A: AMITIZA (24 mcg) twice daily is a prescription medicine for adults used to treat Chronic Idiopathic Constipation (see definition below). It is a soft, orange, oval gelatin capsule.

A: "Chronic" Constipation means that for 3 months or more, you have had infrequent bowel movements or difficulty passing stools through the bowels. "Idiopathic" means that the cause of the constipation is unknown and not due to an underlying illness or medication. The signs and symptoms associated with Chronic Constipation may include straining, hard or lumpy stools, abdominal bloating and discomfort, feeling like your bowel is never completely empty, feeling like there is something blocking your bowel, and generally fewer than 3 bowel movements a week.

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
• Have kidney or liver disease
• 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 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
• 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 plan to take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

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

A: 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.

A: 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.

A: AMITIZA needs to be taken twice a day or as prescribed by your healthcare provider.

AMITIZA should be taken with food and water or a meal. Swallow the gelatin capsule whole and do not break it apart or chew it.

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.

A: In clinical studies, 57% to 63% of patients who received AMITIZA experienced a bowel movement within 24 hours after taking AMITIZA compared to 32% to 37% of patients who received a placebo. Individual results may vary.

A: Although studies have suggested a low risk of interactions with other drugs and products, only your healthcare provider can decide whether AMITIZA is right for you.

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.

Medicines are sometimes prescribed for conditions that are not in the patient information leaflet. 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.

A: This is a summary of the most important information about AMITIZA. 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.

A: Active ingredient: lubiprostone.

Inactive ingredients: medium-chain triglycerides, gelatin, sorbitol, FD&C Red #40, D&C Yellow #10, and purified water.