluminum Lake (200 mg strength only), FD&C Yellow No. 6 Lake (100 mg strength only), lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and yellow iron oxide (150 mg strength only).

This Medication Guide has been approved by the U.S. Food and Drug Administration.

DEPAKENE® and DEPAKOTE® are the property of their respective owners.

Mfd. by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761

Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532

Revised: August 2015
70496-0815-11

Revised: 8/2015
Taro Pharmaceuticals U.S.A., Inc.