Eluxadoline is used to treat irritable bowel syndrome when the main symptom is diarrhea.

Eluxadoline may also be used for purposes not listed in this medication guide.

You should not use eluxadoline if you have a pancreas disorder, severe liver disease, alcoholism, a blockage in your intestines, a gallbladder disorder, or if your gallbladder has been removed.

Eluxadoline may cause pancreatitis or constipation, which could be severe or lead to hospitalization. Call your doctor at once if you have severe or ongoing constipation, severe pain in your upper stomach spreading to your back (with or without nausea and vomiting).

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Eluxadoline may be habit-forming. Misuse can cause addiction, overdose, or death. Selling or giving away eluxadoline is against the law.

Take with food.

Eluxadoline may cause pancreatitis or constipation, which could be severe or lead to hospitalization. Call your doctor at once if you have severe or ongoing constipation, severe pain in your upper stomach spreading to your back (with or without nausea and vomiting).

Store at room temperature away from moisture and heat.

Usual Adult Dose for Irritable Bowel Syndrome:

Usual dose: 100 mg orally twice a day

Comments:
-Dose should be reduced to 75 mg orally twice a day for patients unable to tolerate usual dose.
-If severe constipation develops, this drug should be discontinued.

Use: For the treatment of irritable bowel syndrome with diarrhea.

You should not use eluxadoline if you are allergic to it, or if you have:

• severe constipation or a blockage in your intestines;

• a history of gallbladder obstruction, or if your gallbladder has been removed;

• digestive problems caused by a muscle valve called the sphincter of Oddi (SFINK-ter of OD-dee);

• severe liver disease;

• a pancreas disorder; or

• a habit of drinking more than 3 alcoholic beverages per day.

Tell your doctor if you have ever had:

• liver disease; or

• kidney disease (or if you are on dialysis).

Tell your doctor if you are pregnant or breastfeeding.

Eluxadoline is not approved for use by anyone younger than 18 years old.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

Unless your doctor tells you otherwise, continue your normal diet.

Avoid drinking alcohol. It may increase your risk of pancreas problems.

Avoid taking anti-diarrhea medicine such as loperamide (Imodium) without your doctor's advice. Taking loperamide long-term while you are taking eluxadoline may cause severe constipation.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop taking eluxadoline and call your doctor at once if you have:

• new or worsening stomach pain (may be severe);

• nausea and vomiting;

• severe constipation;

• constipation lasting longer than 4 days; or

• severe pain in your upper stomach spreading to your back.

Side effects may be more likely in older adults.

Common side effects of eluxadoline may include:

• constipation;

• nausea; or

• stomach pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your doctor about all your other medicines, especially:

• alosetron or other medications to treat irritable bowel syndrome;

• opioid pain medicine;

• medicine to treat depression, anxiety, mood disorders, or mental illness;

• cold or allergy medicine (Benadryl and others);

• medicine to treat Parkinson's disease;

• medicine to treat stomach problems, motion sickness, or irritable bowel syndrome;

• medicine to treat overactive bladder; or

• bronchodilator asthma medication.

This list is not complete. Other drugs may affect eluxadoline, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Keep all appointments with your doctor.

Do not let anyone else take your medication. Eluxadoline is a controlled substance. Prescriptions may be refilled only a limited number of times; ask your pharmacist if you have any questions.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.