LAMOTRIGINE- lamotrigine tablet, orally disintegrating 
Amneal Pharmaceuticals of New York LLC

----------

MEDICATION GUIDE

LAMOTRIGINE (la-moe’-tri-jeen) Orally Disintegrating Tablets

Phenylketonurics:     Contains Phenylalanine 1.40 mg Per 25 mg tablet

Contains Phenylalanine 2.80 mg Per 50 mg tablet

Contains Phenylalanine 5.60 mg Per 100 mg tablet

Contains Phenylalanine 11.20 mg Per 200 mg tablet

What is the most important information I should know about lamotrigine orally disintegrating tablets?

1. Lamotrigine orally disintegrating 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 orally disintegrating 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 orally disintegrating 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 orally disintegrating tablets.

2. Other serious reactions, including serious blood problems or liver problems. Lamotrigine orally disintegrating 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 orally disintegrating 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 orally disintegrating 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 orally disintegrating 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 orally disintegrating tablets, which your doctor would check for if you developed meningitis while taking lamotrigine orally disintegrating tablets.

Lamotrigine orally disintegrating 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 orally disintegrating tablets?”

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

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

These pictures show the distinct wording, colors, and shapes of the tablets that help to identify the right strength of lamotrigine orally disintegrating 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 Orally Disintegrating Tablets

Lamotrigine Orally Disintegrating Tablets

What are lamotrigine orally disintegrating tablets?

Lamotrigine orally disintegrating tablets are a prescription medicine used:

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

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

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

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

Who should not take lamotrigine orally disintegrating tablets?

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

What should I tell my healthcare provider before taking lamotrigine orally disintegrating tablets?

Before taking lamotrigine orally disintegrating 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.

If you use lamotrigine orally disintegrating tablets with certain other medicines can affect each other, causing side effects.

How should I take lamotrigine orally disintegrating tablets?

What should I avoid while taking lamotrigine orally disintegrating tablets?

Do not drive a car or operate machinery, or do other dangerous activities until you know how lamotrigine orally disintegrating tablets affect you.

What are possible side effects of lamotrigine orally disintegrating tablets?

Lamotrigine orally disintegrating tablets can cause serious side effects.

See “What is the most important information I should know about lamotrigine orally disintegrating tablets?”

Common side effects of lamotrigine orally disintegrating tablets include:

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 orally disintegrating 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 orally disintegrating tablets?

General information about the safe and effective use of lamotrigine orally disintegrating tablets

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

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

For more information, call Impax Laboratories, Inc. at 1-800-934-6729.

What are the ingredients in lamotrigine orally disintegrating tablets?

Active ingredient: lamotrigine

Inactive ingredients: amino methacrylate copolymer, aspartame, black currant flavor, colloidal silicon dioxide, crospovidone, magnesium stearate, mannitol, microcrystalline cellulose, peppermint flavor, pregelatinized maize starch, sodium chloride, and stearic acid.

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:
Watson Pharma Private Ltd.,
Verna, Salcette Goa 403 722 INDIA

Distributed by:
Impax Generics
Hayward, CA 94544

1737-01
Rev. 02/2016

Revised: 2/2016
Amneal Pharmaceuticals of New York LLC