PANTOPRAZOLE SODIUM  DELAYED-RELEASE- pantoprazole sodium tablet, delayed release 
Wyeth Pharmaceuticals Company, a subsidiary of Pfizer Inc.

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MEDICATION GUIDE

Pantoprazole sodium
Delayed-Release Tablets

Read this Medication Guide before you start taking pantoprazole sodium 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 sodium?

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

Pantoprazole sodium can cause serious side effects, including:

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

What is pantoprazole sodium?

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

Pantoprazole sodium is used in adults:

Pantoprazole sodium is used in children 5 years of age and older for up to 8 weeks to heal acid-related damage to the lining of the esophagus (erosive esophagitis or EE) caused by GERD.

It is not known if pantoprazole sodium is safe if used longer than 8 weeks in children. Pantoprazole sodium is not for use in children under 5 years of age.

Who should not take pantoprazole sodium?

Do not take pantoprazole sodium if you are:

What should I tell my doctor before taking pantoprazole sodium?

Before taking pantoprazole sodium, 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 sodium may affect how other medicines work, and other medicines may affect how pantoprazole sodium works.

Especially tell your doctor if you take:

Ask your doctor or pharmacist for a list of these 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 sodium?

What are the possible side effects of pantoprazole sodium?

Pantoprazole sodium may cause serious side effects, including:

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

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 sodium or during treatment, if you will be taking pantoprazole sodium for a long period of time.

The most common side effects with pantoprazole sodium in adults include:

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

The most common side effects with pantoprazole sodium 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 sodium. For more information, ask your doctor or pharmacist.

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

How should I store pantoprazole sodium?

Keep pantoprazole sodium and all medicines out of the reach of children.

General information about pantoprazole sodium

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use pantoprazole sodium for a condition for which it was not prescribed. Do not give pantoprazole sodium 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 sodium. 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.pfizer.com or call toll-free 1-800-438-1985.

What are the ingredients in pantoprazole sodium?

Active ingredient: pantoprazole sodium sesquihydrate

Inactive ingredients in Pantoprazole Sodium Delayed-Release Tablets: calcium stearate, crospovidone, hypromellose, iron oxide, mannitol, methacrylic acid copolymer, polysorbate 80, povidone, propylene glycol, sodium carbonate, sodium lauryl sulfate, 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.pfizer.com.

Marketed by:
esiLederle Division of Wyeth
Philadelphia, PA 19101

Under license from:
Takeda GmbH
D78467 Konstanz, Germany

LAB-0653-2.0
November 2013

Revised: 11/2013
Document Id: e2a499ab-ca78-4afd-8def-b7c2e27b25f0
Set id: 742ca9f4-9fba-44d4-29a8-1fe3a04f1af6
Version: 12
Effective Time: 20131121
 
Wyeth Pharmaceuticals Company, a subsidiary of Pfizer Inc.