Omeprazole/Aspirin, Oral

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KEY POINTS

• This medicine is taken by mouth to help prevent heart problems and stroke and protect the stomach from ulcers caused by aspirin. Take it exactly as directed.
• If you develop severe diarrhea or diarrhea that lasts more than 2 or 3 days while taking this medicine, or for several weeks after you stop taking this medicine, contact your healthcare provider right away.
• This medicine may cause low levels of magnesium in your blood, which can increase your risk of serious side effects. Keep all appointments for tests to see how this medicine affects you.
• This medicine may cause unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: proton pump inhibitor (prevents acid production)/antiplatelet medicine

Generic and brand names: omeprazole/aspirin, oral; Yosprala

What is this medicine used for?

This medicine is taken by mouth to help prevent:

• Heart problems or stroke in people who have had a heart attack, angina, heart surgery, or stroke
• Stomach ulcers from taking aspirin

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• Anemia, hemophilia, or any other blood disorder or bleeding problems
• Liver or kidney problems
• Lung or breathing problems such as asthma or rhinitis (allergies)
• Lupus
• Nasal polyps
• Osteoporosis
• Problems with alcohol abuse
• Problems with low levels of magnesium in the blood

Females of childbearing age: Talk with your healthcare provider if you are pregnant or plan to become pregnant. Do not take aspirin during the last 3 months of pregnancy unless it has been ordered by your healthcare provider. Do not breast-feed while taking this medicine without your healthcare provider's approval.

How do I take it?

Read the Medication Guide that comes in the medicine package when you start taking this medicine and each time you get a refill.

Check the label on the medicine for directions about your specific dose. Take this medicine exactly as your healthcare provider prescribes. Do not stop taking this medicine without your healthcare provider's approval. Take it for as long as directed, even if you feel better. Do not take more or take it longer than prescribed. Ask your healthcare provider or pharmacist about anything you do not understand.

Check with your healthcare provider before using this medicine in children under age 18. Aspirin can cause serious side effects such as Reye's syndrome in children and teens with viral infections such as the flu or chickenpox.

Take this medicine with water on an empty stomach at least 1 hour before eating. Take it at the same time each day. Swallow the tablet whole. Do not crush or chew the tablets.

What if I miss a dose?

If you miss a dose, take it as soon as you remember unless it is almost time for the next scheduled dose. In that case, skip the missed dose and take the next one as directed. Do not take double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose may include: blurred vision, coma, confusion, diarrhea, dizziness, drowsiness, dry mouth, fast breathing, fast heartbeat, fever, headache, nausea, ringing in the ears, seizures, sweating, vomiting.

What should I watch out for?

People of Asian descent may need to take a different dose of this medicine. Ask your pharmacist or healthcare provider about this.

This medicine may cause or worsen diarrhea. If you develop severe diarrhea or diarrhea that lasts more than 2 or 3 days while taking this medicine, or for several weeks after you stop taking this medicine, contact your healthcare provider right away. Do not take medicine to treat diarrhea without your provider's approval.

This medicine may cause low levels of magnesium in your blood. Talk with your provider about how often you should have blood tests while taking this medicine. This is very important if you take digoxin because low magnesium can increase your risk of serious side effects. Low magnesium can happen in some people who take this medicine for at least 3 months. If this happens, it is usually after a year of treatment. Tell your healthcare provider right away if you have any of these symptoms of low magnesium levels:

• Seizures
• Dizziness
• Irregular or fast heart beat
• Shaking
• Muscle weakness
• Spasms of the hands, feet, or voice box
• Cramps or muscle aches

The omeprazole in this medicine reduces the amount of acid in your stomach. Stomach acid is needed to absorb vitamin B12 properly. If you take this medicine for more than 3 years, talk with your provider about vitamin B12 deficiency.

This medicine may increase your risk for fractures of the hip, wrist, and spine, especially if you take high doses or take this medicine for longer than 1 year. Follow your healthcare provider's instructions about diet and taking vitamin supplements.

Do not give this medicine to someone who has similar symptoms. It may make it hard to recognize other medical problems.

Drinking alcohol and smoking may increase acid in your stomach. Do not drink alcohol or smoke while you are taking this medicine.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; chest pain; swelling of your lips, tongue, and throat); sudden weakness, numbness, or tingling, especially on one side of your body; sudden or severe headache; sudden trouble with vision, speech, balance, or walking.

Serious (Report these to your healthcare provider right away.): Unusual bruising or bleeding; yellowing of your skin or eyes; sores in mouth; seizures; severe dizziness or fainting; irregular or fast heart beat; shaking; muscle weakness, cramps, or spasms; severe diarrhea; bloody or black tarry bowel movements; changes in urination; blood in urine; unexplained weight gain or loss; unexplained swelling; fever; severe stomach pain, nausea, or vomiting; numbness or tingling in hands or feet; unusual tiredness or weakness; severe skin redness, peeling, or blisters; confusion.

Other: Headache, mild diarrhea, nausea, vomiting, gas, heartburn, mild stomach pain, rash.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• ACE inhibitors such as benazepril (Lotensin), captopril, enalapril (Vasotec), fosinopril, lisinopril (Prinivil, Zestril), quinapril (Accupril), and ramipril (Altace)
• Acetazolamide (Diamox)
• Antibiotics such as cefditoren (Spectracef) and rifampin (Rifadin)
• Antidepressants such as citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac), fluvoxamine (Luvox), and sertraline (Zoloft)
• Antifungal medicines such as fluconazole (Diflucan), itraconazole (Sporanox), ketoconazole (Nizoral), and voriconazole (Vfend)
• Antiseizure medicines such as carbamazepine (Carbatrol, Epitol, Equetro, Tegretol), phenytoin (Dilantin, Phenytek), and valproic acid (Depacon, Depakene, Depakote)
• Beta blockers such as acebutolol (Sectral), atenolol (Tenormin), carvedilol (Coreg), labetalol (Trandate), metoprolol (Lopressor, Toprol), nadolol (Corgard), pindolol, and sotalol (Betapace, Sorine)
• Cancer medicines such as bosutinib (Bosulif), dabrafenib (Tafinlar), dasatinib (Sprycel), erlotinib (Tarceva), gefitinib (Iressa), nilotinib (Tasigna), and pazopanib (Votrient)
• Corticosteroids such as betamethasone, dexamethasone, hydrocortisone (A-Hydrocort, Cortef), methylprednisolone (Medrol, Solu-Medrol), prednisone (Prednisone Intensol), and triamcinolone (Aristospan, Kenalog)
• Diabetes medicines such as chlorpropamide, glimepiride (Amaryl), glipizide (Glucotrol), glyburide (Glynase), tolazamide, and tolbutamide
• Diazepam (Valium)
• Digoxin (Lanoxin)
• Disulfiram (Antabuse)
• Diuretics (water pills) such as bumetanide, chlorothiazide (Diuril), chlorthalidone, furosemide (Lasix), hydrochlorothiazide (Microzide), and torsemide (Demadex)
• Hepatitis C medicines such as ledipasvir/sofosbuvir (Harvoni) and sofosbuvir/velpatasvir (Epclusa)
• HIV medicines such as abacavir (Ziagen), atazanavir (Reyataz), delavirdine (Rescriptor), efavirenz (Sustiva), emtricitabine/rilpivirine/tenofovir (Complera, Odefsey), fosamprenavir (Lexiva), indinavir (Crixivan), lopinavir/ritonavir (Kaletra), nelfinavir (Viracept), nevirapine (Viramune), rilpivirine (Edurant), ritonavir (Norvir), saquinavir (Invirase), tenofovir (Viread), and zidovudine (Retrovir)
• Immunosuppressants such as cyclosporine (Gengraf, Neoral, Sandimmune), mycophenolate (CellCept, Myfortic), and tacrolimus (Astagraf, Prograf, Protopic)
• Iron supplements or multivitamins that contain iron, and iron medicines such as ferric carboxymaltose (Injectafer), ferric gluconate (Ferrlecit), ferumoxytol (Feraheme), and iron sucrose (Venofer)
• Medicines to treat or prevent blood clots such as cilostazol (Pletal), clopidogrel (Plavix), dabigatran (Pradaxa), dalteparin (Fragmin), dipyridamole (Persantine), edoxaban (Savaysa), enoxaparin (Lovenox), heparin, pentoxifylline, prasugrel (Effient), rivaroxaban (Xarelto), ticagrelor (Brilinta), and warfarin (Coumadin)
• Mesalamine (Apriso, Canasa)
• Methotrexate (Otrexup, Rasuvo, Rheumatrex, Trexall)
• Natural remedies such as cat's claw, dong quai, evening primrose, feverfew, garlic, ginger, ginkgo, ginseng, green tea, horse chestnut, red clover, and St. John’s wort
• Nonsteroidal anti-inflammatory medicines (NSAIDs) such as celecoxib (Celebrex), diclofenac (Cambia, Voltaren, Zipsor), ibuprofen (Advil, Motrin), indomethacin (Indocin), ketoprofen, ketorolac, nabumetone (Relafen), naproxen (Aleve, Anaprox, Naprelan), oxaprozin (Daypro), piroxicam (Feldene), and sulindac (Clinoril)
• Paroxetine (Brisdelle, Paxil, Pexeva)
• Pentosan (Elmiron)
• Probenecid
• Propranolol (Hemangeol, Inderal, InnoPran)
• Risedronate (Actonel, Atelvia)
• Sucralfate (Carafate) (Take this medicine at least 30 minutes before you take sucralfate.)
• Varicella (chickenpox) vaccine or varicella zoster (shingles) vaccine
• Vitamin E

Do not drink alcohol while taking this medicine without your healthcare provider’s approval.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Protect it from heat, high humidity, and bright light.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.