LAMOTRIGINE- lamotrigine tablet 
Cipla USA Inc.

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MEDICATION GUIDE

Lamotrigine Tablets, USP

(la moe'tri jeen)

What is the most important information I should know about lamotrigine tablets, USP?

1.       Lamotrigine tablets, USP 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, USP but is more likely to happen within the first 2 to 8 weeks of treatment. Children and teenagers between 2 and 17 years have a higher chance of getting this serious skin rash while taking lamotrigine tablets, USP.

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, USP.

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.      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, USP 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 tablets, USP 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 tablets, USP.

Lamotrigine tablets, USP 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, USP?"

5. People prescribed lamotrigine tablets, USP have sometimes been given the wrong medicine because many medicines have names similar to lamotrigine tablets, USP so always check that you receive lamotrigine tablets, USP.

Taking the wrong medication can cause serious health problems. When your healthcare provider gives you a prescription for lamotrigine tablets, USP:

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

tablet

What is lamotrigine tablets, USP?

          Lamotrigine tablets, USP is a prescription medicine used:

o   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.

o   alone when changing from 1 other medicine used to treat partial-onset seizures in people aged 16 years and older.

o   for the long-term treatment of bipolar I disorder to lengthen the time between mood episodes in people who have been treated for mood episodes with other medicine.

          It is not known if lamotrigine tablets, USP is safe or effective in people younger than 18 years with mood episodes such as bipolar disorder or depression.

          It is not known if lamotrigine tablets, USP is safe or effective when used alone as the first treatment of seizures.

          It is not known if lamotrigine tablets, USP is safe or effective for people with mood episodes who have not already been treated with other medicines.

          Lamotrigine tablets, USP should not be used for acute treatment of manic or mixed mood episodes.

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Do not take lamotrigine tablets, USP:

          If you have had an allergic reaction to lamotrigine or to any of the inactive ingredients in lamotrigine tablets, USP. See the end of this leaflet for a complete list of ingredients in lamotrigine tablets, USP.

Before taking lamotrigine tablets USP, 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 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, USP?

What should I avoid while taking lamotrigine tablets, USP?

Do not drive, operate machinery, or do other dangerous activities until you know how lamotrigine tablet, USP affects you.

What are the possible side effects of lamotrigine tablets, USP?

Lamotrigine tablets, USP can cause serious side effects.

See "What is the most important information I should know about lamotrigine Tablets, USP?"

Common side effects of lamotrigine tablets, USP include:

These are not all the possible side effects of lamotrigine tablets, USP.

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 tablets, USP?

General information about the safe and effective use of lamotrigine tablets, USP.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use lamotrigine tablets, USP for a condition for which it was not prescribed. Do not give lamotrigine tablets, USP 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 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, USP.

You can ask your healthcare provider or pharmacist for information about lamotrigine tablets, USP that is written for health professionals.

For more information, call 1-866-604-3268

What are the ingredients in lamotrigine tablets, USP?

Active ingredient: lamotrigine.

Inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, povidone, sodium starch glycolate, black iron oxide, iron oxide red and yellow iron oxide.

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

Disclaimer: Other brands listed are the registered trademarks of their respective owners and are not trademarks of Cipla Limited.

Manufactured by:

Cipla Ltd.,

Verna Goa, INDIA.

Manufactured for:

Cipla USA, Inc.

10 Independence Boulevard, Suite 300, Warren

New Jersey – 07059

Revised: 09/2020

Revised: 9/2020
Cipla USA Inc.