MEDICATION GUIDE

Read this Medication Guide before you start taking Pantoprazole Sodium Delayed-Release Tablets USP 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 USP?    

Pantoprazole Sodium Delayed-Release Tablets USP may help your acid-related symptoms, but you could still have serious stomach problems. Talk with your doctor.     

Pantoprazole Sodium Delayed-Release Tablets USP can cause serious side effects, including:

• Diarrhea. Pantoprazole Sodium Delayed-Release Tablets USP may increase your risk of getting severe diarrhea.This diarrhea may be caused by an infection (Clostridium difficile) in your intestines.

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

• Bone fractures.  People who take multiple daily doses of proton pump inhibitor medicines for a long period of time (a year or longer) may have an increased risk of fractures of the hip, wrist or spine.  You should take Pantoprazole Sodium Delayed-Release Tablets USP exactly as prescribed, at the lowest dose possible for your treatment and for the shortest time needed. Talk to your doctor about your risk of bone fracture if you take Pantoprazole Sodium Delayed-Release Tablets USP.

Pantoprazole Sodium Delayed-Release Tablets USP can have other serious side effects.  See “What are the possible side effects of Pantoprazole Sodium Delayed-Release Tablets USP?”

What is Pantoprazole Sodium Delayed-Release Tablets USP?

Pantoprazole Sodium Delayed-Release Tablets USP is a prescription medicine called a proton pump inhibitor (PPI). Pantoprazole Sodium Delayed-Release Tablets USP reduces the amount of acid in your stomach.

Pantoprazole Sodium Delayed-Release Tablets USP is used in adults:

• for up to 8 weeks to heal acid-related damage to the lining of the esophagus (erosive esophagitis or EE) and to relieve symptoms caused by gastroesophageal reflux disease (GERD).  If needed, your doctor may decide to prescribe another 8 weeks of Pantoprazole Sodium Delayed-Release Tablets USP.

• to maintain the healing of acid-related damage to the lining of the esophagus and help prevent return of heartburn symptoms caused by GERD. It is not known if Pantoprazole Sodium Delayed-Release Tablets USP is safe and effective if used longer than 12 months (1 year).

  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.

• for the long-term treatment of conditions where your stomach makes too much acid.This includes a rare condition called Zollinger-Ellison syndrome.
  

Information describing use in pediatric patients ages five years through 16 years old with erosive esophagitis associated with GERD is approved for Wyeth Pharmaceuticals Inc.’s pantoprazole sodium delayed-release tablets.  However, due to Wyeth Pharmaceuticals Inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.

Pantoprazole Sodium Delayed-Release Tablets USP is not for use in children under 5 years of age.

Who should not take Pantoprazole Sodium Delayed-Release Tablets USP?

Do not take Pantoprazole Sodium Delayed-Release Tablets USP if you are:

• allergic to pantoprazole sodium or any of the other ingredients in Pantoprazole Sodium Delayed-Release Tablets USP. See the end of this Medication Guide for a complete list of ingredients in Pantoprazole Sodium Delayed-Release Tablets USP.

• allergic to any proton pump inhibitor (PPI) medicine.

What should I tell my doctor before taking Pantoprazole Sodium Delayed-Release Tablets USP?

Before taking Pantoprazole Sodium Delayed-Release Tablets, tell your doctor if you:

• have been told that you have low magnesium levels in your blood

• have liver problems

• have any other medical conditions

• are pregnant or plan to become pregnant. It is not known if Pantoprazole Sodium Delayed-Release Tablets USP will harm your unborn baby.

• are breastfeeding or plan to breastfeed. Pantoprazole may pass into your milk. You and your doctor should decide if you will take Pantoprazole Sodium Delayed-Release Tablets USP or breastfeed. You should not do both. Talk with your doctor about the best way to feed your baby if you take Pantoprazole Sodium Delayed-Release Tablets USP.

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 USP may affect how other medicines work, and other medicines may affect how Pantoprazole Sodium Delayed-Release Tablets USP works.

Especially tell your doctor if you take:

• atazanavir (Reyataz)

• nelfinavir (Viracept)

• warfarin (Coumadin,  Jantoven)

• ketoconazole (Nizoral)

• a product that contains iron

• an antibiotic that contains ampicillin

• methotrexate

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 USP?

• Take Pantoprazole Sodium Delayed-Release Tablets USP exactly as prescribed by your  doctor.

• Do not change your dose or stop Pantoprazole Sodium Delayed-Release Tablets USP without talking to your doctor.

• If you forget to take a dose of Pantoprazole Sodium Delayed-Release Tablets USP, take it as soon as you remember. If it is almost time for your next dose, do not take the missed dose. Take the next dose at your regular time. Do not take two doses to try to make up for a missed dose.

• If you take too much Pantoprazole Sodium Delayed-Release Tablets USP, call your doctor right away or go to the nearest hospital emergency room.

• See the Instructions for Use at the end of this Medication Guide for detailed instructions about:

  ●  how to take Pantoprazole Sodium Delayed-Release Tablets USP Tablets

What are the possible side effects of  Pantoprazole Sodium Delayed-Release Tablets USP?

Pantoprazole Sodium Delayed-Release Tablets USP may cause serious side effects, including:

See “What is the most important information I should know about Pantoprazole Sodium Delayed-Release Tablets USP?”

• Chronic (lasting a long time) inflammation of the lining of the stomach (Atrophic Gastritis).Taking Pantoprazole Sodium Delayed-Release Tablets USP for a long period of time may increase the risk of inflammation to your stomach lining. You may or may not have symptoms.  Tell your doctor if you have stomach pain, nausea, vomiting or weight loss.

• Vitamin B-12 deficiency. Pantoprazole Sodium Delayed-Release Tablets USP reduces the amount of acid in your stomach.Stomach acid is needed to absorb vitamin B-12 properly. Talk with your doctor about the possibility of vitamin B-12 deficiency if you have been on Pantoprazole Sodium Delayed-Release Tablets USP for a long time (more than 3 years).

• Low magnesium levels in your body.  This problem can be serious. Low magnesium can happen in some people who take a proton pump inhibitor medicine for at least 3 months. If low magnesium levels happen, it is usually after a year of treatment. You may or may not have symptoms of low magnesium.

Tell your doctor right away if you have any of these symptoms:

• seizures

• dizziness

• abnormal or fast heartbeat

• jitteriness

• jerking movements or shaking (tremors)

• muscle weakness

• spasms of the hands and feet

• cramps or muscle aches

• spasm of the voice box

Your doctor may check the level of magnesium in your body before you start takingPantoprazole Sodium Delayed-Release Tablets USP or during treatment, if you will be taking Pantoprazole Sodium Delayed-Release Tablets USP for a long period of time.

The most common side effects with Pantoprazole Sodium Delayed-Release Tablets USP 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 USP in children include:

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

Other side effects:

• rash

• face swelling

• throat tightnes

• difficult breathing

Your doctor may stop Pantoprazole Sodium Delayed-Release Tablets USP 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 USP. 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 USP?

• Store at 20° to  25°C (68° to 77°F); excursions permitted to 15° to  30°C (59° to 86°F) [See USP Controlled Room Temperature].

Keep Pantoprazole Sodium Delayed-Release Tablets USP and all medicines out of the reach of children.

General information about Pantoprazole Sodium Delayed-Release Tablets USP

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Pantoprazole Sodium Delayed-Release Tablets USP for a condition for which it was not prescribed. Do not give  Pantoprazole Sodium Delayed-Release Tablets USP 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 USP. 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 toll-free 1-800-313-4623.

What are the ingredients in Pantoprazole Sodium Delayed-Release Tablets USP?

Active ingredient: pantoprazole sodium sesquihydrate
Inactive ingredients : sodium carbonate USNF, mannitol USP, sucrose USNF, talc USP, calcium stearate USNF, silicon dioxide USNF, hypromellose USP, polyethylene glycol USNF, methacrylic acid copolymer USNF, triethyl citrate USNF, hypromellose phthalate USNF, titanium dioxide USP, ferric oxide red USNF and ferric oxide black. In addition to the above, printing ink used to imprint the delayed-release tablet contains shellac USNF, propylene glycol USP, ferric oxide black and ammonium hydroxide USNF.  

Instructions for Use

Pantoprazole Sodium Delayed-Release Tablets USP

• You can take Pantoprazole Sodium Delayed-Release Tablets USP tablets with food or on an empty stomach.

• Swallow Pantoprazole Sodium Delayed-Release Tablets USP tablets whole.

• If you have trouble swallowing a Pantoprazole Sodium Delayed-Release Tablets USP 40 mg tablet, you can take two 20 mg tablets instead.

• Do not split, chew, or crush Pantoprazole Sodium Delayed-Release Tablets USP 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 Jubilant Life Sciences Limited.

Rx only

Manufactured by:

Jubilant Life Sciences Limited
Roorkee - 247661, India.

Marketed by:

Jubilant Cadista Pharmaceuticals Inc.
Salisbury, MD21801, USA.

Rev.: 10/2012