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ZELNORM is a prescription medicine used for the treatment of adult women less than 65 years of age who have irritable bowel syndrome with constipation (IBS-C).

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Indication and Important
Safety Information

What is ZELNORM?

ZELNORMTM (tegaserod) is a prescription medicine used to treat adult women less than 65 years of age with irritable bowel syndrome with constipation (IBS-C).

Important Safety Information

ZELNORM is for use in adult women under 65 years of age who do not have a history of ischemic cardiovascular disease and who have no more than one risk factor for cardiovascular disease. Cardiovascular disease risk factors include active smoking, high blood pressure or history of being treated with medicines that lower blood pressure, high cholesterol or are taking medicine to lower your blood cholesterol levels, history of diabetes, age 55 years or over, or obesity. Talk to your healthcare provider about risk factors you may have for a major cardiovascular event before you start taking ZELNORM.

Do not take ZELNORM if you:

  • have had a heart attack, stroke, transient ischemic attack (TIA) or angina.
  • have severe kidney problems or end-stage kidney disease, or moderate or severe liver problems.
  • have or have had inflammation and injury of the intestines caused by reduced blood flow to the intestines (ischemic colitis), intestinal blockage (bowel obstruction), gallbladder problems that caused symptoms, or scar tissue that formed between the tissues and other organs in the abdomen; have or may have had a problem with the muscular valve that controls the flow of digestive juices to the first part of your intestine (sphincter of Oddi).
  • are allergic to ZELNORM.
What is ZELNORM?

ZELNORMTM (tegaserod) is a prescription medicine used to treat adult women less than 65 years of age with irritable bowel syndrome with constipation (IBS-C).

What are the possible side effects of ZELNORM?

ZELNORM can cause serious side effects, including:

  • Major cardiovascular events, such as stroke, heart attack, and death have happened in adults taking ZELNORM who had an increased risk of a cardiovascular event. Talk to your healthcare provider about cardiovascular risk factors you may have before you start taking ZELNORM, and get emergency medical help right away if you have signs or symptoms of a heart attack, stroke, mini stroke (TIA), or angina (chest pain caused by your heart not getting enough oxygen).
  • Ischemic colitis and other problems of the intestines caused by reduced blood flow to the intestines, that sometimes require hospitalization, have happened in some people taking ZELNORM. Stop taking ZELNORM and get medical help if you have symptoms such as rectal bleeding, bloody diarrhea, or new or worsening stomach-area (abdominal) pain.
  • Diarrhea is a common side effect of ZELNORM, and it can sometimes be severe. Stop taking ZELNORM and call your healthcare provider right away if you have severe diarrhea, especially if you also feel lightheaded or dizzy, or if you faint.
  • ZELNORM may increase the risk of suicidal thoughts and behavior. You, your caregiver, and your family should monitor you for changes in behavior. If you have any new or worsening symptoms of depression, unusual changes in mood or behavior, begin to have suicidal thoughts or behavior, or thoughts of self-harm, stop taking ZELNORM right away and tell your healthcare provider.

The most common side effects of ZELNORM are headache, stomach-area (abdominal) pain, nausea, diarrhea, gas, indigestion, and dizziness.

Before you take ZELNORM, tell your healthcare provider:
  • if you are pregnant or plan to become pregnant. It is not known if ZELNORM will harm your unborn baby.
  • if you are breastfeeding or plan to breastfeed. It is not known if ZELNORM passes into breast milk. You should not breastfeed if you take ZELNORM.
  • if you are an active smoker.
  • if you have or have had high blood pressure or are taking medicine to lower your blood pressure.
  • if you have or have had high blood cholesterol levels or are taking medicine to lower your blood cholesterol levels.
  • if you have or have had diabetes.
  • if you are having diarrhea or have diarrhea often.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

To report possible adverse reactions, contact Alfasigma USA at 1-855-697-9232. You may also report possible adverse reactions to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please also see the Medication Guide within the full Prescribing Information.

Alfasigma USA, Inc. holds the highest respect for its customers and guarantees our firm commitment to your privacy. We do not sell any of the information provided by you to any other institutions.

Distributed by: Alfasigma USA, Inc. Covington, LA 70433 © 2019 Alfasigma USA, Inc. ZELNORM is a trademark of Alfasigma USA, Inc. All rights reserved. 09/2019 ALUSA-00051

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