TOPIRAMATE- topiramate tablet, film coated 
Apotex Corp

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MEDICATION GUIDE

Topiramate Tablets, USP 
(toe pyre’ a mate)

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

What is the most important information I should know about topiramate tablets?  

Topiramate tablets may cause decreased sweating and increased body temperature (fever). People, especially children, should be watched for signs of decreased sweating and fever, especially in hot temperatures. Some people may need to be hospitalized for this condition. Call your healthcare provider right away if you have a high fever, a fever that does not go away, or decreased sweating. 

Topiramate tablets can increase the level of acid in your blood (metabolic acidosis). If left untreated, metabolic acidosis can cause brittle or soft bones (osteoporosis, osteomalacia, osteopenia), kidney stones, can slow the rate of growth in children, and may possibly harm your baby if you are pregnant. Metabolic acidosis can happen with or without symptoms. Sometimes people with metabolic acidosis will:

Your healthcare provider should do a blood test to measure the level of acid in your blood before and during your treatment with topiramate tablets. If you are pregnant, you should talk to your healthcare provider about whether you have metabolic acidosis.  

Like other antiepileptic drugs, topiramate 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 topiramate tablets without first talking to a healthcare provider.

How can I watch for early symptoms of suicidal thoughts and actions?

Topiramate tablets can harm your unborn baby.

What are topiramate tablets?

Topiramate tablets are a prescription medicine used:

What should I tell my healthcare provider before taking topiramate tablets? 

Before taking topiramate tablets, tell your healthcare provider about all your medical conditions, including if you:

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins and herbal supplements. Topiramate and other medicines may affect each other causing side effects. 

Especially tell your healthcare provider if you take:

Ask your healthcare provider if you are not sure if your medicine is listed above. 

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist each time you get a new medicine. Do not start a new medicine without talking with your healthcare provider. 

How should I take topiramate tablets?

What should I avoid while taking topiramate tablets?

What are the possible side effects of topiramate tablets? 

Topiramate tablets may cause serious side effects including: 

See “What is the most important information I should know about topiramate tablets?”

Call your healthcare provider right away if you have any of the symptoms above. 

The most common side effects of topiramate 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 topiramate 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.  

For more information call Apotex Drug Information Service at 1-800-706-5575 for more information. 

How should I store topiramate tablets?

General information about topiramate tablets 

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use topiramate tablets for a condition for which it was not prescribed. Do not give topiramate tablets to other people, even if they have the same symptoms that you have. It may harm them. 

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

What are the ingredients in topiramate tablets? 

Active ingredient: topiramate

Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl cellulose, hypromellose, magnesium stearate, methylcellulose, polyethylene glycol, and titanium dioxide. In addition, the 50 mg and 100 mg tablets contain yellow iron oxide and the 200 mg tablets contain red iron oxide. 

Trademarks are the property of their respective owners.

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


APOTEX INC.

TOPIRAMATE TABLETS, USP

25 mg, 50 mg, 100 mg and 200 mg 

Manufactured by: Manufactured for:
Apotex Inc. Apotex Corp.
Toronto, Ontario Weston, Florida
Canada M9L 1T9 33326

Revised: March 2014

Rev. 9

Revised: 03/2014
 
Apotex Corp