TOPIRAMATE- topiramate tablet 



Topiramate Tablets, USP

Rx Only

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 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.

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:

• feel tired

• not feel hungry (loss of appetite)

• feel changes in heartbeat

• have trouble thinking clearly

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 tablets 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?"

•  Metabolic acidosis. Metabolic acidosis can cause:

•  High blood ammonia levels. High ammonia in the blood can affect your mental activities, slow your alertness, make you feel tired, or cause vomiting. This has happened when topiramate tablets is taken with a medicine called valproic acid.

•  Low body temperature: Taking topiramate tablets when you are also taking valproic acid can cause a drop in body temperature to less then 950F, feeling tired, confusion, or coma.

•  Kidney stones. Drink plenty of fluids when taking topiramate tablets to decrease your chances of getting kidney stones.

•  Effects on thinking and alertness. Topiramate tablets may affect how you think, and cause confusion, problems with concentration, attention, memory, or speech. Topiramate tablets may cause depression or mood problems, tiredness, and sleepiness.

•  Dizziness or loss of muscle coordination.

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.

You may also report side effects to Torrent Pharma Inc. at 1-269-544-2299.

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.  

For more information, call 1-269-544-2299.

What are the ingredients in topiramate tablets?

Active ingredient: topiramate, USP

Inactive ingredients: colloidal silicon dioxide, ferric oxide red (200 mg tablets), ferric oxide yellow (50, 100, and 200 mg tablets), hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, sodium starch glycolate, talc and titanium dioxide.

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

Manufactured by:


Dist. Mehsana, INDIA.


TORRENT PHARMA INC., 5380 Holiday Terrace, Suite 40, Kalamazoo, Michigan 49009.

8029988                                                                                                      Revised August 2011


25 mg : label

Revised: 10/2016