Terms and Conditions

Terms and Conditions

This product qualifies for the ZELNORM Patient Assistance program. This private and confidential program provides product free of charge to eligible individuals, primarily the uninsured who, without our assistance, could not afford ZELNORM. Individuals who don’t meet the insurance criteria may still qualify for this program if they attest that they have special circumstances of financial and medical hardship, and their income meets the program criteria. A single application for assistance may provide for up to 6 months of product free of charge to eligible individuals and an individual may reapply every 6 months and as many times as needed. If you have been prescribed ZELNORM, you may be eligible for the program if a combination of the following conditions apply:

  • You are a US or Puerto Rico resident and have a prescription for ZELNORM from a health care provider licensed in the United States or Puerto Rico.
  • You do not have insurance or other coverage for your prescription medicine. Some examples of other insurance coverage include private insurance, HMOs, Medicaid, Medicare, state pharmacy assistance programs, veterans assistance, or any other social service agency support. You cannot afford to pay for your medicine. You may qualify for the program if you have a household income that meets the income levels outlined for this program.

At Alfasigma USA we realize that sometimes exceptions need to be made based on the patient’s individual circumstances. If you do not meet the prescription drug coverage criteria, your income meets the program criteria, and there are special circumstances of financial and medical hardship that apply to your situation, you can request that an exception be made for you.

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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.

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).

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 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.

Distributed by: Alfasigma USA, Inc. Covington, LA 70433 © 2019 Alfasigma USA, Inc. ZELNORM is a trademark of Alfasigma USA, Inc. All rights reserved. ALUSA-00069

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