Aspirin (AS-pir-in), Omeprazole (oh-MEP-ra-zole)

Prevents heart and blood vessel problems (including heart attack, stroke) in patients who need aspirin and who are at risk of developing stomach ulcers caused by aspirin.

Brand Name(s):

Yosprala

When This Medicine Should Not Be Used:

How to Use This Medicine:

Delayed Release Tablet

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• Take this medicine at least 60 minutes before a meal.
• Swallow the tablet whole with liquid. Do not split, chew, crush, or dissolve it.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Do not use this medicine if you are also using medicines containing rilpivirine.
• Some foods and medicines can affect how this medicine works. Tell your doctor if you are using any of the following:
  • Acetazolamide, atazanavir, cilostazol, citalopram, clopidogrel, cyclosporine, dasatinib, diazepam, digoxin, disulfiram, erlotinib, itraconazole, ketoconazole, mycophenolate mofetil, methotrexate, nelfinavir, nilotinib, phenytoin, probenecid, rifampin, rilpivirine, ritonavir, saquinavir, St John's wort, tacrolimus, ticagrelor, valproic acid, voriconazole
  • Blood pressure medicine (including ACE inhibitors, beta blockers)
  • Blood thinner (including heparin, warfarin)
  • Diuretic (water pill)
  • Iron supplements
  • NSAID pain or arthritis medicine (including celecoxib, diclofenac, ibuprofen, naproxen)
  • Oral diabetes medicine
• Avoid drinking too much alcohol (3 or more drinks per day) while using this medicine.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding. Do not use this medicine during the later part of a pregnancy, unless your doctor tells you to.
• Tell your doctor if you have kidney disease, liver disease, bleeding problems, lupus, osteoporosis, stomach problems (including ulcers), or viral infections. Tell your doctor if you drink alcohol.
• Tell your doctor if you are of Asian descent, including Filipino, Chinese, Japanese, Korean, or Taiwanese. You may need a lower dose of this medicine.
• This medicine may cause the following problems:
  • Increased risk of bleeding
  • Stomach or bowel problems (including bleeding, ulcers, or perforation)
  • Kidney problems, including acute tubulointerstitial nephritis
  • Liver problems
  • Increased risk of broken bones in the hip, wrist, or spine (more likely if used several times per day or longer than 1 year)
  • Lupus
  • Vitamin B12 deficiency, when taken for a long time
  • Fundic gland polyps (abnormal growth in the upper part of your stomach)
  • Serious skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalized exanthematous pustulosis, and drug reaction with eosinophilia and systemic symptoms (DRESS)
• This medicine may cause a delay in ovulation for women and may affect their ability to have children. If you plan to have children, talk with your doctor before using this medicine.
• This medicine can cause diarrhea. Call your doctor if the diarrhea becomes severe, does not stop, or is bloody. Do not take any medicine to stop diarrhea until you have talked to your doctor. Diarrhea can occur 2 months or more after you stop taking this medicine.
• Do not stop using this medicine suddenly. Your doctor will need to slowly decrease your dose before you stop it completely.
• Tell any doctor or dentist who treats you that you are using this medicine. This medicine may affect certain medical test results.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blistering, peeling, or red skin rash
• Bloody, black, or tarry stools, coughing up blood, vomiting of blood or material that looks like coffee grounds
• Change in how much or how often you urinate, lower back or side pain, painful urination, swelling in your hands, ankles, or feet, blood in the urine, fever
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Dry mouth, increased thirst, confusion, numbness and tingling around the mouth, fingertips, or feet
• Joint pain, rash on your cheeks or arms that gets worse in the sun
• Pain or swelling in arms or legs without any injury
• Seizures, dizziness, tremors, fast or uneven heartbeat, muscle spasms or cramps
• Severe diarrhea that does not go away, stomach cramps or upset, chest pain, weight loss
• Unusual bleeding, bruising, tiredness, or weakness

If you notice these less serious side effects, talk with your doctor:

• Trouble having an erection

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088