What is zelnorm?

Tegaserod was withdrawn from the U.S. market on March 30, 2007.

Tegaserod increases the action of serotonin (a body chemical) in the intestines. This speeds the movement of stools (bowel movements) through the bowels.

Tegaserod is used to treat severe, chronic, irritable bowel syndrome (IBS) in women who have constipation as their main bowel problem (constipation-predominant). It is also used to treat chronic idiopathic constipation in patients less than 65 years of age. Tegaserod has not been shown to be helpful for men with irritable bowel syndrome.

Tegaserod may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about zelnorm?

Tegaserod was withdrawn from the U.S. market on March 30, 2007.

Stop taking zelnorm and contact your doctor if you experience new or increased stomach pain or blood in your stool. Diarrhea is an occasional side effect of zelnorm. Most often, diarrhea has been reported during the first week of starting zelnorm. Typically, diarrhea diminishes with continued therapy. If severe diarrhea, or diarrhea together with bad cramping, abdominal pain, lightheadedness, fainting, or dizziness develops, stop taking zelnorm and contact your doctor. In studies, patients receiving zelnorm had more abdominal surgery than patients receiving sugar pills. However, it is not known if zelnorm will increase the risk of abdominal surgery. If you suddenly get different or worse abdominal pain, contact your doctor.

What should I discuss with my healthcare provider before taking zelnorm?

Before taking zelnorm, tell your doctor if you have

• diarrhea or if diarrhea is your main symptom of IBS;
• gallbladder problems;
• a bowel obstruction, abdominal adhesions, or sphincter of Oddi dysfunction; or
• kidney disease; or
• liver disease.

You may not be able to take zelnorm, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.

Stop taking zelnorm and contact your doctor if you experience new or increased stomach pain or blood in your stool. Diarrhea is an occasional side effect of zelnorm. Most often, diarrhea has been reported during the first week of starting zelnorm. Typically, diarrhea diminishes with continued therapy. If severe diarrhea, or diarrhea together with bad cramping, abdominal pain, lightheadedness, fainting, or dizziness develops, stop taking zelnorm and contact your doctor. Tegaserod is in the FDA pregnancy category B. This means that it is not expected to be harmful to an unborn baby. Do not take zelnorm without first talking to your doctor if you are pregnant or could become pregnant during treatment. It is not known whether zelnorm passes into breast milk. Do not take zelnorm without first talking to your doctor if you are breast-feeding a baby. Tegaserod has not been shown to be helpful for men with irritable bowel syndrome.

How should I take zelnorm?

Take zelnorm exactly as directed by your doctor. If you do not understand these instructions, ask your pharmacist, nurse, or doctor to explain them to you.

Take each dose with a full glass of water.

Tegaserod should be taken twice a day on an empty stomach shortly before you eat a meal or as your doctor prescribes it.

Tegaserod does not improve the symptoms of IBS for everyone. When zelnorm is beneficial, it helps to reduce pain and discomfort in the abdominal area, bloating, and constipation. Some or all symptoms may improve within one to two weeks. If you do not see any improvement in your symptoms after 4 to 6 weeks, talk to your doctor.

Tegaserod is not a cure for irritable bowel syndrome. If you stop taking zelnorm, symptoms may return within 1 or 2 weeks.

It is important to take zelnorm regularly to get the most benefit.

Store zelnorm at room temperature away from moisture and heat.

What happens if I miss a dose?

If you miss a dose, skip the missed dose and take only the next regularly scheduled dose. Do not take a double dose of this medication.

What happens if I overdose?

Seek emergency medical attention.

Symptoms of a zelnorm overdose may include diarrhea, headache, abdominal pain, flatulence, nausea, and vomiting.

What should I avoid while taking zelnorm?

There are no restrictions on food, beverages, or activity while taking zelnorm, unless otherwise directed by your doctor.

Tegaserod side effects

If you experience an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives) to zelnorm, stop taking this medication and seek emergency medical attention. Stop taking zelnorm and contact your doctor if you experience new or increased stomach pain or blood in your stool. Diarrhea is an occasional side effect of zelnorm. Most often, diarrhea has been reported during the first week of starting zelnorm. Typically, diarrhea diminishes with continued therapy. If severe diarrhea, or diarrhea together with bad cramping, abdominal pain, lightheadedness, fainting, or dizziness develops, stop taking zelnorm and contact your doctor. In studies, patients receiving zelnorm had more abdominal surgery than patients receiving sugar pills. However, it is not known if zelnorm will increase the risk of abdominal surgery. If you suddenly get different or worse abdominal pain, contact your doctor.

Other less serious side effects may be more likely to occur. Continue to take zelnorm and talk to your doctor if you experience

• headache, dizziness or migraine;
• back pain or joint pain; or
• abdominal pain, nausea or flatulence (gas).

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

What other drugs will affect zelnorm?

Other drugs may interact with zelnorm. Talk your doctor and pharmacist before taking any prescription or over-the-counter medicines, including herbal products.