TOPIRAMATE - topiramate tablet, film
Sun Pharmaceutical Industries Limited
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 may cause eye problems. Serious
eye problems include:
- any sudden decrease in vision with or without eye pain and redness
- a blockage of fluid in the eye causing increased pressure in the eye
(secondary angle closure glaucoma).
- These eye problems can lead to permanent loss of vision if not treated. You
should call your healthcare provider right away if you have any new eye
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.
Like other antiepileptic drugs, topiramate tablets may
cause suicidal thoughts or actions in a very small number of people, about 1 in
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
- Stopping topiramate tablets suddenly can cause serious problems.
- Suicidal thoughts or actions can be caused by things other than medicines.
If you have suicidal thoughts or actions, your healthcare provider may check for
How can I watch for early symptoms of suicidal thoughts and
- Pay attention to any changes, especially sudden changes, in mood, behaviors,
thoughts, or feelings.
- Keep all follow-up visits with your healthcare provider as scheduled.
- Call your healthcare provider between visits as needed, especially if you
are worried about symptoms.
What is topiramate tablet?
Topiramate tablet is a prescription medicine used:
- to treat certain types of seizures (partial onset seizures and primary
generalized tonic-clonic seizures) in people 10 years and older
- with other medicines to treat certain types of seizures (partial onset
seizures, primary generalized tonic-clonic seizures, and seizures associated
with Lennox-Gastaut syndrome) in adults and children 2 years and
What should I tell my healthcare provider before taking
Before taking topiramate tablets, tell your healthcare
provider about all your medical conditions, including if you:
- have or have had depression, mood problems or suicidal thoughts or behavior
- have kidney problems, kidney stones, or are getting kidney dialysis
- have a history of metabolic acidosis (too much acid in the blood)
- have liver problems
- have osteoporosis, soft bones, or decreased bone density
- have lung or breathing problems
- have eye problems, especially glaucoma
- have diarrhea
- have a growth problem
- are on a diet high in fat and low in carbohydrates, which is called a
- are having surgery
- are pregnant or plan to become pregnant. It is not known if topiramate
tablets will harm your unborn baby. If you become pregnant while taking
topiramate tablets, talk to your healthcare provider about registering with the
North American Antiepileptic Drug Pregnancy Registry. You can enroll in this
registry by calling 1-888-233-2334. The purpose of this registry is to collect
information about the safety of antiepileptic medicine during pregnancy.
- are breastfeeding. It is not known if topiramate passes into breast milk and
if it can harm your baby. Talk to your healthcare provider about the best way to
feed your baby if you take topiramate tablets.
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
Especially, tell your healthcare provider if you take:
- Valproic acid
- any medicines that impair or decrease your thinking, concentration, or
- birth control pills. Topiramate tablets may make your birth control pills
less effective. Tell your healthcare provider if your menstrual bleeding changes
while you are taking birth control pills and topiramate tablets.
Ask you healthcare provider if you are not sure if your medicine is listed
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?
- Take topiramate tablets exactly as prescribed.
- Your healthcare provider may change your dose. Do not change your dose
without talking to your healthcare provider.
- Topiramate tablets should be swallowed whole. Do not chew the tablets. They
may leave a bitter taste.
- Do not store any medicine and food mixture for later use.
- Topiramate tablets can be taken before, during, or after a meal. Drink
plenty of fluids during the day. This may help prevent kidney stones while
taking topiramate tablets.
- If you take too many topiramate tablets, call your healthcare provider or
poison control center right away or go to the nearest emergency room.
- If you miss a single dose of topiramate tablets, take it as soon as you can.
However, if you are within 6 hours of taking your next scheduled dose, wait
until then to take your usual dose of topiramate tablets, and skip the missed
dose. Do not double your dose. If you have missed more than one dose, you should
call your healthcare professional for advice.
- Do not stop taking topiramate tablets without talking to your healthcare
provider. Stopping topiramate tablets suddenly may cause serious problems. If
you have epilepsy and you stop taking topiramate tablets suddenly, you may have
seizures that do not stop. Your healthcare provider will tell you how to stop
taking topiramate tablets slowly.
- Your healthcare provider may do blood tests while you take topiramate
What should I avoid while taking topiramate
- Do not drink alcohol while taking topiramate tablets. Topiramate tablets and
alcohol can affect each other causing side effects such as sleepiness and
- Do not drive a car or operate heavy machinery until you know how topiramate
tablets affect you. Topiramate tablets can slow your thinking and motor
What are the possible side effects of topiramate
Topiramate tablets may cause serious side effects including:
See “What is the most important information I should know about topiramate
Metabolic Acidosis. Metabolic acidosis can cause:
- loss of appetite
- irregular heartbeat
- impaired consciousness
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 are taken with a
medicine called valproic acid.
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
The most common side effects of topiramate tablets include:
- tingling of the arms and legs (paresthesia)
- not feeling hungry
- a change in the way foods taste
- weight loss
- upper respiratory tract infection
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.
How should I store topiramate tablets?
- Store topiramate tablets at 20° to 25°C (68° to 77°F); excursions permitted
to 15° to 30°C (59° to 86°F).
- Keep topiramate tablets in a tightly closed container
- Keep topiramate tablets dry and away from moisture
Keep topiramate tablets and all medicines out of the reach
General information about topiramate tablets.
Medicines are sometimes prescribed for purposes other than those listed in a
Medication Guide. Do not use topiramate tablet 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 1-800-818-4555
What are the ingredients in topiramate tablets?
Active ingredient: topiramate
This Medication Guide has been approved by the U.S. Food and
11/2009Sun Pharmaceutical Industries