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|Topiramate Sprinkle Capsules

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Topiramate Sprinkle Capsules

Generic Name: Topiramate Sprinkle Capsules (toe-PYRE-a-mate)
Brand Name: Topamax

Topiramate Sprinkle Capsules is used for:

Treating certain kinds of seizures in patients 2 years of age or older. It is also prescribed to prevent migraine headache in adults.

Topiramate Sprinkle Capsules is a carbonic anhydrase inhibitor. It works by controlling nerve impulses in the brain.

Do NOT use Topiramate Sprinkle Capsules if:

you are allergic to any ingredient in Topiramate Sprinkle Capsules
you are taking other carbonic anhydrase inhibitors (eg, acetazolamide)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Topiramate Sprinkle Capsules:

Some medical conditions may interact with Topiramate Sprinkle Capsules. Tell your health care provider if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, plan to become pregnant, or are breast-feeding
if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
if you have allergies to medicines, foods, or other substances
if you have liver or kidney problems, kidney stones, or regularly consume alcohol
if you have diarrhea, a respiratory tract disease, or you are scheduled for surgery
if you have status epilepticus (continuous seizure activity or a series of seizures without a full return to consciousness)
if you are on a diet that increases the amount of ketones in your blood and results in fruity-smelling breath

Some MEDICINES MAY INTERACT with Topiramate Sprinkle Capsules. Tell your health care provider if you are taking any other medicines, especially any of the following:

Carbamazepine or hydantoins (eg, phenytoin) because the effectiveness of Topiramate Sprinkle Capsules may be decreased
Amitriptyline, carbamazepine, hydantoins (eg, phenytoin), or metformin because the actions and side effects of Topiramate Sprinkle Capsules may be increased
Risperidone because its effectiveness may be decreased by Topiramate Sprinkle Capsules

This may not be a complete list of all interactions that may occur. Ask your health care provider if Topiramate Sprinkle Capsules may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Topiramate Sprinkle Capsules:

Use Topiramate Sprinkle Capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Topiramate Sprinkle Capsules may be taken with or without food.
Drink plenty of fluids while taking Topiramate Sprinkle Capsules to prevent kidney stones from forming.
The capsules may be swallowed whole or the capsules may be opened and sprinkled on a small amount (teaspoon) of soft food, such as applesauce, custard, ice cream, oatmeal, pudding, or yogurt.
Hold the capsule upright so that you can read the word "top." Carefully twist off the clear portion of the capsule. It is best to do this over the small portion of soft food. Sprinkle all of the capsule"s contents onto the spoonful of soft food.
Swallow this mixture immediately; do not chew it. Drink fluid immediately after taking the medicine to be sure all of the mixture is swallowed. Do not save the mixture for future use.
Suddenly stopping Topiramate Sprinkle Capsules may cause seizures to occur more often. Stopping therapy should be gradual.
If you miss a dose of Topiramate Sprinkle Capsules, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

Ask your health care provider any questions you may have about how to use Topiramate Sprinkle Capsules.

Important safety information:

Topiramate Sprinkle Capsules may cause dizziness, drowsiness, confusion, difficulty concentrating, or blurred vision. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Topiramate Sprinkle Capsules. Using Topiramate Sprinkle Capsules alone, with other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.
Avoid drinking alcohol or taking other medications that cause drowsiness (eg, sedatives, tranquilizers) while taking Topiramate Sprinkle Capsules. Topiramate Sprinkle Capsules will add to the effects of alcohol and other depressants. Ask your pharmacist if you have questions about which medicines are depressants.
Topiramate Sprinkle Capsules may reduce sweating, which could raise body temperature, especially in children. The risk of this serious side effect is greater in hot weather and/or during vigorous exercise. Drink plenty of fluids and dress lightly while in hot climates or when exercising. Check carefully for signs of decreased sweating. If this occurs, promptly seek cooler or air-conditioned shelter and/or stop exercising. Seek immediate medical attention if your body temperature is above normal, or if you have mental or mood changes, headache, or dizziness.
Additional monitoring of your dose or condition may be needed if you are taking other medicines that reduce sweating. These medicines include anticholinergics (eg, benztropine), amitriptyline, haloperidol, or carbonic anhydrase inhibitors (eg, acetazolamide).
Topiramate Sprinkle Capsules may result in a change in the acidity (pH) of your blood. If you experience loss of appetite, changes in breathing, tiredness, or change in heart rhythm, contact your health care provider.
Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are taking Topiramate Sprinkle Capsules.
Topiramate Sprinkle Capsules may decrease the effectiveness of your birth control pill. To prevent pregnancy, be sure to use an additional form of birth control while using this medicine.
Diabetic patients - Topiramate Sprinkle Capsules may alter blood sugar levels in patients taking metformin. Check your blood sugars more frequently and contact your doctor for dose changes.
LAB TESTS, such as serum bicarbonate, may be performed to monitor your progress. Be sure to keep all doctor and lab appointments.
Topiramate Sprinkle Capsules is not recommended for use in CHILDREN under the age of 2 years; safety and effectiveness in this age group have not been confirmed.
PREGNANCY and BREAST-FEEDING: If you plan on becoming pregnant, discuss with your doctor the benefits and risks of using Topiramate Sprinkle Capsules during pregnancy. Topiramate Sprinkle Capsules is excreted in breast milk. If you are or will be breast-feeding, check with your doctor to discuss the risks to your baby.

Possible side effects of Topiramate Sprinkle Capsules:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Abnormal skin sensations (numbness or tingling, decreased sensitivity); abnormal walking; agitation or aggression; appetite loss; back pain; breast pain; change in speech; clumsiness; coordination decreased; confusion; constipation; decreased hearing; decreased sweating; depression; diarrhea; difficulty with concentration or attention; dizziness; drowsiness; dry mouth; fatigue; flu-like symptoms; hot flushes; injury; indigestion; infection; itching; leg pain;menstrual disorder;mood swings; muscle pain or contractions; nausea; nervousness or anxiety; runny nose; saliva increased; sex drive decreased; sinus swelling; skin disorder; stomach pain or ache; strange taste; sore throat; thinking problems; thirst; tremor; unstable emotions; vomiting; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blood in the urine; blurred vision or sudden worsening of vision; chest pain; difficulty concentrating; fast, deep breathing; feeling of moving slowly; increased body temperature; irregular heartbeat; loss of consciousness; memory problems; painful/red eyes;prostate problems;severe stomach pain; significant weight loss; speech problems; stupor; unexplained fever; unusual eye movements; unusual tiredness; urinary incontinence; urinary tract infection.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately. Symptoms may include abnormal coordination; agitation; blurred vision; convulsions; depression; dizziness; drowsiness; lethargy; mental impairment; speech disturbance; stomach pain; stupor.

Proper storage of Topiramate Sprinkle Capsules:

Store Topiramate Sprinkle Capsules below 77 degrees F (25 degrees C) in a tightly closed container, away from heat, moisture, and light. Do not store in the bathroom. Keep Topiramate Sprinkle Capsules out of the reach of children and away from pets.

General information:

If you have any questions about Topiramate Sprinkle Capsules, please talk with your doctor, pharmacist, or other health care provider.
Topiramate Sprinkle Capsules is to be used only by the patient for whom it is prescribed. Do not share it with other people.
If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Topiramate Sprinkle Capsules. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: November 1, 2006

Database Edition 06.4.1.002

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