This medicine is a nonsteroidal anti-inflammatory drug (NSAID) and H2 (histamine) blocker combination used to treat rheumatoid arthritis and osteoarthritis. It is used to decrease the risk of developing stomach or bowel ulcers in patients using ibuprofen to treat these conditions. It may also be used for other conditions as determined by your doctor.
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. TAKE THIS MEDICINE BY MOUTH WITH OR WITHOUT FOOD. It may be taken with food if it upsets your stomach. Taking it with food may not lower the risk of stomach or bowel problems (eg, bleeding, ulcers). Talk with your doctor or pharmacist if you have persistent stomach upset. TAKE THIS MEDICINE with a full glass of water (8 oz/240 mL) as directed by your doctor. SWALLOW WHOLE. Do not break, crush, or chew before swallowing. IF YOU TAKE CHOLESTYRAMINE, ERLOTINIB, ITRACONAZOLE, OR KETOCONAZOLE, ask your doctor or pharmacist how to take it with this medicine. STORE THIS MEDICINE at room temperature between 59 and 86 degrees F (15 and 30 degrees C), 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. Go back to your regular dosing schedule. Do not take 2 doses at once.
WARNING: THIS MEDICINE CONTAINS A NONSTEROIDAL ANTI-INFLAMMATORY DRUG (NSAID). It may cause an increased risk of serious and sometimes fatal heart and blood vessel problems (eg, heart attack, stroke). The risk may be greater if you already have heart problems or if you take this medicine for a long time. Do not use this medicine right before or after bypass heart surgery. THIS MEDICINE MAY CAUSE AN INCREASED RISK of serious and sometimes fatal stomach or bowel ulcers and bleeding. Elderly patients may be at greater risk. This may occur without warning signs. 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 dasatinib. ADDITIONAL MONITORING OF YOUR DOSE OR CONDITION may be needed if you are taking angiotensin-converting enzyme (ACE) inhibitors (eg, enalapril), anticoagulants (eg, warfarin), antiplatelet medicines (eg, clopidogrel), aspirin, bisphosphonates (eg, alendronate), corticosteroids (eg, prednisone), cyclosporine, dabigatran, desirudin, diuretics (eg, furosemide, hydrochlorothiazide), heparin, itraconazole, ketoconazole, lithium, low molecular weight heparins (LMWHs) (eg, enoxaparin), methotrexate, other NSAIDs (eg, naproxen), probenecid, quinolones (eg, ciprofloxacin), salicylates (eg, aspirin), rivaroxaban, or selective serotonin reuptake inhibitors (SSRIs) (eg, fluoxetine). DO NOT START OR STOP any medicine without doctor or pharmacist approval. Inform your doctor of any other medical conditions, including a history of kidney or liver problems, diabetes, stomach or bowel problems (eg, bleeding, perforation, ulcers, inflammation), swelling or fluid buildup, a connective tissue disease (eg, lupus), asthma, growths in the nose (nasal polyps), mouth inflammation, alcohol abuse, allergies, pregnancy, or breast-feeding. Tell your doctor if you drink alcohol or smoke, or if you have poor health, dehydration or low blood volume, swelling or fluid retention, or low blood sodium levels. Tell your doctor if you have high blood pressure, blood disorders, bleeding or clotting problems, heart problems (eg, heart failure), or blood vessel disease, or if you are at risk for any of these diseases. USE OF THIS MEDICINE IS NOT RECOMMENDED if you have had an asthma attack or a severe allergic reaction (eg, severe rash, hives, trouble breathing, growths in the nose, dizziness) after taking aspirin or an NSAID (eg, naproxen, celecoxib). USE OF THIS MEDICINE IS NOT RECOMMENDED if you are 30 weeks pregnant or more, if you have moderate to severe kidney problems, or if you have recently had or will be having bypass heart surgery. Contact your doctor if you have any questions about taking this medicine.
SIDE EFFECTS that may occur while taking this medicine include constipation, diarrhea, dizziness, gas, headache, heartburn, mild stomach pain or upset, or nausea. If they continue or are bothersome, check with your doctor. CONTACT YOUR DOCTOR IMMEDIATELY if you experience blisters or sores in the mouth; bloody or black, tarry stools; change in the amount of urine produced; chest, jaw, or left arm pain; confusion; fainting; fever, chills, or persistent sore throat; irregular heartbeat; loss of balance or coordination; mental or mood changes (eg, depression); numbness of an arm or leg; one-sided weakness; red, swollen, blistered, or peeling skin; seizures; severe headache, dizziness, or drowsiness; severe or persistent stomach pain or nausea; severe vomiting; shortness of breath; slurred speech; stiff neck; sudden cold sweat; sudden or unexplained weight gain; swelling of hands, legs, or feet; symptoms of liver problems (eg, yellowing of the skin or eyes; dark urine; pale stools; flu-like symptoms; itching; right upper stomach pain; unusual tiredness, loss of appetite, or nausea); trouble walking; unusual bruising or bleeding; unusual joint or muscle pain; unusual sensitivity to light; unusual tiredness or weakness; vision changes (eg, blurred vision, color vision changes, blind spots); or vomit that looks like coffee grounds. 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; trouble breathing or swallowing; tightness in the chest; or swelling of the mouth, face, lips, throat, or tongue. This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care 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 decreased urination; loss of consciousness; seizures; severe dizziness or drowsiness; severe nausea or stomach pain; slow or troubled breathing; unusual bleeding or bruising; unusual eye movements; or vomit that looks like coffee grounds.
DO NOT SHARE THIS MEDICINE with others for whom it was not prescribed. DO NOT USE THIS MEDICINE for other health conditions. CHECK WITH YOUR PHARMACIST about how to dispose of unused medicine.