SYMPROIC- naldemedine tablet
BioDelivery Sciences International Inc
|This Medication Guide has been approved by the U.S. Food and Drug Administration.||Revised: May 2020|
SYMPROIC® (sim proe' ik)
(naldemedine) tablets, for oral use
|SYMPROIC may cause serious side effects, including:
|What is SYMPROIC?|
|SYMPROIC is a prescription medicine used to treat constipation that is caused by prescription pain medicines called opioids in adults with long-lasting (chronic) pain that is not caused by active cancer.
It is not known if SYMPROIC is safe and effective in children.
|Do not take SYMPROIC if you:
|Before you take SYMPROIC, tell your healthcare provider about all of your medical conditions, including if you:
|Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Other medicines may affect the way SYMPROIC works.|
|How should I take SYMPROIC?
|What are the possible side effects of SYMPROIC?|
|See "What is the most important information I should know about SYMPROIC?"|
|The most common side effects of SYMPROIC include stomach (abdomen) pain, diarrhea, nausea and vomiting (gastroenteritis).
Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of SYMPROIC. 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 SYMPROIC?
|Keep SYMPROIC and all medicines out of the reach of children.|
|General information about the safe and effective use of SYMPROIC.|
|Medicines are sometimes prescribed for purposes other than those in a Medication Guide. Do not take SYMPROIC for a condition for which it was not prescribed. Do not give SYMPROIC 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 SYMPROIC that is written for health professionals.|
|What are the ingredients in SYMPROIC?|
|Active Ingredient: naldemedine tosylate|
|Inactive ingredients: D-mannitol, croscarmellose sodium, magnesium stearate, hypromellose, talc, and yellow ferric oxide.
Manufactured for: BioDelivery Sciences International, Inc. Raleigh, NC 27612
SYMPROIC is a registered trademark of Shionogi & Co., Ltd. For more information, go to www.symproic.com or call 1-800-469-0261.