IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

TOPIRAMATE EXTENDED RELEASE SPRINKLE - ORAL

(toe-PYRE-a-mate)

COMMON BRAND NAME(S): Qudexy XR

USES: Topiramate is used alone and with other medications to prevent and control seizures (epilepsy). Topiramate belongs to a class of drugs known as anticonvulsants.

OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

This medication may also be used to prevent migraine headaches.

HOW TO USE: Read the Medication Guide provided by your pharmacist before you start taking topiramate and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth with or without food as directed by your doctor, usually once daily. You may swallow this medication whole, or you may open the capsule and sprinkle the contents on a teaspoonful of soft food (such as applesauce, yogurt). Swallow the drug/food mixture right away. Do not crush or chew the mixture. Do not prepare the mixture ahead of time for later use. Drink some liquid after swallowing the mixture to make sure all of the drug is swallowed.

To prevent kidney stones from forming, drink plenty of fluids while taking this medication unless otherwise directed by your doctor.

The dosage is based on your medical condition and response to treatment. For children, the dosage is also based on weight. To reduce your risk of side effects, your doctor may direct you to start this medication at a low dose and gradually increase your dose. Follow your doctor's instructions carefully.

Take this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day. Do not stop taking this medication without consulting your doctor. Some conditions may become worse when this drug is suddenly stopped. Your dose may need to be gradually decreased.

Tell your doctor if your condition does not improve or if it worsens.

SIDE EFFECTS: Tiredness, drowsiness, dizziness, loss of coordination, tingling of the hands/feet, loss of appetite, changes in how foods taste, diarrhea, and weight loss may occur. Mental problems such as confusion, slowed thinking, trouble concentrating or paying attention, nervousness, memory problems, or speech/language problems may also occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: bone pain, signs of kidney stones (such as severe back/side/abdominal/groin pain, fever, chills, painful/frequent urination, bloody/pink urine), unusual bleeding/bruising.

Get medical help right away if you have any very serious side effects, including: rapid breathing, fast/slow/irregular heartbeat.

A small number of people who take anticonvulsants for any condition (such as seizures, bipolar disorder, pain) may experience depression, suicidal thoughts/attempts, or other mental/mood problems. Tell your doctor right away if you or your family/caregiver notice any unusual/sudden changes in your mood, thoughts, or behavior including signs of depression, suicidal thoughts/attempts, thoughts about harming yourself.

Rarely, topiramate may cause a very serious eye problem, usually within 1 month of starting treatment. This eye problem can lead to permanent blindness. Therefore, get medical help right away if any of these side effects occur: sudden vision changes (such as decreased vision, blurred vision), eye pain/redness.

This medication can rarely cause a serious metabolic problem (high amount of ammonia in the blood), especially if you are also taking valproic acid. Tell your doctor right away if you experience sudden/unexplained tiredness, vomiting, or mental changes (such as decreased alertness).

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking topiramate, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: glaucoma, kidney problems (such as kidney stones), liver problems, lung/breathing problems, mental/mood problems (such as depression, thoughts of suicide), a certain metabolic imbalance (metabolic acidosis), a diet high in fat and low in carbohydrates (ketogenic diet), weak/brittle bones (osteoporosis).

This drug may make you dizzy or drowsy or affect your thinking/coordination. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages.

Topiramate may make you sweat less, making you more likely to get heat stroke. Avoid doing things that may cause you to overheat, such as hard work or exercise in hot weather, or using hot tubs. When the weather is hot, drink a lot of fluids and dress lightly. If you overheat, quickly look for a place to cool down and rest. Get medical help right away if you have a fever that does not go away, mental/mood changes, headache, or dizziness.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Children may be more sensitive to the side effects of this drug, especially weakened bones, slowed growth rate, and decreased sweating.

Older adults may be more sensitive to the side effects of this drug, especially dizziness. Dizziness can increase the risk of falling.

During pregnancy, this medication should be used only when clearly needed. It may harm an unborn baby. However, if you are taking this drug to treat seizures, note that untreated seizures are a serious condition that can harm both a pregnant woman and her unborn baby, so do not stop taking this medication unless directed by your doctor. Discuss the use of reliable forms of birth control with your doctor (see also Drug Interactions section). If you are planning pregnancy, become pregnant, or think you may be pregnant, immediately talk to your doctor about the benefits and risks of using this medication during pregnancy.

This medication passes into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: See also Side Effects section.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

This medication may decrease the effectiveness of hormonal birth control such as pills, patch, or ring. This could cause pregnancy. Discuss with your doctor or pharmacist if you should use additional reliable birth control methods while using this medication. Also tell your doctor if you have any new spotting or breakthrough bleeding, because these may be signs that your birth control is not working well.

Tell your doctor or pharmacist if you are taking other products that cause drowsiness including alcohol, antihistamines (such as cetirizine, diphenhydramine), drugs for sleep or anxiety (such as alprazolam, diazepam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), and narcotic pain relievers (such as codeine).

Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.

OVERDOSE: If overdose is suspected, contact a poison control center or emergency room right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: severe drowsiness, loss of consciousness.

NOTES: Do not share this medication with others.

Laboratory and/or medical tests (such as eye exams, bicarbonate blood level) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up. If you have missed more than one dose, ask your doctor or pharmacist for advice.

STORAGE: Store in a tightly closed container at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

Information last revised October 2015. Copyright(c) 2015 First Databank, Inc.

About Rx Outreach

Rx Outreach is a non-profit pharmacy whose mission is to provide affordable medications to people in need. Each year, we serve over 85,000 people across all fifty states, Puerto Rico, the U.S. Virgin Islands, and Guam. We believe that everyone deserves access to affordable medications. No one should ever have to choose between filling a prescription and feeding their family. That’s why Rx Outreach exists, and why our team is so passionate about the work we do.

Our Medications & Services

Rx Outreach offers more than 600 medication strengths, representing more than 250 different types of medications. There are many online pharmacies that claim to offer cheap drugs. Rx Outreach is different in that we work directly with pharmaceutical manufacturers to ensure we are providing high-quality products at an affordable price. Rx Outreach does not currently offer a Drug Discount Card or prescription coupons, but plans to expand beyond mail order pharmacy services in the future.

Our Pharmacy

The Rx Outreach pharmacy is located in St. Louis, MO and is staffed by more than 60 pharmacists and patient care advocates. We are licensed to dispense medications in all 50 states and U.S. territories. Since we are a mail order pharmacy, we are able to ship medications directly to our patients’ homes. To make it simple and cost-effective for our patients, we usually ship enough medication for 90 or 180 days at a time.