SPL MEDGUIDE SECTION

( zoe nis’ a mide )

Read this Medication Guide before you start taking zonisamide capsules and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment.

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

Zonisamide may cause serious side effects, including:

Serious skin rash that can cause death.
Less sweating and increase in your body temperature (fever).
Suicidal thoughts or actions in some people.
Increased level of acid in your blood (metabolic acidosis).
Problems with your concentration, attention, memory, thinking, speech, or language.
Blood cell changes such as reduced red and white blood cell counts.

These serious side effects are described below.

Zonisamide may cause a serious skin rash that can cause death. These serious skin reactions are more likely to happen when you begin taking zonisamide within the first 4 months of treatment but may occur at later times.
Zonisamide may cause you to sweat less and to increase your body temperature (fever). You may need to be hospitalized for this. You should watch for decreased sweating and fever, especially when it is hot and especially in children taking zonisamide.

Call your health care provider right away if you have:

a skin rash
high fever, recurring fever, or long lasting fever
less sweat than normal

3. Like other antiepileptic drugs, zonisamide may cause suicidal thoughts or actions in a very small number of people, about 1 in 500.

Call a healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you:

thoughts about suicide or dying
attempt to commit suicide
new or worse depression
new or worse anxiety
feeling agitated or restless
panic attacks
trouble sleeping (insomnia)
new or worse irritability
acting aggressive, being angry, or violent
acting on dangerous impulses
an extreme increase in activity and talking (mania)
other unusual changes in behavior or mood
Suicidal thoughts or actions can be caused by things other than medicines. If you have suicidal thoughts or actions, your healthcare provider may check for other causes.

How can I watch for early symptoms of suicidal thoughts and actions?

Pay attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings.
Keep all follow-up visits with your healthcare provider as scheduled.

Call your healthcare provider between visits as needed, especially if you are worried about symptoms.

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

Stopping zonisamide 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).

4. Zonisamide can increase the level of acid in your blood (metabolic acidosis). If left untreated, metabolic acidosis can cause brittle or soft bones (osteoporosis, osteomalacia, osteopenia), kidney stones and can slow the rate of growth in children. Metabolic acidosis can happen with or without symptoms.

Sometimes people with metabolic acidosis will:

feel tired
not feel hungry (loss of appetite)
feel changes in heartbeat
have trouble thinking clearly

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

5. Zonisamide may cause problems with your concentration, attention, memory, thinking, speech, or language.

6. Zonisamide can cause blood cell changes such as reduced red and white blood cell counts. Call your healthcare provider if you develop fever, sore throat, sores in your mouth, or unusual bruising.

Zonisamide can have other serious side effects. For more information ask your healthcare provider or pharmacist. Tell your healthcare provider if you have any side effect that bothers you. Be sure to read the section titled “What are the possible side effects of Zonisamide?”

What is zonisamide?

Zonisamide is a prescription medicine that is used with other medicines to treat partial seizures in adults.

It is not known if zonisamide is safe or effective in children under 16 years of age.

Who should not take zonisamide?

Do not take zonisamide if you are allergic to medicines that contain sulfa.

What should I tell my healthcare provider before taking zonisamide?

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

have or have had depression, mood problems or suicidal thoughts or behavior
have kidney problems
have liver problems
have a history of metabolic acidosis (too much acid in your blood)
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

Tell your healthcare provider if you:

are pregnant or plan to become pregnant. Zonisamide 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 zonisamide.

You and your healthcare provider should decide if you should take zonisamide while you are pregnant.

If you become pregnant while taking zonisamide, 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. Zonisamide can pass into your breast milk. It is not known if zonisamide in your breast milk can harm your baby. Talk to your healthcare provider about the best way to feed your baby if you take zonisamide.

Tell your healthcare provider about all the medicines you take including prescription and non-prescription medicines, vitamins or herbal supplements. Zonisamide and other medicines may affect each other causing side effects.

Know the medicines you take. Keep a list of them with you to show your healthcare provider and pharmacist each time you get a new medicine.

How should I take zonisamide?

Take zonisamide exactly as prescribed. Your healthcare prescriber may change your dose. Your healthcare provider will tell you how much zonisamide to take.
Take zonisamide with or without food.
Swallow the capsules whole.
If you take too much zonisamide, call your local Poison Control Center or go to the nearest emergency room right away.
Do not stop taking zonisamide without talking to your healthcare provider. Stopping zonisamide suddenly can cause serious problems, including seizures that will not stop (status epilepticus).

What should I avoid while taking zonisamide?

Do not drink alcohol or take other drugs that make you sleepy or dizzy while taking zonisamide until you talk to your health care provider. Zonisamide 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 zonisamide affects you. Zonisamide can slow your thinking and motor skills.

What are the possible side effects of zonisamide?

Zonisamide can cause serious side effects including:

The side effects mentioned above (see “ What is the most important information I should know about zonisamide?”)
kidney stones: back pain, stomach pain, or blood in your urine may mean you have kidney stones. Drink plenty of fluids while you take zonisamide to lower your chance of getting kidney stones.
problems with mood or thinking (new or worse depression; sudden changes in mood, behavior, or loss of contact with reality, sometimes associated with hearing voices or seeing things that are not really there; feeling sleepy or tired; trouble concentrating; speech and language problems).Call your healthcare provider right away if you have any of the symptoms listed above.

The most common side effects of zonisamide include:

drowsiness
loss of appetite
dizziness
problems with concentration or memory
trouble with walking and coordination
agitation or irritability

Side effects can happen at any time, but are more likely to happen during the first several weeks after starting zonisamide.

Tell your healthcare provider about any side effect that bothers you or that does not go away. These are not all of the possible side effects of zonisamide. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store zonisamide?

Store at 25°C (77°F), excursions permitted to 15°-30°C (59°-86°F). [See USP Controlled Room Temperature.]
Dry and away from light.

Keep zonisamide capsules and all medicines out of the reach of children.

General Information about the safe and effective use of zonisamide

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use zonisamide for a condition for which it was not prescribed. Do not give zonisamide to other people, even if they have the same symptoms that you have. It may harm them.

This Medication Guide summarizes the most important information about zonisamide. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about zonisamide that is written for health professionals.

For more information, call 1 (888)721-7115.

What are the ingredients in zonisamide capsules?

Active ingredient: zonisamide USP

Inactive ingredients: microcrystalline cellulose, hydrogenated vegetable oil, and sodium lauryl sulfate.

The printed capsule shell of the different strengths is made from the following ingredients:

25 mg - D&C Red #28, FD&C Blue #1, gelatin and titanium dioxide

50 mg - D&C Yellow #10, FD&C Blue #1, FD&C Red #40, gelatin and titanium dioxide

100 mg - D&C Yellow #10, FD&C Blue #1, FD&C Yellow #6, gelatin and titanium dioxide

The dyes used in the printing ink are FD&C Blue #1, FD&C Blue #2, FD&C Red #40, D&C Yellow #10 aluminium lake and iron oxide black. Additionally, the printing ink also contains n-butyl alcohol, ethanol, propylene glycol and shellac.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Manufactured by:

Glenmark Pharmaceuticals Ltd.
Colvale-Bardez, Goa 403 513, India