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AMITIZA & Chronic Constipation

Millions of Adults in the United States Suffer from Chronic Constipation

Chronic Constipation is a real medical condition. It deserves medical attention and possibly prescription drugs. To find out if AMITIZA may be right for you, discuss your symptoms with your healthcare provider.

Symptoms of Chronic Constipation

Some of the telltale symptoms include:

  • Abdominal discomfort and bloating
  • 25% or more of your bowel movements involve hard or lumpy stools
  • Feeling like your bowel is never completely empty
  • Generally fewer than 3 bowel movements a week

Relief from Chronic Constipation

If this all sounds familiar to you, know that help is available. Ask your healthcare provider about trying AMITIZA, a treatment that can provide relief.* In two 4-week clinical studies, people taking AMITIZA averaged 5 to 6 bowel movements per week, versus 3 to 4 without AMITIZA.

AMITIZA (24 mcg) twice daily is approved to treat Chronic Idiopathic Constipation in adults.

AMITIZA improved symptoms† of:

  • straining
  • stool consistency
  • abdominal discomfort
  • abdominal bloating
  • constipation severity

In two 4-week clinical studies a majority of people had a bowel movement within 24 hours.‡ AMITIZA (24 mcg) twice daily, improved abdominal bloating, abdominal discomfort and constipation severity in 6-12-month clinical safety studies.

If you've been living with Chronic Constipation for 3 months or more, AMITIZA may help you find the relief* you're looking for. Individual results may vary.

AMITIZA Has a Demonstrated Safety Profile

The safety profile of AMITIZA was demonstrated in 6-month and 12-month safety studies.

AMITIZA is not for everyone. Before taking AMITIZA you should talk to your healthcare provider if you:

  • Have been told or suspect you may have a bowel blockage. If you are unsure, your healthcare provider should evaluate your condition before starting AMITIZA
  • Are pregnant or plan to become pregnant. AMITIZA has not been studied in pregnant women and should only be used during a pregnancy if the potential benefits justify the potential risk to the fetus. Women should have a negative pregnancy test before beginning treatment with AMITIZA and need to practice effective contraceptive measures. If you become pregnant while being treated with AMITIZA, talk to your healthcare provider to re-evaluate the risks
  • Have severe diarrhea
  • Have a kidney or liver disease
  • Are breastfeeding. It is not known if AMITIZA passes into your milk or, if it does, what effects it has on your child
  • Cannot swallow a capsule

Tell your healthcare provider about all the medicines you take, or are planning to take, including prescription and nonprescription drugs, vitamins, and herbal supplements.

*Relief is defined as 3 or more spontaneous bowel movements per week.

†Based on two 4-week clinical studies, AMITIZA improved symptoms of Chronic Constipation versus placebo, including abdominal bloating, abdominal discomfort, stool consistency, straining, and constipation severity.

‡In two 4-week clinical studies, 57% to 63% of patients experienced a bowel movement within 24 hours after taking AMITIZA compared to 32% to 37% of patients who received placebo.

Indication

AMITIZA (24 mcg) twice daily is approved to treat Chronic Idiopathic Constipation in adults. "Idiopathic" means the cause of the constipation is unknown and not due to an underlying illness or medication.

Important Safety Information

AMITIZA is not for everyone. If you know or suspect you have a bowel blockage, do not take AMITIZA. If you are unsure, your healthcare provider should evaluate your condition before starting AMITIZA. You should not take AMITIZA if you have severe diarrhea.

AMITIZA has not been studied in pregnant women and should only be used during a pregnancy if the potential benefits justify the potential risk to the fetus. Women should have a negative pregnancy test before beginning treatment with AMITIZA and need to practice effective birth control measures. If you are pregnant or become pregnant while being treated with AMITIZA, talk to your healthcare provider to evaluate the risks to the fetus.

Some patients taking AMITIZA may experience nausea or diarrhea. If nausea occurs, take AMITIZA with food. If your nausea or diarrhea becomes severe, tell your healthcare provider.

Within an hour of taking AMITIZA, a sensation of chest tightness and shortness of breath may occur. These symptoms usually go away within three hours, but may recur with repeated use. Tell your healthcare provider if you experience these symptoms.

The most common side effects of taking AMITIZA (24 mcg) twice daily, orange capsules for Chronic Idiopathic Constipation are nausea, diarrhea, and headache. These are not all the side effects associated with AMITIZA.

Tell your doctor if you have liver problems.

Please click here for complete Prescribing Information.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

This site is intended for use by U.S. residents only.

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AMITIZA is a trademark of Sucampo Pharmaceuticals, Inc. registered with the U.S. Patent and Trademark Office and used under license by Takeda Pharmaceuticals America, Inc.

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