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February 10, 2012
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pantoprazole delayed-release - oral, Protonix (cont.)

SIDE EFFECTS: Headache, diarrhea, nausea, vomiting, or stomach/abdominal pain may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor immediately if any of these unlikely but serious side effects occur: signs of increased blood sugar levels (e.g., increased thirst, increased urination, confusion).If you have been taking this drug for a long time (more than 3 years), tell your doctor immediately if any of these rare but very serious side effects occur: signs of low levels of vitamin B12 (e.g., unusual weakness, sore tongue, numbness or tingling of the hands/feet).A serious allergic reaction to this drug is rare. However, seek immediate medical attention you have any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking pantoprazole, tell your doctor or pharmacist if you are allergic to it; or to similar drugs (e.g., lansoprazole, omeprazole); or if you have any other allergies.Before using this medication, tell your doctor or pharmacist your medical history, especially of: severe liver disease, poorly controlled diabetes, other stomach problems (e.g., tumors).Some symptoms may actually be signs of a more serious condition. Tell your doctor immediately if you have: heartburn combined with lightheadedness/sweating/dizziness, chest pain or shoulder/jaw pain (especially with trouble breathing), pain spreading to arms/neck/shoulders, unexplained weight loss.This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.Pantoprazole passes into breast milk and may harm a nursing infant. Therefore, breast-feeding is not recommended. Consult your doctor before breast-feeding.



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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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