Omeprazole is used to treat excess stomach acid in conditions such as non cancerous stomach ulcers, gastroesophageal reflux disease (GERD), active duodenal ulcer, Zollinger-Ellison syndrome and erosive esophagitis. Omeprazole works by blocking gastric acid production and is from the group of medicines called proton pump inhibitors.

Omeprazole may also be given together with antibiotics to treat gastric ulcer caused by infection with Helicobacter pylori (H. pylori).

Over-the-counter (OTC) omeprazole is used in adults to help control heartburn that occurs 2 or more days per week. The OTC brand must be taken as a course on a regular basis for 14 days in a row.

Omeprazole can cause kidney problems. Tell your doctor if you are urinating less than usual, or if you have blood in your urine.

Diarrhea may be a sign of a new infection. Call your doctor if you have diarrhea that is watery or has blood in it.

Omeprazole is not to used for the immediate relief of heartburn symptoms.

Omeprazole may cause new or worsening symptoms of lupus. Tell your doctor if you have joint pain and a skin rash on your cheeks or arms that worsens in sunlight.

You may be more likely to have a broken bone while taking this medicine long term or more than once per day.

Before taking this medicine

Heartburn can mimic early symptoms of a heart attack. Get emergency medical help if you have chest pain that spreads to your jaw or shoulder and you feel sweaty or light-headed.

You should not use omeprazole if you are allergic to it, or if:

• you are also allergic to medicines like omeprazole, such as esomeprazole, lansoprazole, pantoprazole, rabeprazole, Nexium, Prevacid, Protonix, and others;

• you had breathing problems, kidney problems, or a severe allergic reaction after taking omeprazole in the past; or

• you also take HIV medication that contains rilpivirine (such as Complera, Edurant, Odefsey, Juluca).

Ask a doctor or pharmacist if this medicine is safe to use if you have:

• trouble or pain with swallowing;

• bloody or black stools, vomit that looks like blood or coffee grounds;

• heartburn that has lasted for over 3 months;

• frequent chest pain, heartburn with wheezing;

• unexplained weight loss;

• nausea or vomiting, stomach pain;

• liver disease;

• low levels of magnesium in your blood; or

• osteoporosis or low bone mineral density (osteopenia).

You may be more likely to have a broken bone in your hip, wrist, or spine while taking a proton pump inhibitor long-term or more than once per day. Talk with your doctor about ways to keep your bones healthy.

Ask a doctor before using this medicine if you are pregnant or breastfeeding.

Do not give this medicine to a child without medical advice.

Prescription omeprazole comes as a delayed-release (releases the medication in the intestine to prevent break-down of the medication by stomach acids) capsule, and packets of delayed-release (releases the medication in the intestine to prevent break-down of the medication by stomach acids) granules for suspension (to be mixed with liquid) to take by mouth or give through a feeding tube. Nonprescription (over-the-counter) omeprazole comes as a delayed-release tablet to take by mouth. Prescription omeprazole is usually taken once a day before a meal but may be taken twice a day when used with other medications to eliminate H. pylori, or up to three times a day, before meals when used to treat conditions in which the stomach produces too much acid. The nonprescription delayed-release tablets are usually taken once a day in the morning at least 1 hour before eating for 14 days in a row. If needed, additional 14-day treatments may be repeated, not more often than once every 4 months. To help you remember to take omeprazole, take it at around the same time(s) every day. Follow the directions on your prescription label or the package label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take omeprazole exactly as directed. Do not take more or less of it or take it more often or for a longer period of time than prescribed by your doctor or stated on the package.

If you are taking the delayed-release tablets, swallow them whole with a full glass of water. Do not split, chew, or crush them or crush and mix them into food.

Swallow the delayed-release capsules whole. If you have difficulty swallowing the delayed-release capsules, place one tablespoon of soft, cool applesauce in an empty bowl. Open the delayed-release capsule and carefully empty all the granules inside the capsule onto the applesauce. Mix the granules with the applesauce and swallow the mixture immediately with a glass of cool water. Do not chew or crush the granules. Do not store the applesauce/granule mixture for future use.

If you are taking the granules for oral suspension, you will need to mix it with water before use. If you are using the 2.5-mg packet, place 1 teaspoonful (5 mL) of water in a container. If you are using the 10-mg packet, place 1 tablespoonful (15 mL) of water in a container. Add the contents of the powder packet and stir. Wait 2 to 3 minutes to allow the mixture to thicken, and stir the mixture again. Drink the entire mixture within 30 minutes. If any of the mixture is stuck to the container, pour more water into the container, stir and drink all the mixture immediately.

The granules for oral suspension can be given through a feeding tube. If you have a feeding tube, ask your doctor how you should take the medication. Follow the directions carefully.

Do not take nonprescription omeprazole for immediate relief of heartburn symptoms. It may take 1 to 4 days for you to feel the full benefit of the medication. Call your doctor if your symptoms get worse or do not improve after 14 days or if your symptoms return sooner than 4 months after you finish your treatment. Do not take nonprescription omeprazole for longer than 14 days or treat yourself with omeprazole more often than once every 4 months without talking to your doctor.

Continue to take prescription omeprazole even if you feel well. Do not stop taking prescription omeprazole without talking to your doctor. If your condition does not improve or gets worse, call your doctor.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

Take omeprazole exactly as directed on the label, or as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

Use Prilosec OTC (over-the-counter) exactly as directed on the label, or as prescribed by your doctor.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.

Shake the oral suspension (liquid) before you measure a dose. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon).

If you cannot swallow a capsule whole, open it and sprinkle the medicine into a spoonful of applesauce. Swallow the mixture right away without chewing. Do not save it for later use.

You must dissolve omeprazole powder in a small amount of water. This mixture can either be swallowed or given through a nasogastric (NG) feeding tube using a catheter-tipped syringe.

Use this medicine for the full prescribed length of time, even if your symptoms quickly improve.

OTC omeprazole should be taken for only 14 days in a row. It may take 1 to 4 days before your symptoms improve. Allow at least 4 months to pass before you start a new 14-day course of treatment.

Call your doctor if your symptoms do not improve, or if they get worse.

Some conditions are treated with a combination of omeprazole and antibiotics. Use all medications as directed.

This medicine can affect the results of certain medical tests. Tell any doctor who treats you that you are using this medicine.

Store at room temperature away from moisture and heat.

Heartburn can mimic early symptoms of a heart attack. Get emergency medical help if you have chest pain that spreads to your jaw or shoulder and you feel sweaty or light-headed.

You should not use omeprazole if you are allergic to it, or if:

• you are also allergic to medicines like omeprazole, such as esomeprazole, lansoprazole, pantoprazole, rabeprazole, Nexium, Prevacid, Protonix, and others;

• you had breathing problems, kidney problems, or a severe allergic reaction after taking omeprazole in the past; or

• you also take HIV medication that contains rilpivirine (such as Complera, Edurant, Odefsey, Juluca).

Ask a doctor or pharmacist if this medicine is safe to use if you have:

• trouble or pain with swallowing;

• bloody or black stools, vomit that looks like blood or coffee grounds;

• heartburn that has lasted for over 3 months;

• frequent chest pain, heartburn with wheezing;

• unexplained weight loss;

• nausea or vomiting, stomach pain;

• liver disease;

• low levels of magnesium in your blood; or

• osteoporosis or low bone mineral density (osteopenia).

You may be more likely to have a broken bone in your hip, wrist, or spine while taking a proton pump inhibitor long-term or more than once per day. Talk with your doctor about ways to keep your bones healthy.

Ask a doctor before using this medicine if you are pregnant or breastfeeding.

Do not give this medicine to a child without medical advice.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

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 light, excess heat, and moisture (not in the bathroom).

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.

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

Omeprazole can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or bloody, call your doctor before using anti-diarrhea medicine.

Get emergency medical help if you have signs of an allergic reaction to omeprazole: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using this medicine and call your doctor at once if you have:

• severe stomach pain, diarrhea that is watery or bloody;

• new or unusual pain in your wrist, thigh, hip, or back;

• seizure (convulsions);

• kidney problems - fever, rash, nausea, loss of appetite, joint pain, urinating less than usual, blood in your urine, weight gain;

• low magnesium - dizziness, irregular heartbeats, feeling jittery, muscle cramps, muscle spasms, cough or choking feeling; or

• new or worsening symptoms of lupus - joint pain, and a skin rash on your cheeks or arms that worsens in sunlight.

Taking omeprazole long-term may cause you to develop stomach growths called fundic gland polyps. Talk with your doctor about this risk.

If you use this medicine for longer than 3 years, you could develop a vitamin B-12 deficiency. Talk to your doctor about how to manage this condition if you develop it.

Common omeprazole side effects may include:

• cold symptoms such as stuffy nose, sneezing, sore throat (especially in children);

• fever (especially in children);

• stomach pain, gas;

• nausea, vomiting, diarrhea; or

• headache.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Tell your doctor about all your current medicines. Many drugs can affect omeprazole, especially:

• digoxin;

• clopidogrel;

• methotrexate;

• St. John's wort;

• a diuretic or "water pill"; or

• an antibiotic - amoxicillin, clarithromycin, rifampin.

This list is not complete and many Other drugs may interact with omeprazole. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Keep all appointments with your doctor and the laboratory. Your doctor may order certain laboratory tests before and during your treatment.

Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking omeprazole.

Do not let anyone else take your medication. If you are taking prescription omeprazole, ask your pharmacist any questions you have about refilling your prescription.

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.

• Zegerid® (containing Omeprazole, Sodium Bicarbonate)
• Zegerid® OTC (containing Omeprazole, Sodium Bicarbonate)