Topiramate tablets

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.

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 cut, crush or chew this medicine. Swallow the tablets whole. You can take it with or without food. If it upsets your stomach, take it with food. Take your medicine at regular intervals. Do not take it more often than directed. Do not stop taking except on your doctor's advice.

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 pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as 2 years of age for selected conditions, precautions do apply.

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

• blood in the urine

• changes in vision

• confusion

• loss of memory

• pain in lower back or side

• pain when urinating

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

• signs and symptoms of bleeding such as bloody or black, tarry stools; red or dark brown urine; spitting up blood or brown material that looks like coffee grounds; red spots on the skin; unusual bruising or bleeding from the eyes, gums, or nose

• signs and symptoms of increased acid in the body like breathing fast; fast heartbeat; headache; confusion; unusually weak or tired; nausea, vomiting

• suicidal thoughts, mood changes

• trouble speaking or understanding

• unusual sweating

• unusually weak or tired

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

• dizziness

• drowsiness

• fever

• loss of appetite

• nausea, vomiting

• pain, tingling, numbness in the hands or feet

• stomach pain

• tiredness

• upset stomach

What may interact with this medicine?

This medicine may interact with the following medications:

• acetazolamide

• alcohol

• antihistamines for allergy, cough, and cold

• aspirin and aspirin-like medicines

• atropine

• birth control pills

• certain medicines for anxiety or sleep

• certain medicines for bladder problems like oxybutynin, tolterodine

• certain medicines for depression like amitriptyline, fluoxetine, sertraline

• certain medicines for seizures like carbamazepine, phenobarbital, phenytoin, primidone, valproic acid, zonisamide

• certain medicines for stomach problems like dicyclomine, hyoscyamine

• certain medicines for travel sickness like scopolamine

• certain medicines for Parkinson's disease like benztropine, trihexyphenidyl

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

• digoxin

• general anesthetics like halothane, isoflurane, methoxyflurane, propofol

• hydrochlorothiazide

• ipratropium

• lithium

• medicines that relax muscles for surgery

• metformin

• narcotic medicines for pain

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

• phenothiazines like chlorpromazine, mesoridazine, prochlorperazine, thioridazine

• pioglitazone

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.

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). Throw away any unused medicine after the expiration date.

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

• kidney disease

• lung or breathing disease, like asthma

• 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

What should I watch for while using this medicine?

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

Do not stop taking except on your health care professional's advice. You may develop a severe reaction. Your health care professional will tell you how much medicine to take.

Wear a medical ID bracelet or chain. Carry a card that describes your disease and details of your medicine and dosage times.

This medicine can reduce the response of your body to heat or cold. Dress warm in cold weather and stay hydrated in hot weather. If possible, avoid extreme temperatures like saunas, hot tubs, very hot or cold showers, or activities that can cause dehydration such as vigorous exercise.

Check with your health care professional if you have severe diarrhea, nausea, and vomiting, or if you sweat a lot. The loss of too much body fluid may make it dangerous for you to take this medicine.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine 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 effect of this medicine. Avoid alcoholic drinks.

Tell your health care professional right away if you have any change in your eyesight.

Patients and their families should watch out for new or worsening depression or thoughts of suicide. Also watch out for sudden changes in feelings such as feeling anxious, agitated, panicky, irritable, hostile, aggressive, impulsive, severely restless, overly excited and hyperactive, or not being able to sleep. If this happens, especially at the beginning of treatment or after a change in dose, call your healthcare professional.

This medicine may cause serious skin reactions. They can happen weeks to months after starting the medicine. Contact your health care provider 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.

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

Women should inform their health care professional if they wish to become pregnant or think they might be pregnant. There is a potential for serious side effects and harm to an unborn child. Talk to your health care professional for more information.