SPL MEDGUIDE

MEDICATION GUIDE for 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 acoronary 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
            • • drinking alcohol
                • older age

                  NSAID medicines should only be used:

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

                        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 not be used by pregnant women late in their pregnancy.

                                        What are the possible side effects of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?
                                        Serious side effects include: heart attack stroke high blood pressure heart failure from body swelling (fluid retention) kidney problems including kidney failure bleeding and ulcers in the stomach and intestine low red blood cells (anemia) life-threatening skin reactions life-threatening allergic reactions liver problems including liver failure asthma attacks in people who have asthmaOther side effects include: stomach pain constipation diarrhea gas heartburn nausea vomiting dizziness

                                        Get emergency help right away if you have any of the following symptoms:

                                        • if you are breastfeeding. Talk to your doctor.
                                          • shortness of breath or trouble breathing
                                            • chest pain
                                              • weakness in one part or side of your body
                                                • slurred speech

                                                  Stop your NSAID medicine and call your healthcare provider right away if you have any of the following symptoms:

                                                  • swelling of the face or throat
                                                    • nausea
                                                      • more tired or weaker than usual
                                                        • itching
                                                          • your skin or eyes look yellow
                                                            • stomach pain
                                                              • flu-like symptoms
                                                                • vomit blood
                                                                  • there is blood in your bowel movement or it is black and sticky like tar
                                                                    • unusual weight gain
                                                                      • skin rash or blisters with fever

                                                                        These 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)

                                                                        • swelling of the arms and legs, hands and feet
                                                                          • 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.

                                                                            NSAID medicines that need a prescription

                                                                            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.CelecoxibCelebrexDiclofenacCataflamVoltarenArthrotec(combined with misoprostol)DiflunisalDolobidEtodolacLodineLodineXLFenoprofenNalfonNalfonFlurbiprofenAnsaidIbuprofenMotrinTab-ProfenVicoprofen(combined with hydrocodone), Combunox(combined with oxycodone)IndomethacinIndocinIndocinSR, Indo-LemmonIndomethaganKetoprofenOruvailKetorolacToradolMefenamic AcidPonstelMeloxicamMobicNabumetoneRelafenNaproxenNaprosynAnaproxAnaproxEC-NaproxynNaprelanNaprapac(copackaged with lansoprazole)OxaprozinDayproPiroxicamFeldeneSulindacClinorilTolmetinTolectinTolectin DSTolectin600All registered trademarks in this document are the property of their respective owners.
                                                                            
                                                                            This Medication Guide has been approved by the U.S. Food and Drug Administration.

                                                                            • 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.