Newspaper Page Text
PATIENT INFORMATION
TORAMAX® [Toe-pa-max]
(topiramate) Tablets/(topiramate capsules) Sprinkle Capsules
WHAT DO TOPAMAX TABLETS AND SPRINKLE CAPSULES LOOK LIKE?
TOPAMAX* (topiramate) Tablets
®© ® ©
© © C> <0
25 mg 50 mg 100 mg 200 mg
White Ught-hfeHow Vfellow Salmon
Note: The pictures above show the shapes and lettering of TOPAMAX tablets and sprinkle capsules.
The wording describes the strength and colors of the medication. Before taking your medicine, It is
important to compare the tablets or sprinkle capsules you receive from your healthcare professional
or pharmacist with these pictures to make sure you have received the correct medicine.
Please read this patient information carefully before you take TOPAMAX and each time you obtain a refill, in
case any information has changed. This summary does not contain all the information about TOPAMAX and is
not meant to take the place of talking with your healthcare professional. If you have any questions about
TOPAMAX, discuss them with your healthcare professional or pharmacist.
WHAT IS TOPAMAX?
TOPAMAX is a prescription medicine used:
• alone to treat seizures in patients 10 years and older
• with other medicines to treat seizures in adults and children over age 2
• to prevent migraine headaches in adults
WHO SHOULD NOT TAKE TOPAMAX? ~
Do not take TOPAMAX if you are allergic to anything in it. See the end of this leaflet for a complete list of
ingredients in TOPAMAX.
WHAT SHOULD I TELL MY HEALTHCARE PROFESSIONAL BEFORE TAKING TOPAMAX?
Tell your healthcare professional about ail of your medical conditions, including if you:
• have kidney problems, especially kidney stones, or are getting kidney dialysis
• have a history of metabolic acidosis (blood and body fluid abnormality)
• have liver problems
• have osteoporosis (weak or brittle bones) and/or soft bones (osteomalacia) or decreased bone density
(osteopenia)
• have lung or breathing problems
• have eye problems, especially glaucoma
• have diarrhea
• have a growth problem
• are on a diet high in fat called a ketogenic diet
• are having surgery
• are pregnant or planning to become pregnant. It is not known if TOPAMAX can harm your unborn baby.
• are breastfeeding. TOPAMAX may pass into your milk. Talk to your healthcare professional about the best
way to feed your baby while taking TOPAMAX.
• suffer from depression, mood problems or suicidal thoughts or behavior
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 (e.g. 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.
HOW SHOULD I TAKE TOPAMAX? ~ TZ7H77
• Take TOPAMAX exactly as prescribed. Vbur healthcare professional will usually start you on a low dose of
TOPAMAX and slowly increase your dose until the best dose is found for you
• TOPAMAX Tablets should be swallowed whole. Avoid, chewing the tablets as they may leave a bitter taste.
• TOPAMAX Sprinkle Capsules may be swallowed whole or may be opened and sprinkled on a teaspoon of
soft food of any type. Examples are applesauce, custard, ice cream, oatmeal, pudding or yogurt. Drink fluids
right after to make sure all of the food and medicine mixture is swallowed
• Never store any medicine and food mixture for use at a later time.
• TORAMAX can be taken before, during, or after a meal. Drink plenty of fluids dunng the day to prevent
kidney stones while taking TORAMAX.
• If you take too much TORAMAX. call your healthcare professional or poison control center right away or go
to an emergency room.
• If you miss a single dose of TORAMAX, 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 TORAMAX, 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 TORAMAX unless a healthcare professional tells you to stop taking TORAMAX Vbur
healthcare professional will tell you how to slowly stop taking TORAMAX.
WHAT SHOULD I AVOID WHILETAKING TOPAMAX?
• If you are taking Topamax or other antiepileptic drugs for epilepsy or seizures, you may need to avoid
activities where loss of consciousness (passing out) could result in serious danger to yourself or those around
you (including swimming, driving a car, climbing in high places, etc.). Talk to your doctor before engaging in
such activities.
• Unless prescribed by your healthcare professional, you should avoid other medicines that also impair or
TOPAMAX* (topiramate capsules)
Sprinkle Capsules
TOP TOP
15 mg 2Smg
Capsules are white
and clear
decrease your thinking, concentration, or muscle coordination (e.g. central nervous system depressant
medicines).
• >bu should avoid drinking alcohol while taking TORAMAX. Alcohol with TORAMAX can make side effects
such as sleepiness and dizziness worse.
• Do not drive a car or operate heavy machinery until you know how TOPAMAX affects you. TORAMAX can
impair your thinking, motor skills, and/or vision.
WHAT ARETHE POSSIBLE SIDE EFFECTS OFTOPAMAX?
TORAMAX may cause the following side effects which can be serious:
• metabolic acidosis. Metabolic acidosis is a condition that happens when there is too much acid in your
blood Metabolic acidosis can cause symptoms such as tiredness, loss of appetite, irregular heartbeat, and
impaired consciousness. Call your healthcare professional right away if you get these symptoms with
TORAMAX. '(four healthcare professional should do a blood test (measurement of serum bicarbonate) to
monitor your bicarbonate level while you are taking TORAMAX.
• eye problems. Serious eye problems include:
• a sudden decrease in vision (acute myopia) with or without eye pain and
• a blockage of fluid in the eye causing increased pressure in the eye (secondary angle closure glaucoma).
Call your healthcare professional right away if you have a loss in vision or get eye pain. These
problems can lead to blindness if not treated right away. Vbur healthcare professional will probably stop
TORAMAX and may recommend other therapy.
• decreased sweating (oligohidrosis) and increased body temperature (fever). Patients, especially
children, should be watched closely for signs of decreased sweating and fever (increased body temperature),
especially in hot temperatures. Some patients may need hospital treatment for this condition.
• effects on thinking and alertness. TORAMAX may affect thinking skills and cause confusion, problems
with concentration, attention, memory, and/or speech. TOPAMAX may cause depression or mood problems,
tiredness, and sleepiness. Call your healthcare professional right away if you experience any of these side
effects.
• dizziness or loss of muscle coordination in patients who take TOPAMAX alone or with other seizure
medicines.
• high blood ammonia levels and effects on mental activities. High ammonia in the blood can affect your
mental activities and decrease alertness, can make you feel tired or fatigued, or can cause vomiting. This has
happened when TOPAMAX has been used with a medicine called valproic acid (DEPAKENE® and
DEPAKOTE®).
• kidney stones. Drink plenty of fluids when taking TORAMAX to decrease your chances of getting kidney
stones.
• tingling of the arms and legs (paresthesia) is a common side effect of TORAMAX.
Other side effects with TORAMAX include loss of appetite, nausea, a change in the way foods taste, diarrhea,
weight loss, nervousness, aggression, upper respiratory tract infection.
Call your healthcare professional if you have any symptoms that concern you or that do not go away.
These are not all the side effects with TORAMAX. For more information, ask your healthcare professional or
pharmacist.
WHAT SHOULD I DO IF I GET PREGNANT WHILE TAKING TOPAMAX?
It is not clear if there is a risk to the fetus/baby if you are exposed to TORAMAX and you are pregnant.
Various abnormalities have been described in the offspring of animals exposed to TOPAMAX during
pregnancy. If you use TORAMAX while you are pregnant, ask your healthcare professional about reporting
your experience to the North American Drug Pregnancy Registry at Massachusetts General Hospital
(Boston, MA). This registry collects information about the babies born to women who are taking drugs to
treat various conditions. Information about the North American Drug Pregnancy Registry can be found at
http://www.masSQeneral.org/aed/. You can also join the registry by calling 1-877-376-3872.
HOW SHOULD I STORE TOPAMAX?
• Store TORAMAX 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.
General Information About TOPAMAX.
Medicines are sometimes prescribed for purposes other than those listed in Patient Information
leaflets. Do not use TOPAMAX for a condition for which it was not prescribed. Do not give TOPAMAX to
other people, even if they have the same symptoms that you have. It may harm them.
This leaflet summanzes the most important information about TORAMAX. If you would like more information, talk
to your healthcare professional. You can ask your health care professional or pharmacist for information about
TORAMAX that is written for health professionals. Ifou can also visit www.tooamax.com or call 1-800-526-7736
for more information.
WHAT ARETHE INGREDIENTS OFTOPAMAX?
Active Ingredient: topiramate
Inactive Ingredients:
• Tablets - contain lactose monohydrate, pregelatinized starch, microcrystalline cellulose, sodium starch
glycolate, magnesium stearate, purified water, camauba wax, hypromellose, titanium dioxide, polyethylene,
glycol, synthetic iron oxide (50, 100 and 200 mg tablets) and polysorbate 80.
• Sprinkle Capsules - contain sugar spheres (sucrose and starch), povidone, cellulose acetate, gelatin,
sorbitan monolaurate, sodium lauryl sulfate, titanium dioxide, and black pharmaceutical ink.
DEPAKENE® and DERAKOTE® are registered trademarks of Abbott Laboratories.
Manufactured by:
Janssen Ortho, LLC
Gurabo, Puerto Rico 00778
Distributed by:
CP ORTHO-McNEIL NEUROLOGICS, INC.
ORTHO-McNEIL NEUROLOGICS, INC.
Titusville, NJ 08560
© OMN 2005 Revised March 2007 02T606P