Topiramate Sprinkle Capsules

What is this medication?

TOPIRAMATE (toe PYRE a mate) prevents and controls seizures in people with epilepsy. It may also be used to prevent migraine headaches. It works by calming overactive nerves in your body.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Qudexy XR, Topamax Sprinkle

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Bleeding disorder
• Kidney disease
• Lung disease
• Suicidal thoughts, plans or attempt
• An unusual or allergic reaction to topiramate, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

Take this medication by mouth with water. Take it as directed on the prescription label at the same time every day. Do not cut, crush or chew this medicine. You may open the capsule and put the contents in 1 teaspoon of applesauce. Swallow the medication and applesauce right away. Do not chew the medication or applesauce. You can take it with or without food. If it upsets your stomach, take it with food. Keep taking it unless your care team tells you to stop.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your care team about the use of this medication in children. While it may be prescribed for children as young as 2 years for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medication?

• Acetazolamide
• Alcohol
• Antihistamines for allergy, cough, and cold
• Aspirin and aspirin-like medications
• Atropine
• Birth control pills
• Certain medications for anxiety or sleep
• Certain medications for bladder problems like oxybutynin, tolterodine
• Certain medications for depression like amitriptyline, fluoxetine, sertraline
• Certain medications for Parkinson's disease like benztropine, trihexyphenidyl
• Certain medications for seizures like carbamazepine, lamotrigine, phenobarbital, phenytoin, primidone, valproic acid, zonisamide
• Certain medications for stomach problems like dicyclomine, hyoscyamine
• Certain medications for travel sickness like scopolamine
• Certain medications that treat or prevent blood clots like warfarin, enoxaparin, dalteparin, apixaban, dabigatran, and rivaroxaban
• Digoxin
• Diltiazem
• General anesthetics like halothane, isoflurane, methoxyflurane, propofol
• Glyburide
• Hydrochlorothiazide
• Ipratropium
• Lithium
• Medications that relax muscles
• Metformin
• Narcotic medications for pain
• NSAIDs, medications for pain and inflammation, like ibuprofen or naproxen
• Phenothiazines like chlorpromazine, mesoridazine, prochlorperazine, thioridazine
• Pioglitazone

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. Tell your care team if your symptoms do not start to get better or if they get worse.

Do not suddenly stop taking this medication. You may develop a severe reaction. Your care team will tell you how much medication to take. If your care team wants you to stop the medication, the dose may be slowly lowered over time to avoid any side effects.

Wear a medical ID bracelet or chain. Carry a card that describes your condition. List the medications and doses you take on the card.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medication affects you. Do not stand up or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Alcohol may interfere with the effects of this medication. Avoid alcoholic drinks.

This medication may cause serious skin reactions. They can happen weeks to months after starting the medication. Contact your care team right away if you notice fevers or flu-like symptoms with a rash. The rash may be red or purple and then turn into blisters or peeling of the skin. Or, you might notice a red rash with swelling of the face, lips or lymph nodes in your neck or under your arms.

Watch for new or worsening thoughts of suicide or depression. This includes sudden changes in mood, behaviors, or thoughts. These changes can happen at any time but are more common in the beginning of treatment or after a change in dose. Call your care team right away if you experience these thoughts or worsening depression.

This medication may slow your child's growth if it is taken for a long time at high doses. Your care team will monitor your child's growth.

Using this medication for a long time may weaken your bones. The risk of bone fractures may be increased. Talk to your care team about your bone health.

Do not become pregnant while taking this medication. Hormone forms of birth control may not work as well with this medication. Talk to your care team about other forms of birth control. There is potential for serious harm to an unborn child. Tell your care team right away if you think you might be pregnant.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• High acid level—trouble breathing, unusual weakness or fatigue, confusion, headache, fast or irregular heartbeat, nausea, vomiting
• High ammonia level—unusual weakness or fatigue, confusion, loss of appetite, nausea, vomiting, seizures
• Fever that does not go away, decrease in sweat
• Kidney stones—blood in the urine, pain or trouble passing urine, pain in the lower back or sides
• Redness, blistering, peeling or loosening of the skin, including inside the mouth
• Sudden eye pain or change in vision such as blurry vision, seeing halos around lights, vision loss
• Thoughts of suicide or self-harm, worsening mood, feelings of depression

Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):

• Burning or tingling sensation in hands or feet
• Difficulty with paying attention, memory, or speech
• Dizziness
• Drowsiness
• Fatigue
• Loss of appetite with weight loss
• Slow or sluggish movements of the body

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Protect from moisture. Keep the container tightly closed. Get rid of any unused medication after the expiration date.

To get rid of medications that are no longer needed or have expired:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put it in the trash, empty the medication out of the container. Mix the medication with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.