PEGANONE- ethotoin tablet
RECORDATI RARE DISEASES, INC.
Peganone® 250 mg Tablets
(ethotoin tablets, USP)
Read this Medication Guide before you start taking PEGANONE 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 PEGANONE?
Do not stop taking PEGANONE without first talking to your healthcare provider.
Stopping PEGANONE suddenly can cause serious problems.
PEGANONE can cause serious side effects, including:
Like other antiepileptic drugs, PEGANONE 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 PEGANONE without first talking to a healthcare provider.
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.
What is PEGANONE?
PEGANONE is a prescription medicine used to treat tonic-clonic (grand mal) and complex partial (psychomotor) seizures.
It is not known if PEGANONE is safe or effective in children younger than 1 year old.
Who should not take PEGANONE?
Do not take PEGANONE if you have:
What should I tell my healthcare provider before taking PEGANONE?
Before you take PEGANONE, tell your healthcare provider if you:
Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.
Taking PEGANONE with certain other medicines can cause side effects or affect how well they work. Do not start or stop other medicines without talking to your healthcare provider.
Know the medicines you take. Keep a list of them and show it to your healthcare provider and pharmacist when you get a new medicine.
Especially tell your healthcare provider if you take medicines that affect blood clotting.
How should I take PEGANONE?
What are the possible side effects of PEGANONE?
See “What is the most important information I should know about PEGANONE?”.
PEGANONE may cause other rare, but serious side effects. These include:
Call your healthcare provider right away if you have any of the symptoms listed above.
The most common side effects of PEGANONE include:
These are not all the possible side effects of PEGANONE. For more information, ask your healthcare provider or pharmacist.
Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
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 PEGANONE?
Keep PEGANONE and all medicines out of the reach of children.
General Information about PEGANONE
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use PEGANONE for a condition for which it was not prescribed. Do not give PEGANONE 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 PEGANONE. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about PEGANONE that is written for health professionals.
For more information, go to www.recordatirarediseases.com or call 1-888-575-8344.
What are the ingredients in PEGANONE?
Active ingredient: ethotoin
Inactive ingredients: acacia, lactose, sodium carboxymethylcellulose, stearic acid and talc.
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Manufactured by: UPM Pharmaceuticals, 501 5th Street, Bristol, TN 37620, U.S.A.
® Trademark of Recordati Rare Diseases Inc.
Revised: July 2016