MEDICATION GUIDE

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

Pantoprazole can cause serious side effects, including:

• A type of kidney problem (acute interstitial nephritis). Some people who take proton pump inhibitor (PPI) medicines, including Pantoprazole, may develop a kidney problem called acute interstitial nephritis that can happen at any time during treatment with Pantoprazole. Call your doctor if you have a decrease in the amount that you urinate or if you have blood in your urine.

• Diarrhea. Pantoprazole 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 PPI 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 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.

• Certain types of lupus erythematosus. Lupus erythematosus is an autoimmune disorder (the body’s immune cells attack other cells or organs in the body). Some people who take PPI medicines, including Pantoprazole, may develop certain types of lupus erythematosus or have worsening of the lupus they already have. Call your doctor right away if you have new or worsening joint pain or a rash on your cheeks or arms that gets worse in the sun.

Pantoprazole is a prescription medicine called a proton pump inhibitor (PPI).

Pantoprazole reduces the amount of acid in your stomach.

Pantoprazole 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.

• 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 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.

Pantoprazole is 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.

Do not take Pantoprazole if you are:

• allergic to pantoprazole sodium or any of the other ingredients in Pantoprazole. See the end of this Medication Guide for a complete list of ingredients in Pantoprazole.

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

• are taking a medicine that contains rilpivirine (EDURANT, COMPLERA, ODEFSEY) used to treat HIV-1 (Human Immunodeficiency Virus).

Before taking Pantoprazole, tell your doctor if you:

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

• have any other medical conditions

• are pregnant or plan to become pregnant. Pantoprazole may 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 or breastfeed. You should not do both. Talk with your doctor about the best way to feed your baby if you take Pantoprazole.

Tell your doctor about all of the medicines you take, including prescription and non-prescription drugs, vitamins and herbal supplements. Pantoprazole may affect how other medicines work, and other medicines may affect how Pantoprazole works.

Especially tell your doctor if you take:

• atazanavir (Reyataz)

• nelfinavir (Viracept)

• warfarin (Coumadin, Jantoven)

• ketoconazole (Nizoral)

• a product that contains iron

• methotrexate

• mycophenolate mofetil (Cellcept) 

Ask your doctor or pharmacist for a list of these medicines, if you are not sure.

• Take Pantoprazole exactly as prescribed by your doctor.

• Do not change your dose or stop Pantoprazole without talking to your doctor.

• If you forget to take a dose of Pantoprazole, 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, 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 Tablets

Pantoprazole may cause serious side effects, including:

See “What is the most important information I should know about Pantoprazole?”

• Vitamin B-12 deficiency.  Pantoprazole 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 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 PPI 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                                                       ◦  muscle weakness

     ◦  dizziness                                                     ◦  spasms of the hands and feet

     ◦  abnormal or fast heartbeat                          ◦  cramps or muscle aches

     ◦  jitteriness                                                    ◦  spasm of the voice box

     ◦  jerking movements or shaking (tremors)

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

The most common side effects with Pantoprazole in adults include:

                ●   Headache                                                    ●  Vomiting

                ●   Diarrhea                                                      ●  Gas        

                ●    Nausea                                                       ●  Dizziness

                ●    Stomach pain                                             ●  Pain in your joints               

                ●   Upper respiratory infection                      ●  Vomiting

                ●   Headache                                                  ●  Rash    

                ●    Fever                                                        ●  Stomach pain

                ●    Diarrhea

Other side effects:

• Serious allergic reactions.  Tell your doctor if you get any of the following symptoms with Pantoprazole:

  ●   rash                                                           ●  throat tightness                                

  ●   face swelling                                             ● difficult breathing

Your doctor may stop Pantoprazole 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. For more information, ask your doctor or pharmacist.

• ­Store Pantoprazole at room temperature between 59° to 86°F (15° to 30°C).

General information about Pantoprazole

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Pantoprazole for a condition for which it was not prescribed. Do not give Pantoprazole to other people, even if they have the same symptoms you have. It may harm them.