Uses

This medication is used to treat a certain stomach/abdominal disorder (irritable bowel syndrome with diarrhea, or IBS-D). It works by slowing down the motion in your gut. This effect helps lessen symptoms such as belly pain and diarrhea.

How To Use

Read the Medication Guide provided by your pharmacist before you start taking eluxadoline and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth with food as directed by your doctor, usually 2 times a day. The dosage is based on your medical condition, response to treatment, and other medications you may be taking. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Do not increase your dose or use this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of side effects will increase. Properly stop the medication when so directed.

Use this medication regularly to get the most benefit from it. To help you remember, take it at the same times each day.

If you are also taking loperamide to help control diarrhea, do not take it on a regular schedule or you may become constipated. However, you may take it occasionally if needed for severe diarrhea. If you develop constipation, stop taking loperamide and tell your doctor right away.

Though it helps many people, this medication may sometimes cause addiction. This risk may be higher if you have a substance use disorder (such as overuse of or addiction to drugs/alcohol). Take this medication exactly as prescribed to lower the risk of addiction. Ask your doctor or pharmacist for more details.

Tell your doctor if you do not get better or if you get worse.

Side Effects

Constipation, nausea, vomiting, abdominal pain, or drowsiness may occur. If any of these effects last or get worse, tell your doctor or pharmacist right away. If you have severe constipation, stop taking eluxadoline and tell your doctor or pharmacist right away.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including:

• symptoms of pancreatitis or sphincter of Oddi spasm (such as nausea/vomiting that doesn't stop, new or suddenly worse stomach/abdominal pain that may move to your back or shoulder)

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

Before taking eluxadoline, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• personal or family history of a substance use disorder (such as overuse of or addiction to drugs/alcohol)
• gallbladder removal surgery
• liver disease
• kidney disease
• pancreatitis
• other stomach/abdominal problems (such as blockage, sphincter of Oddi disease/dysfunction, previous long-lasting or severe constipation)

This drug may make you drowsy. Alcohol or marijuana (cannabis) can make you more drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis). Drinking a lot of alcohol while taking this medication may increase the risk of pancreatitis.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Older adults may be more sensitive to the side effects of this drug, especially constipation or stomach/abdominal pain.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if eluxadoline passes into breast milk. Consult your doctor before breast-feeding.

Drug Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Alberta residents can call PADIS (Poison and Drug Information Service) 24 hours a day at 1-800-332-1414. Canada residents can call a provincial poison control center.

Notes

Do not share this medication with others. Sharing it is against the law.

Lab tests (such as liver function tests, lipase levels) may be done while you are taking this medication. Keep all medical and lab appointments.

Missed Dose

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

If you have questions about missing a dose or you don't have more medication, contact your healthcare provider or pharmacist.

Storage

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep this medicine in a safe place to prevent theft, misuse, or abuse. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.