Important Safety Information About LAMICTAL

Prescription LAMICTAL Tablets are not for everyone. 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, tremor, and rash. LAMICTAL may cause other side effects not listed here. 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. It is not possible to predict whether a mild rash will develop into a more serious reaction. 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®* (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.

If you experience any of the following with or without a skin rash, tell your doctor immediately: hives, fever, swollen lymph glands, painful sores in the mouth or around the eyes, or swelling of lips or tongue. 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.

Serious blood problems or liver problems have been reported with LAMICTAL, so tell your doctor if you develop symptoms such as unusual bruising or bleeding, severe muscle pain, weakness, fatigue, yellowing of the eyes or skin, and/or frequent infections.

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

Indications:

LAMICTAL is indicated as adjunctive therapy for partial seizures, the generalized seizures of Lennox-Gastaut syndrome, and primary generalized tonic-clonic seizures in adult and pediatric patients (≥2 years of age); and for conversion to monotherapy in adults with partial seizures who are receiving treatment with carbamazepine, phenytoin, phenobarbital, primidone, or valproate as the single AED.

• Safety and effectiveness of LAMICTAL have not been established 1) as initial monotherapy, 2) for conversion to monotherapy from AEDs other than carbamazepine, phenytoin, phenobarbital, primidone, or valproate, or 3) for simultaneous conversion to monotherapy from 2 or more concomitant AEDs.

LAMICTAL is indicated for the maintenance treatment of bipolar I disorder to delay the time to occurrence of mood episodes (depression, mania, hypomania, mixed episodes) in adults treated for acute mood episodes with standard therapy. The effectiveness of LAMICTAL in the acute treatment of mood episodes has not been established.