zonegran medication guide zonegran medication guide zonegran medication guide fda/cder

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Specifications	zonegran medication guide zonegran medication guide zonegran medication guide fda/cder
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NDA 020789/S-012 FDA Approved Labeling Text dated 1/24/2012 Page 23 Medication Guide ZONEGRAN® (ZO-nuh-gran) (zonisamide

Specifications	zonegran medication guide zonegran medication guide zonegran medication guide fda/cder
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Content	NDA 020789/S-012 FDA Approved Labeling Text dated 1/24/2012 Page 23 Medication Guide ZONEGRAN® (ZO-nuh-gran) (zonisamide) capsules Read this Medication Guide before you start taking ZONEGRAN 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 ZONEGRAN? ZONEGRAN may cause serious side effects, including: 1. Serious skin rash that can cause death. 2. Less sweating and increase in your body temperature (fever). 3. Suicidal thoughts or actions in some people. 4. Increased level of acid in your blood (metabolic acidosis). 5. Problems with your concentration, attention, memory, thinking, speech, or language. 6. Blood cell changes such as reduced red and white blood cell counts. These serious side effects are described below. 1. ZONEGRAN may cause a serious skin rash that can cause death. These serious skin reactions are more likely to happen when you begin taking ZONEGRAN within the first 4 months of treatment but may occur at later times. 2. ZONEGRAN 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 ZONEGRAN. Call your health care provider right away if you have: x a skin rash x high fever, recurring fever, or long lasting fever x less sweat than normal 3. Like other antiepileptic drugs, ZONEGRAN 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: x thoughts about suicide or dying Reference ID: 3076348 Page 23 of 28 January 2012 NDA 20-789
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