Omeprazole, Oral

________________________________________________________________________

KEY POINTS

• This medicine is taken by mouth to treat ulcers, gastroesophageal reflux disease, and erosive esophagitis. 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.

________________________________________________________________________

What are other names for this medicine?

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

Generic and brand names: omeprazole, oral; Prilosec; Prilosec OTC; First-Omeprazole; Omeprazole+SyrSpend SF Alka (There may be other brand names for this medicine.)

What is this medicine used for?

This medicine is taken by mouth to treat ulcers, gastroesophageal reflux disease (heartburn), and erosive esophagitis. It blocks the production of stomach acid.

This medicine, along with certain antibiotics, may also be used to treat duodenal ulcers caused by H. pylori infection. It may also be used to treat a long-term condition where your stomach makes too much acid.

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
• Liver disease
• Osteoporosis
• Problems with low levels of magnesium in the blood

Do not use the nonprescription form of this medicine without first talking with your healthcare provider if you have:

• Black, tarry bowel movements or if you ever vomit blood
• Frequent chest pain
• Heartburn that has come back for 3 months or more
• Heartburn with wheezing, sweating, lightheadedness, or pain in the chest, shoulder, jaw, or arm
• Nausea, vomiting, or stomach pain
• Trouble swallowing
• Unexplained weight loss

Females of childbearing age: Talk with your healthcare provider if you are pregnant or plan to become pregnant. It is not known whether this medicine will harm an unborn baby. Do not breast-feed while taking this medicine without your healthcare provider's approval.

How do I take it?

This medicine comes in a prescription strength and a nonprescription strength.

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. If your healthcare provider has not given you specific instructions, follow the directions that come with the medicine package. Ask your healthcare provider or pharmacist about anything you do not understand.

Your healthcare provider may prescribe this medicine along with an antibiotic. Take all medicines each day as prescribed.

Check with your healthcare provider before using this medicine in children. Some brands should not be used in children under a certain age.

If you are taking the prescription medicine, read the Medication Guide that comes in the medicine package when you start taking this medicine and each time you get a refill. The prescription medicine comes in powder, capsules, tablets, or liquid form. The medicine works best if taken on an empty stomach at least 1 hour before eating. You may take it with food if it upsets your stomach. Take it at the same time each day.

Do not chew or crush the capsules or tablets. Swallow them whole. If you cannot swallow the capsules, you may open a capsule and sprinkle the contents on a tablespoon of applesauce that you can swallow without chewing. Swallow the mixture right away with a cool glass of water to ensure complete swallowing of the mixture. Do not store it for later use. Do not warm the mixture, or chew or crush the mixture.

If you have the powder form, use a measuring device (such as an oral syringe) to measure the amount of water you need. Ask your pharmacist for an oral syringe. Closely follow the instructions provided in the medicine package. Ask your healthcare provider or pharmacist about anything you do not understand.

If you have the liquid form of this medicine, use the measuring spoon, cup, dropper, or oral syringe that comes with the medicine, or ask your pharmacist for one. Do not use a kitchen spoon because the dose may not be correct. Shake the medicine well before each use.

The nonprescription form of this medicine comes in a tablet form. Swallow the tablet whole. Do not crush or chew the tablets. Swallow the tablet whole with a glass of water before eating each morning. Do not take more than 1 tablet a day. If your symptoms do not improve or if they get worse, contact your healthcare provider. Do not take more than 1 course of treatment every 4 months.

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: confusion, headache, drowsiness, blurred vision, fast heartbeat, nausea, dry mouth, sweating.

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

This medicine reduces the amount of acid in your stomach. Stomach acid is needed to absorb vitamin B12 properly. If you have taken 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 take this medicine for other conditions unless your healthcare provider approves.

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.

It may take several days for your stomach pain to improve. If your condition does not improve or gets worse, contact your healthcare provider.

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).

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; 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, mild stomach pain, rash, cough, constipation, back pain.

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:

• Antianxiety medicines such as alprazolam (Xanax), diazepam (Valium), lorazepam (Ativan), temazepam (Restoril), and triazolam (Halcion)
• Antibiotics such as cefditoren (Spectracef) and rifampin (Rifadin)
• Antidepressants such as citalopram (Celexa) and escitalopram (Lexapro)
• Antifungal medicines such as fluconazole (Diflucan), itraconazole (Sporanox), ketoconazole (Nizoral), and voriconazole (Vfend)
• Antiseizure medicines such as carbamazepine (Carbatrol, Epitol, Equetro, Tegretol) and phenytoin (Dilantin, Phenytek)
• Cancer medicines such as bosutinib (Bosulif), dabrafenib (Tafinlar), dasatinib (Sprycel), erlotinib (Tarceva), imatinib (Gleevec), nilotinib (Tasigna), pazopanib (Votrient), and vismodegib (Erivedge)
• Cholesterol-lowering medicines such as atorvastatin (Lipitor) and fluvastatin (Lescol)
• Digoxin (Lanoxin)
• Disulfiram (Antabuse)
• Diuretics (water pills) such as bumetanide, chlorothiazide (Diuril), chlorthalidone, furosemide (Lasix), hydrochlorothiazide (Microzide), and torsemide (Demadex)
• HIV medicines such as abacavir (Ziagen), atazanavir (Reyataz), delavirdine (Rescriptor), efavirenz (Sustiva), 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)
• Ledipasvir/sofosbuvir (Harvoni)
• Medicines to treat or prevent blood clots such as cilostazol (Pletal), clopidogrel (Plavix), and warfarin (Coumadin)
• Mesalamine (Apriso, Canasa)
• Methotrexate (Otrexup, Rasuvo, Rheumatrex, Trexall)
• Risedronate (Actonel, Atelvia)
• St. John's wort
• Sucralfate (Carafate) (Take this medicine at least 30 minutes before you take sucralfate.)

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 the tablets, capsules, or powder form of this medicine at room temperature. If you have the liquid medicine, store it in the refrigerator. Keep the container tightly closed. Protect it from heat, high humidity, and bright light. Do not let it freeze. Discard any unused medicine according to the label on the medicine bottle.

---

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.