This medicine is a nonsteroidal anti-inflammatory agent (NSAID) and prostaglandin analog combination used to relieve joint pain, swelling, and stiffness caused by arthritis in patients at high risk of developing ulcers.
Follow the directions for using this medicine provided by your doctor. This medicine has a MEDICATION GUIDE approved by the U.S. Food and Drug Administration. Read it carefully. Ask your doctor, nurse, or pharmacist any questions that you may have about this medicine. SWALLOW WHOLE. Do not break, crush, or chew before swallowing. THIS MEDICINE MAY BE TAKEN WITH FOOD if it upsets your stomach. DO NOT TAKE magnesium-containing antacids while taking this medicine. If an antacid is needed, use one with calcium or aluminum. STORE THIS MEDICINE at room temperature below 77 degrees F (25 degrees C) in a tightly-closed container, away from heat, moisture, and light. KEEP THIS MEDICINE out of the reach of children and away from pets. IF YOU MISS A DOSE OF THIS MEDICINE, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do NOT take 2 doses at once.
WARNING: THE RISK OF SERIOUS AND SOMETIMES FATAL HEART PROBLEMS, HEART ATTACK, AND STROKE may be increased with the use of this medicine. This risk may be increased the longer you use this medicine. Risk may also be higher in patients who have heart problems or who are at risk for heart problems. THIS MEDICINE SHOULD NOT BE USED to treat pain before or after coronary artery heart bypass (CABG) surgery. THE RISK OF SERIOUS AND SOMETIMES FATAL STOMACH AND BOWEL PROBLEMS, including bleeding, ulcers, and holes in the stomach and bowel, is increased while using this medicine. These problems may occur at any time during therapy, with or without symptoms. Elderly patients are at higher risk for serious stomach problems. Ask your doctor or pharmacist for more information about this medicine and its side effects. Some medicines or medical conditions may interact with this medicine. INFORM YOUR DOCTOR OR PHARMACIST of all prescription and over-the-counter medicine that you are taking. DO NOT TAKE THIS MEDICINE if you are also taking heparins or tacrolimus. ADDITIONAL MONITORING OF YOUR DOSE OR CONDITION may be needed if you are taking "blood thinners" (such as warfarin), corticosteroids (such as prednisone), "water pills" (such as hydrochlorothiazide or furosemide), ACE inhibitors (such as lisinopril), serotonin reuptake blocker medicines such as fluoxetine or citalopram, aminoglycoside antibiotics, bisphosphonates (e.g., alendronate, risedronate), cyclosporine, aspirin, lithium, or methotrexate. DO NOT START OR STOP any medicine without doctor or pharmacist approval. Inform your doctor of any other medical conditions including heart problems (such as heart failure or history of heart attack), swelling of the hands, feet, or ankles (edema), high blood pressure, history of stroke, blood clotting problems, stomach or bowel problems (such as bleeding or ulcers), history of tobacco use or alcohol use, kidney problems, liver problems, blood or bleeding problems (such as anemia), asthma, growths in the nose (nasal polyps), any allergies - especially aspirin/NSAID allergy (e.g., ibuprofen, celecoxib), pregnancy, or breast-feeding. USE OF THIS MEDICINE IS NOT RECOMMENDED if you have a history of anemia, low platelets, low white blood cells, severe kidney disease, or if you are going to have or have recently had coronary artery heart bypass (CABG) surgery. Contact your doctor or pharmacist if you have any questions or concerns about taking this medicine.
SIDE EFFECTS that may occur while taking this medicine include diarrhea; dizziness; drowsiness; gas; headache; indigestion; nausea; stomach pain or upset; or vomiting. If they continue or are bothersome, check with your doctor. CONTACT YOUR DOCTOR IMMEDIATELY if you experience black, tarry stools; bleeding and ulcers in the stomach and intestines; chest pain; change in amount of urine produced; dark urine; dizziness, blurred vision; fast or irregular heartbeat; loss of appetite; mental or mood changes; one-sided weakness; pale stools; red, swollen, blistered or peeling skin; seizures; severe diarrhea or stomach pain; severe nausea and vomiting; severe headache and stiff neck; sudden or unexplained weight gain; swelling of hands, legs, or feet; symptoms of infection (eg, chills, fever, sore throat); seizures; trouble breathing or shortness of breath; unusual bleeding or bruising; vaginal bleeding after menopause; vision, hearing, or speech problems; vomit that looks like coffee grounds; weakness, fatigue, fainting; weight loss; or yellowing of the skin or eyes. AN ALLERGIC REACTION TO THIS MEDICINE is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; or unusual hoarseness. This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your healthcare provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
If overdose is suspected, contact your local poison control center or emergency room immediately. Symptoms of overdose may include confusion; convulsions; diarrhea; difficulty breathing; dizziness; drowsiness; fever; lightheadedness; nausea; sleepiness; stomach pain; tremor; or unusually fast or slow heartbeat.
DO NOT SHARE THIS MEDICINE with others for whom it was not prescribed. DO NOT USE THIS MEDICINE for other health conditions. IF USING THIS MEDICINE FOR AN EXTENDED PERIOD OF TIME, obtain refills before your supply runs out.