Prescription only
Read this information carefully before you start taking AMITIZA. Each time you get more AMITIZA, read the accompanying information. There may be important new information on safety or other factors. This information does not take the place of talking to your healthcare provider about your medical condition or treatment. Only your healthcare provider can determine if treatment with AMITIZA may be right for you.
Q: What is AMITIZA?
A: AMITIZA (8 mcg) twice daily is a prescription medicine for women 18 years and older used to treat Irritable Bowel Syndrome with Constipation (see definition below). It is a soft, pink, oval gelatin capsule.
Q: What is Irritable Bowel Syndrome with Constipation (IBS-C)?
A: Irritable Bowel Syndrome with Constipation (IBS-C) is just one form of Irritable Bowel Syndrome (IBS) in which the predominant symptom is abdominal pain, associated with constipation. You may be living with IBS-C if you have experienced the following symptoms in the last 3 months, starting at least 6 months ago:
- Re-occurring abdominal pain or discomfort at least 3 days a month in the past 3 months associated with 2 or more of the following:
- Improvement with a bowel movement
- Changes in the number of bowel movements
- Changes in stool appearance
- Hard or lumpy stools at least 25% of the time and loose or watery stools in less than 25% of bowel movements (without the use of anti-diarrhea medications or laxatives)
Q: What should I tell my healthcare provider before starting AMITIZA?
A: AMITIZA is not for everyone. You should talk to your healthcare provider if you:
- Know or suspect you have a bowel blockage. If you are unsure, your healthcare provider should evaluate your condition before starting AMITIZA
- Have severe diarrhea
- Are pregnant or plan to become pregnant. AMITIZA has not been studied in pregnant women. Based on animal studies, AMITIZA may cause fetal harm. AMITIZA should only be used during pregnancy if the potential benefits justify the potential risk to the fetus. Talk to your healthcare provider to evaluate the risks to the fetus. Tell your doctor if you are nursing and monitor infants for diarrhea
- Have kidney or liver disease
- Cannot swallow a capsule
Tell your healthcare provider about all the medicines you take or plan to take, including prescription and non-prescription medicines, vitamins, and herbal supplements.
Q: Who should not take AMITIZA?
A: Do not take AMITIZA if:
- You know or suspect you have a bowel blockage
- You have severe diarrhea
- You are pregnant, unless, after discussion with your healthcare provider, the potential benefit justifies the potential risk to the fetus
- You are allergic to AMITIZA or any of its ingredients. See the last question for a complete list of ingredients
Q: What other important information should I know about AMITIZA?
A: 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.
AMITIZA has not been studied in pregnant women. Based on animal studies, AMITIZA may cause fetal harm. AMITIZA should only be used during pregnancy if the potential benefits justify the potential risk to the fetus. If you are pregnant or become pregnant while being treated with AMITIZA, talk to your healthcare provider to evaluate the risks to the fetus. Tell your doctor if you are nursing and monitor infants for diarrhea.
Q: What are the possible side effects of AMITIZA (8 mcg) twice daily?
A: The most common side effects of taking AMITIZA (8 mcg) twice daily, pink capsules for IBS-C are nausea, diarrhea, and abdominal pain. These are not all the side effects associated with AMITIZA.
Q: How should I take AMITIZA?
A: AMITIZA needs to be taken twice a day, or as prescribed by your healthcare provider.
AMITIZA should be taken with food and water. Swallow the gelatin capsule whole and do not break it apart or chew it. Tell your doctor if you have liver problems.
Q: What should I do if I miss a dose?
A: If you miss a dose of AMITIZA, just skip that dose. Do not take 2 capsules to make up for the missed dose. Instead, just wait until the next time you are supposed to take it, and then take your normal dose.
Q: Will AMITIZA interfere with other medications?
A: AMITIZA may affect how other medicines work and other medicines may affect how AMITIZA works. Only your healthcare provider can decide whether AMITIZA may be right for you.
Q: How do I store AMITIZA?
A: Store AMITIZA at room temperature in a childproof container that is tightly closed and out of the reach of children. Do not use AMITIZA past the expiration date shown on the package.
General information about AMITIZA
Medicines are sometimes prescribed for diseases and conditions other than those approved by the FDA. Use AMITIZA only the way your healthcare provider tells you. Do not share AMITIZA with other people, even if they have the same symptoms you have. It may harm them.
Q: Where can I find more information about AMITIZA?
A: If you would like more information, talk with your healthcare professional. If you would like more information about AMITIZA, you may access the complete Prescribing Information by clicking here.
Q: What are the ingredients in AMITIZA (8 mcg)?
A: Active ingredient: lubiprostone. Inactive ingredients: medium-chain triglycerides, gelatin, sorbitol, ferric oxide, titanium dioxide, and purified water.
