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|Zelnorm

Zelnorm

Zelnorm is used for:

Treatment of patients younger than 65 years of age with chronic idiopathic constipation (ie, constipation lasting more than 6 months and not caused by other diseases or medications). It is also used for short term treatment of women with irritable bowel syndrome (IBS) with constipation as their main bowel problem. It may also be used for certain conditions as determined by your doctor, which may not be listed in the professional package insert.

Zelnorm is a selective serotonin receptor agonist. It works by stimulating the release of certain chemicals in the intestines that increase the movement of stools (bowel movement) through the bowel.

Do NOT use Zelnorm if:

• you are allergic to any ingredient in Zelnorm
• you have moderate to severe kidney or liver disease
• you have ever had bowel obstruction (intestinal blockage), gallbladder disease, abdominal adhesions causing pain or intestinal blockage
• you now have diarrhea or have diarrhea often

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

Before using Zelnorm :

Some medical conditions may interact with Zelnorm . 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, or other substances

Some MEDICINES MAY INTERACT with Zelnorm . However, no specific interactions with this medicine are known at this time.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Zelnorm 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 Zelnorm :

Use Zelnorm as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Zelnorm on an empty stomach, shortly before you eat a meal, or as your doctor prescribes it.
• Zelnorm comes with an additional patient leaflet. Read it carefully.
• If a dose is missed, just skip that dose. Do not take 2 doses to catch up. Instead, wait until it is time for the next dose and then take your normal dose.

Ask your health care provider any questions you may have about how to use Zelnorm .

Important safety information:

• Do not take any over-the-counter or prescription medications without talking with your health care provider. This includes any herbal preparations or dietary supplements.
• Zelnorm may cause dizziness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Zelnorm . Using Zelnorm alone, with certain other medicines, or with alcohol may lessen your ability to drive or to perform other potentially dangerous tasks.
• If you get new or worse abdominal (stomach) pain, or blood in your stools, stop taking Zelnorm and contact your doctor.
• Zelnorm causes diarrhea; if you experience so much diarrhea that you get lightheaded, dizzy, or faint, stop taking Zelnorm and contact your doctor.
• Zelnorm 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 Zelnorm during pregnancy. It is unknown if Zelnorm is excreted in the breast milk. Do not breast-feed while taking Zelnorm .

Possible side effects of Zelnorm :

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:

Back pain; diarrhea; gas; headache; joint pain or swelling; nausea; stomach pain.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); abdominal (stomach) pain; blood in stools; diarrhea with severe cramping, fainting, or dizziness; severe diarrhea.

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: diarrhea; gas; headache; lightheadedness especially upon standing; nausea; stomach pain; vomiting.

Store Zelnorm at 77 degrees F (25 degrees C); excursions permitted to 59 to 86 degrees F (15 to 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Zelnorm out of the reach of children and away from pets.

General information:

• If you have any questions about Zelnorm , please talk with your doctor, pharmacist, or other health care provider.
• Zelnorm 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 summary only. It does not contain all information about Zelnorm . 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.