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Clinical Studies
Goodwin GM, Bowden CL, Calabrese JR, et al. A pooled analysis of 2 placebo-controlled 18-month trials of lamotrigine and lithium maintenance in bipolar I disorder.
Calabrese JR, Bowden CL, Sachs G, et al. A placebo-controlled 18-month trial of lamotrigine and lithium maintenance treatment in recently depressed patients with bipolar I disorder.
Bowden CL, Calabrese JR, Sachs G, et al. A placebo-controlled 18-month trial of lamotrigine and lithium maintenance treatment in recently manic or hypomanic patients with bipolar I disorder. |
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Important Safety Information About LAMICTAL® (lamotrigine) Tablets 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 if you need more information, call your doctor. Although most patients who develop a 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) and 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. Always check that you receive LAMICTAL. Some patients prescribed LAMICTAL have been given the wrong medicine in error. Taking the wrong medication can cause serious health problems. When your healthcare provider gives you a prescription for LAMICTAL, make sure that both you and your pharmacist can read it clearly. Compare the tablets in the pill bottle to those pictured in the Patient Information leaflet that comes with your prescription. |
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