In the U.S.—

In Canada—

• Serotonin agonist

Tegaserod ( te-GAS-a-rod) is a medicine for short term treatment of women who have irritable bowel syndrome (IBS) with constipation (not enough or hard bowel movements) as their main bowel problem. Tegaserod increases the movement of stools (bowel movement) through the bowels. Tegaserod does not cure irritable bowel syndrome. Tegaserod decreases pain and discomfort in the abdominal area, bloating, and constipation. If you stop taking tegaserod your irritable bowel syndrome symptoms may return in one to two weeks.

This medicine is available only with your healthcare professional's prescription, in the following dosage forms:

Oral
• Tablets (U.S. and Canada)

In deciding to use a medicine, the risks of using the medicine must be weighed against the good it will do. This is a decision you and your healthcare professional will make. For tegaserod the following should be considered:

Allergies—Tell your healthcare professional if you have ever had any unusual or allergic reaction to tegaserod. Also tell your healthcare professional and pharmacist if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Tegaserod has not been studied in pregnant women. Before taking this medicine, make sure your healthcare professional knows if you are pregnant or if you may become pregnant.

Breast-feeding—It is not known if tegaserod passes into the breast milk. Many medicines pass into breast milk and they may cause unwanted effects in nursing babies. Mothers who are taking this medicine and wish to breast feed should discuss this with their healthcare professional and be sure they understand the risks and benefits of the medicine.

Children—Studies on this medicine have been done only in adult patients and there is no specific information comparing the use of tegaserod in children with use in other age groups.

Older adults—Many medicines have not been specifically studied in older people. Therefore it may not be known whether they work the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing the use of tegaserod in older patients with use in other age groups.

• Abdominal adhesions or
• Bowel obstructions or intestinal blockage (or history of) or
• Gallbladder disease or gallstones (or history of) or
• Liver disease or
• Kidney disease or
• Sphincter of Oddi dysfunction (severe stomach pain with nausea and vomiting)—Tegaserod should not be used if you have any of these conditions

• Abdominal pain, new or sudden worsening of—Tegaserod should be stopped immediately

• Diarrhea—Serious side effects such as dizziness, lightheadedness, and dehydration can occur when using tegaserod. If you have any of these symptoms, notify your doctor immediately and stop taking this medicine. Tegaserod should not be used if you are currently experiencing or frequently experience diarrhea.

Dosing—

The dose of tegaserod will be different for different patients. Follow your healthcare professional's orders or the directions on the label. The following information includes only the average doses of tegaserod. If your dose is different, do not change it unless your healthcare professional tells you to do so.

• For oral dosage form (tablets):
  • For irritable bowel syndrome:
    • Adults—Oral, 6 milligrams (mg) twice daily on an empty stomach shortly before you eat a meal. You will take tegaserod for 4 to 6 weeks. If you feel better your healthcare professional might want to continue the medicine for an additional 4 to 6 weeks.

Missed dose—

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

To store this medicine:

• Keep out of the reach of children.
• Store this medicine at room temperature
• Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Do not keep outdated medicine or medicine no longer needed. Ask your health care professional how you should dispose of any medicine you do not use. Be sure that any discarded medicine is out of the reach of children.

Your healthcare professional will want to check your progress at regular visits, especially during the first few weeks that you take this medicine.

It is important to check with your healthcare professional or pharmacist if you are taking or plan to take any prescription or over-the-counter medicines while taking tegaserod

It is very important to tell your healthcare professional immediately if you become pregnant

You should consult your healthcare professional if you experience severe diarrhea, or if the diarrhea is accompanied by severe cramping, abdominal pain, or dizziness. You should also consult your healthcare professional if you experience new or worsening abdominal pain.

Do not take this medication if you have diarrhea now or have diarrhea often.

This medicine may cause some people to become dizzy. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your healthcare professional immediately if any of the following side effects occur:

• More common
  • Diarrhea;  stomach pain 
  
  

• Less common
  • Dizziness;  feeling of warmth;  itching skin;  redness of the face, neck, arms and occasionally, upper chest;  swelling or puffiness of face 
  
  

• Frequency not determined
  • Black, tarry stools;  bloody diarrhea ;  bloody stools;  constipation;  fainting;  indigestion;  nausea;  new or worsening abdominal pain;  rectal bleeding;  severe stomach pain with nausea and vomiting;  vomiting 
  
  

• Symptoms of overdose

  Get emergency help immediately if any of the following symptoms of overdose occur

  • Bloated, full feeling;  chills;  cold sweats;  confusion;  diarrhea;  dizziness, faintness, or lightheadedness when getting up from lying or sitting position;  excess air or gas in stomach or intestines;  headache ;  nausea;  passing gas;  stomach pain;  vomiting 
  
  

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your healthcare professional if any of the following side effects continue or are bothersome.

• More common
  • Bloated, full feeling;  excess air or gas in stomach or intestines;  headache;  nausea;  passing gas 
  
  

• Less common or rare
  • Back pain;  disease or abnormality of the joint;  headache, severe and throbbing;  leg pain 
  
  

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your healthcare professional.