Omeprazole-Sodium Bicarbonate

Store the capsules and powder packets at room temperature away from light and moisture. Do not store in the bathroom. Do not open the packets until you are ready to use the medication. Store the suspension in the refrigerator away from light. Do not freeze. Discard any unused suspension after 30 days. 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.

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 on an empty stomach (at least 1 hour before a meal) as directed by your doctor, usually once daily. If you are self-treating, follow all directions on the product package. The dosage and length of treatment are based on your medical condition and response to treatment. Children's dosage is also based on weight. Do not increase your dose or take this drug more often than directed. If you have any questions, ask your doctor or pharmacist.

If you are taking the capsule, swallow it whole with a full glass of water (8 ounces/240 milliliters). Do not use other liquids. Do not open the capsule or sprinkle the contents into food.

If you are using the powder packet, empty the contents into a small cup with 1 to 2 tablespoons (15 to 30 milliliters) of water. Do not use any other liquids or foods. Stir well and drink the entire mixture right away. To make sure you take the entire dose, add more water to the cup and drink all of it.

If you are using the suspension, shake the bottle well before each dose. Carefully measure the dose using a special measuring device/spoon. Do not use a household spoon because you may not get the correct dose.

If you are giving the powder or suspension through a tube into the stomach (nasogastric or gastric tube), ask your health care professional for detailed instructions on how to properly give it. For patients receiving continuous tube feedings, the tube feeding should be stopped for 3 hours before and 1 hour after giving this medication.

Do not substitute the capsules, the powder packets, or the suspension for each other, unless approved by your doctor, because they contain different amounts of sodium bicarbonate. Also, do not substitute one strength of the same dosage form for another strength (such as taking two 20-milligram capsules instead of one 40-milligram capsule). Doing so may give you too much sodium bicarbonate and increase your risk of side effects (such as swelling of the hands/feet).

If you are also taking sucralfate, take this medication at least 30 minutes before sucralfate.

Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day. Continue to take this medication for the prescribed length of treatment even if you are feeling better. If you are self-treating with the over-the-counter product, do not take it for more than 14 days unless directed by your doctor.

Tell your doctor if your condition lasts or gets worse. If you are self-treating, tell your doctor if your heartburn lasts after 14 days or if you need to use this medication more than once every 4 months. The risk of side effects goes up over time. Ask your doctor how long you should take this medication. If you think you may have a serious medical problem, get medical help right away.

See also Precautions section.

Headache or abdominal pain may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

If your doctor has directed you to use this product, remember that 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: swelling of the hands/feet, symptoms of a low magnesium blood level (such as muscle spasms, irregular heartbeat, seizures), sudden weight gain, 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).

When taken with sodium bicarbonate, large doses of calcium from your diet, medications, or supplements can rarely cause a serious problem called milk-alkali syndrome. Ask your doctor or pharmacist about using calcium products safely while you are using this medication. Tell your doctor right away if any of these serious side effects occur: dizziness, muscle aches/spasms, mental/mood changes (such as confusion, irritability, memory problems), vomiting, weakness.

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 MedWatch: The FDA Safety Information and Adverse Event Reporting Program.

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 omeprazole/sodium bicarbonate, tell your doctor or pharmacist if you are allergic to it; or to similar drugs (such as esomeprazole, lansoprazole, pantoprazole); 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 taking this medication, tell your doctor or pharmacist your medical history, especially of: kidney problems (such as Bartter's syndrome, kidney failure), liver disease (such as cirrhosis), low blood calcium or potassium levels, metabolic imbalance (such as acid-base balance problems), lupus.

This medication contains salt (sodium). Consult your doctor or pharmacist if you are on a low-salt diet or if you have a condition which could be worsened with an increase in salt intake (such as heart failure, swelling/edema).

Some symptoms may actually be signs of a more serious condition. Get medical help right away if you have: heartburn with lightheadedness/sweating/dizziness, chest/jaw/arm/shoulder pain (especially with shortness of breath, unusual sweating), unexplained weight loss.

In addition, before you self-treat with this medication, get medical help right away if you have any of these signs of a serious condition: trouble/pain swallowing food, bloody vomit, vomit that looks like coffee grounds, bloody/black stools, heartburn for over 3 months, frequent chest pain, frequent wheezing (especially with heartburn), nausea/vomiting, stomach pain.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

The suspension form may contain sugar. Caution is advised if you have diabetes or any other condition that requires you to limit/avoid sugar in your diet. Ask your doctor or pharmacist about using this product safely.

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), and C. difficile infection (see Side Effects section).

Children may be more sensitive to the side effects of omeprazole, especially fever, cough, and infections of the nose/throat/airways.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

This medication passes into breast milk. The effects on a nursing infant are unknown. Consult your doctor before breastfeeding.

See also How to Use section.

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: clopidogrel, mavacamten, memantine, methotrexate (especially high-dose treatment), rifampin, St John's wort.

Some products need stomach acid so that the body can absorb them properly. Omeprazole/sodium bicarbonate 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.

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

This medication may interfere with certain lab 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: confusion, unusual sweating, blurred vision, unusually fast heartbeat, seizures.

If your doctor has prescribed this medication for you, do not share it with others.

If your doctor instructs you to use this medication regularly for a long time, lab and/or medical tests (such as a magnesium blood test, vitamin B-12 levels) may be done while you are taking this medication. Keep all medical and lab appointments. Consult your doctor for more details.