Aspirin, ASA; Omeprazole oral tablets, delayed release

What is this medicine?

ASPIRIN; OMEPRAZOLE is used in people who have had heart problems or strokes caused by blood clots to help reduce their risk of further heart problems or strokes and in people who are at risk of developing stomach ulcers with aspirin.

How should I use this medicine?

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

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• breathing problems

• chest pain or chest tightness

• diarrhea

• feeling faint or lightheaded

• redness, blistering, peeling or loosening of the skin, including inside the mouth

• signs and symptoms of kidney injury like trouble passing urine or change in the amount of urine

• signs and symptoms of liver injury like dark yellow or brown urine; general ill feeling or flu-like symptoms; light-colored stools; loss of appetite; nausea; right upper belly pain; unusually weak or tired; yellowing of the eyes or skin

• signs and symptoms of low magnesium like muscle cramps, pain, or weakness; tremors; seizures; or fast, irregular heartbeat

• signs and symptoms of low vitamin B-12 levels like shortness of breath; lightheaded; irregular heartbeat; muscle weakness; pale skin; feeling tired; changes in emotions or mood; and tingling or numbness

• signs of bleeding such as bloody or black, tarry stools; red or dark-brown urine; spitting up blood or brown material that looks like coffee grounds; red spots on the skin; unusual bruising of bleeding from the eye, gums, or nose

• stomach polyps

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

• constipation

• dry mouth

• headache

• nausea, vomiting

• stomach pain

What may interact with this medicine?

Do not take this medicine with any of the following medications:

• certain antiretrovirals for HIV or AIDS like atazanavir, nelfinavir, and rilpivirine

• clopidogrel

• rifampin

• St. John's Wort

• ticagrelor

• voriconazole

This medicine may also interact with the following medications:

• acetazolamide

• certain medicines for blood pressure called ACE inhibitors and beta blockers

• certain medicines for diabetes

• certain medicines that treat or prevent blood clots like heparin and warfarin

• certain other antiretrovirals for HIV or AIDS

• citalopram

• cilostazol

• cyclosporine

• diazepam

• digoxin

• disulfiram

• diuretics

• high dose methotrexate

• mycophenolate

• NSAIDs, medicines for pain and inflammation, like ibuprofen or naproxen

• phenytoin

• probenacid

• tacrolimus

• valproic acid

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.

Where should I keep my medicine?

Keep out of the reach of children.

Store between 20 and 25 degrees C (68 and 77 degrees F). Keep this medicine in the original container. Throw away any unused medicine after the expiration date.

What should I tell my health care provider before I take this medicine?

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

• bleeding disorders

• child with chicken pox, the flu, or other viral infections

• drink more than 3 or more alcohol-containing drinks per day

• history of stomach bleeding

• kidney disease

• liver disease

• lung or breathing diease like asthma

• lupus

• an unusual or allergic reaction to aspirin, NSAIDs, omeprazole, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

What should I watch for while using this medicine?

Do not take other medicines that contain aspirin, ibuprofen, or naproxen with this medicine. Side effects such as stomach upset, nausea, or ulcers may be more likely to occur. Many medicines available without a prescription should not be taken with this medicine.

This medicine can cause ulcers and bleeding in the stomach and intestines at any time during treatment. This can happen with no warning and may cause death. There is increased risk with taking this medicine for a long time. Smoking, drinking alcohol, older age, and poor health can also increase risks. Call your doctor right away if you have stomach pain or blood in your vomit or stool.

Do not treat diarrhea with over the counter products. Contact your doctor if you have diarrhea that lasts more than 2 days or if it is severe and watery.