(as' pir in) (oh me' pray zol)

Brand Name(s): Yosprala^®

WHY is this medicine prescribed?

The combination of aspirin and omeprazole is used to reduce the risk of stroke or heart attack in patients who have had or are at risk of these conditions and are also at risk of developing a stomach ulcer when taking aspirin. Aspirin is in a class of medications called antiplatelet agents. It works by preventing platelets (a type of blood cell) from collecting and forming clots that may cause a heart attack or stroke. Omeprazole is in a class of medications called proton-pump inhibitors. It works by decreasing the amount of acid made in the stomach.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

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.

What SPECIAL PRECAUTIONS should I follow?

Before taking aspirin and omeprazole,

• tell your doctor and pharmacist if you are allergic to aspirin, other nonsteroidal anti-inflammatory drugs (NSAIDs) including ibuprofen (Advil, Motrin, others) and indomethacin (Indocin), omeprazole, any other medications, or any of the ingredients in the combination of aspirin and omeprazole delayed-release tablets. Ask your pharmacist for a list of the ingredients.

• Some medications should not be taken with aspirin and omeprazole. Other medications may cause dosing changes or extra monitoring when taken with aspirin and omeprazole. Make sure you have discussed any medications you are currently taking or plan to take before starting aspirin and omeprazole with your doctor and pharmacist. Before starting, stopping, or changing any medications while taking aspirin and omeprazole, please get the advice of your doctor or pharmacist..

• The following nonprescription or herbal products may interact with aspirin and omeprazole: St. John's wort; nonsteroidal anti-inflammatory drugs (NSAIDs) such as naproxen (Aleve, Naprosyn). Be sure to let your doctor and pharmacist know that you are taking these medications before you start using aspirin and omeprazole. Do not start any of these medications while using aspirin and omeprazole without discussing with your healthcare provider.

• tell your doctor if you have or have ever had severe shortness of breath, chest tightness or pain, coughing or wheezing (asthma), rhinitis (frequent stuffed or runny nose), or nasal polyps (growths on the linings of the nose) after taking aspirin or other NSAIDs including ibuprofen (Advil, Motrin, others). Your doctor may tell you that you should not take aspirin and omeprazole if you have any of these conditions.

• tell your doctor if you are of Asian descent or if you drink three or more alcoholic drinks every day. Also, tell your doctor if you have or have ever had a low level of magnesium in your blood, bleeding problems such as hemophilia, lupus, or liver or kidney disease.

• you should know that aspirin should not be taken by children and teenagers who have chicken pox, flu, flu symptoms, or who have received the varicella virus (chicken pox) vaccine in the past six weeks because of the risk of Reye's Syndrome (a serious condition in which fat builds up on the brain, liver, and other body organs).

• tell your doctor if you are pregnant, plan to become pregnant; or are breast-feeding. Aspirin or aspirin-containing medications may harm the fetus and cause problems with delivery if it is taken around 20 weeks or later during pregnancy. Do not take aspirin around or after 20 weeks of pregnancy, unless you are told to do so by your doctor. If you become pregnant while taking aspirin, call your doctor.

• you should know that this medication may decrease fertility in women. Talk to your doctor about the risks of taking aspirin and omeprazole.

• if you are 70 years of age or older, do not take this medication for a longer period of time than recommended by your doctor.

What SPECIAL DIETARY instructions should I follow?

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

What should I do IF I FORGET to take a dose?

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

Aspirin and omeprazole may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• heartburn
• vomiting

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:

• unusual bruising or bleeding
• bloody or black, tarry stools
• bloody vomit
• vomit that looks like coffee grounds
• severe diarrhea (watery or bloody stools) that may occur with or without fever and stomach cramps
• frequent nose bleeds
• changes in urination, swelling of the hands and feet, rash, itching, or having breath that smells like ammonia
• yellowing of the skin or eyes
• dark urine
• pain or discomfort in right upper stomach area
• shortness of breath, lightheadedness, muscle weakness, pale skin, feeling tired, mood changes, or numbness
• seizures, dizziness, muscle aches, or hand or feet spasms
• rash, especially a rash on the cheeks or arms that gets worse in sunlight
• increased or decreased urination, blood in urine, fatigue, nausea, loss of appetite, fever, rash, or joint pain

People who take proton pump inhibitors such as omeprazole may be more likely to fracture their wrists, hips, or spine than people who do not take one of these medications. The risk is highest in people who take high doses of one of these medications or take them for one year or longer.

Aspirin and omperazole may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

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.

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include:

• ringing in the ears
• fever
• confusion
• drowsiness
• blurred vision
• rapid heartbeat
• nausea
• vomiting
• sweating
• flushing
• headache
• dry mouth

What OTHER INFORMATION should I know?

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.

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. represents that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. makes no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS^® Patient Medication Information™. © Copyright, 2024. The American Society of Health-System Pharmacists^®, 4500 East-West Highway, Suite 900, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

Selected Revisions: November 15, 2023.