LAMOTRIGINE - lamotrigine tablet 
REMEDYREPACK INC.

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SPL MEDGUIDE

LAMOTRIGINE ( la MOE tri jeen) TABLETS

Read this Medication Guide before you start taking lamotrigine tablets 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 lamotrigine tablets, ask your healthcare provider or pharmacist.

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 to stop lamotrigine tablets; 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 lamotrigine tablets, within the first 2 to 8 weeks of treatment. But it can happen in people who have taken lamotrigine tablets 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 tablets.

The risk of getting a rash is higher if you:

  

Lamotrigine tablets 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:

These symptoms may be the first signs of a serious reaction. A healthcare provider should examine you to decide if you should continue taking lamotrigine tablets.

2. 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?

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

Lamotrigine tablets 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 lamotrigine tablets?”

4. Patients 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 tablets:

 The wording describes the actual tablet shape, size, color and printing that is on each strength of lamotrigine tablets. Immediately call your pharmacist if you receive a lamotrigine tablet that does not look like one of the tablets described below, as you may have received the wrong medication.

25 mg – white to off-white, diamond-shaped tablets, debossed with the number “93” on one side and scored between the two numbers, and debossed “39” on the other side of the tablet.

100 mg – peach, diamond-shaped tablets, debossed with the number “93” on one side and scored between the two numbers, and debossed “463” on the other side of the tablet.

150 mg – cream, diamond-shaped tablets, debossed with the number “93” on one side and scored between the two numbers, and debossed “7247” on the other side of the tablet.

200 mg – blue, diamond-shaped tablets, debossed with the number “93” on one side and scored between the two numbers, and debossed “7248” on the other side of the tablet.

What are lamotrigine tablets?

Lamotrigine tablets are a prescription medicine used:

  1. together with other medicines to treat certain types of seizures (partial seizures, primary generalized tonic-clonic seizures, generalized seizures of Lennox-Gastaut syndrome) in people 2 years or older.
  2. alone when changing from other medicines used to treat partial seizures in people 16 years or older.
  3. for the long-term treatment of Bipolar I Disorder to lengthen the time between mood episodes in people 18 years or older who have been treated for mood episodes with other medicine.

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

Who should not take lamotrigine tablets?

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

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

Before taking lamotrigine tablets, 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. Using lamotrigine tablets with certain other medicines can affect each other, causing side effects.

How should I take lamotrigine tablets?

What should I avoid while taking lamotrigine tablets?

What are possible side effects of lamotrigine tablets?

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 tablets. 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 lamotrigine tablets

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

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

For more information, call 1-888-838-2872, MEDICAL AFFAIRS.

What are the ingredients in lamotrigine tablets?

Active ingredient: lamotrigine.

Inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, and sodium starch glycolate. In addition, the 100 mg strength contains FD&C Yellow #6, the 150 mg strength contains ferric oxide yellow, and the 200 mg strength contains FD&C Blue #2 aluminum lake.

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

All brand names listed are the registered trademarks of their respective owners and are not trademarks of Teva Pharmaceuticals USA.

Manufactured In Israel By:

TEVA PHARMACEUTICAL IND. LTD.

Jerusalem, 91010, Israel

Manufactured For:

TEVA PHARMACEUTICALS USA

Sellersville, PA 18960

Rev. F 9/2012

 

Revised: 04/2013
 
REMEDYREPACK INC.