What is the most important information I should know about lamotrigine tablets?
1. Lamotrigine tablets 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 lamotrigine tablets, but is more likely to happen within the first 2 to 8 weeks of treatment. Children and teenagers aged between 2 and 17 years have a higher chance of getting this serious skin rash while taking lamotrigine tablets.
The risk of getting a serious skin rash is higher if you: 
●   take lamotrigine tablets while taking valproate [DEPAKENE (valproic acid) or DEPAKOTE(divalproex sodium)].
●   take a higher starting dose of lamotrigine tablets than your healthcare provider prescribed.
●   increase your dose of lamotrigine tablets faster than prescribed.

The risk of serious skin reactions may be associated with a variant in genes called HLA-B*1502 in people from Asian origin (mainly of Han Chinese and Thai origin). See, “Before taking lamotrigine tablets, tell your healthcare provider about all of your health conditions”.

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 lamotrigine tablets.
2. Other serious reactions, including serious blood problems or liver problems. Lamotrigine tablets 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, looking pale
●  weakness, fatigue
●  yellowing of your skin or the white part of your eyes

• trouble walking or seeing

• seizures for the first time or happening more often

• pain and/or tenderness in the area towards the top of your stomach (enlarged liver and/or spleen)

3. In patients with known heart problems, the use of lamotrigine tablets may lead to a fast heart beat. Call your healthcare provider right away if you:
• have a fast, slow, or pounding heart beat.
• feel your heart skip a beat.
• have shortness of breath.
• have chest pain.

• feel lightheaded.

4.  Like other antiepileptic drugs, lamotrigine tablets 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 lamotrigine tablets without first talking to a healthcare provider.
●  Stopping lamotrigine tablets 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 in myself or a family member?
●  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.
5. Lamotrigine tablets may 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 lamotrigine tablets, which your doctor would check for if you developed meningitis while taking lamotrigine tablets.
Lamotrigine tablets can cause 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 lamotrigine tablets?"
6.   People prescribed lamotrigine tablets have sometimes been given the wrong medicine because many medicines have names similar to lamotrigine tablets, so always check that you receive lamotrigine tablets.
Taking the wrong medication can cause serious health problems. When your healthcare provider gives you a prescription for lamotrigine tablets:
●  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 lamotrigine tablets. Immediately call your pharmacist if you receive a lamotrigine tablet that does not look like one of the tablets shown below, as you may have received the wrong medication.
Lamotrigine Tablets

Before taking lamotrigine tablets, tell your healthcare provider about all of your health 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 a history of heart problems or irregular heart beats or any of your family members have any heart problem, including genetic abnormalities.

●  have had aseptic meningitis after taking lamotrigine tablets.
●  are taking estrogen-containing products, including oral contraceptives (birth control pills) or other female hormonal medicines (such as hormone replacement therapy). 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 while you are taking lamotrigine tablets may cause side effects (such as dizziness, lack of coordination, or double vision). Starting these medicines may lessen how well lamotrigine tablet works.
●  are pregnant or plan to become pregnant. It is not known if lamotrigine tablets may harm your unborn baby. If you become pregnant while taking lamotrigine tablets, 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. Lamotrigine passes into breast milk and may cause side effects in a breastfed baby. If you breastfeed while taking lamotrigine tablets, 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 lamotrigine tablets.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Lamotrigine tablets and certain other medicines may interact with each other. This may cause serious side effects.
Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

General information about the safe and effective use of lamotrigine tablets.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use lamotrigine tablets for a condition for which it was not prescribed. Do not give lamotrigine tablets to other people, even if they have the same symptoms that you have. It may harm them.
If you take a urine drug screening test, lamotrigine tablets 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 lamotrigine tablets.
You can ask your healthcare provider or pharmacist for information about lamotrigine tablets that is written for health professionals.

For more information, call 1-800-912-9561.