NEXIUM - esomeprazole magnesium capsule, delayed release 
REMEDYREPACK INC.

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SPL MEDGUIDE

NEXIUM® (nex-e-um)

(esomeprazole magnesium)

Delayed-Release Capsules

NEXIUM® (nex-e-um)

(esomeprazole magnesium)

For Delayed-Release
Oral Suspension

Read the Medication Guide that comes with NEXIUM before you start taking NEXIUM and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment.

What is the most important information I should know about NEXIUM?

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

NEXIUM can cause serious side effects, including:

Diarrhea. NEXIUM may increase your risk of getting severe diarrhea. This diarrhea may be caused by an infection (Clostridium difficile) in your intestines.
Call your doctor right away if you have watery stool, stomach pain, and fever that does not go away.
Bone fractures. People who take multiple daily doses of Proton Pump Inhibitor medicines for a long period of time (a year or longer) may have an increased risk of fractures of the hip, wrist, or spine. You should take NEXIUM exactly as prescribed, at the lowest dose possible for your treatment and for the shortest time needed. Talk to your doctor about your risk of bone fracture if you take NEXIUM.

NEXIUM can have other serious side effects. See “What are the possible side effects of NEXIUM?”

What is NEXIUM?

NEXIUM is a prescription medicine called a proton pump inhibitor (PPI). NEXIUM reduces the amount of acid in your stomach.

NEXIUM is used in adults:

•for 4 to 8 weeks to treat the symptoms of gastroesophageal reflux disease (GERD). NEXIUM may also be prescribed to heal acid-related damage to the lining of the esophagus (erosive esophagitis), and to help continue this healing. •GERD happens when acid in your stomach backs up into the tube (esophagus) that connects your mouth to your stomach. This may cause a burning feeling in your chest or throat, sour taste, or burping.•for up to 6 months to reduce the risk of stomach ulcers in some people taking pain medicines called non-steroidal anti-inflammatory drugs (NSAIDs).•to treat patients with a stomach infection (Helicobacter pylori), along with the antibiotics amoxicillin and clarithromycin.•for the long-term treatment of conditions where your stomach makes too much acid, including Zollinger-Ellison Syndrome. Zollinger-Ellison Syndrome is a rare condition in which the stomach produces a more than normal amount of acid.

For children and adolescents 1 year to 17 years of age, NEXIUM may be prescribed for up to 8 weeks for short-term treatment of GERD.

In children ages 1 month to less than 1 year of age, NEXIUM is only used to treat GERD with acid-related damage to the esophagus (erosive esophagitis) for up to 6 weeks.

It is not known if NEXIUM is effective in children under 1 month of age.

Who should not take NEXIUM?

Do not take NEXIUM if you:

•are allergic to esomeprazole magnesium or any of the ingredients in NEXIUM. See the end of this Medication Guide for a complete list of ingredients in NEXIUM.•are allergic to any other Proton Pump Inhibitor (PPI) medicine.

What should I tell my doctor before taking NEXIUM?

Before you take NEXIUM, tell your doctor if you:

•have been told that you have low magnesium levels in your blood•have liver problems•are pregnant or plan to become pregnant. It is not known if NEXIUM can harm your unborn baby.•are breastfeeding or planning to breastfeed. It is not known if NEXIUM passes into your breastmilk. You and your doctor should decide if you will take NEXIUM or breastfeed. You should not do both. Talk to your doctor about the best way to feed your baby if you take NEXIUM.

Tell your doctor about all of the medicines you take, including prescription and non-prescription drugs, vitamins and herbal supplements. NEXIUM may affect how other medicines work, and other medicines may affect how NEXIUM works.

•Especially tell your doctor if you take:•warfarin (Coumadin, Jantoven)•ketoconazole (Nizoral)•voriconazole (Vfend)•atazanavir (Reyataz)•nelfinavir (Viracept)•saquinavir (Fortovase)•products that contain iron •digoxin (Lanoxin)•St.John’s Wort (Hypericum perforatum)•Rifampin (Rimactane, Rifater, Rifamate)•cilostazol (Pletal) •diazepam (Valium) •tacrolimus (Prograf)•erlotinib (Tarceva)•methotrexate•clopidogrel (Plavix)

How should I take NEXIUM?

•Take NEXIUM exactly as prescribed by your doctor. •Do not change your dose or stop NEXIUM without talking to your doctor.•Take NEXIUM at least 1 hour before a meal.•Swallow NEXIUM capsules whole. Never chew or crush NEXIUM.•If you have difficulty swallowing NEXIUM capsules, you may open the capsule and empty the contents into a tablespoon of applesauce. Do not crush or chew the granules. Be sure to swallow the applesauce right away. Do not store it for later use.•If you forget to take a dose of NEXIUM, 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 NEXIUM, call your doctor or local poison control center right away, or go to the nearest hospital emergency room. •See the “Instructions for Use” at the end of this Medication Guide for instructions how to take NEXIUM For Delayed-Release Oral Suspension, and how to mix and give NEXIUM Delayed-Release Capsules and NEXIUM For Delayed-Release Oral Suspension, through a nasogastric tube or gastric tube.

What are the possible side effects of NEXIUM?

NEXIUM can cause serious side effects, including:

•See “What is the most important information I should know about NEXIUM?”Chronic (lasting a long time) inflammation of the stomach lining (Atrophic Gastritis). Using NEXIUM for a long period of time may increase the risk of inflammation to your stomach lining. You may or may not have symptoms. Tell your doctor if you have stomach pain, nausea, vomiting, or weight loss.•Low magnesium levels in your body. This problem can be serious. Low magnesium can happen in some people who take a proton pump inhibitor medicine for at least 3 months. If low magnesium levels happen, it is usually after a year of treatment. You may or may not have symptoms of low magnesium.
Tell you doctor right away if you have any of these symptoms:•seizures•dizziness•abnormal or fast heart beat•jitteriness•jerking movements or shaking (tremors)•muscle weakness•spasms of the hands and feet•cramps or muscle aches•spasm of the voice box

Your doctor may check the level of magnesium in your body before you start taking NEXIUM or during treatment if you will be taking NEXIUM for a long period of time.

The most common side effects with NEXIUM may include:

•headache•diarrhea •nausea •gas •abdominal pain•constipation•dry mouth•drowsiness

Other side effects:

Serious allergic reactions. Tell your doctor if you get any of the following symptoms with NEXIUM:

•rash•face swelling•throat tightness•difficulty breathing

Your doctor may stop NEXIUM if these symptoms happen.

Tell your doctor if you have any side effects that bother you or that do not go away. These are not all the possible side effects with NEXIUM.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store NEXIUM?

•Store NEXIUM at room temperature between 68°F to 77°F (20°C to 25°C).•Keep the container of NEXIUM closed tightly.

Keep NEXIUM and all medicines out of the reach of children.

General information about NEXIUM

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use NEXIUM for a condition for which it was not prescribed. Do not give NEXIUM to other people, even if they have the same symptoms you have. It may harm them.

This Medication Guide summarizes the most important information about NEXIUM. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about NEXIUM that is written for health professionals.

For more information, go to www.purplepill.com or call 1-800-463-9486.

What are the ingredients in NEXIUM?

Active ingredient: esomeprazole magnesium trihydrate

Inactive ingredients in NEXIUM Delayed-Release Capsules (including the capsule shells): glyceryl monostearate 40-55, hydroxypropyl cellulose, hypromellose, magnesium stearate, methacrylic acid copolymer type C, polysorbate 80, sugar spheres, talc, triethyl citrate, gelatin, FD&C Blue #1, FD&C Red #40, D&C Red #28, titanium dioxide, shellac, ethyl alcohol, isopropyl alcohol, n-butyl alcohol, propylene glycol, sodium hydroxide, polyvinyl pyrrolidone, and D&C Yellow #10.

Inactive granules in NEXIUM For Delayed-Release Oral Suspension: dextrose, xanthan gum, crospovidone, citric acid, iron oxide, and hydroxypropyl cellulose.

Instructions for Use

For instructions on taking Delayed-Release Capsules, see the section of this leaflet called “How should I take NEXIUM?

Take NEXIUM For Delayed-Release Oral Suspension as follows:

•NEXIUM For Delayed-Release Oral Suspension comes in foil packets containing 2.5 mg, 5 mg, 10 mg, 20 mg, or 40 mg strengths.•You should use an oral syringe to measure the amount of water needed to mix your dose. Ask your pharmacist for an oral syringe.•If your prescribed dose is 2.5 mg or 5 mg, add 5 mL of water to a container, then add the contents of a foil packet containing the dose prescribed by your doctor.•If your prescribed dose is 10 mg, 20 mg, or 40 mg, add 15 mL of water to a container, then add the contents of a foil packet containing the dose prescribed by your doctor. •If you or your child are instructed to use more than one foil packet for the prescribed dose, follow the mixing instructions provided by your pharmacist or doctor. •Stir.•Leave 2 to 3 minutes to thicken.•Stir and take dose within 30 minutes. If not used within 30 minutes, throw away this dose and mix a new dose. •If any medicine remains after drinking, add more water, stir, and take dose right away.•For young children, you can give the dose with an oral syringe. Rinse the oral syringe with water after each use.

NEXIUM Delayed-Release Capsules and NEXIUM 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:

NEXIUM Delayed-Release Capsules:

•Open the capsule and empty the granules into a 60 mL catheter tipped syringe. Mix with 50 mL of water. Use only a catheter tipped syringe to give NEXIUM through a NG tube.•Replace the plunger and shake the syringe well for 15 seconds. Hold the syringe with the tip up and check for granules in the tip.•Give the medicine right away.•Do not give the granules if they have dissolved or have broken into pieces.•Attach the syringe to the NG tube. Give the medicine in the syringe through the NG tube into the stomach. •After giving the granules, flush the NG tube with more water.

NEXIUM For Delayed-Release Oral Suspension:

•NEXIUM For Delayed-Release Oral Suspension comes in foil packets containing 2.5 mg, 5 mg, 10 mg, 20 mg, or 40 mg strengths.•Use only a catheter tipped syringe to give NEXIUM through a NG tube or gastric tube•If your prescribed dose is 2.5 mg or 5 mg, add 5 mL of water to a catheter tipped syringe, then add the contents of a foil packet containing the dose prescribed by your doctor.•If your prescribed dose is 10 mg, 20 mg, or 40 mg, add 15 mL of water to a catheter tipped syringe, then add the contents of a foil packet containing the dose prescribed by your doctor. •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 the same amount of water (either 5 mL or 15 mL of water depending on your dose).•Shake the syringe and flush any remaining medicine from the NG tube or gastric tube into the stomach.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

AstraZeneca Pharmaceuticals LP

Wilmington, DE 19850

Issued November 2012

NEXIUM is a registered trademark of the AstraZeneca group of companies.

©2012 AstraZeneca Pharmaceuticals LP. All rights reserved

 

 

Revised: 02/2013
 
REMEDYREPACK INC.