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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Types of Partial Seizures

Not all seizure disorders are alike. They can differ in the way they affect the brain and in the symptoms they produce. Here's a summary of the types of seizures LAMICTAL XR treats.

Partial Seizures

Partial seizures begin in just one part of the brain. About 60% of people with epilepsy have partial seizures. There are two types of partial seizures:

  • Simple partial seizures may cause unusual feelings or sensations that can take many forms, such as sudden, unexplained feelings of joy, anger, sadness, or nausea. It's not uncommon to hear, smell, taste, see, or feel things that are not real. During simple partial seizures, you may remain alert and aware.
  • Complex partial seizures cause a change in or loss of consciousness. Altered consciousness can produce a dreamlike experience. Strange, repetitious behaviors such as blinks, twitches, mouth movements, or even walking in a circle may occur. Throwing objects or striking walls or furniture, as if in anger or fear, may also occur.
  • Secondary generalized seizures occur when simple or complex seizures spread to involve your entire brain. They may begin as a complex partial seizure with staring and nonpurposeful movements. The seizure then becomes more intense, leading to generalized convulsions characterized by stiffening and shaking of your extremities and your body with loss of consciousness.

Symptoms of partial seizures can be mistaken for other disorders. For example, the dreamlike experience of partial seizures may be mistaken for migraine headaches. In people with partial seizures, the progression of symptoms tends to be similar every time.

 

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.

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