TOPIRAMATE- topiramate capsule, extended release 
Cadila Healthcare Limited

----------

SPL MEDGUIDE

TOPIRAMATE (toe pyre' a mate) Extended-release Capsules

What is the most important information I should know about topiramate extended-release capsules?

Take topiramate extended-release capsules whole. Do not sprinkle topiramate extended-release capsules on food, or break, crush, dissolve, or chew topiramate extended-release capsules before swallowing. If you cannot swallow topiramate extended-release capsules whole, tell your healthcare provider. You may need a different medicine.

Do not drink alcohol within 6 hours prior to and 6 hours after topiramate extended-release capsules administration.

Topiramate extended-release capsules may cause eye problems. Serious eye problems include:

Topiramate extended-release capsules 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 extended-release capsules 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 extended-release capsules. If you are pregnant, you should talk to your healthcare provider about whether you have metabolic acidosis.

Like other antiepileptic drugs, topiramate extended-release capsules 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 extended-release capsules without first talking to a healthcare provider.

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

Topiramate extended-release capsules can harm your unborn baby.

What are topiramate extended-release capsules?

Topiramate extended-release capsules are a prescription medicine used:

Before taking topiramate extended-release capsules, 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. 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 extended-release capsules?

What should I avoid while taking topiramate extended-release capsules?

What are the possible side effects of topiramate extended-release capsules? 

Topiramate extended-release capsules may cause serious side effects, including:

See "What is the most important information I should know about topiramate extended-release capsules?"

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

The most common side effects of topiramate extended-release capsules 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 extended-release capsules.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Please address medical inquiries to, MedicalAffairs@zydususa.com or Tel.: 1-877-993-8779.

How should I store topiramate extended-release capsules?

General information about the safe and effective use of topiramate extended-release capsules.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use topiramate extended-release capsules for a condition for which it was not prescribed. Do not give topiramate extended-release capsules 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 extended-release capsules that is written for health professionals.

What are the ingredients in topiramate extended-release capsules?

Active ingredient: topiramate, USP

Inactive ingredients: ethyl cellulose, hypromellose, hydrogenated castor oil, microcrystalline cellulose, povidone, polyethylene glycol, talc, and triethyl citrate. The capsule shells contain gelatin, sodium lauryl sulfate and titanium dioxide. All capsule shells are imprinted with black pharmaceutical ink that contains butyl alcohol, dehydrated alcohol, ferrosoferric oxide, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water, shellac and strong ammonia solution.

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

The brands listed are registered trademark of their respective owners.

Revised: 4/2019
Cadila Healthcare Limited