LAMOTRIGINE- lamotrigine tablet, extended release 
Wockhardt USA LLC.

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MEDICATION GUIDE

Lamotrigine Extended-Release Tablets

Read this Medication Guide before you start taking lamotrigine extended-release tablets and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or treatment. If you have questions about lamotrigine extended-release tablets, ask your healthcare provider or pharmacist.

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 to stop lamotrigine extended-release tablets; it may rarely cause death.

There is no way to tell if a mild rash will develop into a more serious reaction. These serious skin reactions are more likely to happen when you begin taking lamotrigine extended-release tablets, within the first 2 to 8 weeks of treatment. But it can happen in people who have taken lamotrigine extended-release tablets for any period of time. Children between 2 to 16 years of age have a higher chance of getting this serious skin reaction while taking lamotrigine. Lamotrigine extended-release tablet is not approved for use in children less than 13 years of age.

The risk of getting a rash is higher if you:

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 the 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 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. 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?

3. Lamotrigine extended-release tablets may rarely 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 have 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?"

4. Patients 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 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, debossing, and sizes 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.

Tablets

What is lamotrigine extended-release tablet?

Lamotrigine extended-release tablet is a prescription medicine used:

It is not known if lamotrigine extended-release tablet is safe or effective in children less than 13 years of age. Other forms of lamotrigine can be used in children 2 to 12 years.

Who should not take lamotrigine extended-release tablets?

You should not take lamotrigine extended-release tablets if you have had an allergic reaction to lamotrigine or to any of the inactive ingredients in lamotrigine extended-release tablets. See the end of this leaflet for a complete list of ingredients in lamotrigine extended-release tablets.

What should I tell my healthcare provider before taking lamotrigine extended-release tablets?

Before taking lamotrigine extended-release tablets, tell your healthcare provider about all of your medical conditions, including if you:

Tell your healthcare provider about all the medicines you take or if you are planning to take a new medicine, including prescription and non-prescription medicines, vitamins, and herbal supplements. Using lamotrigine extended-release tablets with certain other medicines can affect each other, causing side effects.

How should I take lamotrigine extended-release tablets?

What should I avoid while taking lamotrigine extended-release tablets?

Do not drive a car or operate complex, hazardous machinery until you know how lamotrigine extended-release tablet affects you.

What are possible side effects of 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.

Tell your healthcare provider about any side effect that bothers you or that does not go away. These are not all the possible side effects of lamotrigine extended-release tablets. For more information, ask your healthcare provider or pharmacist.

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?

General information about 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 you have. It may harm them.

This Medication Guide summarizes the most important information about lamotrigine extended-release tablets. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about lamotrigine extended-release tablets that is written for healthcare professionals.

For more information, call 1-800-346-6854.

What are the ingredients in lamotrigine extended-release tablets?

Active ingredient: Lamotrigine.

Inactive ingredients: diethyl phthalate, hypromellose, lactose monohydrate, magnesium stearate, methacrylic acid copolymer, polyethylene glycol, talc, titanium dioxide, iron oxide yellow for (25 mg and 100 mg) and iron oxide red for (50 mg, 100 mg, 200 mg and 300 mg).

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

DEPAKENE® and DEPAKOTE® are registered trademarks of Abbott Laboratories.

Manufactured by:

Wockhardt Limited,

Mumbai, India.

Distributed by:

Wockhardt USA LLC.

20 Waterview Blvd.

Parsippany, NJ 07054

USA.

Iss.240812

Revised: 08/2012
 
Wockhardt USA LLC.