Aspirin and omeprazole is a combination medicine used to help lower the risk of heart problems, strokes, or death in people who have had heart problems caused by blood clots.

Aspirin and omeprazole is also used in people who have had surgery to improve blood flow to the heart and also have another condition that is already being treated with aspirin.

Omeprazole helps reduce the risk of stomach ulcers that may be caused by aspirin, especially in people who are 55 or older, or those who have had stomach ulcers in the past.

Aspirin and omeprazole may also be used for purposes not listed in this medication guide.

Aspirin can make you bleed more easily. Call your doctor if you have any unusual bleeding or bruising, or if you cough up blood or have bloody or tarry stools.

Omeprazole can cause kidney problems. Tell your doctor if you are urinating less than usual, or if you have blood in your urine.

Diarrhea may be a sign of a new infection. Call your doctor if you have diarrhea that is watery or has blood in it.

Omeprazole may cause new or worsening symptoms of lupus. Tell your doctor if you have joint pain and a skin rash on your cheeks or arms that worsens in sunlight.

You may be more likely to have a broken bone while taking this medicine long term or more than once per day.

The combination of aspirin and omeprazole comes as a delayed-release tablet (releases the medication in the intestine to prevent damage to the stomach) to take by mouth. It is usually taken once daily with liquid at least 60 minutes before a meal. Take the combination of aspirin and omeprazole at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take the combination of aspirin and omeprazole exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow the delayed-release tablets whole; do not split, dissolve, chew, or crush them.

Continue to take aspirin and omeprazole even if you feel well. Do not stop taking aspirin and omeprazole without talking to your doctor. If you stop taking aspirin and omeprazole, there is a higher risk that you may have a heart attack or stroke.

Do not take the combination of aspirin and omeprazole to treat sudden signs and symptoms of a heart attack or stroke.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the lowest dose that is effective in treating your condition.

Take this medicine with a full glass of water. The usual dose is once daily, 1 hour before a meal.

Swallow the tablet whole and do not crush, chew, or break it.

This medicine can affect the results of certain medical tests. Tell any doctor who treats you that you are using aspirin and omeprazole.

Omeprazole may affect a drug-screening urine test and you could have false results. Tell the laboratory staff that you use aspirin and omeprazole.

Do not stop using this medicine suddenly, even if you feel fine. Stopping suddenly may increase your risk of heart attack or stroke. Follow your doctor's instructions about tapering your dose.

Store at room temperature away from moisture and heat. Keep the tablets in their original container, along with the packet or canister of moisture-absorbing preservative.

You should not use aspirin and omeprazole if you are allergic to aspirin or omeprazole, or if:

• you are also allergic to medicines like esomeprazole, lansoprazole, pantoprazole, rabeprazole, Nexium, Prevacid, Protonix, and others;

• you take medicine that contains rilpivirine (Edurant, Complera, Juluca, Odefsey);

• you have had an asthma attack or severe allergic reaction (sneezing, runny or stuffy nose, wheezing, chest pain, shortness of breath) after taking aspirin or another NSAID; or

• if you had breathing problems, kidney problems, or a severe allergic reaction after taking this medicine in the past.

Aspirin and omeprazole should not be used to treat a sudden onset of heart attack or stroke symptoms (chest pain, sudden numbness or weakness, slurred speech).

This medicine is not approved for use by anyone younger than 18 years old. Aspirin can cause Reye's syndrome, a serious and sometimes fatal condition in children.

Tell your doctor if you have ever had:

• a bleeding disorder or vitamin K deficiency;

• low levels of magnesium in your blood;

• a habit of drinking more than 3 alcoholic beverages per day;

• liver or kidney disease;

• lupus; or

• if you are of Asian descent.

You may be more likely to have a broken bone in your hip, wrist, or spine while taking this medicine long-term or more than once per day. Talk with your doctor about ways to keep your bones healthy.

Taking aspirin during late pregnancy may cause bleeding in the mother or the baby during delivery. Tell your doctor if you are pregnant or plan to become pregnant.

This medicine may temporarily affect your ability to get pregnant. Talk with your doctor if this concerns you.

You should not breastfeed while using aspirin and omeprazole.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time unless your doctor tells you to.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include ringing in your ears, increased thirst, muscle pain or weakness, trouble breathing, or feeling cold.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Your medication may come with a desiccant packet (small packet that contains a substance that absorbs moisture to keep the medication dry) in the container. Leave the packet in the bottle, do not throw it away.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

Unless your doctor tells you otherwise, continue your normal diet.

Ask a doctor or pharmacist before using over-the-counter medicines. They may contain ingredients similar to aspirin or omeprazole.

Taking regular aspirin together with omeprazole (Prilosec) will not work the same way as taking combination aspirin and omeprazole (Yosprala). Do not substitute aspirin and omeprazole with over-the-counter products.

Drinking alcohol can increase your risk of stomach bleeding.

Get emergency medical help if you have signs of an allergic reaction: sneezing, runny or stuffy nose; wheezing or trouble breathing; hives; swelling of your face, lips, tongue, or throat.

Aspirin and omeprazole may cause serious side effects. Call your doctor at once if you have:

• severe nausea, vomiting, stomach pain, or diarrhea that is watery or bloody;

• bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;

• easy bruising, unusual bleeding (such as a nosebleed), or any bleeding that will not stop;

• sudden pain or trouble moving your hip, wrist, or back;

• kidney problems--fever, rash, nausea, loss of appetite, joint pain, urinating less than usual, blood in your urine, weight gain;

• liver problems--stomach pain, itching, dark urine, jaundice (yellowing of the skin or eyes);

• low magnesium--dizziness, fast or irregular heart rate, tremors (shaking) or jerking muscle movements, feeling jittery, muscle cramps, muscle spasms in your hands and feet, cough or choking feeling; or

• new or worsening symptoms of lupus--joint pain, and a skin rash on your cheeks or arms that worsens in sunlight.

Taking aspirin and omeprazole long-term may cause you to develop stomach growths called fundic gland polyps. Talk with your doctor about this risk.

If you use this medicine for longer than 3 years, you could develop a vitamin B-12 deficiency. Talk to your doctor about how to manage this condition if you develop it.

Common side effects of aspirin and omeprazole may include:

• heartburn, stomach pain, indigestion;

• nausea, diarrhea; or

• chest pain (may happen when you eat).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Tell your doctor about all your current medicines. Many drugs can affect aspirin and omeprazole, especially:

• clopidogrel;

• digoxin;

• methotrexate;

• rifampin;

• St. John's wort;

• ticagrelor;

• a diuretic or "water pill;" or

• NSAIDs (nonsteroidal anti-inflammatory drugs)--aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others.

This list is not complete and many other drugs may affect aspirin and omeprazole. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Keep all appointments with your doctor and the laboratory. Your doctor may order certain laboratory tests before and during your treatment, especially if you have severe diarrhea.

Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking aspirin and omperazole.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.