ZONISAMIDE- zonisamide capsule 
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MEDICATION GUIDE


Zonisamide Capsules


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 Capsules?


  1. Zonisamide capsules may cause a serious skin rash that can cause death. These serious skin reactions are more likely to happen when you begin taking zonisamide capsules within the first 4 months of treatment but may occur at later times.
  2. Zonisamide capsules 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 capsules.


    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 capsules 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 capsules without first talking to a healthcare provider.
    Stopping zonisamide capsules 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 capsules 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 your treatment with zonisamide capsules.

  5. Zonisamide capsules may cause problems with your concentration, attention, memory, thinking, speech, or language.
  6. Zonisamide capsules 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 capsules 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 Capsules?"

What is Zonisamide Capsule?

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

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


Who should not take Zonisamide Capsules?

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


What should I tell my healthcare provider before taking Zonisamide Capsules?

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

Tell your healthcare provider if you:

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

If you become pregnant while taking zonisamide capsules, 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.

Tell your healthcare provider about all the medicines you take including prescription and non-prescription medicines, vitamins or herbal supplements. Zonisamide capsules 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 Capsules?

What should I avoid while taking Zonisamide Capsules?

What are the possible side effects of Zonisamide Capsules?

Zonisamide capsules can cause serious side effects including:

Call your healthcare provider right away if you have any of the symptoms listed above.

The most common side effects of zonisamide capsules include:

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

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 capsules. 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 Capsules?

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


General Information about the safe and effective use of Zonisamide Capsules

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use zonisamide capsules for a condition for which it was not prescribed. Do not give zonisamide capsules 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 capsules. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about zonisamide capsules that is written for health professionals.

For more information, call 1-800-818-4555.


What are the ingredients in Zonisamide Capsules?

Active ingredient: zonisamide

Inactive ingredients: microcrystalline cellulose, hydrogenated vegetable oil, gelatin, and titanium dioxide.

In addition, individual empty hard gelatin capsule shell contains:
50 mg: Black iron oxide
100 mg: FD&C Blue # 1 and FD&C Red # 40.


The imprinting ink contains black iron oxide, shellac glaze, propylene glycol and also contains either FD & C Blue No. 2, FD & C Red No. 40, FD & C Blue No. 1 and D & C Yellow No.10 or strong ammonia solution and potassium hydroxide.

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

Distributed by:
Caraco Pharmaceutical Laboratories, Ltd.
1150 Elijah McCoy Drive, Detroit, MI 48202


Manufactured by:
Sun Pharmaceutical Industries Ltd.
Acme Plaza, Andheri-Kurla Road,
Andheri (East), Mumbai - 400 059, India.

PJPI0265A
ISS. 07/2010

Revised: 07/2014
 
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