LAMOTRIGINE- lamotrigine tablet
Advagen Pharma Limited
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:
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 tablets.
2. Other serious reactions, including serious blood problems or liver problems.
Lamotrigine 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. 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:
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:
Do not stop lamotrigine 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?
5. Lamotrigine 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, which your doctor would check for if you developed meningitis while taking lamotrigine.
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
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, USP
What are lamotrigine tablets?
Do not take lamotrigine tablets:
• if you have had an allergic reaction to lamotrigine or to any of the inactive ingredients in lamotrigine tablets. See the end of this leaflet for a complete list of ingredients in lamotrigine tablets.
Before taking lamotrigine tablets tell your healthcare provider about all of your health conditions, including if you:
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.
How should I take lamotrigine tablets?
Take lamotrigine tablets exactly as prescribed.
What should I avoid while taking lamotrigine tablets?
Do not drive, operate machinery, or do other dangerous activities until you know how lamotrigine tablets affect you.
What are the possible side effects of lamotrigine tablets?
Lamotrigine tablets can cause serious side effects.
See “What is the most important information I should know about lamotrigine tablets?”
Common side effects of lamotrigine tablets include:
• tremor • back pain
• headache • nausea, vomiting
• rash • diarrhea
• blurred or double vision • tiredness
• fever • insomnia
• lack of coordination • dry mouth
• abdominal pain • stuffy nose
• infections, including seasonal flu • sore throat
These are not all the possible side effects of lamotrigine tablets.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1800-FDA-1088.
How should I store lamotrigine tablets?
• Store lamotrigine tablets at room temperature between 68 oF to 77 oF (20 oC to 25 oC).
Keep lamotrigine tablets and all medicines out of the reach of children.
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 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 about Lamotrigine tablets go to http://www.fda.gov. For medical inquiries or to report side effects regarding Lamotrigine tablets please contact Advagen Pharma Limited, at 888-413-0949 or FDA at 1-800-FDA-1088.
What are the ingredients in lamotrigine tablets?
Lamotrigine Tablets, USP
Active ingredient: lamotrigine.
Inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose and sodium starch glycolate.
This Medication Guide has been approved by the U.S. Food and Drug Administration.
All registered trademarks in this document are the property of their respective owners.
Advagen Pharma Limited,
666 Plainsboro Road
Plainsboro Suite 605,
Plainsboro, NJ, 08536, USA
Rubicon Research Private Limited
Ambernath, Dist: Thane, 421506 India.