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What is the most important information I should know about lamotrigine extended-release tablets?
1. Lamotrigine extended-release 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 extended-release tablets, 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 lamotrigine extended-release tablets. Lamotrigine extended-release tablets are not approved for use in children younger than 13 years.
The risk of getting a serious skin rash is higher if you:
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- take lamotrigine extended-release tablets while taking valproate [DEPAKENE (valproic acid) or DEPAKOTE (divalproex sodium)].
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- take a higher starting dose of lamotrigine extended-release tablets than your healthcare provider prescribed.
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- increase your dose of lamotrigine extended-release tablets faster than prescribed.
Call your healthcare provider right away if you have any of the following:
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a skin rash
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blistering or peeling of your skin
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hives
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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 extended-release tablets.
2. Other serious reactions, including serious blood problems or liver problems. Lamotrigine extended-release 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:
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- fever
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- frequent infections
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- severe muscle pain
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- swelling of your face, eyes, lips, or tongue
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- swollen lymph glands
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- unusual bruising or bleeding, looking pale
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- weakness, fatigue
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- yellowing of your skin or the white part of your eyes
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- trouble walking or seeing
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- seizures for the first time or happening more often
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- 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 extended-release tablets may lead to a fast heart beat. Call your healthcare provider right away if you:
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- have a fast, slow, or pounding heart beat.
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- feel your heart skip a beat.
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- have shortness of breath.
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- have chest pain.
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- feel lightheaded.
4. Like other antiepileptic drugs, lamotrigine extended-release 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:
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- thoughts about suicide or dying
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- attempt to commit suicide
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- new or worse depression
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- new or worse anxiety
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- feeling agitated or restless
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- panic attacks
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- trouble sleeping (insomnia)
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- new or worse irritability
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- acting aggressive, being angry, or violent
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- acting on dangerous impulses
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- an extreme increase in activity and talking (mania)
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- other unusual changes in behavior or mood
Do not stop lamotrigine extended-release tablets without first talking to a healthcare provider.
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- Stopping lamotrigine extended-release tablets suddenly can cause serious problems.
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- 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?
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- Pay attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings.
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- Keep all follow-up visits with your healthcare provider as scheduled.
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- Call your healthcare provider between visits as needed, especially if you are worried about symptoms.
5. Lamotrigine extended-release 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:
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- headache
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- fever
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- nausea
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- vomiting
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- stiff neck
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- rash
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- unusual sensitivity to light
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- muscle pains
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- chills
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- confusion
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- drowsiness
Meningitis has many causes other than lamotrigine extended-release tablets, which your doctor would check for if you developed meningitis while taking lamotrigine extended-release tablets.
Lamotrigine extended-release 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 extended-release tablets?”
6.People prescribed lamotrigine extended-release tablets have sometimes been given the wrong medicine because many medicines have names similar to lamotrigine extended-release tablets, so always check that you receive lamotrigine extended-release tablets.
Taking the wrong medication can cause serious health problems. When your healthcare provider gives you a prescription for lamotrigine extended-release tablets:
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- Make sure you can read it clearly.
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- Talk to your pharmacist to check that you are given the correct medicine.
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- 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 extended-release tablets. Immediately call your pharmacist if you receive a lamotrigine extended-release tablet that does not look like one of the tablets shown below, as you may have received the wrong medication.
Lamotrigine extended-release tablets
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