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|Protonix Delayed-Release Tablets

Protonix Delayed-Release Tablets

Protonix Delayed-Release Tablets is used for:

The short-term treatment and short-term healing relief of severe inflammation and erosion of the food pipe associated with gastroesophageal reflux disease (GERD, or stomach contents rising back into the food pipe). It is also used to control daytime and nighttime heartburn symptoms in patients with GERD. It is also used to treat Zollinger-Ellison syndrome.

Protonix Delayed-Release Tablets is a proton pump inhibitor (PPI). It works by reducing gastric acid secretion by blocking the final step of acid production in the stomach lining.

Do NOT use Protonix Delayed-Release Tablets if:

• you are allergic to any ingredient in Protonix Delayed-Release Tablets
• you are on an HIV protease inhibitor (eg, ritonavir)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Protonix Delayed-Release Tablets:

Some medical conditions may interact with Protonix Delayed-Release Tablets. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have severe liver function impairment

Some MEDICINES MAY INTERACT with Protonix Delayed-Release Tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:

• HIV protease inhibitors (eg, ritonavir) or imidazoles (eg, ketoconazole) because the effectiveness of Protonix Delayed-Release Tablets may be decreased.
• Imidazoles (eg, ketoconazole) or voriconazole because side effects such as diarrhea and stomach upset may occur.
• Clarithromycin, digoxin, or methotrexate because the risk of side effects of these medicines may be increased.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Protonix Delayed-Release Tablets may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Protonix Delayed-Release Tablets:

Use Protonix Delayed-Release Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Protonix Delayed-Release Tablets can be taken with food or on an empty stomach.
• Protonix Delayed-Release Tablets may be taken with antacids if your doctor has instructed you to take antacids.
• Swallow this tablet whole. Do not break, crush, or chew before swallowing.
• If taking Protonix Delayed-Release Tablets while on imidazoles (eg, ketoconazole), take the imidazole at least 2 hours before Protonix Delayed-Release Tablets. The imidazole will not work properly if these medicines are not separated by at least 2 hours.
• Protonix Delayed-Release Tablets is taken once daily for up to 8 weeks. If you have not responded properly to Protonix Delayed-Release Tablets, you may take Protonix Delayed-Release Tablets for an additional 8 weeks.
• For best results, continue taking Protonix Delayed-Release Tablets for the full course of treatment even if you feel better in a few days.
• If a dose is missed, take it as soon as possible. If several hours have passed or if it is nearing time for the next dose, do not double the dose to catch up, unless advised by your doctor. If more than one dose is missed, restart therapy and advise your doctor or pharmacist at your next visit.

Ask your health care provider any questions you may have about how to use Protonix Delayed-Release Tablets.

Important safety information:

• Protonix Delayed-Release Tablets may cause changes in vision. Use caution while driving or performing other tasks that this change may affect.
• Protonix Delayed-Release Tablets may affect the results of certain lab tests (eg, false positive urine screen for tetrahydrocannabinol). Make sure laboratory personnel and your doctors know you use Protonix Delayed-Release Tablets. Keep all doctor and laboratory appointments while you are using Protonix Delayed-Release Tablets.
• LAB TESTS may be needed to monitor your condition. Be sure to keep all appointments. Protonix Delayed-Release Tablets may affect the results of certain lab tests (eg, false positive urine screen for tetrahydrocannabinol). Make sure laboratory personnel and your doctors know you use Protonix Delayed-Release Tablets.
• Protonix Delayed-Release Tablets is NOT recommended for use in CHILDREN; safety and effectiveness have not been confirmed.
• If you plan on becoming pregnant, discuss with your doctor the benefits and risks of using Protonix Delayed-Release Tablets during pregnancy.
• It is unknown if this medicine is excreted in the breast milk. If you are or will be breast-feeding while you are using Protonix Delayed-Release Tablets, check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Protonix Delayed-Release Tablets:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Changes in vision; diarrhea; dizziness; headache; nausea; rash; stomach discomfort.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, hands, eyes, throat, or tongue); difficulty swallowing; heart and liver disorders; hoarseness; skin reactions.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately. Symptoms may include blurred vision; confusion; drowsiness; dry mouth; flushing; headache; heavy sweating; nausea; rapid heartbeat.

Store at room temperature between 68 and 77 degrees F (20 and 25 degrees C), away from heat, moisture, and light. Do not store in the bathroom. Keep Protonix Delayed-Release Tablets out of the reach of children and away from pets.

General information:

• If you have any questions about Protonix Delayed-Release Tablets, please talk with your doctor, pharmacist, or other health care provider.
• Protonix Delayed-Release Tablets is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Protonix Delayed-Release Tablets. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.