Zonisamide Oral capsule

What is this medicine?

ZONISAMIDE (zoe NIS a mide) is used to control partial seizures in adults 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:

• dehydrated

• diarrhea

• history of metabolic acidosis (too much acid in your blood)

• ketogenic diet

• kidney disease

• liver disease

• lung disease

• osteoporosis

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

• an unusual or allergic reaction to zonisamide, sulfa drugs, 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. Swallow whole. Do not break open the capsule. This medicine may be taken with or without food. Take your doses at regular intervals. Do not take your medicine more often than directed. Do not stop taking this medicine unless instructed by your doctor or health care professional.

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 16 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 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?

• barbiturates like phenobarbital

• carbamazepine

• phenytoin

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. Wear a medical identification bracelet or chain to say you have epilepsy, and carry a card that lists all your medications.

It is important to take this medicine exactly as directed. When first starting treatment, your dose will need to be adjusted slowly. It may take weeks or months before your dose is stable. You should contact your doctor or health care professional if your seizures get worse or if you have any new types of seizures. Do not stop taking except on your doctor's advice. You may develop a severe reaction. Your doctor will tell you how much medicine to take.

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 dizzy or fainting spells, do not sit or stand up quickly, especially if you are an older patient. Alcohol can increase drowsiness and dizziness. Avoid alcoholic drinks.

Avoid extreme heat. This medicine can cause you to sweat less than normal. Your body temperature could increase to dangerous levels, which may lead to heat stroke.

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.

This medicines may increase the risk of kidney stones. Drinking 6 to 8 glasses of water a day may help prevent the formation of kidney stones.

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.

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 immediately:

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

• decreased sweating or a rise in body temperature, especially in patients under 17 years old

• difficulty breathing or tightening of the throat

• feeling faint or lightheaded, falls

• fever, sore throat, sores in your mouth, or bruising easily

• hallucination, loss of contact with reality

• irregular heartbeat

• loss of appetite

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

• severe drowsiness, difficulty concentrating, or coordination problems

• speech or language problems

• sudden back pain, abdominal pain, pain when urinating, bloody or dark urine

• suicidal thoughts or depression

• unusual changes in behavior or mood

• unusually weak or tired

• vomiting

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

• headache

• nausea

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 reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Keep in a dry place protected from light. Throw away any unused medicine after the expiration date.