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PROTONIX® (pantoprazole sodium) delayed-release tablets, for delayed-release oral suspension Information for Patients

MEDICATION GUIDE
PROTONIX (pro-TAH-nix)
(pantoprazole sodium)
delayed-release tablets
and
PROTONIX (pro-TAH-nix)
(pantoprazole sodium)
for delayed-release oral suspension
What is the most important information I should know about PROTONIX?
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 interstitial nephritis). Some people who take proton pump inhibitor (PPI) medicines, including PROTONIX, may develop a kidney problem called acute interstitial nephritis that can happen at any time during treatment with PROTONIX. 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 in the hip, wrist, or spine 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, especially in the hip, wrist, or spine.
  • 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 PROTONIX, 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.
Talk to your doctor about your risk of these serious side effects.
PROTONIX can have other serious side effects. See "What are the possible side effects of PROTONIX?"
What is PROTONIX?
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. This includes a rare condition called 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.
It is not known if PROTONIX is safe and effective in children for treatment other than EE.
Do not take PROTONIX if you are:
  • allergic to pantoprazole sodium, any other PPI medicine, or any of the ingredients in PROTONIX. See the end of this Medication Guide for a complete list of ingredients.
  • taking a medicine that contains rilpivirine (EDURANT, COMPLERA, ODEFSEY) used to treat HIV-1 (Human Immunodeficiency Virus).
Before taking PROTONIX, tell your doctor about all of your medical conditions, including if you:
  • have low magnesium levels in your blood.
  • are pregnant or plan to become pregnant. PROTONIX may harm your unborn baby. Tell your doctor if you become pregnant or think you may be pregnant during treatment with PROTONIX.
  • are breastfeeding or plan to breastfeed. PROTONIX can pass into your breast milk. You and your doctor should decide if you will take PROTONIX or breastfeed. You should not do both. Talk with your doctor about the best way to feed your baby if you take PROTONIX.
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 PROTONIX?
  • Take PROTONIX exactly as prescribed by your doctor.
    PROTONIX delayed-release tablets (PROTONIX tablets):
    • Do not split, chew, or crush PROTONIX tablets.
    • Swallow PROTONIX tablets whole, with or without food.
    • Tell your doctor if you are not able to swallow your PROTONIX tablet.
    • You may use antacids while taking PROTONIX tablets.
    PROTONIX for delayed-release oral suspension (PROTONIX for 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.
    • See the "Instructions for Use" at the end of this Medication Guide for instructions on how to mix and take PROTONIX for oral suspension by mouth in applesauce or apple juice or how to mix and give the suspension through an NG tube or gastrostomy tube mixed in apple juice.
  • If you miss a dose of PROTONIX, 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. Do not take 2 doses at the same time.
  • If you take too much PROTONIX, call your doctor or your poison control center at 1-800-222-1222 right away or go to the nearest emergency room.
What are the possible side effects of PROTONIX?
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.
  • Low magnesium 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.
  • 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.
The most common side effects of PROTONIX in adults include: headache, diarrhea, nausea, stomach-area (abdominal) pain, vomiting, gas, dizziness, and joint pain.
The most common side effects of PROTONIX 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 PROTONIX. 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 PROTONIX?
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.
General information about the safe and effective use of PROTONIX.
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.
What are the ingredients in PROTONIX?
Active ingredient: pantoprazole sodium sesquihydrate
Inactive 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 citrate.
Inactive 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.
For more information go to www.pfizer.com or call 1-800-438-1985.

Instructions for Use
PROTONIX (pro-TAH-nix)
(pantoprazole sodium)
for delayed-release oral suspension

PROTONIX for delayed-release oral suspension (PROTONIX for oral suspension):

Important information:

  • 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 taken with applesauce or apple juice.
    • should not be mixed in water or other liquids, or other foods.
    • packet should not be divided to make a smaller dose.
    Taking PROTONIX for oral suspension with applesauce:
    1. Open the packet of PROTONIX for oral suspension.
    2. Sprinkle all of the granules in the packet on 1 teaspoon of applesauce.
    3. Swallow the granules and applesauce within 10 minutes of putting the granules on the teaspoon of applesauce.
    4. Take sips of water to make sure the granules are washed down into the stomach. Take more sips of water as needed.
    Taking PROTONIX for oral suspension with apple juice:
    1. Open the packet of PROTONIX for oral suspension.
    2. Empty all of the granules in the packet into a small cup that contains 1 teaspoon of apple juice.
    3. Stir the granules-apple juice mixture for 5 seconds. The granules will not break up.
    4. Swallow the mixture right away.
    5. To make sure that the entire dose is taken, add more apple juice to the cup, stir and swallow the apple juice right away.
    6. Repeat step 5 if there are granules left in the cup.
    Giving PROTONIX for oral suspension through a nasogastric (NG) tube or gastrostomy tube:
    • PROTONIX for oral suspension may be given through an NG tube or gastrostomy tube that is size 16 French or larger. Do not give PROTONIX for oral suspension through an NG tube or gastrostomy tube smaller than size 16 French.
    • Mix PROTONIX for oral suspension only in apple juice when giving through an NG tube or gastrostomy tube.
      1. Remove the plunger from a 60 mL (2 ounce) catheter-tip syringe. Throw away the plunger.
      2. Connect the tip of the catheter-tip syringe to the NG tube or gastrostomy tube.
      3. Hold the syringe attached to the NG tube or gastrostomy tube as high as possible while giving PROTONIX for oral suspension to prevent the tubing from bending.
      4. Open the packet of PROTONIX for oral suspension.
      5. Empty all the granules in the packet into the catheter-tip syringe.
      6. Add 10 mL (2 teaspoons) of apple juice into the catheter-tip syringe and gently tap or shake the syringe to help empty the syringe.
      7. Repeat step 6 at least 2 more times until there are no granules left in the catheter-tip syringe.

How should I store PROTONIX?

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.

This Medication Guide and Instructions for Use 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 go to www.pfizer.com.

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under license from
Takeda GmbH
D78467 Konstanz, Germany

LAB-0574-13.0

Revised: June 2018

Prescribing information (PDF)

Open Prescribing information
Information for Healthcare Professionals

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