Complete Prescribing Information for LAMICTAL^® (lamotrigine)

Patient Information leaflet

Important Safety Information About LAMICTAL

Most people who take LAMICTAL tolerate it well. The most 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 here. If you develop any side effects or symptoms you are concerned about, or if you 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 (brand names are Depakene^®* and Depakote^®*), 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 one. 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.

*Depakene (valproic acid) and Depakote (divalproex sodium) are registered trademarks of Abbott Laboratories.