When This Medicine Should Not Be Used:
This medicine is not right for everyone. Do not use it if you had an allergic reaction to omeprazole or similar medicines.

How to Use This Medicine:
Delayed Release Capsule, Packet, Powder for Suspension, Delayed Release Tablet

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Follow the instructions on the medicine label if you are using this medicine without a prescription. If you are using the over-the-counter medicine, do not take it for more than 14 days or use the treatment more often than every 4 months unless your doctor tells you to.
• Take this medicine at least 1 hour before a meal and for the full time of treatment, even if you begin to feel better after a few days.
• Capsule or tablet:
  
  • Swallow whole. Do not crush or chew it.
  • If you cannot swallow the capsule, you may open it and pour the medicine into a small amount of applesauce. Stir this mixture well and swallow it without chewing. To help make sure you get the full dose, drink a full glass of water.
• Oral packet:
  
  • Mix the contents of a 2.5-milligram (mg) packet with 5 milliliters (mL) of water or mix the contents of a 10-mg packet with 15 mL of water. Do not use other liquids or food.
  • Stir well. Let the mixture thicken for 2 to 3 minutes.
  • Stir again and drink the medicine within 30 minutes.
  • If there is any medicine left, add more water, stir, and drink immediately.
    
    • To prepare the oral packet for a feeding tube:
      
      • Add 5 mL of water to a catheter-tipped syringe. Then add the contents of a 2.5-mg packet (or use 15 mL of water for the 10-mg packet).
      • Shake the syringe right away. Let the mixture thicken for 2 to 3 minutes.
      • Shake the syringe once more. Give the medicine through the tube within 30 minutes.
      • Refill the syringe with an equal amount of water and shake it. Use the water to flush the tube to make sure all the medicine is given.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Do not use omeprazole if you are also using medicines that contain rilpivirine.
• Some medicines can affect how omeprazole works. Tell your doctor if you are using any of the following:
  
  • Amoxicillin, atazanavir, cilostazol, citalopram, clarithromycin, clopidogrel, cyclosporine, dasatinib, digoxin, disulfiram, erlotinib, itraconazole, ketoconazole, methotrexate, mycophenolate mofetil, nelfinavir, nilotinib, phenytoin, rifampin, saquinavir, St John's wort, tacrolimus, voriconazole
  • Benzodiazepine medicine (including diazepam)
  • Blood thinner (including warfarin)
  • Diuretic (water pill)
  • Iron supplements

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have liver disease or osteoporosis.
• This medicine may cause the following problems:
  
  • Kidney problems
  • Low vitamin B12 or magnesium levels in the blood
  • Increased risk of broken bones in the hip, wrist, or spine
• This medicine can cause diarrhea. Call your doctor if the diarrhea becomes severe, does not stop, or is bloody. Do not take any medicine to stop diarrhea until you have talked to your doctor. Diarrhea can occur 2 months or more after you stop taking this medicine.
• Tell any doctor or dentist who treats you that you are using this medicine. This medicine may affect certain medical test results.
• Your doctor will check your progress and the effects of this medicine at regular visits. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blistering, peeling, red skin rash
• Fever, joint pain, swelling in the body, unusual weight gain, change in how much or how often you urinate
• Seizures, dizziness, uneven heartbeat, muscle cramps or twitching
• Severe diarrhea, stomach cramps, fever
• Stomach pain, nausea, vomiting, weight loss

If you notice these less serious side effects, talk with your doctor:

• Headache
• Mild diarrhea or stomach pain

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088