Aspirin; Omeprazole Delayed-Release Tablets

What is this medication?

ASPIRIN; OMEPRAZOLE (AS pir in; oh ME pray zol) lowers the risk of heart attack, stroke, or blood clots. It works by preventing blood cells (platelets) from clumping together to form a clot. It also reduces the risk of developing stomach ulcers when taking NSAID medications. It works by reducing the amount of acid in the stomach. It is a combination of an NSAID and a PPI.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Yosprala

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Bleeding disorders
• Child with chicken pox, the flu, or other viral infections
• Frequently drink alcohol
• History of stomach bleeding
• Kidney disease
• Liver disease
• Lung or breathing diease like asthma
• Lupus
• An unusual or allergic reaction to aspirin, omeprazole, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

Take this medication by mouth with a glass of water. Follow the directions on the prescription label. Take this medication on an empty stomach at least 1 hour before a meal. Do not take with food. Do not cut, crush, or chew this medication. Take your medication at regular intervals. Do not take it more often than directed. Do not stop taking except on your care team's advice.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your care team about the use of this medication in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medication?

Do not take this medication with any of the following:

• Certain antiretrovirals for HIV or AIDS, such as atazanavir, nelfinavir, rilpivirine
• Clopidogrel
• Rifampin
• St. John's wort
• Ticagrelor
• Voriconazole

This medication may also interact with the following:

• Acetazolamide
• Alcohol
• Certain medications for blood pressure called ACE inhibitors and beta blockers
• Certain medications for diabetes
• Certain medications that treat or prevent blood clots, such as heparin and warfarin
• Certain other antiretrovirals for HIV or AIDS
• Citalopram
• Cilostazol
• Cyclosporine
• Diazepam
• Digoxin
• Disulfiram
• Diuretics
• High dose methotrexate
• Mycophenolate
• NSAIDs, medications for pain and inflammation, such as ibuprofen or naproxen
• Phenytoin
• Probenecid
• Tacrolimus
• Valproic acid

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. Tell your care team if your symptoms do not start to get better or if they get worse.

Do not take aspirin or other NSAIDs, such as ibuprofen or naproxen, while you are taking this medication. Side effects, such as upset stomach, nausea, and ulcers, may be more likely to occur. Many over-the-counter medications contain aspirin, ibuprofen, or naproxen. It is important to read labels carefully. Talk to your care team about all the medications you take. They can tell you what is safe to take together.

This medication can cause serious bleeding, ulcers, or tears in the stomach. These problems can occur at any time and with no warning signs. They are more common with long-term use. Talk to your care team right away if you have stomach pain, bloody or black, tar-like stools, or vomit blood that is red or looks like coffee grounds.

This medication may cause serious skin reactions. They can happen weeks to months after starting the medication. Talk to your care team right away if you have fevers or flu-like symptoms with a rash. The rash may be red or purple and then turn into blisters or peeling of the skin. Or you might notice a red rash with swelling of the face, lips, or lymph nodes in your neck or under your arms.

This medication may affect your coordination, reaction time, or judgment. Do not drive or operate machinery until you know how this medication affects you. Sit up or stand slowly to reduce the risk of dizzy or fainting spells. Drinking alcohol with this medication can increase the risk of these side effects.

Be careful brushing or flossing your teeth or using a toothpick because you may get an infection or bleed more easily. If you have any dental work done, tell your dentist you are receiving this medication.

Make sure you get enough vitamin B12 while you are taking this medication. Discuss the foods you eat and the vitamins you take with your care team.

Talk to your care team if you may be pregnant. Taking this medication after 20 weeks of pregnancy may cause serious fetal side effects. Use of this medication after 30 weeks of pregnancy is not recommended.

This medication may cause infertility. It is usually temporary. Talk to your care team if you are concerned about your fertility.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Bleeding—bloody or black, tar-like stools, vomiting blood or brown material that looks like coffee grounds, red or dark brown urine, small red or purple spots on skin, unusual bruising or bleeding
• Hearing loss, ringing in ears
• Kidney injury—decrease in the amount of urine, swelling of the ankles, hands, or feet
• Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
• Low magnesium level—muscle pain or cramps, unusual weakness or fatigue, fast or irregular heartbeat, tremors
• Low vitamin B12 level—pain, tingling, or numbness in the hands or feet, muscle weakness, dizziness, confusion, trouble concentrating
• Rash, fever, and swollen lymph nodes
• Rash on the cheeks or arms that gets worse in the sun
• Redness, blistering, peeling, or loosening of the skin, including inside the mouth
• Round red or dark patches on the skin that may itch, burn, and blister
• Severe diarrhea, fever

Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):

• Headache
• Loss of appetite
• Nausea
• Upset stomach

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store between 20 and 25 degrees C (68 and 77 degrees F). Keep this medication in the original container.

Get rid of any unused medication after the expiration date.

To get rid of medications that are no longer needed or have expired:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put it in the trash, empty the medication out of the container. Mix the medication with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.