ZONISAMIDE- zonisamide capsule
Proficient Rx LP
( 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.
Zonisamide may cause serious side effects, including:
These serious side effects are described below.
Call your health care provider right away if you have:
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:
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).
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:
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?”
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 if you are allergic to medicines that contain sulfa.
Before taking zonisamide, 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 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.
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.
Zonisamide can cause serious side effects including:
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.
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.
Keep zonisamide capsules and all medicines out of the reach of children.
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.
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.