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Frequently Asked Questions



About TOPAMAX

What's different about TOPAMAX?
How does TOPAMAX work?
How long will it take for TOPAMAX to work?
Will I still need to take other migraine medications?
Can I take TOPAMAX with other prescription medications?
How long has TOPAMAX been available in the U.S.?
How is TOPAMAX dosed?
What if I miss a dose of TOPAMAX?
How should TOPAMAX tablets be stored?
Do I need to take TOPAMAX with food?
What TOPAMAX side effects might I experience?
Could I experience eye problems while taking TOPAMAX?
Is TOPAMAX safe to take while pregnant?
Is TOPAMAX safe to take while breast-feeding?
How should TOPAMAX be discontinued?

About Migraines

What causes migraines?
How do I know if I am having a migraine or just a bad headache?
Should I talk to my healthcare professional?
What steps can I take to manage my migraines better?
Where can I go for more information?



What's different about TOPAMAX?

Unlike medicine you take when you feel migraine headache pain coming on, TOPAMAX is a daily prescription medication that helps keep migraines from starting in the first place so you can get fewer of them to think about.
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How does TOPAMAX work?

Although the exact way TOPAMAX works is unknown, it's believed to help "calm" overexcitable nerve cells in the brain so they don't send out the signals that can cause migraines.
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How long will it take for TOPAMAX to work?

Clinical studies found that TOPAMAX began reducing the frequency of migraines at 1 month and showed sustained improvement throughout the 6-month studies.

To achieve best results, TOPAMAX should be taken for 2 to 3 months and then its effectiveness can be determined.
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Will I still need to take other migraine medications?

While TOPAMAX may help reduce the number of migraines you suffer, some patients could still have an occasional migraine attack. For this reason, your healthcare professional might prescribe an additional medication along with TOPAMAX as part of a treatment program.
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Can I take TOPAMAX with other prescription medications?

Tell your healthcare professional about all the medicines you take including prescription and nonprescription medicines, vitamins and herbal supplements. TOPAMAX and certain other medicines can affect each other. Sometimes the dose of some of your other medicines or TOPAMAX will have to be adjusted. Especially, tell your healthcare professional if you are taking:

  • Other medicines that impair or decrease your thinking, concentration, or muscle coordination (eg, central nervous system depressant medicines)
  • Birth control pills. TOPAMAX may make your birth control pills less effective. Tell your healthcare professional if your menstrual bleeding changes while you are taking birth control pills and TOPAMAX.

Keep a list of all the medicines you take. Show this list to your healthcare professionals and pharmacists before you start a new medicine.
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How long has TOPAMAX been available in the U.S.?

TOPAMAX has been available in the U.S. since 1996. Worldwide, more than 4 million patients have been treated with TOPAMAX (regardless of condition). Like many other migraine preventive medications, TOPAMAX was initially studied for another medical condition and was then approved in the U.S. in 2004 for use in reducing migraine frequency.
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How is TOPAMAX dosed?

The rule with TOPAMAX is to "start low and go slow." That is, your healthcare professional will adjust your medication. You'll start with a low dose and then slowly increase the amount of TOPAMAX you take until you reach the dosage that works best for you. Like many other medications, TOPAMAX needs time to build up to the right level in your bloodstream before it is completely effective, so remember to be patient. For most patients, the recommended dose of TOPAMAX for the prevention of migraine headache is 50 mg twice a day.
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What if I miss a dose of TOPAMAX?

If you miss a single dose of TOPAMAX, 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 TOPAMAX, 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.
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How should TOPAMAX Tablets be stored?

Store TOPAMAX tablets in tightly closed containers at room temperature, 59°F to 86°F (15°C to 30°C). Protect from moisture.

Store TOPAMAX sprinkle capsules in tightly closed containers at or below 77°F (25°C). Protect from moisture.

Keep TOPAMAX and all medicines out of the reach of children.
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Do I need to take TOPAMAX with food?

TOPAMAX can be taken with or without food.
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What TOPAMAX side effects might I experience?

Like most other over-the-counter and prescription medications, TOPAMAX may cause side effects. Side effects with TOPAMAX are mostly mild or moderate, and occurred most often during the initial phase of therapy. While these side effects vary for everyone, most people continue their TOPAMAX therapy. To read a list of the most common side effects see the bottom of every page throughout this site. To view a description of TOPAMAX side effects, click here.
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Could I experience eye problems while taking TOPAMAX?

Before taking TOPAMAX, tell your healthcare professional if you have eye problems, especially glaucoma. TOPAMAX may cause eye problems, which can be serious.

Call your healthcare professional right away if you have a decrease in vision or get eye pain. These problems can lead to blindness if not treated right away. Your healthcare professional will probably stop TOPAMAX and may recommend other therapy.
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Is TOPAMAX safe to take while pregnant?

If you take TOPAMAX during pregnancy, your baby has a higher risk for birth defects called cleft lip and cleft palate. These defects can begin early in pregnancy, even before you know you are pregnant.

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 TOPAMAX. If the decision is made to use TOPAMAX, 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 TOPAMAX.

Tell your healthcare provider right away if you become pregnant while taking TOPAMAX. You and your healthcare provider should decide if you will continue to take TOPAMAX while you are pregnant.

Pregnancy Registry: If you become pregnant while taking TOPAMAX, 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 drugs during pregnancy.
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Is TOPAMAX safe to take while breast-feeding?

TOPAMAX passes into breast milk. It is not known if the TOPAMAX that passes into breast milk can harm your baby. Talk to your healthcare provider about the best way to feed your baby if you take TOPAMAX.
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How should TOPAMAX be discontinued?

Do not stop taking your medicine without talking to your healthcare professional first. Stopping Topamax suddenly can cause serious problems. Your healthcare professional will tell you how to slowly stop taking TOPAMAX. In clinical trials of TOPAMAX, daily dosages were decreased gradually.
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What causes migraines?

No one knows exactly why migraines happen, but it's thought that a series of events begins with the excitement of nerve cells in the brain. These overexcitable nerve cells then send out impulses to the blood vessels in the brain. The nerve releases substances that cause inflammation and swelling of the blood vessels resulting in throbbing.
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How do I know if I am having a migraine or just a bad headache?

Migraines are not always easy to detect. That's why you should always let your healthcare professional identify your symptoms.

Tension headaches are the most common type of headache. Most people describe these headaches as a mild or moderate pressing, or tightening, head pain. Typically, tension headaches respond well to over-the-counter treatments. Unlike migraines, they are not accompanied by nausea or light and sound sensitivity. Also, normal activity will not typically aggravate them.

Migraine headaches, on the other hand, often feature:

  • Throbbing head pain
  • Worsening pain with routine activity
  • Nausea and/or vomiting
  • Light and sound sensitivity

Often, people with watery eyes, runny nose, nasal congestion, and headache may think they have a sinus headache. What they may be experiencing is a migraine. Nearly half of all migraine patients experience ocular or nasal symptoms, along with head pain. That's why it's always critical to talk to your healthcare professional.
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Should I talk to my healthcare professional?

Your healthcare professional is always the best person to review your medical history, understand your migraine patterns, and recommend treatment. Of course, you are a partner in your migraine management. That's why it's important to do your part. Prepare for your appointment by bringing your migraine diary and completed discussion guide. This will help you get the most from your appointment.
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What steps can I take to manage my migraines better?

A migraine is triggered under specific conditions. Migraine patients get headaches sooner than other people because they have less resistance to the triggers that can aggravate or stimulate a response.

Different people respond to different triggers, but the most common include:

  • Dietary factors (irregular meal patterns, missing meals, sweets, starchy foods, too much caffeine)
  • Sleep disturbances (irregular sleep patterns, too much or too little sleep)
  • Emotional factors (excitement, anger, fear, anxiety, stress, letdowns)
  • Environmental factors (weather changes, bright or glaring lights, loud noise, strong odors)
  • Alcohol (wine, champagne, beer, liquors)
  • Food additives (such as MSG and nitrates that are found in pepperoni, luncheon meats, and hot dogs)
  • Hormone cycles or changes (menstruation, oral contraceptives, estrogen replacement)
  • Medication overuse (frequent use of over-the-counter or prescription pain relievers)

And you can begin to understand your individual triggers better by tracking them with a migraine diary.
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Where can I go for more information?

American Headache Society Committee for Headache Education (ACHE)
Consumer-friendly site where you'll find discussion groups and a handy physician search tool.

National Headache Foundation
Some of the latest research and treatment developments, educational resources, and events.

American Academy of Neurology
Valuable resource for medical specialists worldwide who are committed to improving the care of patients with neurological diseases

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Attention TOPAMAX Patients and Medical Professionals
Dispensing errors have been reported between TOPAMAX® (topiramate) tablets and TOPROL-XL® (metoprolol succinate) extended-release tablets.

Please be sure to check your tablets to ensure you are taking the right medicine.

*TOPROL-XL is a registered trademark of the AstraZeneca group of companies.

TOPAMAX® is approved for migraine prevention in adults only.
TOPAMAX® is not used to stop a migraine after it starts.

IMPORTANT SAFETY INFORMATION

Warnings and Precautions

TOPAMAX® may cause eye problems. Serious eye problems include: sudden decrease in vision with or without eye pain and redness; 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 professional right away if you have any new eye symptoms.

TOPAMAX® 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.

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

Like other antiepileptic drugs, TOPAMAX® may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. Pay attention to any changes and call your doctor 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), or other unusual changes in behavior or mood.

TOPAMAX® may affect how you think, and cause confusion, problems with concentration, attention, memory, or speech, depression or mood problems, tiredness, and sleepiness.
Do not stop taking TOPAMAX® without first talking to your doctor. Stopping TOPAMAX® suddenly can cause serious problems.

If you take TOPAMAX® during pregnancy, your baby has a higher risk for birth defects called cleft lip and cleft palate. These defects can begin early in pregnancy, even before you know you are pregnant. 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 TOPAMAX®. If the decision is made to use TOPAMAX®, you should use effective birth control (contraception) unless you are planning to become pregnant. Tell your healthcare provider right away if you become pregnant while taking TOPAMAX®. You and your healthcare provider should decide if you will continue to take TOPAMAX® while you are pregnant. Metabolic acidosis may have harmful effects on your baby. Talk to your healthcare provider if TOPAMAX® has caused metabolic acidosis during your pregnancy. If you become pregnant while taking TOPAMAX®, 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 drugs during pregnancy.

TOPAMAX® may cause high blood ammonia levels. High ammonia in the blood can affect your mental activities, slow your alertness, make you feel tired, or cause vomiting.

Taking TOPAMAX® when you are also taking valproic acid can cause a drop in body temperature (hypothermia) to less than 95ºF, feeling tired, confusion, or coma.

Adverse Reactions

The most common side effects of TOPAMAX® include: tingling in arms and legs, loss of appetite, nausea, taste change, diarrhea, weight loss, nervousness, and upper respiratory tract infection.

Tell your doctor about other medications that you are taking. Report any side effect that bothers you or that does not go away.

These are not all the possible side effects of TOPAMAX®. For more information, ask your healthcare professional or pharmacist.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Please see full US Prescribing Information and Medication Guide

March 4, 2011 - FDA Drug Safety Communication: TOPAMAX® (topiramate) use during pregnancy can cause fetal harm, including an increased risk for cleft lip and/or cleft palate. For information from the company click here. The FDA announcement can be found at www.fda.gov.
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