ESOMEPRAZOLE MAGNESIUM- esomeprazole magnesium capsule, delayed release pellets 
Mylan Institutional Inc.

----------

Medication Guide

Esomeprazole Magnesium Delayed-Release Capsules, USP
(es″ oh mep′ ra zole mag nee′ zee um)

Read the Medication Guide that comes with esomeprazole magnesium delayed-release capsules before you start taking esomeprazole magnesium delayed-release capsules 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 esomeprazole magnesium delayed-release capsules?

Esomeprazole magnesium delayed-release capsules may help your acid-related symptoms, but you could still have serious stomach problems. Talk with your doctor.

Esomeprazole magnesium delayed-release capsules can cause serious side effects, including:

What are esomeprazole magnesium delayed-release capsules?

Esomeprazole magnesium delayed-release capsules are a prescription medicine called a proton pump inhibitor (PPI). Esomeprazole magnesium delayed-release capsules reduce the amount of acid in your stomach.

Esomeprazole magnesium delayed-release capsules are used in adults:

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

Who should not take esomeprazole magnesium delayed-release capsules?

Do not take esomeprazole magnesium delayed-release capsules if you:

What should I tell my doctor before taking esomeprazole magnesium delayed-release capsules?

Before you take esomeprazole magnesium delayed-release capsules, tell your doctor if you:

Tell your doctor about all of the medicines you take, including prescription and non-prescription drugs, vitamins and herbal supplements. Esomeprazole magnesium delayed-release capsules may affect how other medicines work, and other medicines may affect how esomeprazole magnesium delayed-release capsules work.

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 ®)
  • mycophenolate mofetil (Cellcept ®)

How should I take esomeprazole magnesium delayed-release capsules?

What are the possible side effects of esomeprazole magnesium delayed-release capsules?

Esomeprazole magnesium delayed-release capsules can cause serious side effects, including:

  • 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 esomeprazole magnesium delayed-release capsules or during treatment if you will be taking esomeprazole magnesium delayed-release capsules for a long period of time.

The most common side effects with esomeprazole magnesium delayed-release capsules 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 esomeprazole magnesium delayed-release capsules:

  • rash
  • face swelling
  • throat tightness
  • difficulty breathing

Your doctor may stop esomeprazole magnesium delayed-release capsules 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 esomeprazole magnesium delayed-release capsules.

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 esomeprazole magnesium delayed-release capsules?

Keep esomeprazole magnesium delayed-release capsules and all medicines out of the reach of children.

General information about esomeprazole magnesium delayed-release capsules

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use esomeprazole magnesium delayed-release capsules for a condition for which they were not prescribed. Do not give esomeprazole magnesium delayed-release capsules to other people, even if they have the same symptoms you have. They may harm them.

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

For more information, call Mylan at 1-877-446-3679 (1-877-4-INFO-RX).

What are the ingredients in esomeprazole magnesium delayed-release capsules?

Active Ingredient: esomeprazole magnesium

Inactive Ingredients in Esomeprazole Magnesium Delayed-Release Capsules (including the capsule shells): crospovidone, gelatin, hydroxypropyl cellulose, mannitol, methacrylic acid - ethyl acrylate copolymer dispersion, sucrose, sugar spheres (corn starch and sucrose), talc, titanium dioxide and triethyl citrate. The imprinting ink contains black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution.

Instructions for Use

For instructions on taking delayed-release capsules, see the section of this leaflet called “How should I take esomeprazole magnesium delayed-release capsules?”

Esomeprazole magnesium delayed-release capsules may be given through a nasogastric tube (NG tube) or gastric tube, as prescribed by your doctor. Follow the instructions below:

Esomeprazole Magnesium Delayed-Release Capsules:

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

The brands listed are trademarks of their respective owners.

Manufactured for:
Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.

Manufactured by:
Mylan Laboratories Limited
Hyderabad — 500 096, India

Distributed by:
Mylan Institutional Inc.
Rockford, IL 61103 U.S.A.

S-12275 R2
5/19

Revised: 9/2019
Mylan Institutional Inc.