DICLOFENAC SODIUM- diclofenac sodiumĀ tablet, extended releaseĀ 
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SPL MEDGUIDE

Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)

(See the end of this Medication Guide for a list of prescription NSAID medicines.)<

What is the most important information I should know about medicines called Non- Steroidal Anti-Inflammatory Drugs (NSAIDs)?

NSAID medicines may increase the chance of a heart attack or stroke that can lead to death.


This chance increases:

  • with longer use of NSAID medicines

    NSAID medicines should never be used right before or after a heart surgery called a

    coronary artery bypass graft (CABG).

    NSAID medicines can cause ulcers and bleeding in the stomach and intestines at any time during treatment. Ulcers and bleeding:

    • in people who have heart disease
      • can happen without warning symptoms

        The chance of a person getting an ulcer or bleeding increases with:

        • may cause death
        • taking medicines calledcorticosteroidsandanticoagulants
          • longer use
            • smoking
              • drinking alcohol
                • older age

                  NSAID medicines should only be used:

                  • having poor health
                    • exactly as prescribed
                      • at the lowest dose possible for your

                        What are Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?

                        NSAID medicines are used to treat pain and redness, swelling, and heat (inflammation) from medical conditions such as:

                        • for the shortest time needed
                          • different types of arthritis

                            Who should not take a Non-Steroidal Anti-Inflammatory Drug (NSAID)?
                            Do not take an NSAID medicine:

                            • menstrual cramps and other types of short-term pain
                              • if you had an asthma attack, hives, or other allergic reaction with aspirin or any other NSAID medicine

                                Tell your healthcare provider:

                                • for pain right before or after heart bypass surgery
                                  • about all your medical conditions.
                                    • about all of the medicines you take. NSAIDs and some other medicines can interact with each other and cause serious side effects. Keep a list of your medicines to show to your healthcare provider and pharmacist.
                                      • if you are pregnant. NSAID medicines should

                                        What are the possible side effects of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?

                                        Serious side effects include:Other side effects include:heart attackstomach painstrokeconstipationhigh blood pressurediarrheaheart failure from body swelling (fluid retention)gaskidney problems including kidney failureheartburnbleeding and ulcers in the stomach and intestinenausealow red blood cells (anemia)vomitinglife-threatening skin reactionslife-threatening allergic reactionsContinued on reverse sideContinuedSerious side effects include:Other side effects include:liver problems including liver failuredizzinessasthma attacks in people who have asthmaGet emergency help right away if you have any of the following symptoms:
                                        shortness of breath or trouble breathingslurred speechchest painswelling of the faceweakness in one part or side of your bodyor throatStop your NSAID medicine and call your healthcare provider right away if you have any of the following symptoms:
                                        nauseathere is blood in your bowel movement or it is black and sticky like tarmore tired or weaker than usualitchingunusual weight gainyour skin or eyes look yellowskin rash or blisters with feverstomach painswelling of the arms and legs, hands and feetflu-like symptomsvomit bloodThese are not all the side effects with NSAID medicines. Talk to your healthcare provider or pharmacist for more information about NSAID medicines. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

                                        Other information about Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)

                                        • if you are breastfeeding. Talk to your doctor.
                                          • Aspirin is an NSAID medicine but it does not increase the chance of a heart attack. Aspirin can cause bleeding in the brain, stomach, and intestines. Aspirin can also cause ulcers in the stomach and intestines.
                                            • Some of these NSAID medicines are sold in lower doses without a prescription (over-the-counter). Talk to your healthcare provider before using over-the-counter NSAIDs for more than 10 days.

                                              Generic NameTradename* Vicoprofen contains the same dose of ibuprofen as over-the-counter (OTC) NSAIDs, and is usually used for less than 10 days to treat pain. The OTC NSAID label warns that long term continuous use may increase the risk of heart attack or stroke.This Medication Guide has been approved by the U.S. Food and Drug Administration.

                                              • NSAID medicines that need a prescription
Revised: 10/2016
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