ZONISAMIDE- zonisamide capsule
Glenmark Pharmaceuticals Inc., USA
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Zonisamide ( zoe nis’ a mide ) Capsules
What is the most important information I should know about zonisamide?
Zonisamide may cause serious side effects, including:
These serious side effects are described below.
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:
How can I watch for early symptoms of suicidal thoughts and actions?
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).
Your healthcare provider should do a blood test to measure the level of acid in your blood before and during your treatment with zonisamide.
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
Glenmark Pharmaceuticals Inc., USA
Mahwah, NJ 07430
Questions? 1 (888) 721-7115
www.glenmarkpharma-us.com
October 2020