PANTOPRAZOLE SODIUM - pantoprazole sodium tablet, delayed release 
Aurobindo Pharma Limited

----------

MEDICATION GUIDE


 Pantoprazole Sodium Delayed-Release Tablets, USP   
(pan toe' pra zole soe' dee um)


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

You should take pantoprazole sodium delayed-release tablets exactly as prescribed, at the lowest dose possible and for the shortest time needed.

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

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


Talk to your doctor about your risk of these serious side effects.


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 sodium  delayed-release tablets?

A prescription medicine called a proton pump inhibitor (PPI) used to reduce the amount of acid in your stomach.


In adults, pantoprazole sodium delayed-release tablets are used for:


In children 5 years of age and older, pantoprazole sodium delayed-release tablets are used for:

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.


It is not known if pantoprazole sodium delayed-release tablets are safe and effective in children for treatment other than EE.

 

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


Before taking pantoprazole sodium delayed-release tablets, tell your doctor about all of your medical conditions, including if you:


Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. Especially tell your doctor if you take methotrexate (Otrexup, Rasuvo, Trexall, XATMEP), digoxin (LANOXIN), or a water pill (diuretic).

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 tablets can cause serious side effects, including:

The most common side effects of pantoprazole sodium delayed-release tablets in adults include: headache, diarrhea, nausea, stomach-area (abdominal) pain, vomiting, gas, dizziness, and joint pain.


The most common side effects of pantoprazole sodium delayed-release tablets in children include: upper respiratory infection, headache, fever, diarrhea, vomiting, rash, and stomach-area (abdominal) pain.


These are not all the possible side effects of pantoprazole sodium delayed-release tablets. 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?

Store pantoprazole sodium  delayed-release tablets at room temperature between 68° to 77°F (20° to 25°C).


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

General information about the safe and effective use of 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 that you have. It may harm them. You can ask your doctor or pharmacist for information about pantoprazole sodium  delayed-release tablets that is written for health professionals.


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

Active ingredient: pantoprazole sodium


Inactive ingredients in pantoprazole sodium  delayed-release tablets: calcium stearate, crospovidone, ferric oxide, hydroxypropyl cellulose, hypromellose, mannitol, methacrylic acid and ethyl acrylate copolymer dispersion, sodium carbonate, and triethyl citrate. The tablets are imprinted with brown ink containing ammonium hydroxide, iron oxide black, iron oxide red, iron oxide yellow, isopropyl alcohol, N-butyl alcohol, propylene glycol, and shellac  glaze in ethanol.


For more information, call Aurobindo Pharma USA, Inc. at 1-866-850-2876.


The brands listed are trademarks of their respective owners and are not trademarks of Aurobindo Pharma Limited.


Dispense with Medication Guide available at: www.aurobindousa.com/medication-guides

  

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


Distributed by:
Aurobindo Pharma USA, Inc.
279 Princeton-Hightstown Road
East Windsor, NJ 08520

Manufactured by:
Aurobindo Pharma Limited
Hyderabad-500 032, India

Revised: 08/2021


Revised: 9/2021
Aurobindo Pharma Limited