DICLOFENAC SODIUM AND MISOPROSTOL DR- diclofenac sodium and misoprostol tablet, film coated
Advanced Rx Pharmacy of Tennessee, LLC
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MEDICATION GUIDE
Medication Guide for DICLOFENAC SODIUM/MISOPROSTOL (diclofenac sodium and misoprostol delayed-release tablets) for oral use |
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What is the most important information I should know about diclofenac sodium/misoprostol? |
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Diclofenac sodium/misoprostol contains diclofenac (a nonsteroidal anti-inflammatory drug (NSAID)) and misoprostol, and can cause uterus to tear (uterine rupture), abortion, premature birth, or birth defects. The risk of uterine rupture increases as your pregnancy advances, if you have given birth to 5 or more children, and if you have had surgery on the uterus, such as a cesarean delivery. Do not take diclofenac sodium/misoprostol if you are pregnant.
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What is the most important information I should know about medicines containing Nonsteroidal Anti-inflammatory Drugs (NSAIDs)? |
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NSAIDs can cause serious side effects, including:
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Do not take NSAID containing medicines right before or after a heart surgery called a "coronary artery bypass graft (CABG)." |
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Avoid taking NSAID containing medicines 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: |
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NSAID containing medicines should only be used: |
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What is diclofenac sodium/misoprostol?
Diclofenac sodium/misoprostol is a prescription medicine used to treat:
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What are NSAIDs?
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Who should not take diclofenac sodium/misoprostol?
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Before taking diclofenac sodium/misoprostol, tell your healthcare provider about all of your medical conditions, including if you: |
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Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements.NSAIDs and some other medicines can interact with each other and cause serious side effects. Do not start taking any new medicine without talking to your healthcare provider first. |
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What are the possible side effects of NSAIDs? |
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NSAIDs can cause serious side effects, including: |
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Get emergency help right away if you get any of the following symptoms: |
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Stop taking your NSAID and call your healthcare provider right away if you get any of the following symptoms: |
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If you take too much of your NSAID, call your healthcare provider or get medical help right away. |
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These are not all the possible side effects of NSAIDs. For more information, ask your healthcare provider or pharmacist about NSAIDs. |
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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 |
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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. |
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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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Active ingredients:diclofenac sodium, misoprostol.
For more information, go to www.greenstonellc.comor call 1-800-438-1985 LAB-0801-6.0 |
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This Medication Guide has been approved by the U.S. Food and Drug Administration. |
Revised: August 2022 |