PROTONIX  DELAYED-RELEASE- pantoprazole sodium tablet, delayed release 
PROTONIX  DELAYED-RELEASE- pantoprazole sodium granule, delayed release 
Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc.

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MEDICATION GUIDE

PROTONIX (pro-TAH-nix)
(pantoprazole sodium)
Delayed-Release Tablets
and
For Delayed-Release Oral Suspension

Read this Medication Guide before you start taking PROTONIX 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 PROTONIX?

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

PROTONIX can cause serious side effects, including:

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

What is PROTONIX?

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

PROTONIX reduces the amount of acid in your stomach.

PROTONIX is used in adults:

PROTONIX 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 PROTONIX is safe if used longer than 8 weeks in children. PROTONIX is not for use in children under 5 years of age.

Who should not take PROTONIX?

Do not take PROTONIX if you are:

What should I tell my doctor before taking PROTONIX?

Before taking PROTONIX, 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. PROTONIX may affect how other medicines work, and other medicines may affect how PROTONIX 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 PROTONIX?

What are the possible side effects of PROTONIX?

PROTONIX may cause serious side effects, including:

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

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

The most common side effects with PROTONIX in adults include:

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

The most common side effects with PROTONIX in children include:

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

Other side effects:

Your doctor may stop PROTONIX 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 PROTONIX. 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 PROTONIX?

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

General information about PROTONIX

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use PROTONIX for a condition for which it was not prescribed. Do not give PROTONIX 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 PROTONIX. 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 PROTONIX?

Active ingredient: pantoprazole sodium sesquihydrate

Inactive ingredients in PROTONIX 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.

Inactive ingredients in PROTONIX For Delayed-Release Oral Suspension: crospovidone, hypromellose, methacrylic acid copolymer, microcrystalline cellulose, polysorbate 80, povidone, sodium carbonate, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate, and yellow ferric oxide.

Revised: 12/2013
Document Id: bb53b8c6-8ad2-43d8-8d33-b4fe55b379e3
Set id: 08098cb2-c048-4640-f387-6beec4a38936
Version: 21
Effective Time: 20131223
 
Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc.