PANTOPRAZOLE SODIUM- pantoprazole tablet, delayed release 
Aphena Pharma Solutions - Tennessee, LLC

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MEDICATION GUIDE

Pantoprazole (pan-TOE-pra-zole) Sodium Delayed-release Tablets

Read this Medication Guide before you start taking pantoprazole sodium delayed-release tablets 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 delayed-release tablets?

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

Pantoprazole sodium delayed-release tabletscan cause serious side effects, including:

              Call your doctor right away if you have watery stool, stomach pain, and fever that does not go away.

Pantoprazole sodium delayed-release tablets can have other serious side effects. See “What are the possible side effects of pantoprazole sodium delayed-release tablets?”

What are pantoprazole sodiumdelayed-release tablets?

Pantoprazole sodium delayed-release tablets are a prescription medicine called a proton pump inhibitor (PPI).

Pantoprazole sodium delayed-release tablets reduce the amount of acid in your stomach.

Pantoprazole sodium delayed-release tablets are used in adults:

              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.

Pantoprazole sodium delayed-release tablets are 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 delayed-release tablets are safe if used longer than 8 weeks in children. Pantoprazole sodium delayed-release tablets are not for use in children under 5 years of age.

Who should not take pantoprazole sodium delayed-release tablets?

Do not take pantoprazole sodium delayed-release tablets if you are:

What should I tell my doctor before taking pantoprazole sodium delayed-release tablets?

Before taking pantoprazole sodium delayed-release tablets, 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 delayed-release tablets may affect how other medicines work, and other medicines may affect how pantoprazole sodium delayed-release tablets 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 delayed-release tablets?

What are the possible side effects of pantoprazole sodium delayed-release tablets?

Pantoprazole sodium delayed-release tabletsmay cause serious side effects, including:

See “What is the most important information I should know about pantoprazole sodium delayed-release tablets?”

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

The most common side effects with pantoprazole sodium delayed-release tablets in adults include:

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

The most common side effects with pantoprazole sodium delayed-release tablets in children include:

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

Other side effects:

Your doctor may stop pantoprazole sodium delayed-release tablets 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 delayed-release tablets. 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 sodium delayed-release tablets?

Keep pantoprazole sodium delayed-release tabletsand all medicines out of the reach of children.

General information about pantoprazole sodium delayed-release tablets

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use pantoprazole sodium delayed-release tablets for a condition for which it was not prescribed. Do not give pantoprazole sodium delayed-release tablets 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 delayed-release tablets. 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.amneal.com or call toll-free 1-877-835-5472.

What are the ingredients in pantoprazole sodium delayed-release tablets?

Active ingredient: pantoprazole sodium sesquihydrate

Inactive ingredients in pantoprazole sodium delayed-release tablets: ammonium hydroxide, crospovidone, hydroxyl propyl cellulose, hypromellose, iron oxide black, iron oxide yellow, mannitol, methacrylic acid copolymer dispersion, polyethylene glycol, polyvinyl alcohol, povidone, propylene glycol, shellac, sodium carbonate, sodium hydroxide, sodium stearyl fumarate, 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.amneal.com.

Manufactured by:

Amneal Pharmaceuticals Pvt. Ltd.

Ahmedabad, INDIA 382220

Distributed by:

Amneal Pharmaceuticals

Bridgewater, NJ  08807

Rev. 11-2015-00

Revised: 8/2017
Aphena Pharma Solutions - Tennessee, LLC