LAMOTRIGINE - lamotrigine tablet, chewable 
Jubilant Cadista Pharmaceuticals Inc.

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MEDICATION GUIDE

Lamotrigine Tablets (Chewable, Dispersible)
(la-MOE-tri-jeen)
                                                                        

RX Only


Phenylketonurics: Contains phenylalanine 0.224 mg and 1.12 mg per 5 mg and 25 mg lamotrigine tablets (chewable, dispersible) respectively. 

What is the most important information I should know about
Lamotrigine Tablets (chewable, dispersible)?

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.         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?

4.   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?”  

5. 
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 (chewable, dispersible). Immediately call your pharmacist if you receive a lamotrigine tablet (chewable, dispersible) that does not look like one of the tablets shown below, as you may have received the wrong medication.  

Lamotrigine Tablets (Chewable, Dispersible)

Tablets Image 5 mg 5 mg, White to off-white, caplet-shaped tablets debossed "CA3" on one side and scored on the other side  Tablets Image 25 mg 25 mg, White to off-white, round tablets debossed “A4” on one side and “C” on the other side 

What is lamotrigine tablets (chewable, dispersible)?

Lamotrigine is a prescription medicine used:

It is not known if lamotrigine tablets are 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 are safe or effective when used alone as the first treatment of seizures. It is not known if lamotrigine tablets are safe or effective for people with mood episodes who have not already been treated with other medicines.  

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

Who should not take lamotrigine tablets (chewable, dispersible)?
 

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

What should I tell my healthcare provider before taking lamotrigine tablets (chewable, dispersible)?
 

Before taking lamotrigine, 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 over-the-counter medicines, vitamins, and herbal supplements.  

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

How should I take lamotrigine tablets (chewable, dispersible)?

What should I avoid while taking lamotrigine tablets (chewable, dispersible)?

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 tablets (chewable, dispersible)?Lamotrigine can cause serious side effects. 

See “What is the most important information I should know about lamotrigine tablets (chewable, dispersible)?”  

Common side effects of lamotrigine include:

Common side effects of lamotrigine 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. 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 tablets (chewable, dispersible)?

General information about the safe and effective use of lamotrigine tablets (chewable, dispersible)

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 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.

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

For more information, call 1-800-313-4623

What are the ingredients in lamotrigine tablets (chewable, dispersible)?


Active ingredient: lamotrigine, USP.

Inactive ingredients: aspartame NF, acesulfame potassium NF, colloidal silicon dioxide NF, orange flavor, mannitol USP, microcrystalline cellulose NF and magnesium stearate NF.

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

Lamotrigine Tablets (chewable, dispersible) are manufactured and distributed by:
Jubilant Cadista Pharmaceuticals Inc.
Salisbury, MD 21801, USA

For: Jubilant Generics Ltd.
1A, Sector-16A, Noida, India-201301

* DEPAKENE and DEPAKOTE are registered trademarks of Abbott Laboratories.

0311/MG
Rev. # 12/2015

Revised: 12/2015
Jubilant Cadista Pharmaceuticals Inc.