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FDA-APPROVED PATIENT INFORMATION

Pantoprazole sodium delayed-release tablets, USP
Read the Patient Information that comes with pantoprazole sodium delayed-release tablets before
you start taking them and each time you get a refill. There may be new information. This leaflet
does not take the place of talking with your doctor about your medical condition or your
treatment.

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 tablets are used in adults for:
Up to 8 weeks for short-term treatment of acid-related damage to the lining of the esophagus (erosive esophagitis) caused by gastroesophageal reflux disease (GERD). If needed, your doctor may prescribe an additional 8 weeks of pantoprazole sodium delayed-release tablets. Maintain healing of acid-related damage to the lining of the esophagus and helps prevent return of heartburn symptoms caused by GERD. Pantoprazole sodium delayed-release tablets have not been studied for treatment lasting longer than 1 year Treating a rare condition called Zollinger-Ellison Syndrome, where the stomach makes more than the normal amount of acid
Information describing use in pediatric patients ages five years through 16 years old with erosive
esophagitis associated with GERD is approved for Wyeth Pharmaceuticals Inc.’s pantoprazole
sodium delayed-release tablets. However, due to Wyeth Pharmaceuticals Inc.’s marketing
exclusivity rights, this drug product is not labeled with that pediatric information.
Pantoprazole sodium delayed-release tablets are not for children under 5 years old.

Who should not take pantoprazole sodium delayed-release tablets?

Do not take pantoprazole sodium delayed-release tablets if you are:
allergic to any of the ingredients in pantoprazole sodium delayed-release tablets. See the end of this leaflet for a complete list of ingredients in pantoprazole sodium delayed-release tablets. allergic to any proton pump inhibitor (PPI). If you do not know if your medicines are PPIs, please ask your doctor.
What should I tell my doctor before taking pantoprazole sodium delayed-release tablets?

Before taking pantoprazole sodium delayed-release tablets, tell your doctor if you:

have been told that you have low magnesium levels in your blood are pregnant, think you may be pregnant, or are planning to become pregnant. It is not known if pantoprazole sodium delayed-release tablets will harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant. are breastfeeding or planning to breastfeed. Pantoprazole may pass into your milk. 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 non-prescription 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 work. Especially tell your doctor if you take: Warfarin (Coumadin, Athrombin-K, Jantoven, Panwarfin) Atazanavir (Reyataz), Nelfinavir (Viracept)
Ask your doctor if you are not sure if any of your medicines are the kind listed above.
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. See the Patient Instructions for Use at the end of this leaflet for detailed instructions about: how to take pantoprazole sodium delayed-release tablets
What are the possible side effects of pantoprazole sodium delayed-release tablets?
Serious allergic reactions. Tell your doctor if you get any of the following
symptoms with pantoprazole sodium delayed-release tablets.
Stomach lining weakening with long-term use Your doctor may stop pantoprazole sodium delayed-release tablets if these symptoms happen. Low magnesium levels in your body. This problem can be serious. Low
magnesium can happen in some people who take a proton pump inhibitor
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: 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: The most common side effects with pantoprazole sodium delayed-release tablets in children include: People who are taking multiple daily doses of proton pump inhibitor medicines for a long period of time may have an increased risk of fractures of the hip, wrist or spine. 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. Talk with your doctor or pharmacist if you have any questions about side effects. Call your doctor for medical advice about side effects. You may report side effects to the 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); excursions permitted to 15°-30°C (59°-86°F). [see USP Controlled Room Temperature]. Keep pantoprazole sodium delayed-release tablets and all medicines out of the reach of children.
General Information
Medicines are sometimes prescribed for purposes other than those listed in the Patient
Information leaflet. 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 Patient Information leaflet provides a summary of 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.
For more information, call 1-269-544-2299.

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.

Patient Instructions for Use

Pantoprazole sodium delayed-release tablets
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. Manufactured by:
TORRENT PHARMACEUTICALS LTD., Indrad-382 721, Dist. Mehsana, INDIA. TORRENT PHARMA INC., 5380 Holiday Terrace, Suite 40, Kalamazoo, Michigan 49009.

Source: http://torrentian.com/pisheet/upload/pi_sheet_us/other/13_3.pdf

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