TOPIRAMATE- topiramate tablet 
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SPL MEDGUIDE

Topiramate (toe pir'a mate) Tablets USP

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

Topiramate tablets may cause eye problems. Serious eye problems include:

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. If a high fever, a fever that does not go away, or decreased sweating develops, call your healthcare provider right away.

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:

Donotstoptopiramate tabletswithoutfirsttalkingtoahealthcareprovider.

HowcanIwatchforearlysymptomsofsuicidalthoughtsandactions?

Topiramate tabletscanharmyourunbornbaby.

What is topiramate tablets?

Topiramate tablets is a prescription medicine used:

Before taking topiramate tablets, tell your healthcare provider about all of your medical 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. 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. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

You may also report side effects to Cipla Ltd. India. at 1-866-604-3268.

How should I store topiramate tablets?

Keep Topiramate and all medicines out of the reach of children.

General information about the safe and effective use of topiramate tablets.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Topiramate 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. 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 USP

Inactive ingredients:

Disclaimer: Other brands listed are the registered trademarks of their respective owners and are not trademarks of Cipla Limited.

Manufactured by:

Cipla Ltd Kurkumbh,

India

Manufactured for:

Cipla USA, Inc.

10 Independence Boulevard, Suite 300

Warren, NJ 07059

For more information, call 1-866-604-3268.

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

Revised: 6/2020

Revised: 2/2022
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