TOPIRAMATE- topiramate tablet 
Lake Erie Medical DBA Quality Care Products LLC

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MEDICATIONGUIDE

TOPIRAMATETABLETS, USP

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.

WhatisthemostimportantinformationIshouldknowabouttopiramate tablets?

Topiramate tablets maycauseeyeproblems. 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. Call your healthcare provider right away if you have a high fever, a fever that does not go away, or decreased sweating.

Topiramate tablets may 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.

Likeotherantiepilepticdrugs, topiramate tabletsmaycausesuicidalthoughtsoractionsinaverysmallnumberofpeople, about1in500.

Callahealthcareproviderrightawayifyouhaveanyofthesesymptoms, especiallyiftheyarenew, worse, orworryyou:

Donotstoptopiramate tabletswithoutfirsttalkingtoahealthcareprovider.

HowcanIwatchforearlysymptomsofsuicidalthoughtsandactions?

Topiramate tabletscanharmyourunbornbaby.

Whatistopiramate tablets ?

Topiramate tablets is a prescription medicine used:

WhatshouldItellmyhealthcareproviderbeforetakingtopiramate 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.

HowshouldItaketopiramate tablets?

WhatshouldIavoidwhiletakingtopiramate tablets ?

Whatarethepossiblesideeffectsoftopiramate tablets?

Topiramate tablets may cause serious side effects including:

See "what is the most important information i should know about topiramate tablets?"

     ● Highbloodammonialevels. 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 (DEPAKENE and DEPAKOTE).

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

     ● Lowbodytemperature. Taking topiramate tablets when you are also taking valproic acid can cause a drop in body temperature to less than 95°F, feeling tired, confusion, or coma.

     ● Effectsonthinkingandalertness. 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.

     ● Dizzinessorlossofmusclecoordination.

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 Cipla Ltd. at 1-866-604-3268

HowshouldIstoretopiramate tablets

Generalinformationabouttopiramate 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 1-866-604-3268

Whataretheingredientsintopiramate tablets?

Activeingredient: Topiramate USP

Inactiveingredients:

Manufactured by:

Cipla Ltd Kurkumbh, India

Manufacture for:

Cipla USA, Inc., 9100 S. Dadeland Blvd., Suite 1500 Miami, FL 33156

Revised:  1/2015

ThisMedicationGuidehasbeenapprovedbytheU.S.FoodandDrugAdministration.

Revised: 7/2019
Lake Erie Medical DBA Quality Care Products LLC