Topamax Sprinkle Capsules

Topamax Sprinkle Capsules is used for:

Treating seizures in certain patients. It may be used alone or with other medicines. It is also used to prevent migraine headaches. It may also be used for other conditions as determined by your doctor.

Topamax Sprinkle Capsules is an anticonvulsant that is also effective for preventing migraine headaches. It affects several chemicals in the brain that help to reduce seizure activity and prevent migraine headaches from occurring.

Do NOT use Topamax Sprinkle Capsules if:

• you are allergic to any ingredient in Topamax Sprinkle Capsules
• you are taking a carbonic anhydrase inhibitor (eg, acetazolamide)

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

Before using Topamax Sprinkle Capsules:

Some medical conditions may interact with Topamax 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, planning 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, osteoporosis (weak bones), or metabolic problems, you drink alcohol regularly, or you are on a ketogenic diet
• if you have diarrhea, lung or breathing problems, or low bicarbonate levels in the blood, or you will be having surgery
• if you have a history of status epilepticus (continuous seizure activity or a series of seizures without a full return to consciousness)
• if you have a history of mental or mood problems, or suicidal thoughts or actions

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

• Anticholinergics (eg, benztropine), carbonic anhydrase inhibitors (eg, acetazolamide), haloperidol, or tricyclic antidepressants (eg, nortriptyline) because the risk of decreased sweating may be increased
• Valproic acid because a serious side effect with symptoms of confusion, lethargy, and vomiting may occur
• Metformin or pioglitazone because blood glucose control may be altered; monitor your blood sugar carefully if you use Topamax Sprinkle Capsules with metformin or pioglitazone
• Hydrochlorothiazide because it may increase the risk of Topamax Sprinkle Capsules's side effects
• Carbamazepine or hydantoins (eg, phenytoin) because they may decrease Topamax Sprinkle Capsules's effectiveness
• Amitriptyline because the risk of its side effects may be increased by Topamax Sprinkle Capsules
• Lithium because Topamax Sprinkle Capsules may have an effect on lithium blood levels
• Hormonal birth control (eg, birth control pills) or risperidone because their effectiveness may be decreased by Topamax Sprinkle Capsules

This may not be a complete list of all interactions that may occur. Ask your health care provider if Topamax 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 Topamax Sprinkle Capsules:

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

• An extra patient leaflet is available with Topamax Sprinkle Capsules. Talk to your pharmacist if you have questions about this information.
• Take Topamax Sprinkle Capsules by mouth with or without food.
• Drink plenty of fluids while taking Topamax Sprinkle Capsules to prevent kidney stones from forming.
• The capsules may be swallowed whole. You may also open the capsules and sprinkle the contents over a spoonful of soft food, such as applesauce, custard, ice cream, oatmeal, pudding, or yogurt. Do not crush or chew the beads inside the capsule.
• To open the capsules, 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 use at a later time.
• Do not suddenly stop taking Topamax Sprinkle Capsules. Suddenly stopping Topamax Sprinkle Capsules may cause seizures to occur more often. If you need to stop Topamax Sprinkle Capsules, your doctor will gradually lower your dose.
• If you miss a dose of Topamax 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. Do not take 2 doses at once.

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

Important safety information:

• Topamax Sprinkle Capsules may cause drowsiness, dizziness, confusion, or trouble concentrating. These effects may be worse if you take it with alcohol or certain medicines. Use Topamax Sprinkle Capsules with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Topamax Sprinkle Capsules; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
• Topamax Sprinkle Capsules may reduce sweating, which could raise body temperature, especially in children. This risk is greater in hot weather and/or during vigorous exercise. Drink plenty of fluids. 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 medical attention right away if you have unexplained fever, or if you have mental or mood changes, headache, or dizziness.
• Tell your doctor or dentist that you take Topamax Sprinkle Capsules before you receive any medical or dental care, emergency care, or surgery.
• Hormonal birth control (eg, birth control pills) may not work as well while you are using Topamax Sprinkle Capsules. To prevent pregnancy, use an extra form of birth control (eg, condoms).
• Lab tests, including serum bicarbonate levels, may be performed while you use Topamax Sprinkle Capsules. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Use Topamax Sprinkle Capsules with caution in the ELDERLY; they may be more sensitive to its effects.
• Caution is advised when using Topamax Sprinkle Capsules in CHILDREN; they may be more sensitive to its effects, especially decreased sweating and decreased bicarbonate levels.
• Topamax Sprinkle Capsules may affect growth rate in CHILDREN and teenagers in some cases. They may need regular growth checks while they take Topamax Sprinkle Capsules.
• Topamax Sprinkle Capsules should be used with extreme caution in CHILDREN for migraines and in CHILDREN younger than 2 years old for seizures; safety and effectiveness in these children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Topamax Sprinkle Capsules while you are pregnant. Topamax Sprinkle Capsules is found in breast milk. If you are or will be breast-feeding while you use Topamax Sprinkle Capsules, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Topamax 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:

Constipation; decreased sweating; diarrhea; dizziness; drowsiness; dry mouth; flu-like symptoms; headache; loss of appetite; nausea; nervousness or anxiety; numbness or tingling of the skin; runny nose; sore throat; stomach pain or upset; taste changes; tiredness; trouble sleeping; weight loss.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blood in the urine; blurred vision; bone pain; chest pain; confusion; decreased coordination; depression; double vision or other vision changes; eye pain; irregular heartbeat; loss of consciousness; memory problems; menstrual changes; mental or mood changes; muscle or joint pain, cramps, or weakness; rapid, shallow breathing; red, swollen, blistered, or peeling skin; ringing in the ears; severe or persistent loss of appetite; severe stomach, side, or back pain; significant weight loss; speech problems; stupor; suicidal thoughts or actions; tremor; trouble thinking, concentrating, or remembering things; trouble walking; unexplained fever; unusual bruising or bleeding; unusual eye movements; unusual tiredness.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. 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 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), or emergency room immediately. Symptoms may include agitation; depression; lethargy; loss of coordination; mental impairment; seizures; severe drowsiness or dizziness; severe or persistent stomach pain; stupor; vision problems (eg, blurred or double vision).

Store Topamax Sprinkle Capsules at room temperature, below 77 degrees F (25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Topamax Sprinkle Capsules out of the reach of children and away from pets.

General information:

• If you have any questions about Topamax Sprinkle Capsules, please talk with your doctor, pharmacist, or other health care provider.
• Topamax 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 Topamax 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.

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