Lamotrigine

Brand Name: Lamictal

Information for the Patient (included in package insert)

LAMICTAL^® (lamotrigine) Tablets
LAMICTAL^® (lamotrigine) Chewable Dispersible Tablets

ALWAYS CHECK THAT YOU RECEIVE LAMICTAL Patients prescribed LAMICTAL (lah-MICK-tall) have sometimes been given the wrong medicine in error because many medicines have names similar to LAMICTAL. Taking the wrong medication can cause serious health problems. When your healthcare provider gives you a prescription for LAMICTAL

• make sure you can read it clearly.
• talk to your pharmacist to check that you are given the correct medicine.
• check the tablets you receive against the pictures of the tablets below. The pictures show actual tablet shape and size and the wording describes the color and printing that is on each strength of LAMICTAL Tablets and Chewable Dispersible Tablets.

LAMICTAL (lamotrigine) Tablets

LAMICTAL (lamotrigine) Chewable Dispersible Tablets

Please read this leaflet carefully before you take LAMICTAL and read the leaflet provided with any refill, in case any information has changed. This leaflet provides a summary of the information about your medicine. Please do not throw away this leaflet until you have finished your medicine. This leaflet does not contain all the information about LAMICTAL and is not meant to take the place of talking with your doctor. If you have any questions about LAMICTAL, ask your doctor or pharmacist.

Information About Your Medicine:

The name of your medicine is LAMICTAL (lamotrigine). The decision to use LAMICTAL is one that you and your doctor should make together. When taking lamotrigine, it is important to follow your doctor's instructions.

1. The Purpose of Your Medicine: For Patients With Epilepsy: LAMICTAL is intended to be used either alone or in combination with other medicines to treat seizures in people aged 2 years or older.

For Patients With Bipolar Disorder: LAMICTAL is used as maintenance treatment of Bipolar I Disorder to delay the time to occurrence of mood episodes in people aged 18 years or older treated for acute mood episodes with standard therapy.

2. Who Should Not Take LAMICTAL:

You should not take LAMICTAL if you had an allergic reaction to it in the past.

3. Side Effects to Watch for:

• Most people who take LAMICTAL tolerate it well. Common side effects with LAMICTAL include dizziness, headache, blurred or double vision, lack of coordination, sleepiness, nausea, vomiting, insomnia, and rash. LAMICTAL may cause other side effects not listed in this leaflet. If you develop any side effects or symptoms you are concerned about or need more information, call your doctor.
• Although most patients who develop rash while receiving LAMICTAL have mild to moderate symptoms, some individuals may develop a serious skin reaction that requires hospitalization. Rarely, deaths have been reported. These serious skin reactions are most likely to happen within the first 8 weeks of treatment with LAMICTAL. Serious skin reactions occur more often in children than in adults.
• Rashes may be more likely to occur if you: (1) take LAMICTAL in combination with valproate [DEPAKENE^® (valproic acid) or DEPAKOTE^® (divalproex sodium)], (2) take a higher starting dose of LAMICTAL than your doctor prescribed, or (3) increase your dose of LAMICTAL faster than prescribed.
• It is not possible to predict whether a mild rash will develop into a more serious reaction.

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Therefore, if you experience a skin rash, hives, fever, swollen lymph glands, painful sores in the mouth or around the eyes, or swelling of lips or tongue, tell a doctor immediately, since these symptoms may be the first signs of a serious reaction. A doctor should evaluate your condition and decide if you should continue taking LAMICTAL.

4. The Use of LAMICTAL During Pregnancy and Breast-feeding:

The effects of LAMICTAL during pregnancy are not known at this time. If you are pregnant or are planning to become pregnant, talk to your doctor. Some LAMICTAL passes into breast milk and the effects of this on infants are unknown. Therefore, if you are breast-feeding, you should discuss this with your doctor to determine if you should continue to take LAMICTAL.

5. Use of Birth Control Pills or Other Female Hormonal Preparations:

• Do not start or stop using birth control pills or other female hormonal products until you have consulted your doctor.
  • Tell your doctor as soon as possible if you experience changes in your menstrual pattern (e.g., break-through bleeding) while taking LAMICTAL and birth control pills or other female hormonal products.
  • 6. How to Use LAMICTAL:
• It is important to take LAMICTAL exactly as instructed by your doctor. The dose of LAMICTAL must be increased slowly. It may take several weeks or months before your final dosage can be determined by your doctor, based on your response.
• Do not increase your dose of LAMICTAL or take more frequent doses than those indicated by your doctor. Contact your doctor, if you stop taking LAMICTAL for any reason. Do not restart without consulting your doctor.
• If you miss a dose of LAMICTAL, do not double your next dose.
• Always tell your doctor and pharmacist if you are taking any other prescription or over-the-counter medicines. Tell your doctor before you start any other medicines.
• Do NOT stop taking LAMICTAL or any of your other medicines unless instructed by your doctor.
• Use caution before driving a car or operating complex, hazardous machinery until you know if LAMICTAL affects your ability to perform these tasks.
• If you have epilepsy, tell your doctor if your seizures get worse or if you have any new types of seizures.

7. How to Take LAMICTAL:

LAMICTAL Tablets should be swallowed whole. Chewing the tablets may leave a bitter taste.

LAMICTAL Chewable Dispersible Tablets may be swallowed whole, chewed, or mixed in water or diluted fruit juice. If the tablets are chewed, consume a small amount of water or diluted fruit juice to aid in swallowing.

To disperse LAMICTAL Chewable Dispersible Tablets, add the tablets to a small amount of liquid (1 teaspoon, or enough to cover the medication) in a glass or spoon. Approximately 1 minute later, when the tablets are completely dispersed, mix the solution and take the entire amount immediately.

8. Storing Your Medicine:

Store LAMICTAL at room temperature away from heat and light. Always keep your medicines out of the reach of children.

This medicine was prescribed for your use only to treat seizures or to treat Bipolar Disorder. Do not give the drug to others.

If your doctor decides to stop your treatment, do not keep any leftover medicine unless your doctor tells you to. Throw away your medicine as instructed.

Manufactured for GlaxoSmithKline Research Triangle Park, NC 27709 by DSM Pharmaceuticals, Inc. Greenville, NC 27834 or GlaxoSmithKline Research Triangle Park, NC 27709

DEPAKENE and DEPAKOTE are registered trademarks of Abbott Laboratories.

©2004, GlaxoSmithKline. All rights reserved.

August 2004 RL-2119

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