PANTOPRAZOLE SODIUM- pantoprazole sodium tablet, delayed release
Wockhardt USA LLC.
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Pantoprazole Sodium (pan-TOE-pra-zole SOE-dee-um)
Delayed-Release Tablets, USP
What is the most important information I should know about pantoprazole sodium delayed-release tablets?
You should take pantoprazole sodium delayed-release tablets exactly as prescribed, at the lowest dose possible and for the shortest time needed.
Pantoprazole sodium delayed-release tablets may help your acid-related symptoms, but you could still have serious stomach problems. Talk with your doctor.
Pantoprazole sodium delayed-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 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 pantoprazole sodium delayed-release tablets, 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.
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?
A prescription medicine called a proton pump inhibitor (PPI) used to reduce the amount of acid in your stomach.
In adults, pantoprazole sodium delayed-release tablets are used for:
In children 5 years of age and older, pantoprazole sodium delayed-release tablets are used for:
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.
It is not known if pantoprazole sodium delayed-release tablets are safe and effective in children for treatment other than EE.
Do not take pantoprazole sodium delayed-release tablets if you are:
Before taking pantoprazole sodium delayed-release tablets, tell your doctor about all of your medical conditions, including if you:
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 pantoprazole sodium delayed-release tablets?
Pantoprazole sodium delayed-release tablets:
o Do not split, chew, or crush pantoprazole sodium delayed-release tablets.
o Swallow pantoprazole sodium delayed-release tablets whole, with or without food.
o Tell your doctor if you are not able to swallow your pantoprazole sodium delayed-release tablets.
o You may use antacids while taking pantoprazole sodium delayed-release tablets.
What are the possible side effects of pantoprazole sodium delayed-release tablets?
Pantoprazole sodium delayed-release tablets can cause serious side effects, including:
The most common side effects of pantoprazole sodium delayed-release tablets in adults include: headache, diarrhea, nausea, stomach-area (abdominal) pain, vomiting, gas, dizziness, and joint pain.
The most common side effects of pantoprazole sodium delayed-release tablets 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 pantoprazole sodium delayed-release tablets. 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°-25°C (68°-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 the safe and effective use of 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 that you have. It may harm them. You can ask your doctor or pharmacist for information about pantoprazole sodium delayed-release tablets that is written for health professionals.
What are the ingredients in pantoprazole sodium delayed-release tablets?
Active ingredient: pantoprazole sodium sesquihydrate, USP
Inactive ingredients in pantoprazole sodium delayed-release tablets, USP: aerosil 200, calcium stearate, colloidal silicon dioxide, mannitol, pregelatinized starch, shellac glaze, sodium carbonate anhydrous, sodium starch glycolate and talc. Each delayed-release tablet contains ammonium hydroxide, eudragit L 100-55, FD & C Blue #2, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, polyethylene glycol 400, polyethylene glycol 4000, polyethylene glycol 6000, propylene glycol, sodium hydroxide, titanium dioxide and triethyl citrate as the coating ingredients.
For more information, call toll-free 1-800-346-6854.
The brand name mentioned in this medication guide is registered trademarks of their respective manufacturers.
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Wockhardt Limited
H-14/2, M.I.D.C. Area, Waluj,
Aurangabad, Maharashtra,
India.
Distributed by:
Wockhardt USA LLC.
20 Waterview Blvd.
Parsippany, NJ 07054
USA.
Rev.110718