TIVORBEX- indomethacin capsule
Iroko Pharmaceuticals, LLC
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Medication Guide for Nonsteroidal Anti-inflammatory Drugs (NSAIDs) | |
What is the most important information I should know about medicines called Nonsteroidal Anti-inflammatory Drugs (NSAIDs)?
NSAIDs can cause serious side effects, including:
Avoid taking NSAIDs after a recent heart attack, unless your healthcare provider tells you to. You may have an increased risk of another heart attack if you take NSAIDs after a recent heart attack.
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The risk of getting an ulcer or bleeding increases with: | |
○ past history of stomach ulcers, or stomach or intestinal bleeding with use of NSAIDs | |
○ taking medicines called “corticosteroids”, “anticoagulants”, “SSRIs”, or “SNRIs” | |
○ increasing doses of NSAIDs | ○ older age |
○ longer use of NSAIDs | ○ poor health |
○ smoking | ○ advanced liver disease |
○ drinking alcohol | ○ bleeding problems |
NSAIDs should only be used:
○ exactly as prescribed ○ at the lowest dose possible for your treatment ○ for the shortest time needed |
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What are NSAIDs?
NSAIDs are used to treat pain and redness, swelling, and heat (inflammation) from medical conditions such as different types of arthritis, menstrual cramps, and other types of short-term pain. |
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Who should not take NSAIDs?
Do not take NSAIDs:
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Before taking NSAIDs, tell your healthcare provider about all of your medical conditions, including if you:
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What are the possible side effects of NSAIDs?
NSAIDs can cause serious side effects, including: See “What is the most important information I should know about medicines called Nonsteroidal Anti-inflammatory Drugs (NSAIDs)?”
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Get emergency help right away if you get any of the following symptoms: | |
• shortness of breath or trouble breathing | • slurred speech |
• chest pain | • swelling of the face or throat |
• weakness in one part or side of your body | |
Stop taking your NSAID and call your healthcare provider right away if you get any of the following symptoms: | |
• nausea | • vomit blood |
• more tired or weaker than usual | • there is blood in your bowel movement or it is black and sticky like tar |
• diarrhea | • unusual weight gain |
• itching | • skin rash or blisters with fever |
• your skin or eyes look yellow | • swelling of the arms, legs, hands and feet |
• indigestion or stomach pain | |
• indigestion or stomach pain • flu-like symptoms | |
If you take too much of your NSAID, call your healthcare provider or get medical help right away.
These are not all the possible side effects of NSAIDs. For more information, ask your healthcare provider or pharmacist about NSAIDs. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. |
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Other information about NSAIDs
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General information about the safe and effective use of NSAIDs
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use NSAIDs for a condition for which it was not prescribed. Do not give NSAIDs to other people, even if they have the same symptoms that you have. It may harm them. If you would like more information about NSAIDs, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about NSAIDs that is written for health professionals. |
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Manufactured (under license from iCeutica Pty Ltd) for and Distributed by:
Iroko Pharmaceuticals, LLC One Kew Place 150 Rouse Boulevard Philadelphia, PA 19112 For more information, go to www.iroko.com or call 1-877-757-0676. |
This Medication Guide has been approved by the U.S. Food and Drug Administration. Issued or Revised: May 2016