IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
OMEPRAZOLE DELAYED-RELEASE CAPSULE – ORAL
COMMON BRAND NAME(S): Prilosec
USES: Omeprazole is used to treat certain stomach and esophagus problems (such as acid reflux, ulcers). It works by decreasing the amount of acid your stomach makes. It relieves symptoms such as heartburn, difficulty swallowing, and persistent cough. This medication helps heal acid damage to the stomach and esophagus, helps prevent ulcers, and may help prevent cancer of the esophagus. Omeprazole belongs to a class of drugs known as proton pump inhibitors (PPIs). If you are self-treating with this medication, over-the-counter omeprazole products are used to treat frequent heartburn (occurring 2 or more days a week). Since it may take 1 to 4 days to have full effect, these products do not relieve heartburn right away. For over-the-counter products, carefully read the package instructions to make sure the product is right for you. Check the ingredients on the label even if you have used the product before. The manufacturer may have changed the ingredients. Also, products with similar brand names may contain different ingredients meant for different purposes. Taking the wrong product could harm you.
HOW TO USE: Read the Patient Information Leaflet if available from your pharmacist before you start taking omeprazole and each time you get a refill. Take this medication by mouth as directed by your doctor, usually once daily, before a meal. If you are self-treating, follow all directions on the product package. Dosage and length of treatment are based on your medical condition and response to treatment. Do not increase your dose or take this drug more often than directed. If you have any questions, ask your doctor or pharmacist. Do not crush, break, or chew this medication. Swallow the capsules whole. If you have trouble swallowing the capsule, you may open the capsule if it is not sealed and carefully sprinkle its contents on a spoonful of soft, cool applesauce. Swallow all of the mixture right away without chewing it. Then drink a glass of cool water to make sure you have swallowed all of the dose. Do not prepare the mixture ahead of time for later use. Doing so may destroy the drug. If needed, antacids may be taken along with this medication. If you are also taking sucralfate, take omeprazole 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 persists or worsens. If you are self-treating, tell your doctor if your heartburn persists after 14 days or if you need to use this medication more than once every 4 months. If you think you may have a serious medical problem, get medical help right away.
SIDE EFFECTS: Headache or abdominal pain may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly. If your doctor has directed you to use this product, remember that he or she 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: symptoms of a low magnesium blood level (such as unusually fast/slow/irregular heartbeat, persistent muscle spasms, seizures). This medication may rarely cause a severe intestinal condition (Clostridium difficile-associated diarrhea) due to a type of bacteria. Do not use anti-diarrhea products or narcotic pain medications if you have any of the following symptoms because these products may make them worse. Tell your doctor right away if you develop: persistent diarrhea, abdominal or stomach pain/cramping, fever, blood/mucus in your stool. 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: 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. In Canada – Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Before taking omeprazole, tell your doctor or pharmacist if you are allergic to it; or to similar drugs (such as 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 using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease. Some symptoms may actually be signs of a more serious condition. Tell your doctor immediately if you have: heartburn with lightheadedness/sweating/dizziness, chest pain or shoulder pain (especially with trouble breathing, sweating, lightheadedness, pain spreading to arms/jaw/neck/shoulders), unexplained weight loss. In addition, before you self-treat with this medication, tell your doctor 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. 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. Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). 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 breast-feeding.
DRUG INTERACTIONS: 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: cilostazol, clopidogrel, methotrexate (especially high-dose treatment), rifampin, St John’s wort, warfarin. Some products need stomach acid so that the body can absorb them properly. Omeprazole decreases stomach acid, so it may change how well these products work. Some affected products include amphetamines, ampicillin, atazanavir, digoxin, erlotinib, nelfinavir, rilpivirine, certain azole antifungals (itraconazole, ketoconazole, posaconazole), among others. This medication may interfere with certain laboratory tests, possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.
OVERDOSE: If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: confusion, unusual sweating, blurred vision, unusually fast heartbeat.
NOTES: 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, laboratory and medical tests (such as a magnesium blood test) may be performed periodically to monitor your progress or check for side effects. Keep all regular medical and laboratory appointments.
MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.
STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. 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.