TOPIRAMATE- topiramate tablet, film coated 
NCS HealthCare of KY, Inc dba Vangard Labs

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MEDICATION GUIDE

Topiramate (TOE-pee-rah-mate)

Tablets

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:

  • thoughts about suicide or dying
  • attempts to commit suicide
  • new or worse depression
  • new or worse anxiety
  • feeling agitated or restless
  • panic attacks
  • trouble sleeping (insomnia)
  • new or worse irritability
  • acting aggressive, being angry, or violent
  • acting on dangerous impulses
  • an extreme increase in activity and talking (mania)
  • other unusual changes in behavior or mood

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 is topiramate tablets?

Topiramate tablets are 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 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?

Your healthcare provider may do blood tests while you take topiramate tablets.

What should I avoid while taking topiramate tablets?

Do not drive a car or operate machinery until you know how topiramate tablets affects you. Topiramate tablets can slow your thinking and motor skills, and may affect vision.

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:

  • tingling of the arms and legs (paresthesia)
  • not feeling hungry
  • nausea
  • a change in the way foods taste
  • diarrhea
  • weight loss
  • nervousness
  • upper respiratory tract infection
  • speech problems
  • tiredness
  • dizziness
  • sleepiness/drowsiness
  • slow reactions
  • difficulty with memory
  • pain in the abdomen
  • fever
  • abnormal vision
  • decreased feeling or sensitivity, especially in the skin

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. 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 Glenmark Pharmaceuticals Inc., USA at 1(888)721-7115.

How should I store topiramate tablets?

Keep topiramate tablets 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 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. 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: hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, polyethylene glycol, polysorbate 80, sodium starch glycolate, and titanium dioxide. The 50 mg tablets also contain FD&C yellow# 6 and iron oxide yellow for color. The 100 mg and 200 mg tablets also contain iron oxide red and iron oxide yellow for color.

Trademarks are the property of their respective owners.

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

Medication Guide available at:

www.glenmarkpharma-us.com/medguides

Manufactured by:

Glenmark Pharmaceuticals Ltd.

India

Manufactured for:

Image

Glenmark Pharmaceuticals Inc., USA

Mahwah, NJ 07430

Questions? 1 (888) 721-7115

www.glenmarkpharma-us.com

June 2019

PE521660519-1

Revised: 2/2020
NCS HealthCare of KY, Inc dba Vangard Labs