Lamictal

LAMICTAL®
(la-MIK-tal)
(lamotrigine) tablets and chewable dispersible tablets

LAMICTAL ODT®
(lamotrigine) orally disintegrating tablets

Read this Medication Guide before you start taking LAMICTAL and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or treatment. If you have questions about LAMICTAL, ask your healthcare provider or pharmacist.

What is the most important information I should know about LAMICTAL?

1. LAMICTAL may cause a serious skin rash that may cause you to be hospitalized or even cause death.

There is no way to tell if a mild rash will become more serious. A serious skin rash can happen at any time during your treatment with LAMICTAL, but is more likely to happen within the first 2 to 8 weeks of treatment. Children aged between 2 and 16 years have a higher chance of getting this serious skin rash while taking LAMICTAL.

The risk of getting a serious skin rash is higher if you:

• take LAMICTAL while taking valproate [DEPAKENE® (valproic acid) or DEPAKOTE® (divalproex sodium)].
• take a higher starting dose of LAMICTAL than your healthcare provider prescribed.
• increase your dose of LAMICTAL faster than prescribed.

Call your healthcare provider right away if you have any of the following:

• a skin rash
• blistering or peeling of your skin
• hives
• painful sores in your mouth or around your eyes

These symptoms may be the first signs of a serious skin reaction. A healthcare  provider should examine you to decide if you should continue taking LAMICTAL.

2. Other serious reactions, including serious blood problems or liver problems. LAMICTAL can also cause other types of allergic reactions or serious problems that may affect organs and other parts of your body like your liver or blood cells. You may or may not have a rash with these types of reactions. Call your healthcare provider right away if you have any of these symptoms:

• fever
• frequent infections
• severe muscle pain
• swelling of your face, eyes, lips, or tongue
• swollen lymph glands
• unusual bruising or bleeding
• weakness, fatigue
• yellowing of your skin or the white part of your eyes

3. Like other antiepileptic drugs, LAMICTAL may cause suicidal thoughts or actions in a very small number of people, about 1 in 500.

Call a healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you:

• thoughts about suicide or dying
• attempt to commit suicide
• new or worse depression
• new or worse anxiety
• feeling agitated or restless
• panic attacks
• trouble sleeping (insomnia)
• new or worse irritability
• acting aggressive, being angry, or violent
• acting on dangerous impulses
• an extreme increase in activity and talking (mania) • other unusual changes in behavior or mood

Do not stop LAMICTAL without first talking to a healthcare provider.

• Stopping LAMICTAL suddenly can cause serious problems.
• Suicidal thoughts or actions can be caused by things other than medicines. If you have suicidal thoughts or actions, your healthcare provider may check for other causes.

How can I watch for early symptoms of suicidal thoughts and actions?

• Pay attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings.
• Keep all follow-up visits with your healthcare provider as scheduled.
• Call your healthcare provider between visits as needed, especially if you are worried about symptoms.

4. LAMICTAL may rarely cause aseptic meningitis, a serious inflammation of the protective membrane that covers the brain and spinal cord.

Call your healthcare provider right away if you have any of the following symptoms:

• headache
• fever
• nausea
• vomiting
• stiff neck
• rash
• unusual sensitivity to light
• muscle pains
• chills
• confusion
• drowsiness

Meningitis has many causes other than LAMICTAL, which your doctor would check for if you developed meningitis while taking LAMICTAL.

LAMICTAL can have other serious side effects. For more information ask your healthcare provider or pharmacist. Tell your healthcare provider if you have any side effect that bothers you. Be sure to read the section below entitled “What are the possible side effects of LAMICTAL?”

5. Patients prescribed LAMICTAL have sometimes been given the wrong medicine because many medicines have names similar to LAMICTAL, so always check that you receive 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.
• Each time you fill your prescription, check the tablets you receive against the pictures of the tablets below.

These pictures show the distinct wording, colors, and shapes of the tablets that help to identify the right strength of LAMICTAL Tablets, Chewable Dispersible Tablets, and Orally Disintegrating Tablets. Immediately call your pharmacist if you receive a LAMICTAL tablet that does not look like one of the tablets shown below, as you may have received the wrong medication.

LAMICTAL (lamotrigine) tablets

LAMICTAL (lamotrigine) chewable dispersible tablets

LAMICTAL ODT (lamotrigine) orally disintegrating tablets

What is LAMICTAL?

LAMICTAL is a prescription medicine used:

1. together with other medicines to treat certain types of seizures (partial-onset seizures, primary generalized tonic-clonic seizures, generalized seizures of Lennox-Gastaut syndrome) in people aged 2 years and older.
2. alone when changing from 1 other medicine used to treat partial-onset seizures in people aged 16 years and older.
3. for the long-term treatment of bipolar I disorder to lengthen the time between mood episodes in people aged 18 years and older who have been treated for mood episodes with other medicine.

It is not known if LAMICTAL is safe or effective in children or teenagers younger than 18 years with mood disorders such as bipolar disorder or depression.

It is not known if LAMICTAL is safe or effective when used alone as the first treatment of seizures.

Who should not take LAMICTAL?

You should not take LAMICTAL if you have had an allergic reaction to lamotrigine or to any of the inactive ingredients in LAMICTAL. See the end of this leaflet for a complete list of ingredients in LAMICTAL.

What should I tell my healthcare provider before taking LAMICTAL?

Before taking LAMICTAL, tell your healthcare provider about all of your medical conditions, including if you:

• have had a rash or allergic reaction to another antiseizure medicine.
• have or have had depression, mood problems, or suicidal thoughts or behavior.
• have had aseptic meningitis after taking LAMICTAL or LAMICTAL XR (lamotrigine).
• are taking oral contraceptives (birth control pills) or other female hormonal medicines. Do not start or stop taking birth control pills or other female hormonal medicine until you have talked with your healthcare provider. Tell your healthcare provider if you have any changes in your menstrual pattern such as breakthrough bleeding. Stopping these medicines may cause side effects (such as dizziness, lack of coordination, or double vision). Starting these medicines may lessen how well LAMICTAL works.
• are pregnant or plan to become pregnant. It is not known if LAMICTAL will harm your unborn baby. If you become pregnant while taking LAMICTAL, talk to your healthcare provider about registering with the North American Antiepileptic Drug Pregnancy Registry. You can enroll in this registry by calling 1-888-233-2334. The purpose of this registry is to collect information about the safety of antiepileptic drugs during pregnancy.
• are breastfeeding. LAMICTAL passes into breast milk and may cause side effects in a breastfed baby. If you breastfeed while taking LAMICTAL, watch your baby closely for trouble breathing, episodes of temporarily stopping breathing, sleepiness, or poor sucking. Call your baby's healthcare provider right away if you see any of these problems. Talk to your healthcare provider about the best way to feed your baby if you take LAMICTAL.

Tell your healthcare provider about all the medicines you take or if you are planning to take a new medicine, including prescription and non-prescription medicines, vitamins, and herbal supplements. If you use LAMICTAL with certain other medicines, they can affect each other, causing side effects.

How should I take LAMICTAL?

• Take LAMICTAL exactly as prescribed.
• Your healthcare provider may change your dose. Do not change your dose without talking to your healthcare provider.
• Do not stop taking LAMICTAL without talking to your healthcare provider. Stopping LAMICTAL suddenly may cause serious problems. For example, if you have epilepsy and you stop taking LAMICTAL suddenly, you may have seizures that do not stop. Talk with your healthcare provider about how to stop LAMICTAL slowly.
• If you miss a dose of LAMICTAL, take it as soon as you remember. If it is almost time for your next dose, just skip the missed dose. Take the next dose at your regular time. Do not take 2 doses at the same time.
• If you take too much LAMICTAL, call your healthcare provider or your local Poison Control Center or go to the nearest hospital emergency room right away.
• You may not feel the full effect of LAMICTAL for several weeks.
• If you have epilepsy, tell your healthcare provider if your seizures get worse or if you have any new types of seizures.
• Swallow LAMICTAL Tablets whole.
• If you have trouble swallowing LAMICTAL Tablets, tell your healthcare provider because there may be another form of LAMICTAL you can take.
• LAMICTAL ODT should be placed on the tongue and moved around the mouth. The tablet will rapidly disintegrate, can be swallowed with or without water, and can be taken with or without food.
• LAMICTAL chewable dispersible tablets may be swallowed whole, chewed, or mixed in water or diluted fruit juice. If the tablets are chewed, drink a small amount of water or diluted fruit juice to help in swallowing. To break up LAMICTAL chewable dispersible tablets, add the tablets to a small amount of liquid (1 teaspoon, or enough to cover the medicine) in a glass or spoon. Wait at least 1 minute or until the tablets are completely broken up, mix the solution together, and take the whole amount right away.
• If you receive LAMICTAL in a blisterpack, examine the blisterpack before use. Do not use if blisters are torn, broken, or missing.

What should I avoid while taking LAMICTAL?

Do not drive a car or operate complex, hazardous machinery until you know how LAMICTAL affects you.

What are the possible side effects of LAMICTAL?

See “What is the most important information I should know about LAMICTAL?”

Common side effects of LAMICTAL include:

• dizziness
• tremor
• headache
• rash
• blurred or double vision
• fever
• lack of coordination
• abdominal pain
• sleepiness
• back pain
• nausea, vomiting, diarrhea
• tiredness
• insomnia
• dry mouth

Tell your healthcare provider about any side effect that bothers you or that does not go away.

These are not all the possible side effects of LAMICTAL. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store LAMICTAL?

• Store LAMICTAL at room temperature between 68°F and 77°F (20°C and 25°C).
• Keep LAMICTAL and all medicines out of the reach of children.

General information about LAMICTAL

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use LAMICTAL for a condition for which it was not prescribed. Do not give LAMICTAL to other people, even if they have the same symptoms you have. It may harm them.

If you take a urine drug screening test, LAMICTAL may make the test result positive for another drug. If you require a urine drug screening test, tell the healthcare professional administering the test that you are taking LAMICTAL.

This Medication Guide summarizes the most important information about LAMICTAL. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about LAMICTAL that is written for healthcare professionals.

For more information, go to www.lamictal.com or call 1-888-825-5249.

What are the ingredients in LAMICTAL?

LAMICTAL tablets

Active ingredient: lamotrigine.

Inactive ingredients: lactose; magnesium stearate, microcrystalline cellulose, povidone, sodium starch glycolate, FD&C Yellow No. 6 Lake (100-mg tablet only), ferric oxide, yellow (150-mg tablet only), and FD&C Blue No. 2 Lake (200-mg tablet only).

LAMICTAL chewable dispersible tablets

Active ingredient: lamotrigine.

Inactive ingredients: blackcurrant flavor, calcium carbonate, low-substituted hydroxypropylcellulose, magnesium aluminum silicate, magnesium stearate, povidone, saccharin sodium, and sodium starch glycolate.

LAMICTAL ODT orally disintegrating tablets

Active ingredient: lamotrigine.

Inactive ingredients: artificial cherry flavor, crospovidone, ethylcellulose, magnesium stearate, mannitol, polyethylene, and sucralose.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Lamictal is a prescription medication used to treat epilepsy and bipolar disorder. Lamictal belongs to a group of drugs called anticonvulsants, which decrease abnormal brain activity.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Lamotrigine and other medicines may affect each other. Always check with your doctor before starting or stopping any medicines. Especially tell your doctor if you take:

• valproic acid (Depakene);
• divalproex (Depakote);
• methotrexate (Rheumatrex, Trexall); other medications for seizures such as carbamazepine (Tegretol), oxcarbazepine (Trileptal), phenobarbital (Luminal, Solfoton), phenytoin (Dilantin), and primidone (Mysoline);
• pyrimethamine (Daraprim);
• rifampin (Rifadin, Rimactane);
• trimethoprim (Proloprim);
• hormonal contraceptives (birth control pills, patches, rings, injections, implants, or intrauterine devices)
• hormone replacement therapy medicines (estrogens, progestins and combination medicines)

If you take too much lamotrigine call your local Poison Control Center or seek emergency medical attention right away.

Before taking lamotrigine, tell your doctor if you have kidney or liver disease, a history of depression or suicidal thoughts, or if you are allergic to other seizure medications.

Lamotrigine may cause severe or life-threatening skin rash, especially in children and in people who take too high of a dose at the start of treatment with lamotrigine. Serious skin rash may also be more likely to occur if you are taking lamotrigine together with valproic acid (Depakene) or divalproex (Depakote).

Seek emergency medical attention if you have: fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

You may have thoughts about suicide while taking this medication. Your doctor will need to check you at regular visits. Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, depression, anxiety, or if you feel agitated, hostile, restless, hyperactive (mentally or physically), or have thoughts about suicide or hurting yourself.

Do not stop taking lamotrigine without first talking to your doctor, even if you feel fine. You may have increased seizures if you stop using lamotrigine suddenly.

Contact your doctor if your seizures get worse or you have them more often while taking lamotrigine.

Taking this medication during early pregnancy can increase the risk of the baby being born with cleft lip or cleft palate. Tell your doctor if you are pregnant or if you become pregnant during treatment.

Lamotrigine is used alone or together with other medicines to help control certain types of seizures (e.g., partial seizures, tonic-clonic seizures, or Lennox-Gastaut syndrome) in the treatment of epilepsy. This medicine cannot cure epilepsy and will only work to control seizures for as long as you continue to take it. It can also be used in the treatment of bipolar disorder (manic-depressive illness) in adults older than 18 years of age.

This medicine is available only with your doctor's prescription.

Human Overdose Experience

Overdoses involving quantities up to 15 g have been reported for Lamictal, some of which have been fatal. Overdose has resulted in ataxia, nystagmus, seizures (including tonic-clonic seizures), decreased level of consciousness, coma, and intraventricular conduction delay.

Management of Overdose

There are no specific antidotes for lamotrigine. Following a suspected overdose, hospitalization of the patient is advised. General supportive care is indicated, including frequent monitoring of vital signs and close observation of the patient. If indicated, emesis should be induced; usual precautions should be taken to protect the airway. It should be kept in mind that immediate-release lamotrigine is rapidly absorbed [see Clinical Pharmacology (12.3)]. It is uncertain whether hemodialysis is an effective means of removing lamotrigine from the blood. In 6 renal failure patients, about 20% of the amount of lamotrigine in the body was removed by hemodialysis during a 4-hour session. A Poison Control Center should be contacted for information on the management of overdosage of Lamictal.

Get emergency medical help if you have any signs of an allergic reaction to Lamictal: hives; fever; swollen glands; painful sores in or around your eyes or mouth; difficulty breathing; swelling of your face, lips, tongue, or throat.

Seek emergency medical attention if you have signs of a life-threatening skin rash: fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

If you have to stop taking Lamictal because of a serious skin rash, you may not be able to take it again in the future.

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, depression, anxiety, or if you feel agitated, hostile, restless, hyperactive (mentally or physically), or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have:

• the first sign of any skin rash, no matter how mild;

• changes in your menstrual periods;

• low blood cell counts - flu-like symptoms, swollen gums, mouth sores, skin sores, rapid heart rate, pale skin, easy bruising, unusual bleeding, feeling light-headed;

• possible signs of brain inflammation - fever, chills, headache, neck stiffness, increased sensitivity to light, purple spots on the skin, confusion, drowsiness; or

• signs of inflammation in your body - swollen glands, severe tingling or numbness, muscle weakness, upper stomach pain, jaundice (yellowing of the skin or eyes), chest pain, new or worsening cough with fever, trouble breathing.

Common Lamictal side effects may include:

• headache, dizziness;

• blurred vision, double vision;

• tremor, loss of coordination;

• dry mouth, nausea, vomiting, stomach pain, diarrhea;

• fever, sore throat, runny nose;

• drowsiness, tired feeling;

• back pain; or

• sleep problems (insomnia).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Common side effects of Lamictal include: ataxia, blurred vision, diplopia, dizziness, drowsiness, headache, insomnia, nausea, rhinitis, skin rash, tremor, vomiting, abdominal pain, and fever. Other side effects include: dysmenorrhea, dyspepsia, vaginitis, abnormal gait, asthenia, bronchitis, constipation, pain, pruritus, and emotional lability. See below for a comprehensive list of adverse effects.

Applies to lamotrigine: oral tablet, oral tablet disintegrating, oral tablet dispersible, oral tablet extended release

Hypersensitivity

Uncommon (0.1% to 1%): Allergic reaction, chills, malaise[Ref]

Nervous system

Very common (10% or more): Dizziness (38%), headache (29%), ataxia (22%), somnolence (14%)
Common (1% to 10%): Seizure exacerbation, incoordination, insomnia, tremor, speech disorder, amnesia, hypoesthesia, pain, gait abnormality, vertigo, dyspraxia, confusion, paresthesia
Uncommon (0.1% to 1%): Akathisia, aphasia, central nervous system depression, dysarthria, dyskinesia, hyperkinesia, hypertonia, movement disorder, myoclonus
Rare (less than 0.1%): Choreoathetosis, dystonia, extrapyramidal syndrome, faintness, grand mal seizures, hemiplegia, hyperalgesia, hyperesthesia, hypokinesia, hypotonia, neuralgia, muscle spasm, neuralgia, paralysis, peripheral neuritis
Very rare (less than 0.01%): Muscle spasm, paralysis, peripheral neuritis
Postmarketing reports: Exacerbation of Parkinsonian symptoms in patients with pre-existing Parkinson's disease, tics[Ref]

Ocular

Very common (10% or more): Diplopia (28%), blurred vision (16%)
Common (1% to 10%): Vision abnormality, nystagmus, photosensitivity, amblyopia
Uncommon (0.1% to 1%): Abnormality of accommodation, conjunctivitis, dry eyes, photophobia
Rare (less than 0.1%): Lacrimation disorder, oscillopsia, ptosis, strabismus, uveitis, visual field defect[Ref]

Gastrointestinal

Very common (10% or more): Vomiting (20%), nausea (19%), diarrhea (10%)
Common (1% to 10%): Abdominal pain, vomiting, dyspepsia, constipation, anorexia, dry mouth, rectal hemorrhage, peptic ulcer, flatulence
Uncommon (0.1% to 1%): Dysphagia, eructation, gastritis, gingivitis, increased appetite, increased salivation, mouth ulceration
Rare (less than 0.1%): Gastrointestinal hemorrhage, glossitis, gum hemorrhage, gum hyperplasia, hematemesis, hemorrhagic colitis, melena, stomach ulcer, stomatitis, tongue edema
Very rare (less than 0.01%): Pancreatitis, esophagitis[Ref]

Respiratory

Very common (10% or more): Rhinitis (14%)
Common (1% to 10%): Pharyngitis, increased cough, epistaxis, dyspnea, bronchitis, sinusitis, bronchospasm
Uncommon (0.1% to 1%): Yawn
Rare (less than 0.1%): Hiccup, hyperventilation
Postmarketing reports: Apnea[Ref]

Dermatologic

Very common (10% or more): Rash (14%)
Common (1% to 10%): Contact dermatitis, dry skin, sweating, eczema, pruritus
Uncommon (0.1% to 1%): Acne, alopecia, hirsutism, maculopapular rash, skin discoloration, urticaria, ecchymosis, leukopenia
Rare (less than 0.1%): Angioedema, erythema, exfoliative dermatitis, fungal dermatitis, herpes zoster, leukoderma, multiforme erythema, petechial rash, pustular rash, Stevens-Johnson syndrome, vesiculobullous rash, anemia, eosinophilia, fibrin decrease, fibrinogen decrease, iron deficiency anemia, leukocytosis, lymphocytosis, macrocytic anemia, thrombocytopenia[Ref]

Genitourinary

Common (1% to 10%): Dysmenorrhea, vaginitis, amenorrhea, libido increase, urinary tract infection (both male and female), urinary frequency
Uncommon (0.1% to 1%): Libido decreased, abnormal ejaculation, hematuria, impotence, menorrhagia, polyuria, urinary incontinence
Rare (less than 0.1%): Anorgasmia, breast abscess, breast neoplasm, creatinine increase, cystitis, dysuria, epididymitis, female lactation, nocturia, urinary retention, urinary urgency[Ref]

Other

Very common (10% or more): Fever (15%), accidental injury (14%)
Common (1% to 10%): Fatigue
Uncommon (0.1% to 1%): Ear pain, taste perversion, tinnitus
Rare (less than 0.1%): Alcohol intolerance, deafness, taste loss, parosmia, taste loss[Ref]

Metabolic

Common (1% to 10%): Weight decrease, weight gain, peripheral edema, facial edema
Rare (less than 0.1%): Bilirubinemia, general edema, gamma glutamyl transpeptidase increase, hyperglycemia[Ref]

Musculoskeletal

Common (1% to 10%): Neck pain, arthralgia, myalgia, decreased reflexes, back pain, increased reflexes, asthenia
Uncommon (0.1% to 1%): Arthritis, leg cramps, myasthenia, twitching
Rare (less than 0.1%): Bursitis, muscle atrophy, pathological fracture, tendinous contracture
Postmarketing reports: Rhabdomyolysis[Ref]

Cardiovascular

Common (1% to 10%): Chest pain, migraine
Uncommon (0.1% to 1%): Flushing, hot flashes, hypertension, palpitations, postural hypotension, syncope, tachycardia, vasodilation[Ref]

Hematologic

Postmarketing reports: Agranulocytosis, hemolytic anemia, lymphadenopathy not associated with hypersensitivity disorder[Ref]

Psychiatric

Common (1% to 10%): Depression, anxiety, irritability, disturbance of concentration, emotional lability, abnormal thinking, nervousness
Uncommon (0.1% to 1%): Apathy, euphoria, hallucinations, hostility, depersonalization, memory decrease, mind racing, panic attack, paranoid reaction, personality disorder, psychosis, sleep disorder, stupor, suicidal ideation
Rare (less than 0.1%): Delirium, delusions, dysphoria, manic depression reaction, neurosis
Postmarketing reports: Aggression, nightmares[Ref]

Hepatic

Common (1% to 10%): Lymphadenopathy
Uncommon (0.1% to 1%): Liver function tests abnormal, aspartate transaminase (AST) increased
Rare (less than 0.1%): Hepatitis, alanine transaminase ALT) increased, acute kidney failure, kidney failure, kidney pain[Ref]

Immunologic

Postmarketing reports: Progressive immunosuppression
Postmarketing reports: Lupus-like reaction, vasculitis[Ref]

Some side effects of Lamictal may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

• Lamictal is a brand (trade) name for lamotrigine which may be used either alone or in combination with other anticonvulsants to treat epilepsy. It may also be used to stabilize mood in people with bipolar disorder.
• Experts are not sure exactly how lamotrigine works But some have suggested that it inhibits voltage-sensitive sodium channels, stabilizing nerve membranes and moderating the release of excitatory amino acids such as glutamate and aspartate.
• Lamictal belongs to the class of medicines known as triazine anticonvulsants.

If you are between the ages of 18 and 60, take no other medication or have no other medical conditions, side effects you are more likely to experience include:

• Dizziness, coordination problems, sleepiness, headache, double or blurred vision, nausea, vomiting, and rash. Risk of side effects increases at higher dosages and with concomitant carbamazepine.
• Rarely, life-threatening skin rashes that require hospitalization and discontinuation of Lamictal treatment. The risk is higher in younger children and possibly with higher Lamictal dosages or co-administration with valproate. Most, but not all, cases occur within two to eight weeks of treatment initiation. Lamictal may also cause a benign, non-problematic rash and distinguishing between different rashes caused by Lamictal may be difficult. Seek urgent medical advice at first sign of a rash with Lamictal, unless the rash is clearly not drug-related. Discontinuation of Lamictal may be needed.
• Rarely, potentially fatal hypersensitivity reactions may also occur. Seek medical advice with any sign of fever or swollen lymph nodes.
• As with other anti-epileptics, Lamictal may increase the risk of suicidal thoughts or behavior; monitor for worsening depression or mood changes.
• May interact with several drugs including other anticonvulsants (such as carbamazepine and phenytoin), estrogen-containing oral contraceptives, and some HIV antivirals.
• Rarely, has been associated with sudden unexplained death.
• Caution may be needed when using in people with renal or hepatic impairment and some other medical conditions.

Notes: In general, seniors or children, people with certain medical conditions (such as liver or kidney problems, heart disease, diabetes, seizures) or people who take other medications are more at risk of developing a wider range of side effects. For a complete list of all side effects, click here.

Substance Name

Lamotrigine

CAS Registry Number

84057-84-1

Drug Class

Anticonvulsants

Antimanic Agents

Antidepressive Agents

You should not take lamotrigine if you are allergic to it.

Lamotrigine may cause a severe or life-threatening skin rash, especially in children and in people who take too high a dose at the start of treatment. Serious skin rash may also be more likely to occur if you are taking lamotrigine together with valproic acid (Depakene) or divalproex (Depakote).

To make sure lamotrigine is safe for you, tell your doctor if you have:

• kidney or liver disease;

• a history of depression or suicidal thoughts or actions; or

• if you are allergic to other seizure medications.

Some people have thoughts about suicide while taking this medicine. Your doctor will need to check your progress at regular visits. Your family or other caregivers should also be alert to changes in your mood or symptoms.

Do not start or stop taking seizure medication during pregnancy without your doctor's advice. Having a seizure during pregnancy could harm both mother and baby. Tell your doctor right away if you become pregnant.

If you are pregnant, your name may be listed on a pregnancy registry. This is to track the outcome of the pregnancy and to evaluate any effects of lamotrigine on the baby.

Birth control pills can make lamotrigine less effective, resulting in increased seizures. Tell your doctor if you start or stop using birth control pills while you are taking lamotrigine. Your lamotrigine dose may need to be changed.

Lamotrigine can pass into breast milk and may harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Get emergency medical help if you have signs of an allergic reaction: hives; fever; swollen glands; painful sores in or around your eyes or mouth; difficulty breathing; swelling of your face, lips, tongue, or throat.

Seek emergency medical attention if you have signs of a life-threatening skin rash: fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

If you have to stop taking lamotrigine because of a serious skin rash, you may not be able to take it again in the future.

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, depression, anxiety, or if you feel agitated, hostile, restless, hyperactive (mentally or physically), or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have:

• the first sign of any skin rash, no matter how mild;

• changes in your menstrual periods;

• low blood cell counts--flu-like symptoms, swollen gums, mouth sores, skin sores, rapid heart rate, pale skin, easy bruising, unusual bleeding, feeling light-headed;

• possible signs of brain inflammation--fever, chills, headache, neck stiffness, increased sensitivity to light, purple spots on the skin, confusion, drowsiness; or

• signs of inflammation in your body--swollen glands, severe tingling or numbness, muscle weakness, upper stomach pain, jaundice (yellowing of the skin or eyes), chest pain, new or worsening cough with fever, trouble breathing.

Common side effects may include:

• headache, dizziness;

• blurred vision, double vision;

• tremor, loss of coordination;

• dry mouth, nausea, vomiting, stomach pain, diarrhea;

• fever, sore throat, runny nose;

• drowsiness, tired feeling;

• back pain; or

• sleep problems (insomnia).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.