LAMOTRIGINE- lamotrigine tablet 
Mylan Pharmaceuticals Inc.

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MEDICATION GUIDE
LAMOTRIGINE TABLETS, USP
(la moe′ tri jeen)

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. 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 serious rash is higher if you:

    • take lamotrigine tablets while taking valproate [DEPAKENE® (valproic acid) or DEPAKOTE® (divalproex sodium)]
    • take a higher starting dose of lamotrigine tablets than your healthcare provider prescribed
    • increase your dose of lamotrigine tablets faster than prescribed.

        

      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:

      • 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 lamotrigine tablets.

  2.  Other serious reactions, including serious blood problems or liver problems.

    Lamotrigine tablets 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:

    • fever
    • frequent infections
    • severe muscle pain
    • swelling of your face, eyes, lips or tongue
    • swollen lymph glands
    • unusual bruising or bleeding
    • weakness, fatigue
    • yellowing of your skin or the white part of your eyes
  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:

    •  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 lamotrigine tablets without first talking to a healthcare provider.

    • Stopping lamotrigine tablets 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.  
  4. 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:

    • Headache
    • Fever
    • Nausea
    • Vomiting
    • Stiff neck
    • Rash
    • Unusual sensitivity to light
    • Muscle pains
    • Chills
    • Confusion
    • Drowsiness
       

    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?”

  5. Patients prescribed lamotrigine tablets have sometimes been given the wrong medicine because many medicines have names similar to lamotrigine, 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:

    • 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 below.


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

 

 

Lamotrigine Tablets
25 mg Tablet 100 mg Tablet 150 mg Tablet 200 mg Tablet
25 mg, white to off-white debossed with M on one side of the tablet and L above the score and 51 below the score on the other side. 100 mg, white to off-white debossed with M above the score and L52 below the score on one side of the tablet and blank on the other side. 150 mg, white to off-white debossed with M above the score and L53 below the score on one side of the tablet and blank on the other side. 200 mg, green debossed with M above the score and L54 below the score on one side of the tablet and blank on the other side.

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 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 lamotrigine is 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?

Common side effects of lamotrigine tablets include:

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 it was not prescribed. Do not give lamotrigine tablets 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 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 Mylan Pharmaceuticals Inc. toll free at 1-877-446-3679 (1-877-4-INFO-RX).

What are the ingredients in lamotrigine tablets, USP?

Active ingredient: lamotrigine, USP.

Inactive ingredients: anhydrous lactose, colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, pregelatinized starch and sodium lauryl sulfate. In addition, the 200 mg tablets contain D&C Yellow No. 10 Aluminum Lake and FD&C Blue No. 1 Aluminum Lake.

*DEPAKENE® and DEPAKOTE® are registered trademarks of Abbott Laboratories.

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

Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.

REVISED SEPTEMBER 2012
LAMO:R7mpbmt/MG:LAMO:R5

Revised: 10/2012
 
Mylan Pharmaceuticals Inc.