PANTOPRAZOLE SODIUM- pantoprazole sodium tablet, delayed release 
Teva Pharmaceuticals USA Inc

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MEDICATION GUIDE

Pantoprazole Sodium (pan-TOE-pra-zole SOE-dee-um) Delayed-Release Tablets USP

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 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:

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?

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:

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 work.

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 tablets may 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:

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

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 tablets and 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 they were not prescribed. Do not give pantoprazole sodium delayed-release tablets to other people, even if they have the same symptoms you have. They 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, call 1-888-838-2872.

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

Active ingredient: pantoprazole sodium sesquihydrate

Inactive ingredients in pantoprazole sodium delayed-release tablets: calcium carbonate, calcium stearate, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, iron oxide black, iron oxide yellow, lactose monohydrate, low-substituted hydroxypropyl cellulose, methacrylic acid copolymer, microcrystalline cellulose, polyethylene glycol, propylene glycol, shellac glaze, sodium carbonate anhydrous, stearic acid, 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.

All brand names listed are the registered trademarks of their respective owners and are not trademarks of Teva Pharmaceuticals USA.

Manufactured In Israel By:

TEVA PHARMACEUTICAL IND. LTD.

Jerusalem, 91010, Israel

Manufactured For:

TEVA PHARMACEUTICALS USA

Sellersville, PA 18960

Rev. B 12/2013

Revised: 02/2014
 
Teva Pharmaceuticals USA Inc