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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Treatment Goals

The goal of epilepsy treatment is to help you become as close to seizure-free as possible. Medicine can help prevent seizures, and today, many different antiseizure medicines are available.

Epilepsy is commonly a long-term illness, so you should talk to your doctor about your immediate needs and long-term goals. The treatment of epilepsy focuses on these main goals:

  • Good control of seizures
  • As few side effects as possible
  • As few interactions with medicines as possible
  • Improved quality of life
  • Resuming normal growth and development in children

You may find that by taking medicine, you have fewer or milder seizures—or that your seizures are prevented altogether.

It may take some time working together with your doctor to find the right antiseizure
medicine(s). Not only do you want to find the medicine(s) that best control(s) seizures, you want to find medicines that you can comfortably take with minimal side effects.

You can help by:

  • Discussing your individual treatment goals with your doctor.
  • Taking the Treatment Satisfaction Questionnaire and discussing your answers with your doctor.
  • Keeping track of your seizures and how you feel on a daily basis using an Events Calendar (PDF) to share with your doctor at each visit.

The importance of continuing your antiseizure medicine(s)

It's natural to want to stop taking medicine once you feel better. After all, you stop taking cold medicine once the cold is gone, and you don't take aspirin after your headache is gone. But that's not the case with epilepsy.

It is very important to keep taking antiseizure medicine for as long as your doctor prescribes it — and never stop taking antiseizure medicine without specific instructions. That means taking your antiseizure medicine even after the seizures are under control and you are feeling better.

If you experience problems with your antiseizure medicine, call your doctor.

Stopping the antiseizure medicine without a doctor's advice is one of the major reasons people who have been seizure-free may start having breakthrough seizures. Seizures that result from stopping medicine can be very serious.

Other treatment options

In addition to medication, other types of treatment for seizure disorders include:

  • Surgery — When seizures cannot be adequately controlled with medication, doctors may recommend that a person be evaluated for surgery. Surgery can involve removing damaged sections of brain tissue, or it can involve making a series of small cuts to prevent seizures from spreading to other parts of the brain. However, surgery for epilepsy does not always successfully reduce seizures, and surgery can cause changes in personality or brain function.
  • Vagal nerve stimulation — The vagus nerve stimulator was approved by the FDA in 1997 for use in people with seizures that are not well controlled by medication. The stimulator is a battery-powered device that is surgically implanted under the skin of the chest, much like a pacemaker, and is attached to the vagus nerve in the lower neck. The device delivers short bursts of electrical energy to the brain that can reduce seizures.
  • Ketogenic diet — Studies have shown that, in some cases, children may experience fewer seizures if they maintain a strict diet rich in fats and low in carbohydrates. This unusual diet, called the ketogenic diet, causes the body to break down fats instead of carbohydrates to create a condition called ketosis. Researchers are not sure how ketosis inhibits seizures. People who try this diet should seek the guidance of a dietician to ensure that it does not lead to serious nutritional deficiencies and other problems such as kidney stones.

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.

Next: Seizure Triggers