Protonix®(pantoprazole)

You should take PROTONIX exactly as prescribed, at the lowest dose possible and for the shortest time needed. PROTONIX may help your acid-related symptoms, but you could still have serious stomach problems. Talk with your doctor.PROTONIX can cause serious side effects, including:• A type of kidney problem (acute tubulointerstitial nephritis). Some people who take proton pump inhibitor (PPI) medicines may develop a kidney problem that can happen at any time during treatment. Call your doctor right away if you have a decrease in the amount that you urinate or if you have blood in your urine.• Diarrhea caused by an infection (Clostridium difficile) in your intestines. Call your doctor right away if you have watery stools or stomach pain that does not go away. You may or may not have a fever.• Bone fractures (hip, wrist, or spine). Bone fractures may happen in people who take multiple daily doses of PPI medicines and for a long period of time (a year or longer). Tell your doctor if you have a bone fracture.• Certain types of lupus erythematosus. Some people who take PPI medicines may develop certain types of lupus 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.• Low magnesium and other mineral levels in your body. Can happen in people who have taken PROTONIX for at least 3 months. Tell your doctor if you have symptoms of low magnesium levels, including seizures, dizziness, irregular heartbeat, jitteriness, muscle aches or weakness, and spasms of hands, feet or voice.

PROTONIX is a prescription medicine called a proton pump inhibitor (PPI) used to reduce the amount of acid in your stomach.In adults, PROTONIX is used for:• up to 8 weeks for the healing and symptom relief of acid-related damage to the lining of the esophagus (called erosive esophagitis or EE). Your doctor may prescribe another 8 weeks of PROTONIX in patients whose EE does not heal.• maintaining healing of EE and to help prevent the return of heartburn symptoms caused by GERD. It is not known if PROTONIX is safe and effective when used for longer than 12 months for this purpose.• the long-term treatment of conditions where your stomach makes too much acid, including Zollinger-Ellison Syndrome.In children 5 years of age and older, PROTONIX is used for:• up to 8 weeks for the healing and symptom relief of EE. It is not known if PROTONIX is safe if used longer than 8 weeks in children.PROTONIX is not for use in children under 5 years of age.

• are allergic to pantoprazole sodium, any other PPI medicine, or any of the ingredients in PROTONIX. See the end of this leaflet for a complete list of ingredients.• are taking a medicine that contains rilpivirine (EDURANT, COMPLERA, ODEFSEY, JULUCA) used to treat HIV-1.

• have low magnesium levels, low calcium levels, or low potassium levels in your blood• are pregnant or plan to become pregnant. PROTONIX may harm your unborn baby.• are breastfeeding or plan to breastfeed. PROTONIX can pass into your breast milk.Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.Especially tell your healthcare provider if you take:• methotrexate (Otrexup, Rasuvo, Trexall, XATMEP)• digoxin (LANOXIN)• a water pill (diuretic)

PROTONIX delayed-release tablets:• Do not split, chew, or crush PROTONIX tablets.• Swallow PROTONIX tablets whole, with or without food.PROTONIX for delayed-release oral suspension:• Do not split, chew, or crush PROTONIX for oral suspension.• Take PROTONIX for oral suspension about 30 minutes before a meal.• PROTONIX for oral suspension should only be given by mouth mixed in apple juice or applesauce, or through a nasogastric (NG) tube or gastrostomy tube mixed in apple juice.• Do not mix PROTONIX for oral suspension in liquids other than apple juice or foods other than applesauce.• Do not divide a packet of PROTONIX for oral suspension to make a smaller dose.If you miss a dose, take it as soon as possible. If it is almost time for your next dose, do not take the missed dose. Take the next dose at your regular time.

PROTONIX can cause serious side effects, including:• See "What is the most important information I should know about PROTONIX?"• Low vitamin B-12 levels in your body can happen in people who have taken PROTONIX for a long time (more than 3 years). Tell your doctor if you have symptoms of low vitamin B-12 levels, including shortness of breath, lightheadedness, irregular heartbeat, muscle weakness, pale skin, feeling tired, mood changes, and tingling or numbness in the arms and legs.• Stomach growths (fundic gland polyps). People who take PPI medicines for a long time have an increased risk of developing a certain type of stomach growths called fundic gland polyps, especially after taking PPI medicines for more than 1 year.• Severe skin reactions. PROTONIX can cause rare but severe skin reactions that may need to be treated in a hospital and may be life threatening. Stop taking PROTONIX and call your doctor right away if you have skin rash with blistering, peeling or bleeding, fever, chills, body aches, or enlarged lymph nodes.The most common side effects of PROTONIX in adults include:• headache• diarrhea• nausea• stomach-area (abdominal) pain• vomiting• gas• dizziness• joint painThe most common side effects of PROTONIX in children include:• upper respiratory infection• headache• fever• diarrhea• vomiting• rash• stomach-area (abdominal) painThese are not all the possible side effects of PROTONIX. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

• Store PROTONIX at room temperature between 68°F to 77°F (20°C to 25°C).• Keep PROTONIX and all medicines out of the reach of children.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use PROTONIX for a condition for which it was not prescribed. Do not give PROTONIX 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 PROTONIX that is written for health professionals.

Active ingredient: pantoprazole sodium sesquihydrateInactive ingredients in PROTONIX delayed-release tablets: calcium stearate, crospovidone, hypromellose, iron oxide, mannitol, methacrylic acid copolymer, polysorbate 80, povidone, propylene glycol, sodium carbonate, sodium lauryl sulfate, titanium dioxide, and triethyl citrateInactive ingredients in PROTONIX for delayed-release oral suspension: crospovidone, hypromellose, methacrylic acid copolymer, microcrystalline cellulose, polysorbate 80, povidone, sodium carbonate, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate, and yellow ferric oxide