Topiramate Oral capsule, extended-release

What is this medicine?

TOPIRAMATE (toe PYRE a mate) is used to treat seizures in adults or children with epilepsy.

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

What should I tell my health care provider before I take this medicine?

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

• cirrhosis of the liver or liver disease

• diarrhea

• glaucoma

• kidney stones or kidney disease

• lung disease like asthma, obstructive pulmonary disease, emphysema

• metabolic acidosis

• on a ketogenic diet

• scheduled for surgery or a procedure

• suicidal thoughts, plans, or attempt; a previous suicide attempt by you or a family member

• an unusual or allergic reaction to topiramate, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. Trokendi XR capsules must be swallowed whole. Do not sprinkle on food, break, crush, dissolve, or chew. Qudexy XR capsules may be swallowed whole or opened and sprinkled on a small amount of soft food. This mixture must be swallowed immediately. Do not chew or store mixture for later use. You may take this medicine with meals. Take your medicine at regular intervals. Do not take it more often than directed.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed. While Trokendi XR may be prescribed for children as young as 6 years and Qudexy XR 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 medicine?

Do not take this medicine with any of the following medications:

• probenecid

This medicine may also interact with the following medications:

• acetazolamide

• alcohol

• amitriptyline

• birth control pills

• digoxin

• hydrochlorothiazide

• lithium

• medicines for pain, sleep, or muscle relaxation

• metformin

• methazolamide

• other seizure or epilepsy medicines

• pioglitazone

• risperidone

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 medicine?

Visit your doctor or health care professional for regular checks on your progress. Do not stop taking this medicine suddenly. This increases the risk of seizures if you are using this medicine to control epilepsy. Wear a medical identification bracelet or chain to say you have epilepsy or seizures, and carry a card that lists all your medicines.

This medicine can decrease sweating and increase your body temperature. Watch for signs of deceased sweating or fever, especially in children. Avoid extreme heat, hot baths, and saunas. Be careful about exercising, especially in hot weather. Contact your health care provider right away if you notice a fever or decrease in sweating.

You should drink plenty of fluids while taking this medicine. If you have had kidney stones in the past, this will help to reduce your chances of forming kidney stones.

If you have stomach pain, with nausea or vomiting and yellowing of your eyes or skin, call your doctor immediately.

You may get drowsy, dizzy, or have blurred vision. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. To reduce dizziness, do not sit or stand up quickly, especially if you are an older patient. Alcohol can increase drowsiness and dizziness. Avoid alcoholic drinks. Do not drink alcohol for 6 hours before or 6 hours after taking Trokendi XR.

If you notice blurred vision, eye pain, or other eye problems, seek medical attention at once for an eye exam.

The use of this medicine may increase the chance of suicidal thoughts or actions. Pay special attention to how you are responding while on this medicine. Any worsening of mood, or thoughts of suicide or dying should be reported to your health care professional right away.

This medicine may increase the chance of developing metabolic acidosis. If left untreated, this can cause kidney stones, bone disease, or slowed growth in children. Symptoms include breathing fast, fatigue, loss of appetite, irregular heartbeat, or loss of consciousness. Call your doctor immediately if you experience any of these side effects. Also, tell your doctor about any surgery you plan on having while taking this medicine since this may increase your risk for metabolic acidosis.

Birth control pills may not work properly while you are taking this medicine. Talk to your doctor about using an extra method of birth control.

Women who become pregnant while using this medicine may enroll in the North American Antiepileptic Drug Pregnancy Registry by calling 1-888-233-2334. This registry collects information about the safety of antiepileptic drug use during pregnancy.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• decreased sweating and/or rise in body temperature

• depression

• difficulty breathing, fast or irregular breathing patterns

• difficulty speaking

• difficulty walking or controlling muscle movements

• hearing impairment

• redness, blistering, peeling or loosening of the skin, including inside the mouth

• tingling, pain or numbness in the hands or feet

• unusually weak or tired

• worsening of mood, thoughts or actions of suicide or dying

Side effects that usually do not require medical attention (Report these to your doctor or health care professional if they continue or are bothersome.):

• altered taste

• back pain, joint or muscle aches and pains

• diarrhea, or constipation

• headache

• loss of appetite

• nausea

• stomach upset, indigestion

• tremors

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 medicine?

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F) in a tightly closed container. Protect from moisture. Throw away any unused medicine after the expiration date.

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.

Topiramate Oral capsule, sprinkles

What is this medicine?

TOPIRAMATE (toe PYRE a mate) is used to treat seizures in adults or children with epilepsy. It is also used for the prevention of migraine headaches.

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

What should I tell my health care provider before I take this medicine?

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

• bleeding disorders

• cirrhosis of the liver or other liver disease

• diarrhea

• glaucoma

• kidney stones or kidney disease

• low blood counts, like low white cell, platelet, or red cell counts

• lung disease like asthma, obstructive pulmonary disease, emphysema

• metabolic acidosis

• on a ketogenic diet

• schedule for surgery or a procedure

• suicidal thoughts, plans, or attempt; a previous suicide attempt by you or a family member

• an unusual or allergic reaction to topiramate, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

Take this medicine by mouth. The capsules can be swallowed whole or opened carefully and the contents sprinkled on about on a small amount of soft food, such as applesauce, pudding, ice cream, oatmeal, or yogurt. This mixture must be swallowed immediately. Do not chew or store the sprinkles on the food for later use. Be sure to take the entire dose. You may take this medicine with meals. Take your doses at regular intervals. Do not take your medicine more often than directed.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed. While this drug may be prescribed for children as young as 2 years of age 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 your next dose is to be taken in less than 6 hours, then do not take the missed dose. Take the next dose at your regular time. Do not take double or extra doses.

What may interact with this medicine?

Do not take this medicine with any of the following medications:

• probenecid

This medicine may also interact with the following medications:

• acetazolamide

• alcohol

• amitriptyline

• aspirin and aspirin-like medicines

• birth control pills

• certain medicines for depression

• certain medicines for seizures

• certain medicines that treat or prevent blood clots like warfarin, enoxaparin, dalteparin, apixaban, dabigatran, and rivaroxaban

• digoxin

• hydrochlorothiazide

• lithium

• medicines for pain, sleep, or muscle relaxation

• metformin

• methazolamide

• NSAIDS, medicines for pain and inflammation, like ibuprofen or naproxen

• pioglitazone

• risperidone

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 medicine?

Visit your doctor or health care professional for regular checks on your progress. Do not stop taking this medicine suddenly. This increases the risk of seizures if you are using this medicine to control epilepsy. Wear a medical identification bracelet or chain to say you have epilepsy or seizures, and carry a card that lists all your medicines.

This medicine can decrease sweating and increase your body temperature. Watch for signs of deceased sweating or fever, especially in children. Avoid extreme heat, hot baths, and saunas. Be careful about exercising, especially in hot weather. Contact your health care provider right away if you notice a fever or decrease in sweating.

You should drink plenty of fluids while taking this medicine. If you have had kidney stones in the past, this will help to reduce your chances of forming kidney stones.

If you have stomach pain, with nausea or vomiting and yellowing of your eyes or skin, call your doctor immediately.

You may get drowsy, dizzy, or have blurred vision. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. To reduce dizziness, do not sit or stand up quickly, especially if you are an older patient. Alcohol can increase drowsiness and dizziness. Avoid alcoholic drinks.

If you notice blurred vision, eye pain, or other eye problems, seek medical attention at once for an eye exam.

The use of this medicine may increase the chance of suicidal thoughts or actions. Pay special attention to how you are responding while on this medicine. Any worsening of mood, or thoughts of suicide or dying should be reported to your health care professional right away.

This medicine may increase the chance of developing metabolic acidosis. If left untreated, this can cause kidney stones, bone disease, or slowed growth in children. Symptoms include breathing fast, fatigue, loss of appetite, irregular heartbeat, or loss of consciousness. Call your doctor immediately if you experience any of these side effects. Also, tell your doctor about any surgery you plan on having while taking this medicine since this may increase your risk for metabolic acidosis.

Birth control pills may not work properly while you are taking this medicine. Talk to your doctor about using an extra method of birth control.

Women who become pregnant while using this medicine may enroll in the North American Antiepileptic Drug Pregnancy Registry by calling 1-888-233-2334. This registry collects information about the safety of antiepileptic drug use during pregnancy.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• decreased sweating and/or rise in body temperature

• depression

• difficulty breathing, fast or irregular breathing patterns

• difficulty speaking

• difficulty walking or controlling muscle movements

• hearing impairment

• redness, blistering, peeling or loosening of the skin, including inside the mouth

• tingling, pain or numbness in the hands or feet

• unusual bleeding or bruising

• unusually weak or tired

• worsening of mood, thoughts or actions of suicide or dying

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

• altered taste

• back pain, joint or muscle aches and pains

• diarrhea, or constipation

• headache

• loss of appetite

• nausea

• stomach upset, indigestion

• tremors

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 medicine?

Keep out of the reach of children.

Store at or below 25 degrees C (77 degrees F) in a tightly closed container. Protect from moisture. Throw away any unused medicine after the expiration date.

Topiramate Oral tablet

What is this medicine?

TOPIRAMATE (toe PYRE a mate) is used to treat seizures in adults or children with epilepsy. It is also used for the prevention of migraine headaches.

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

What should I tell my health care provider before I take this medicine?

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

• bleeding disorders

• cirrhosis of the liver or liver disease

• diarrhea

• glaucoma

• kidney stones or kidney disease

• low blood counts, like low white cell, platelet, or red cell counts

• lung disease like asthma, obstructive pulmonary disease, emphysema

• metabolic acidosis

• on a ketogenic diet

• schedule for surgery or a procedure

• suicidal thoughts, plans, or attempt; a previous suicide attempt by you or a family member

• an unusual or allergic reaction to topiramate, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. Do not crush or chew. You may take this medicine with meals. Take your medicine at regular intervals. Do not take it more often than directed.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed. While this drug may be prescribed for children as young as 2 years of age 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 your next dose is to be taken in less than 6 hours, then do not take the missed dose. Take the next dose at your regular time. Do not take double or extra doses.

What may interact with this medicine?

Do not take this medicine with any of the following medications:

• probenecid

This medicine may also interact with the following medications:

• acetazolamide

• alcohol

• amitriptyline

• aspirin and aspirin-like medicines

• birth control pills

• certain medicines for depression

• certain medicines for seizures

• certain medicines that treat or prevent blood clots like warfarin, enoxaparin, dalteparin, apixaban, dabigatran, and rivaroxaban

• digoxin

• hydrochlorothiazide

• lithium

• medicines for pain, sleep, or muscle relaxation

• metformin

• methazolamide

• NSAIDS, medicines for pain and inflammation, like ibuprofen or naproxen

• pioglitazone

• risperidone

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 medicine?

Visit your doctor or health care professional for regular checks on your progress. Do not stop taking this medicine suddenly. This increases the risk of seizures if you are using this medicine to control epilepsy. Wear a medical identification bracelet or chain to say you have epilepsy or seizures, and carry a card that lists all your medicines.

This medicine can decrease sweating and increase your body temperature. Watch for signs of deceased sweating or fever, especially in children. Avoid extreme heat, hot baths, and saunas. Be careful about exercising, especially in hot weather. Contact your health care provider right away if you notice a fever or decrease in sweating.

You should drink plenty of fluids while taking this medicine. If you have had kidney stones in the past, this will help to reduce your chances of forming kidney stones.

If you have stomach pain, with nausea or vomiting and yellowing of your eyes or skin, call your doctor immediately.

You may get drowsy, dizzy, or have blurred vision. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. To reduce dizziness, do not sit or stand up quickly, especially if you are an older patient. Alcohol can increase drowsiness and dizziness. Avoid alcoholic drinks.

If you notice blurred vision, eye pain, or other eye problems, seek medical attention at once for an eye exam.

The use of this medicine may increase the chance of suicidal thoughts or actions. Pay special attention to how you are responding while on this medicine. Any worsening of mood, or thoughts of suicide or dying should be reported to your health care professional right away.

This medicine may increase the chance of developing metabolic acidosis. If left untreated, this can cause kidney stones, bone disease, or slowed growth in children. Symptoms include breathing fast, fatigue, loss of appetite, irregular heartbeat, or loss of consciousness. Call your doctor immediately if you experience any of these side effects. Also, tell your doctor about any surgery you plan on having while taking this medicine since this may increase your risk for metabolic acidosis.

Birth control pills may not work properly while you are taking this medicine. Talk to your doctor about using an extra method of birth control.

Women who become pregnant while using this medicine may enroll in the North American Antiepileptic Drug Pregnancy Registry by calling 1-888-233-2334. This registry collects information about the safety of antiepileptic drug use during pregnancy.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• decreased sweating and/or rise in body temperature

• depression

• difficulty breathing, fast or irregular breathing patterns

• difficulty speaking

• difficulty walking or controlling muscle movements

• hearing impairment

• redness, blistering, peeling or loosening of the skin, including inside the mouth

• tingling, pain or numbness in the hands or feet

• unusual bleeding or bruising

• unusually weak or tired

• worsening of mood, thoughts or actions of suicide or dying

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

• altered taste

• back pain, joint or muscle aches and pains

• diarrhea, or constipation

• headache

• loss of appetite

• nausea

• stomach upset, indigestion

• tremors

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 medicine?

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F) in a tightly closed container. Protect from moisture. Throw away any unused medicine after the expiration date.