IMPORTANT SAFETY INFORMATION

ZONISADE® (zonisamide oral suspension), 100 mg/5mL

ZONISADE is indicated as adjunctive therapy for the treatment of partial-onset seizures in adults and pediatric patients 16 years of age and older.

A calibrated measuring device is recommended to measure and deliver the prescribed dose accurately. A household teaspoon or tablespoon is not an adequate measuring device. Ask your pharmacist or doctor for assistance in the selection of a measuring device.

ADDITIONAL IMPORTANT SAFETY INFORMATION

Do not take ZONISADE if you are allergic to medicines that contain sulfa, zonisamide, or any formulation ingredients.

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

ZONISADE may cause serious side effects, including:

• Serious skin rash that can cause death
• Serious allergic reactions that may affect different parts of the body
• Less sweating and increase in your body temperature (fever)
• Serious eye problems
• Suicidal thoughts or actions in some people
• Increased level of acid in your blood (metabolic acidosis)
• Problems with your concentration, attention, memory, mood, thinking, speech, or language
• Blood cell changes such as reduced red and white blood cell counts
• Back pain, stomach pain, or blood in your urine may indicate you have a kidney stone. Drink plenty of fluids when taking ZONISADE to decrease your chances of getting kidney stones
• New or worse depression, sudden changes in mood or behavior, loss of contact with reality (sometimes associated with hearing voices or seeing things that are not really there), feeling sleepy or tired, trouble concentrating, and speech or language problems. Call your healthcare provider right away if you have any problems with the symptoms listed above
• High ammonia levels in the blood can affect your mental activities, slow your alertness, make you feel tired, or cause vomiting

Before taking ZONISADE, tell your healthcare provider about all your medical conditions, including if you:

• have or have had depression, mood problems, suicidal thoughts or behavior
• have kidney problems
• have liver problems
• have a history of too much acid in your blood (metabolic acidosis)
• have weak, brittle bones or soft bones (osteomalacia, osteopenia, or osteoporosis)
• have a growth problem
• are on a diet high in fat called a ketogenic diet
• have diarrhea
• have high blood levels of ammonia

What should I avoid while taking ZONISADE?

• Do not drink alcohol or take other drugs that make you sleepy or dizzy while taking ZONISADE until you talk to your healthcare provider. ZONISADE taken with alcohol or drugs that cause sleepiness or dizziness may make your sleepiness or dizziness worse
• Do not drive, operate heavy machinery, or do other dangerous activities until you know how ZONISADE affects you. ZONISADE can slow your thinking and motor skills

Certain reactions can be very serious and can cause death.
Watch for decreased sweating and fever, especially when it is hot and especially in children taking ZONISADE.

While taking ZONISADE, call your healthcare provider right away if you have:

• high fever, recurring fever, long-lasting fever, or less sweat than normal
• severe muscle pain
• rash
• swollen lymph glands
• swelling of your face
• unusual bruising or bleeding
• weakness or fatigue
• yellowing of your skin or the white part of your eyes

Also, call your healthcare provider right away if you:

• have any new eye symptoms, including any eye pain or redness or any new problems with your vision
• have sudden changes in mood or behavior, loss of contact with reality (sometimes associated with hearing voices or seeing things that are not really there), feel sleepy or tired, have trouble concentrating, or speech and language problems
• develop a fever, sore throat, sores in your mouth, or unusual bruising

Your healthcare provider should do a blood test to measure the level of acid in your blood before and during your treatment with ZONISADE.

Like other antiepileptic drugs, ZONISADE may cause suicidal thoughts or actions. Call a healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you:

Do not stop ZONISADE without first talking to a healthcare provider.

Stopping ZONISADE suddenly can cause serious problems. Stopping a seizure medicine suddenly in a patient who has epilepsy can cause seizures that will not stop (status epilepticus).

Tell your healthcare provider if you:

• are pregnant or plan to become pregnant. ZONISADE may harm your unborn baby. Women who can become pregnant should use effective birth control. Tell your healthcare provider right away if you become pregnant while taking ZONISADE. You and your healthcare provider should decide if you should take ZONISADE while you are pregnant. If you become pregnant while taking ZONISADE, talk to your healthcare provider about registering with the North American Antiepileptic Drug Pregnancy Registry. You can enroll in this registry by calling 1-888-233-2334. The purpose of this registry is to collect information about the safety of antiepileptic drugs during pregnancy
• are breastfeeding or plan to breastfeed. ZONISADE can pass into your breast milk. It is not known if ZONISADE in your breast milk can harm your baby. Talk to your healthcare provider about the best way to feed your baby if you take ZONISADE

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

The most common side effects of ZONISADE include:

Store ZONISADE at room temperature and discard unused portions 30 days after first opening.

The Important Safety Information does not include all the information needed to use ZONISADE safely and effectively. Please talk to your healthcare provider and see the complete Prescribing Information for ZONISADE.

To report SUSPECTED ADVERSE REACTIONS, contact Azurity Pharmaceuticals, Inc. at 1-800-461-7449, or FDA at 1-800-FDA-1088 or www.fda.gov/MedWatch.

PP-ZON-US-0061