MEDICATION GUIDE

Topiramate (toe pir' a mate)

Capsules, for oral use

What is the most important information I should know about topiramate capsules?
Topiramate capsules 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 symptoms, including any new problems with your vision.

Topiramate 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 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:

feel tired	feel changes in heartbeat
not feel hungry (loss of appetite)	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 capsules. If you are pregnant, you should talk to your healthcare provider about whether you have metabolic acidosis.

Like other antiepileptic drugs, topiramate 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:

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

Do not stop topiramate capsules without first talking to a healthcare provider.

• Stopping topiramate capsules 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 other causes.

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

• 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.

Topiramate capsules can harm your unborn baby.

• If you take topiramate capsules during pregnancy, your baby has a higher risk for birth defects including cleft lip and cleft palate. These defects can begin early in pregnancy, even before you know you are pregnant.
• Birth defects may happen even in children born to women who are not taking any medicines and do not have other risk factors.
• There may be other medicines to treat your condition that have a lower chance of birth defects.
• All women of childbearing age should talk to their healthcare providers about using other possible treatments instead of topiramate capsules. If the decision is made to use topiramate capsules, you should use effective birth control (contraception) unless you are planning to become pregnant. You should talk to your doctor about the best kind of birth control to use while you are taking topiramate capsules.
• Tell your healthcare provider right away if you become pregnant while taking topiramate capsules. You and your healthcare provider should decide if you will continue to take topiramate capsules while you are pregnant.
• If you take topiramate during pregnancy, your baby may be smaller than expected at birth. The long-term effects of this are not known. Talk to your healthcare provider if you have questions about this risk during pregnancy.
• Metabolic acidosis may have harmful effects on your baby. Talk to your healthcare provider if topiramate capsules have caused metabolic acidosis during your pregnancy.

Topiramate capsules may decrease the density of bones when used over a long period.

Topiramate capsules may slow height increase and weight gain in children and adolescents when used over a long period.

 

What is topiramate capsules?

Topiramate capsules are a prescription medicine used:

• to treat certain types of seizures (partial-onset seizures and primary generalized tonic-clonic seizures) in adults and children 2 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 older,
•  to prevent migraine headaches in adults and adolescents 12 years and older.

Before taking topiramate capsules, tell your healthcare provider about all of your medical conditions, including if you:

• have or have had depression, mood problems, or suicidal thoughts or behavior.
• have kidney problems, have kidney stones, or are getting kidney dialysis.
• have a history of metabolic acidosis (too much acid in the blood).
• have liver problems.
• have weak, brittle, or soft bones (osteomalacia, osteoporosis, osteopenia, 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 ketogenic diet.
• are having surgery.
• are pregnant or plan to become pregnant.
• are breastfeeding or plan to breastfeed. Topiramate passes into breast milk. Breastfed babies may be sleepy or have diarrhea. It is not known if the topiramate that passes into breast milk can cause other serious harm to your baby. Talk to your healthcare provider about the best way to feed your baby if you take topiramate capsules.

 Tell your healthcare provider about all the medicines you take, including prescription and over-the- counter medicines, vitamins, and herbal supplements. Topiramate capsules and other medicines may affect each other causing side effects.

Especially tell your healthcare provider if you take:

• Valproic acid (such as DEPAKENE or DEPAKOTE).
• any medicines that impair or decrease your thinking, concentration, or muscle coordination.
• birth control that contains hormones (such as pills, implants, patches or injections). Topiramate capsules may make your birth control less effective. Tell your healthcare provider if your menstrual bleeding changes while you are using birth control and topiramate capsules.

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 capsules?

• Take topiramate capsules exactly as prescribed.
• Your healthcare provider may change your dose. Do not change your dose without talking to your healthcare provider.
• Topiramate capsules may be swallowed whole or may be opened and sprinkled on a teaspoon of soft food. Drink fluids right after eating the food and medicine mixture to make sure it is all swallowed. Do not chew the food and medicine mixture.
• Do not store any medicine and food mixture for later use.
• Topiramate capsules 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 capsules.
• If you take too much topiramate capsules, call your healthcare provider right away or go to the nearest emergency room.
• If you miss a single dose of topiramate capsules, 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 capsules, and skip the missed dose. Do not double your dose. If you have missed more than one dose, you should call your healthcare provider for advice.
• Do not stop taking topiramate capsules without talking to your healthcare provider. Stopping topiramate capsules suddenly may cause serious problems. If you have epilepsy and you stop taking topiramate capsules suddenly, you may have seizures that do not stop. Your healthcare provider will tell you how to stop taking topiramate capsules slowly.
•  Your healthcare provider may do blood tests while you take topiramate capsules.

What should I avoid while taking topiramate capsules?

• You should not drink alcohol while taking topiramate capsules. Topiramate capsules and alcohol can affect each other causing side effects such as sleepiness and dizziness.
•  Do not drive a car or operate machinery until you know how topiramate capsules affects you. Topiramate capsules can slow your thinking and motor skills, and may affect vision.

What are the possible side effects of topiramate capsules?

Topiramate capsules may cause serious side effects including:

See “What is the most important information I should know about topiramate capsules?”

• 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 capsules are taken with a medicine called valproic acid (DEPAKENE and DEPAKOTE).
• Effects on thinking and alertness. Topiramate capsules may affect how you think and cause confusion, problems with concentration, attention, memory, or speech. Topiramate capsules may cause depression or mood problems, tiredness, and sleepiness.
• Dizziness or loss of muscle coordination.
• Serious skin reactions. Topiramate capsules may cause a severe rash with blisters and peeling skin, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome). Topiramate capsules may also cause a rash with blisters and peeling skin over much of the body that may cause death (toxic epidermal necrolysis). Call your healthcare provider right away if you develop a skin rash or blisters.
• Kidney stones. Drink plenty of fluids when taking topiramate capsules to decrease your chances of getting kidney stones.
• Low body temperature. Taking topiramate capsules when you are also taking valproic acid can cause a drop in body temperature to less than 95°F, or can cause tiredness, confusion, or coma.

Call your healthcare provider right away if you have any of the symptoms above. The most common side effects of topiramate capsules include:

tingling of the arms and legs (paresthesia)	nervousness	slow reactions
not feeling hungry	upper respiratory tract infection	difficulty with memory
nausea	speech problems	pain in the abdomen
a change in the way foods taste	tiredness	fever
diarrhea	dizziness	abnormal vision
weight loss	sleepiness/drowsiness	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 capsules. 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 Ascend Laboratories, LLC at 1-877-272-7901.

How should I store topiramate capsules?

• Store topiramate capsules at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
• Keep topiramate capsules in a tightly closed container.
• Keep topiramate capsules dry and away from moisture.

Keep topiramate capsules and all medicines out of the reach of children.

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

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

What are the ingredients in topiramate capsules?

Active ingredient: topiramate

Inactive ingredients:

• Sprinkle Capsules - black iron oxide, cellulose acetate, gelatin, hypromellose, potassium hydroxide, povidone, propylene glycol, shellac, sodium lauryl sulfate, sugar sphere, talc and titanium dioxide.

Dispense with Medication Guide available at:
http://www.ascendlaboratories.com/mg/topiramatecap.pdf

Manufactured by:

Alkem Laboratories Ltd.,

INDIA.

Distributed by:

Ascend Laboratories, LLC

Parsippany, NJ 07054

For more information, call Ascend Laboratories, LLC at 1-877-272-7901.

This Medication Guide has been approved by the U.S. Food and Drug Administration                     Revised: 6/2023