aspirin 81 mg-omeprazole 40 mg tablet,immediate and delayed release

Generic name:
Aspirin/omeprazole - oral

Pronunciation
(AS-pir-in/oh-MEP-ra-zole)

Brand name(s)
Yosprala

This combination product contains two medications: aspirin and omeprazole. It is used to reduce the risk of stroke or heart attack in people who have had "mini-strokes" (transient ischemic attacks), or a stroke due to a blood clot, or who have heart disease. This product is used by people who are at risk for developing ulcers while taking aspirin.

Aspirin belongs to a class of drugs known as antiplatelets. It has many uses, such as for pain relief or to reduce a fever. In low doses (such as this product), it is used to prevent harmful blood clots that can cause a stroke or heart attack. It works by stopping platelets in your blood from clumping together to form clots. Omeprazole belongs to a class of drugs known as proton pump inhibitors (PPIs). It works by decreasing the amount of acid your stomach makes. This effect helps prevent ulcers and other stomach-related problems (such as heartburn) that can be caused by aspirin.

This medication contains a delayed-release form of aspirin. It should not be used to treat conditions that require an immediate-release form of aspirin, such as right after a heart attack or before certain heart procedures (such as percutaneous coronary intervention-PCI). Also, this combination product is not the same as taking aspirin and omeprazole separately.

Read the Medication Guide provided by your pharmacist before you start taking this medication and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth as directed by your doctor, usually once daily at least 60 minutes before a meal. Swallow the tablet whole with a full glass of water (8 ounces or 240 milliliters) unless your doctor directs you otherwise. Do not lie down for at least 10 minutes after taking this medication. Do not split, crush, chew, or dissolve the tablet. Doing so can release all of the drug at once, increasing the risk of side effects.

The dosage is based on your medical condition and response to treatment. Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day.

Upset stomach or heartburn may occur. If either of these effects lasts or gets worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including:

• easy bleeding/bruising
• unusual tiredness
• signs of liver problems (such as nausea/vomiting that doesn't stop, loss of appetite, yellowing eyes/skin, dark urine)
• symptoms of a low magnesium blood level (such as muscle spasms, irregular heartbeat, seizures)
• signs of lupus (such as rash on nose and cheeks, new or worsening joint pain)
• signs of kidney problems (such as change in the amount of urine, pink/bloody urine)

This drug may rarely cause serious (rarely fatal) bleeding from the stomach or intestines. If you notice any of the following unlikely but serious side effects, stop taking this medication and consult your doctor or pharmacist right away:

• stomach/abdominal pain that doesn't go away
• black stools
• vomit that looks like coffee grounds

This medication may rarely cause a severe intestinal condition due to a bacteria called C. difficile. This condition may occur during treatment or weeks to months after treatment has stopped. Tell your doctor right away if you develop:

• diarrhea that doesn't stop
• abdominal or stomach pain/cramping
• blood/mucus in your stool

If you have these symptoms, do not use anti-diarrhea or opioid products because they may make symptoms worse.

Rarely, proton pump inhibitors (such as omeprazole) have caused vitamin B-12 deficiency. The risk is increased if they are taken every day for a long time (3 years or longer). Tell your doctor right away if you develop symptoms of vitamin B-12 deficiency (such as unusual weakness, sore tongue, or numbness/tingling of the hands/feet).

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• fever
• swollen lymph nodes
• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before taking this medication, tell your doctor if you are allergic to aspirin or omeprazole; or to other salicylates (such as choline salicylate); or to NSAIDs (such as ibuprofen, naproxen); or to other PPIs (such as esomeprazole, lansoprazole); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• aspirin-sensitive asthma (a history of worsening breathing with runny/stuffy nose after taking aspirin or other NSAIDs)
• bleeding/blood problems (such as hemophilia, vitamin K deficiency)
• stomach/intestinal/esophagus problems (such as bleeding, heartburn, ulcers)
• kidney disease
• liver disease
• growths in the nose (nasal polyps)
• lupus

This medicine may cause stomach bleeding. Daily use of alcohol and tobacco while using this medicine may increase your risk for stomach bleeding. Limit alcohol and stop smoking. Ask your doctor or pharmacist about how much alcohol you may safely drink.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Your doctor may instruct you to stop this medication before surgery. Do not stop taking it without first talking with your doctor.

Proton pump inhibitors (such as omeprazole) may increase your risk for bone fractures, especially with longer use, higher doses, and in older adults. Talk with your doctor or pharmacist about ways to prevent bone loss/fracture, such as by taking calcium (such as calcium citrate) and vitamin D supplements.

Older adults may be more sensitive to the side effects of this drug, especially bone loss and fractures (see above), bleeding, and C. difficile infection (see Side Effects section).

This drug contains aspirin. Children and teenagers younger than 18 years should not take aspirin if they have chickenpox, flu, or any undiagnosed illness or if they have recently received a vaccine. In these cases, taking aspirin increases the risk of Reye's syndrome, a rare but serious illness.

Aspirin is not recommended for use to treat pain or fever during pregnancy. Before using this medication, women of childbearing age should talk with their doctor(s) about the benefits and risks. Tell your doctor if you are pregnant or if you plan to become pregnant. This medication may harm an unborn baby and cause problems with normal labor/delivery. It is not recommended for use in pregnancy from 20 weeks until delivery. If your doctor decides that you need to use this medication between 20 and 30 weeks of pregnancy, you should use the lowest effective dose for the shortest possible time. In some cases, low-dose aspirin (usually 81-162 milligrams a day) may be used safely during pregnancy to prevent certain conditions. Talk to your doctor for more details.

Aspirin passes into breast milk. When used in large amounts (such as to treat pain or fever), it may harm a nursing infant and breastfeeding is not recommended while using this medication. However, low-dose aspirin for heart attack or stroke prevention may be used if directed by your doctor. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include:

• corticosteroids (such as prednisone)
• mavacamten
• methotrexate (especially high-dose treatment)
• mifepristone
• ginkgo biloba
• other drugs that can cause bleeding/bruising (including antiplatelet drugs such as clopidogrel, ticagrelor, NSAIDs such as ibuprofen/naproxen, "blood thinners" such as warfarin/dabigatran)

Check all prescription and nonprescription medicine labels carefully since many medications contain pain relievers/fever reducers (aspirin, NSAIDs such as ibuprofen or naproxen). These drugs are similar to this medication and may increase your risk of side effects if taken together. Ask your doctor or pharmacist for more details.

Some products need stomach acid so that the body can absorb them properly. Omeprazole decreases stomach acid, so it may change how well these products work. Some affected products include atazanavir, erlotinib, levoketoconazole, nelfinavir, pazopanib, rilpivirine, sparsentan, certain azole antifungals (itraconazole, ketoconazole, posaconazole), among others.

Other medications can affect the removal of omeprazole from your body, which may affect how this product works. Examples include rifampin, St John's wort, among others.

Omeprazole is very similar to esomeprazole. Do not use any medications containing esomeprazole while using omeprazole.

This medication may interfere with certain lab or medical tests, possibly causing false test results. Make sure lab personnel and all your doctors know you use this drug.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669. Symptoms of overdose may include: ringing in the ears, flushing, sweating, restlessness, weakness, dizziness, fast heartbeat.

Do not share this medication with others.

Lab tests (such as magnesium blood test, vitamin B-12 levels) may be done while you are taking this medication. Keep all medical and lab appointments.

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.