PANTOPRAZOLE SODIUM - pantoprazole sodium tablet, delayed release 
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MEDICATION GUIDE

Pantoprazole (pan-TOE-pruh-zole) Sodium Delayed-Release Tablets, USP

CIA76418B Rev. 5E 12/2012

Read this Medication Guide before you start taking Pantoprazole 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 Pantoprazole?

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

Pantoprazole can cause serious side effects, including:

Pantoprazole can have other serious side effects. See "What are the possible side effects of Pantoprazole?"

What is Pantoprazole?

Pantoprazole is a prescription medicine called a proton pump inhibitor (PPI).

Pantoprazole reduces the amount of acid in your stomach.

Pantoprazole is used in adults:

Information describing use in pediatric patients ages five years through 16 years old with erosive esophagitis associated with GERD is approved for Wyeth Pharmaceuticals Inc.'s pantoprazole sodium delayed-release tablets. However, due to Wyeth Pharmaceuticals Inc.'s marketing exclusivity rights, this drug product is not labeled with that pediatric information.

Pantoprazole is not for use in children under 5 years of age.

Who should not take Pantoprazole?

Do not take Pantoprazole if you are:

What should I tell my doctor before taking Pantoprazole?

Before you take Pantoprazole, 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. Pantoprazole may affect how other medicines work, and other medicines may affect how Pantoprazole works.

Especially tell your doctor if you take:

Ask your doctor or pharmacist for a list of medicines, if you are not sure.

Know the medicines that you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.

How should I take Pantoprazole?

What are the possible side effects of Pantoprazole?

Pantoprazole may cause serious side effects, including:

See "What is the most important information I should know about Pantoprazole?"

Tell your doctor right away if you have any of these symptoms:

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

The most common side effects with Pantoprazole in adults include:

  • Headache
  • Diarrhea
  • Nausea
  • Stomach pain
  • Vomiting
  • Gas
  • Dizziness
  • Pain in your joints

The most common side effects with Pantoprazole in children include:

  • Upper respiratory infection
  • Headache
  • Fever
  • Diarrhea
  • Vomiting
  • Rash
  • Stomach pain

Other side effects:

Your doctor may stop Pantoprazole if these symptoms happen.

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 Pantoprazole. For more information, ask your doctor or pharmacist.

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 Pantoprazole?

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

General information about Pantoprazole

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Pantoprazole for a condition for which it was not prescribed. Do not give Pantoprazole 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 Pantoprazole. 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.kremersurban.com or call toll-free 1-866-822-0068.

What are the ingredients in Pantoprazole?

Active ingredient: pantoprazole sodium sesquihydrate

Inactive ingredients in Pantoprazole Sodium Delayed-Release Tablets: black iron oxide, crospovidone, glyceryl behenate, hypromellose, isopropyl alcohol, lactose monohydrate, methacrylic acid copolymer dispersion, propylene glycol, talc, titanium dioxide, and triethyl citrate.

Instructions for Use

Pantoprazole Sodium Delayed-Release Tablets:

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

This product's label may have been updated. For current full prescribing information, please visit www.kremersurban.com.

Manufactured for:
AvKARE, Inc.
Pulaski, TN 38478

Mfg. Rev. 12/12

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AV 01/13 ( P)


Revised: 01/2013
 
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