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PRILOSEC
(pry'-lo-sec)
(omeprazole) Delayed-Release Capsules And Delayed-Release Oral Suspension

Read the patient information that comes with PRILOSEC (omeprazole) before you start taking it and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your doctor about your medical condition or your treatment.

If you have any questions about PRILOSEC (omeprazole) , ask your doctor.

WHAT IS PRILOSEC (omeprazole) ?

PRILOSEC (omeprazole) is a prescription medicine called a proton pump inhibitor (PPI). PRILOSEC (omeprazole) reduces the amount of acid in your stomach. PRILOSEC (omeprazole) is used in adults:

• for up to 4 weeks to treat heartburn and other symptoms that happen with gastroesophageal reflux disease (GERD).
  GERD is a chronic condition (lasts a long time) that occurs when acid from the stomach backs up into the esophagus (food pipe) causing symptoms, such as heartburn, or damage to the lining of the esophagus. Common symptoms include frequent heartburn that will not go away, a sour or bitter taste in the mouth, and difficulty swallowing.
• for up to 8 weeks to heal acid-related damage to the lining of the esophagus (called erosive esophagitis or EE)
• to maintain healing of the esophagus. PRILOSEC (omeprazole) has not been studied for treatment lasting longer than 12 months (1 year)
• for up to 8 weeks for healing stomach ulcers
• for up to 8 weeks for healing ulcers in the first part of the small bowel (duodenal ulcers)
• to treat patients with a stomach infection (Helicobacter pylori), along with the antibiotics amoxicillin and clarithromycin.
• for lowering the amount of stomach acid in people with certain conditions which cause them to make too much acid, including those with Zollinger-Ellison Syndrome.

For children and adolescents 1 to 17 years of age, PRILOSEC (omeprazole) is used:

• for up to 4 weeks to treat the symptoms of gastroesophageal reflux disease (GERD).
• for up to 8 weeks to heal acid-related damage to the lining of the esophagus (called erosive esophagitis or EE)
• to maintain healing of the esophagus

PRILOSEC (omeprazole) is not recommended for children under the age of 1 year.

PRILOSEC (omeprazole) may help your acid-related symptoms, but you could still have serious stomach problems. Talk with your doctor.

WHO SHOULD NOT TAKE PRILOSEC (omeprazole) ?

Do not take PRILOSEC (omeprazole) if you:

• are allergic to any of the ingredients in PRILOSEC (omeprazole) . See the end of this leaflet for a complete list of ingredients in PRILOSEC (omeprazole) .
• are allergic to any other Proton Pump Inhibitor (PPI) medicine.

WHAT SHOULD I TELL MY DOCTOR BEFORE TAKING PRILOSEC (omeprazole) ?

Tell your doctor about all your medical conditions, including if you:

• have liver problems
• are pregnant or plan to become pregnant. It is not known if PRILOSEC (omeprazole) will harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant.
• are breastfeeding or planning to breastfeed. You and your doctor should decide if you will take PRILOSEC (omeprazole) or breastfeed. You should not do both.

Tell your doctor about all of the medicines you take including prescription and non-prescription drugs, vitamins and herbal supplements. PRILOSEC (omeprazole) may affect how other medicines work, and other medicines may affect how PRILOSEC (omeprazole) works. Especially tell your doctor if you take:

• atazanavir (Reyataz)
• nelfinavir (Viracept)
• saquinavir (Fortovase)
• cilostazol (Pletal)
• ketoconazole (Nizoral)
• voriconazole (Vfend)
• ampicillin (Unasyn)
• products that contain iron
• warfarin (Coumadin)
• digoxin (Lanoxin, Lanoxincaps)
• tacrolimus (Prograf)
• diazepam (Valium)
• phenytoin (Dilantin)
• disulfiram (Antabuse)
• clopidogrel (Plavix)

HOW SHOULD I TAKE PRILOSEC (omeprazole) ?

• Take PRILOSEC (omeprazole) exactly as prescribed by your doctor.
• Do not change your dose or stop PRILOSEC (omeprazole) without talking to your doctor.
• Take PRILOSEC (omeprazole) at least 1 hour before a meal.
• Swallow PRILOSEC (omeprazole) capsules whole. Never chew or crush PRILOSEC (omeprazole) .
• If you have difficulty swallowing PRILOSEC (omeprazole) capsules, you may open the capsule and empty the contents into a tablespoon of applesauce. Be sure to swallow the applesauce right away. Do not store it for later use.
• If you forget to take a dose of PRILOSEC (omeprazole) , take it as soon as you remember. If it is almost time for your next dose, do not take the missed dose. Take the next dose on time. Do not take a double dose to make up for a missed dose.
• If you take too much PRILOSEC (omeprazole) , tell your doctor right away.
• See the “Patient Instructions for Use” at the end of this leaflet for instructions how to take PRILOSEC (omeprazole) Delayed-Release Oral Suspension, and how to mix and give PRILOSEC (omeprazole) For Delayed-Release Oral Suspension, through a nasogastric tube or gastric tube.

WHAT ARE THE POSSIBLE SIDE EFFECTS OF PRILOSEC (omeprazole) ?

Serious allergic reactions. Tell your doctor if you get any of the following symptoms with PRILOSEC (omeprazole) .

• rash
• face swelling
• throat tightness
• difficulty breathing

Your doctor may stop PRILOSEC (omeprazole) if these symptoms happen.

The most common side effects with PRILOSEC (omeprazole) in adults and children include:

• Headache
• Abdominal pain
• Nausea
• Diarrhea
• Vomiting
• Gas
• Respiratory system events
• Fever

People who are taking multiple daily doses of proton pump inhibitor medicines for a long period of time may have an increased risk of fractures of the hip, wrist or spine.

Tell your doctor about any side effects that bother you or that do not go away. These are not all the possible side effects with PRILOSEC (omeprazole) . Talk with your doctor or pharmacist if you have any questions about side effects. You may report side effects to the FDA at 1-800-FDA1088.

HOW SHOULD I STORE PRILOSEC (omeprazole) ?

Store PRILOSEC (omeprazole) at room temperature between 59°F to 86°F (15°C to 30°C).

Keep the container of PRILOSEC (omeprazole) closed tightly.

Keep PRILOSEC (omeprazole) and all medicines out of the reach of children. GENERAL ADVICE

Medicines are sometimes prescribed for purposes other than those listed in the Patient Information leaflet. Do not use PRILOSEC (omeprazole) for a condition for which it was not prescribed. Do not give PRILOSEC (omeprazole) to other people, even if they have the same symptoms you have. It may harm them.

This Patient Information leaflet provides a summary of the most important information about PRILOSEC (omeprazole) . For more information, ask your doctor. You can ask your doctor or pharmacist for information that is written for healthcare professionals. For more information, go to www. astrazeneca-us.com or call toll free 1-800-236-9933.

PATIENT INSTRUCTIONS FOR USE

For instructions on taking Delayed-Release Capsules, please see “HOW SHOULD I TAKE PRILOSEC (omeprazole) ?”

Take PRILOSEC (omeprazole) Delayed-Release Oral Suspension as follows:

• Empty the contents of a 2.5 mg packet into a container containing 1 teaspoon (5 mL) of water or empty the contents of a 10 mg packet into a container with 1 tablespoon (15 mL) of water
• Stir.
• Leave 2 to 3 minutes to thicken.
• Stir and drink within 30 minutes.

If any medicine remains after drinking, add more water, stir, and drink right away.

PRILOSEC (omeprazole) for Delayed-Release Oral Suspension may be given through a nasogastric tube (NG tube) or gastric tube, as prescribed by your doctor. Follow the instructions below:

PRILOSEC (omeprazole) for Delayed-Release Oral Suspension:

• Add 5 mL of water to a catheter tipped syringe and then add the contents of a 2.5 mg packet (or 15 mL of water for the 10 mg packet), as instructed by your doctor. Use only a catheter tipped syringe to give PRILOSEC (omeprazole) through a NG tube or gastric tube.
• Shake the syringe right away and then leave it for 2 to 3 minutes to thicken.
• Shake the syringe and give the medicine through the NG or gastric tube (French size 6 or larger) into the stomach within 30 minutes.
• Refill the syringe with an equal amount of water.
• Shake and flush any remaining contents from the NG tube or gastric tube into the stomach.

WHAT ARE THE INGREDIENTS IN PRILOSEC (omeprazole) ?

Active ingredient in PRILOSEC Delayed-Release Capsules:

omeprazole

Inactive ingredients in PRILOSEC (omeprazole) Delayed-Release Capsules

(including the capsule shells): cellulose, disodium hydrogen phosphate, hydroxypropyl cellulose, hypromellose, lactose, mannitol, sodium lauryl sulfate, gelatin-NF, FD&C Blue #1, FD&C Red #40, D&C Red #28, titanium dioxide, synthetic black iron oxide, isopropanol, butyl alcohol, FD&C Blue #2, D&C Red #7 Calcium Lake, and, in addition, the 10 mg and 40 mg capsule shells also contain D&C Yellow #10.

Active ingredient in PRILOSEC for Delayed-Release Oral Suspension: omeprazole magnesium

Inactive ingredients in PRILOSEC (omeprazole) for Delayed-Release Oral Suspension: glyceryl monostearate, hydroxypropyl cellulose, hypromellose, magnesium stearate, methacrylic acid copolymer C, polysorbate, sugar spheres, talc, and triethyl citrate.

Inactive granules in PRILOSEC (omeprazole) Delayed-Release Oral Suspension: citric acid, crospovidone, dextrose, hydroxypropyl cellulose, iron oxide and xantham gum.

Last reviewed on RxList: 3/15/2011
This monograph has been modified to include the generic and brand name in many instances.