PANTOPRAZOLE SODIUM- pantoprazole sodium tablet, delayed release
Aphena Pharma Solutions - Tennessee, LLC
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MEDICATION GUIDE
Pantoprazole sodium (pan TOE pra zole SO-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:
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 is used for:
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:
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Before taking pantoprazole sodium delayed-release tablets, tell your doctor about all of your medical conditions, including if you:
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How should I take 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.
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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 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° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°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 : calcium stearate, crospovidone, hydroxypropyl cellulose, hypromellose, mannitol, methacrylic acid copolymer dispersion, propylene glycol, sodium carbonate, talc, titanium dioxide, and triethyl citrate. For more information go to www.torrentpharma.com. or call 1-800-912-9561. |
Trademarks are the property of their respective owners.
Keep pantoprazole sodium delayed-release tablets 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 visit www.torrentpharma.com.
TORRENT PHARMACEUTICALS LTD., Indrad-382 721, Dist. Mehsana, INDIA.
For:
TORRENT PHARMA INC., 150 Allen Road, Suite 102, Basking Ridge, NJ 07920
8067455 Revised January 2018