Patient Information Sheet: Lamotrigine (marketed as Lamictal)

What Is Lamictal?

What Are The Risks?

What Should I Tell My Healthcare Professional?

Can Other Medicines Or Food Affect Lamictal?

Is There Anything Else I Need to Know?

The following are the risks and potential side effects of Lamictal therapy. However, this list is not complete.

Lamictal may cause serious rashes that may need to be treated in a hospital. Rarely, deaths have been reported. Tell your doctor if you are taking valproic acid (Depakene) or divalproex (Depakote), because taking these medicines with Lamictal may increase your chance of developing a serious rash.

Some side effects can be serious. If you experience any of the following symptoms, call your doctor right away:

Patient Information Sheet
Lamotrigine (marketed as Lamictal)

FDA ALERT [9/2006]

New information suggests that babies exposed to Lamictal during the first three months of pregnancy may have a higher chance of being born with a cleft lip or cleft palate. Babies born with cleft lip or cleft palate have a gap in the upper lip or roof of the mouth.

If you take Lamictal and are pregnant or are thinking of becoming pregnant, talk with your doctor. Lamictal is used for seizures or bipolar disorder, serious conditions that need treatment even during pregnancy. Do not start or stop using Lamictal without talking to your doctor.

More research is needed to be sure about this possibly increased chance of cleft lip or cleft palate in babies born to mothers who take Lamictal.

This information reflects FDA’s preliminary analysis of data concerning this drug. FDA is considering, but has not reached a final conclusion about, this information. FDA intends to update this sheet when additional information or analyses become available.

This is a summary of the most important information about Lamictal. For details, talk to your healthcare professional.

Lamictal is used to:

treat certain types of seizures
increase the time between episodes of depression, mania, and other abnormal moods in patients with bipolar I disorder

seizures that happen more often, last longer, or are different than the seizures you had in the past
rash, hives, fever, painful sores in the mouth or irritation around the eyes, or swelling of lips or tongue
depression

Some common side effects that may occur with Lamictal include:

dizziness
headache
blurred or double vision
loss of balance or coordination
sleepiness
nausea
vomiting
difficulty falling asleep or staying asleep
rash

Before you start taking Lamictal tell your healthcare professional if you:

are trying to become pregnant, are already pregnant, or are breast-feeding
have or had heart, liver or kidney disease
have a blood disorder

Lamictal and certain other medicines can interact with each other. Tell your healthcare professional about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Know the medicines you take. Keep a list of them with you to show your healthcare professional.

Especially tell your healthcare professional if you take:

valproic acid (Depakene)
divalproex (Depakote)
carbamazepine (Tegretol)
phenobarbital
phenytoin (Dilantin)
primidone (Mysoline)
birth control pills
hormone replacement therapy (HRT)
rifampin (Rifadin)

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FDA/Center for Drug Evaluation and Research

Some patients taking Lamictal have been given the wrong medication at the pharmacy because other medications have similar names. Examples of drugs with similar names are Lamisil, lamivudine, Ludiomil, labetalol and Lomotil. Therefore, if your Lamictal tablet looks different, check with the pharmacist to be sure that you have been given the correct medication.

Date created: September 28, 2006