MEDICATION GUIDE

Pantoprazole Sodium Delayed-Release Tablets

pan toe’ pra zole soe’ dee um

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 sodiumdelayed-release tablets may help your acid-related symptoms, but you could still have serious stomach problems. Talk with your doctor.
Pantoprazole sodiumdelayed-release tablets 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 sodium delayed-release tablets, may develop a kidney problem called acute interstitial nephritis that can happen at any time during treatment with pantoprazole sodium delayed-release tablets. Call your doctor if you have a decrease in the amount that you urinate or if you have blood in your urine.
•   Diarrhea. Pantoprazole sodium delayed-release tablets 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 offractures of the hip, wrist or spine. You should take pantoprazole sodium delayed-release tablets 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 tablet.
•  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 sodium delayed-release tablet, 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 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 tablet reduces the amount of acid in your stomach.
Pantoprazole sodium delayed-release tablets are 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 tablet.  
• 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 tablet 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 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 sodiumdelayed-release tablets?
Do not take pantoprazole sodium delayed-release tablets if you are:
• allergic to pantoprazole sodium or any of the other ingredients in pantoprazole sodium delayed-release tablets. See the end of this Medication Guide for a complete list of    ingredients in pantoprazole sodium delayed-release tablets.
• 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).
What should I tell my doctor before taking pantoprazole sodium delayed-release tablets?
Before taking pantoprazole sodiumdelayed-release tablets, 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 sodium delayed-release tablets may harm your unborn baby.
•are breastfeeding or plan to breastfeed. Pantoprazole sodium  may pass into your milk. You and your doctor should decide if you will take pantoprazole sodium delayed-release tablets or breastfeed. You hould not do both. Talk with your doctor about the best way to feed your baby if you take pantoprazole 
sodium delayed-release tablets.

  Tell your doctor about all of the medicines you take, including prescription and non­prescription 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 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
• mycophenolate mofetil (Cellcept)

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?

• Take pantoprazole sodium delayed-release tablets exactly as prescribed by your doctor.
• Do not change your dose or stop pantoprazole sodium delayed-release tablets without talking to your doctor.
• If you forget to take a dose of pantoprazole sodium delayed-release tablets, 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, 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       

   

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 sodium delayed-release tablets?”

• Vitamin B-12 deficiency. Pantoprazole sodium delayed-release tablets 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 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
• 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 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:

•   Headache •   Diarrhea •   Nausea •   Stomach pain

•   Vomiting •   Gas •   Dizziness •   Pain in your joints

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

•   Upper respiratory infection •   Headache •   Fever •   Diarrhea

•   Vomiting •   Rash •   Stomach pain

 Other side effects:
• Serious allergic reactions. Tell your doctor if you get any of the following symptoms with pantoprazole sodium delayed-release tablets:

• rash
• face swelling
• throat tightness
• difficult breathing

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?

     •   Store pantoprazole sodium delayed-release tablets at 20° to 25°C (68° to 77°F) [see

         USP Controlled Room Temperature].

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 it was not prescribed. Do not give pantoprazole sodium delayed-release tablets 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. For more information, ask your doctor. You can ask your doctor or pharmacist for information that is written for healthcare professionals.

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

Active ingredient: pantoprazole sodium sesquihydrate USP

Inactive ingredients: calcium stearate, ferric oxide yellow, hydroxy propyl cellulose, hypromellose, lactose monohydrate, methacrylic acid copolymer, polysorbate 80, propylene glycol, sodium carbonate anhydrous, sodium lauryl sulfate, titanium dioxide, and triethyl citrate. The tablets are imprinted with opacode black containing ammonium hydroxide, iron oxide black, propylene glycol and shellac.

Instructions for Use
• You can take pantoprazole sodium delayed-release tablets with food or on an    empty stomach.
•  Swallow pantoprazole sodium delayed-release tablets whole.
•  If you have trouble swallowing a pantoprazole sodium delayed-release 40 mg tablet,   you can take two 20 mg tablets instead.
•  Do not split, chew, or crush pantoprazole sodium delayed-release tablets.

  This Medication Guide and Instructions for Use has been approved by the U.S. Food and Drug Administration.

  

Manufactured for:
Camber Pharmaceuticals Inc.
Piscataway, NJ 08854

By: HETERO TM
Hetero Labs Limited Unit V, Polepally,
Jadcherla, Mahaboob Nagar – 509 301, India.

Revised: August 2017