LAMOTRIGINE- lamotrigine tablet 
American Health Packaging

----------

Medication Guide

8231801/0522

Lamotrigine (la-MOE-tri-jeen) Tablets, USP

Phenylketonurics:
Phenylalanine is a component of aspartame. Each lamotrigine tablet for oral suspension (chewable, dispersible tablets), 5 mg and 25 mg contains 0.7 mg of phenylalanine.

What is the most important information I should know about Lamotrigine?
1. Lamotrigine 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, 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.

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.

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 may lead to a fast heart beat. Call your healthcare provider right away if you:

4. Like other antiepileptic drugs, lamotrigine 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 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 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?"

6. People prescribed lamotrigine have sometimes been given the wrong medicine because many medicines have names similar to lamotrigine, so always check that you receive lamotrigine.
Taking the wrong medication can cause serious health problems. When your healthcare provider gives you a prescription for lamotrigine:

These pictures show the distinct wording, colors, and shapes of the tablets that help to identify the right strength of lamotrigine tablets and lamotrigine tablets for oral suspension. 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

Lamotrigine Tablets

Lamotrigine Tablets for Oral Suspension

Lamotrigine Tablets for Oral Suspension (Chewable, Dispersible Tablets)

What is lamotrigine?

Do not take lamotrigine:

Before taking lamotrigine, 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?

What should I avoid while taking lamotrigine?
Do not drive, operate machinery, or do other dangerous activities until you know how lamotrigine affects you.

What are the possible side effects of lamotrigine?
Lamotrigine can cause serious side effects.
See "What is the most important information I should know about lamotrigine?"
Common side effects of lamotrigine include:

These are not all the possible side effects of lamotrigine.

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?

General information about the safe and effective use of lamotrigine
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use lamotrigine for a condition for which it was not prescribed. Do not give lamotrigine 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 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.

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

Please address medical inquiries to, MedicalAffairs@zydususa.com or Tel.: 1-877-993-8779.

What are the ingredients in Lamotrigine?
Lamotrigine Tablets
Active ingredient: lamotrigine, USP
Inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone and sodium starch glycolate.

Lamotrigine Tablets for Oral Suspension
Active ingredient: lamotrigine, US
Inactive ingredients: aspartame, croscarmellose sodium, flavour black currant, magnesium stearate, mannitol, microcrystalline cellulose, silicon dioxide and tribasic calcium phosphate.

To order more Medication Guides call American Health Packaging at 1-800-707-4621.

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

DEPAKENE and DEPAKOTE are registered trademarks of Abbott Laboratories.

Distributed by:
American Health Packaging
Columbus, OH 43217

8231801/0522

Revised: 12/2023
American Health Packaging