Medication Guide

Zonisamide ( zoe nis’ a mide ) Capsules

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

Zonisamide may cause serious side effects, including:

1.

Serious skin rash that can cause death.

2.

Serious allergic reactions that may affect different parts of the body.

3.

Less sweating and increase in your body temperature (fever).

4.

Serious eye problems

5.

Suicidal thoughts or actions in some people.

6.

Increased level of acid in your blood (metabolic acidosis).

7.

Problems with your concentration, attention, memory, thinking, speech, or language.

8.

Blood cell changes such as reduced red and white blood cell counts.

These serious side effects are described below.

1.

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.

2.

Zonisamide can cause other types of allergic reactions or serious problems that may affect different parts of the body such as your liver, kidneys, heart, or blood cells. You may or may not have a rash with these types of reactions. These reactions can be very serious and can cause death. Call your health care provider right away if you have:

1.2.

fever

2.2.

severe muscle pain

3.2.

rash

4.2.

swollen lymph glands

5.2.

swelling of your face

6.2.

unusual bruising or bleeding

7.2.

weakness, fatigue

8.2.

yellowing of your skin or the white part of your eyes

3.

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.

NaN

Call your health care provider right away if you have:

5 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).

1.

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:

2.

feel tired

3.

not feel hungry (loss of appetite)

4.

feel changes in heartbeat

5.

have trouble thinking clearly

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

1.

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

2.

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.

Do not take zonisamide:

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

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

 

Tell your healthcare provider if you:

 

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

How should I take zonisamide?

 

What should I avoid while taking zonisamide?

 

What are the possible side effects of zonisamide?

Zonisamide can cause serious side effects. See “What is the most important information I should know about zonisamide?”

Other serious side effects include:

 

The most common side effects of zonisamide include:

 

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

These are not all the possible side effects of zonisamide. 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?

 

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. You can ask your pharmacist or healthcare provider for information about zonisamide that is written for health professionals.

What are the ingredients in zonisamide capsules?

Active ingredient: zonisamide, USP

Inactive ingredients: hydrogenated vegetable oil, microcrystalline cellulose, 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 aluminum lake and iron oxide black. Additionally, the printing ink also contains propylene glycol and shellac.

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

Medication Guide available at

www.glenmarkpharma-us.com/medguides

Manufactured for:

Glenmark Pharmaceuticals Inc., USA
Mahwah, NJ 07430

Questions? 1 (888) 721-7115
www.glenmarkpharma-us.com

October 2020