PANTOPRAZOLE SODIUM- pantoprazole tablet, delayed release 
Bryant Ranch Prepack

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MEDICATION GUIDE

Pantoprazole Sodium (pan toe’ pra zole soe’ dee um) Delayed-release Tablets

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?

Pantoprazole 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?

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, USP 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.

For more information, go to www.amneal.com or call 1-877-835-5472.

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.

All brands listed are trademark of their respective owner.

Manufactured by:
Amneal Pharmaceuticals Pvt. Ltd.

Ahmedabad 382220, INDIA

Distributed by:
Amneal Pharmaceuticals LLC

Bridgewater, NJ  08807

Rev. 08-2018-04

Revised: 11/2018
Bryant Ranch Prepack