LAMOTRIGINE- lamotrigine tablet, film coated, extended release
Amneal Pharmaceuticals LLC
Lamotrigine (la moe’ tri jeen) Extended-release Tablets
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:
Call your healthcare provider right away if you have any of the following:
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:
3. 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:
Do not stop lamotrigine extended-release tablets without first talking to a healthcare provider.
How can I watch for early symptoms of suicidal thoughts and actions in myself or a family member ?
4. 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:
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?”
5. People prescribed lamotrigine extended-release have sometimes been given the wrong medicine because many medicines have names similar to lamotrigine extended-release, 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:
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
25 mg, yellow
50 mg, green
What are lamotrigine extended-release tablets?
Do not take lamotrigine extended-release tablets:
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. Lamotrigine extended-release 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.
How should I take lamotrigine extended-release tablets?
What should I avoid while taking lamotrigine extended-release tablets?
Do not drive, operate machinery, or do other dangerous activities until you know how lamotrigine extended-release tablets affects you.
What are the possible side effects of lamotrigine extended-release tablets?
Lamotrigine extended-release tablets can cause serious side effects.
See “What is the most important information I should know about lamotrigine extended-release tablets?”
Common side effects of lamotrigine extended-release tablets include:
Other common side effects that have been reported with another form of lamotrigine include headache, sleepiness, blurred vision, runny nose and rash.
These are not all the possible side effects of lamotrigine extended-release tablets.
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 lamotrigine extended-release tablets?
Keep lamotrigine extended-release tablets and all medicines out of the reach of children.
General information about the safe and effective use of lamotrigine extended-release tablets
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use lamotrigine extended-release tablets for a condition for which it was not prescribed. Do not give lamotrigine extended-release 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 extended-release 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 extended-release tablets.
You can ask your healthcare provider or pharmacist for information about lamotrigine extended-release tablets that is written for health professionals.
What are the ingredients in lamotrigine extended-release tablets?
Active ingredient: lamotrigine, USP
Inactive ingredients: colloidal silicon dioxide, hypromellose, lactose monohydrate, macrogol, magnesium stearate, methacrylic acid copolymer dispersion, polyvinyl alcohol, talc, titanium dioxide and triethyl citrate. The 25 mg tablets also contain D&C Yellow No. 10 and FD&C Yellow No. 6. The 50 mg tablets also contain FD&C Blue No. 2 and iron oxide yellow. The 100 mg tablets also contain iron oxide red and iron oxide yellow. The 200 mg tablets also contain FD&C Blue No. 2. The 250 mg tablets also contain FD&C Blue No. 2 and FD&C Red No. 40. The 300 mg tablets also contain black iron oxide.
For more information, go to www.amneal.com or call 1-877-835-5472.
This Medication Guide has been approved by the U.S. Food and Drug Administration.
All trademarks are the property of their respective owner.
Amneal Pharmaceuticals LLC
Bridgewater, NJ 08807