What is the most important information I should know about zonisamide?

Do not use this medication if you are allergic to zonisamide, or to other sulfa drugs such as sulfamethoxazole (Gantanol), sulfisoxazole (Gantrisin), or sulfamethoxazole-trimethoprim (Bactrim, Septra, Cotrim, and others). A sulfa drug allergic reaction can be fatal.

You may have thoughts about suicide while taking this medication. Your doctor will need to check you at regular visits. Do not miss any scheduled appointments.

Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, depression, anxiety, or if you feel agitated, hyperactive (mentally or physically), or have thoughts about suicide or hurting yourself.

Zonisamide can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Do not stop taking zonisamide without first talking to your doctor, even if you feel fine. Stopping zonisamide suddenly may cause you to have seizures. You may need to use less and less before you stop the medication completely.

If you need to have any type of surgery, tell the surgeon ahead of time that you are taking zonisamide.

Carry an ID card or wear a medical alert bracelet stating that you are taking zonisamide, in case of emergency. Any doctor, dentist, or emergency medical care provider who treats you should know that you are taking a seizure medication.

What is zonisamide?

Zonisamide is a sulfa drug with anti-convulsant effects.

Zonisamide is used together with other anti-convulsant medications to treat partial seizures in adults with epilepsy.

Zonisamide may also be used for other purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking zonisamide?

Do not use this medication if you are allergic to zonisamide, or to other sulfa drugs such as sulfamethoxazole (Gantanol), sulfisoxazole (Gantrisin), or sulfamethoxazole-trimethoprim (Bactrim, Septra, Cotrim, and others). A sulfa drug allergic reaction can be fatal.

If you have certain conditions, you may need a dose adjustment or special tests to safely use this medication. Before you take zonisamide, tell your doctor if you have:

• liver disease;
• kidney disease;
• asthma or other breathing problems;
• stomach flu or illness causing diarrhea; or
• if you have been on a high-protein, low-carb diet.

FDA pregnancy category C. It is not known whether this medication is harmful to an unborn baby. Before taking zonisamide, tell your doctor if you are pregnant or plan to become pregnant during treatment.

You may have thoughts about suicide while taking this medication. Tell your doctor if you have new or worsening depression or suicidal thoughts during the first several months of treatment, or whenever your dose is changed.

Your family or other caregivers should also be alert to changes in your mood or symptoms. Your doctor will need to check you at regular visits. Do not miss any scheduled appointments.

It is not known whether zonisamide passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Do not give this medication to a child younger than 16 years old without the advice of a doctor.

How should I take zonisamide?

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

Take this medicine with a full glass of water. Drink 6 to 8 glasses of water each day to prevent kidney stones while you are taking zonisamide.

Zonisamide can be taken with or without food.

Swallow the zonisamide capsule whole. Do not crush, chew, open, or break it.

To be sure this medication is not causing harmful effects, your blood may need to be tested on a regular basis. Do not miss any follow-up visits to your doctor.

Seizures are often treated with a combination of different drugs. To best treat your condition, use all of your medications as directed by your doctor. Be sure to read the medication guide or patient instructions provided with each of your medications. Do not change your doses or medication schedule without advice from your doctor.

Do not stop taking zonisamide without first talking to your doctor, even if you feel fine. Stopping zonisamide suddenly may cause you to have seizures. You may need to use less and less before you stop the medication completely.

If you do stop taking zonisamide for any reason, talk with your doctor before restarting the medication. You may need to restart at a lower dose.

If you need to have any type of surgery, tell the surgeon ahead of time that you are taking zonisamide.

Carry an ID card or wear a medical alert bracelet stating that you are taking zonisamide, in case of emergency. Any doctor, dentist, or emergency medical care provider who treats you should know that you are taking a seizure medication.

Store zonisamide at room temperature away from moisture, heat, and light.

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include slow heart rate, feeling light-headed, fainting, and slow or shallow breathing.

What should I avoid while taking zonisamide?

Zonisamide can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Avoid drinking alcohol. It can increase some of the side effects of zonisamide.

What are the possible side effects of zonisamide?

Get emergency medical help if you have any of these signs of an allergic reaction: any form of skin rash; hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, depression, anxiety, or if you feel agitated, hyperactive (mentally or physically), or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have any of these serious side effects:

• fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;
• the first sign of any skin rash, no matter how mild;
• increased or worsening seizures;
• rapid breathing or feeling short of breath with dry mouth, confusion, dizziness or weakness, numbness or tingling, chest pain;;
• fast, pounding, or uneven heartbeats;
• pale skin, easy bruising or bleeding, unusual weakness;
• fever, chills, body aches, flu symptoms, white patches or sores inside your mouth or on your lips;
• problems with thinking or speech, trouble concentrating;
• nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• dizziness or weakness and hot, dry skin without sweating;
• urinating less than usual or not at all; or
• sudden back pain, stomach or side pain, pain or bleeding when urinating, bloody or dark urine.

Less serious side effects may include:

• drowsiness, dizziness, headache, tired feeling;
• mild loss of appetite, weight loss;
• loss of balance or coordination;
• sore throat, cough; or
• blurred vision, ringing in your ears.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect zonisamide?

Cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for depression or anxiety can add to sleepiness caused by zonisamide. Tell your doctor if you regularly use any of these medicines, or any other seizure medication.

Tell your doctor about all other seizure medications you use, especially:

• carbamazepine (Carbatrol, Tegretol);
• phenytoin (Dilantin); or
• phenobarbital (Solfoton).

This list is not complete and there may be other drugs that can interact with zonisamide. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about zonisamide.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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