Tegaserod (patient information)

IMPORTANT WARNING:

In some clinical studies, more people who took tegaserod had heart attacks, serious chest pain, or strokes than people who did not take tegaserod. The Food and Drug Administration (FDA) has decided that the benefits of taking tegaserod are not greater than the risk of experiencing a heart attack, chest pain, or a stroke for most people. However, for certain people, the benefits of taking tegaserod may be greater than these risks. In order to be sure that only people in this group take tegaserod, the FDA has decided to make tegaserod available in the United States through a special distribution program.

The special distribution program will allow people who meet certain requirements to receive tegaserod directly from the manufacturer after arrangements are made by their doctors. You may qualify for the program if you are a woman younger than 55 years old, you have irritable bowel syndrome or chronic idiopathic constipation and your symptoms did not improve when you took other medications or your symptoms did improve when you took tegaserod in the past.

If you have certain other medical conditions, you may not be able to receive tegaserod through the distribution program. Tell your doctor if you have or have ever had any type of heart disease including a heart attack; angina (chest pain); pounding or irregular heartbeat; shortness of breath; a stroke or 'mini-stroke'; high blood pressure; high cholesterol; diabetes; or circulation problems such as varicose veins, blood clots in the legs, or Raynaud's disease (problems with blood flow to the fingers, toes, ears, and nose). Your doctor will also ask you if you have or have had other medical conditions or have certain habits such as smoking or drinking alcohol to determine if you qualify for the tegaserod distribution program.

If you do not meet the requirements for the special distribution program but you and your doctor believe that you need to take tegaserod to treat a condition that is life-threatening or severely limits your ability to do the things you need to do, your doctor should contact the FDA. There may be another way for you to receive tegaserod.

Your doctor will give you information to read before you begin treatment with tegaserod. Read the information carefully and ask your doctor or pharmacist if you have any questions. You also can obtain more information from the Food and Drug Administration (FDA) website (http://www.fda.gov) or the manufacturer's website. After you read this information for the first time, your doctor will ask you to sign an agreement that says that you understand the benefits and risks of taking tegaserod and that you will follow the directions for taking tegaserod safely.

Talk to your doctor about the risks of taking tegaserod.

Why is this medication prescribed

Tegaserod is used to relieve pain, bloating, and constipation caused by irritable bowel syndrome (IBS; a condition that causes stomach pain, bloating, constipation, and diarrhea) in women whose main symptom is constipation. This medication is also used to increase the frequency of bowel movements and relieve bloating, straining, and stomach pain in women and men with chronic idiopathic constipation (constipation that is not due to other diseases or medications and that has been a problem for longer than 6 months). Tegaserod is in a class of medications called serotonin agonists. It works by improving muscle movement and increasing production of fluid in the bowels.

How should this medicine be used

Tegaserod comes as a tablet to take by mouth. It is usually taken twice a day on an empty stomach shortly before a meal. Take tegaserod at around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take tegaserod exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

If you have IBS with constipation, your doctor will probably tell you to take tegaserod for 4 to 6 weeks. If your symptoms improve, your doctor may tell you to take tegaserod for another 4 to 6 weeks. If you have chronic idiopathic constipation, you should talk to your doctor regularly to see if you should continue to take tegaserod. Be sure to tell your doctor how you are feeling, and do not take tegaserod for longer than your doctor prescribes.

Tegaserod controls the symptoms of irritable bowel syndrome and chronic idiopathic constipation, but does not cure these conditions. Continue to take tegaserod even if you feel well. Do not stop taking tegaserod without talking to your doctor. If you stop taking tegaserod, your symptoms may return within 1 to 2 weeks.

Other uses for this medicine

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What special precautions should I follow

Before taking tegaserod:

• tell your doctor and pharmacist if you are allergic to tegaserod or any other medications.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, herbal products, or nutritional supplements you are taking. Your doctor may need to adjust the dose of your medications or monitor you more carefully for side effects.
• tell your doctor if you have diarrhea now or if you often have diarrhea, and if you have or have ever had gallbladder, kidney, or liver disease; a blockage in your intestines or unexplained stomach pain; abdominal surgery (surgery on the area between your chest and hips); jaundice (yellowing of the skin or eyes); sphincter of Oddi dysfunction (blockage of bile or digestive juices flowing into the intestine that causes pain and/or jaundice); or ischemic colitis (decreased blood flow to the intestines causing rectal bleeding, bloody diarrhea, or stomach pain).
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking tegaserod, call your doctor. Do not breastfeed while you are taking tegaserod.
• you may have some diarrhea, especially during your first week of taking tegaserod. However, if you have a lot of diarrhea, or if you also have severe cramping, dizziness, light-headedness, fainting, blurred vision, upset stomach or a fast heartbeat, you should stop taking tegaserod and call your doctor immediately.

What special dietary instructions should I follow

Unless your doctor tells you otherwise, continue your normal diet.

What should I do if I forget a dose

You should skip the missed dose. Wait until the next time you are supposed to take tegaserod, and then take your normal dose. Do not take a double dose to make up for a missed dose.

Side effects

Mild side effects

Tegaserod may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• headache
• diarrhea
• upset stomach
• vomiting
• gas
• leg or back pain
• joint pain or problems
• difficulty falling asleep or staying asleep
• runny nose, congestion, or other cold symptoms

Severe side effects

Some side effects can be serious. If you experience either of the following symptoms or the symptoms mentioned in the SPECIAL PRECAUTIONS section, call your doctor immediately:

• rash
• hives
• itching
• swelling of the face, throat, tongue, lips, or eyes
• difficulty breathing and swallowing
• hoarseness

People with IBS may need to have abdominal surgery (surgery on any part of the body between the chest and the hips), especially gall bladder surgery, more often than people who do not have IBS. People with IBS who took tegaserod needed this type of surgery somewhat more often than people who did not take tegaserod. It is not known if taking tegaserod increases your chance of needing abdominal surgery. Talk to your doctor about the risk of taking this medication.

You should know that tegaserod rarely may cause ischemic colitis (decreased blood flow to the bowels). Tell your doctor and stop taking tegaserod right away if you have new or worsening stomach pain, bloody diarrhea, rectal bleeding, or blood in your stools.

Tegaserod may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/MedWatch/report.htm] or by phone [1-800-332-1088].

==What storage conditions are needed for this medicine? Return to top Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

In case of emergency/overdose

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

Symptoms of overdose may include:

• diarrhea
• headache
• stomach pain
• gas
• upset stomach
• vomiting
• dizziness, lightheadedness, or fainting when getting up too quickly from a lying position

What other information should I know

Keep all appointments with your doctor.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

Brand names

• Zelnorm®