When This Medicine Should Not Be Used:
This medicine is not right for everyone. Do not use it if you had an allergic reaction to eluxadoline, or if you have a gallbladder blockage, sphincter of Oddi disease, history of pancreatitis, pancreas disease (including a blockage), or a bowel blockage.

How to Use This Medicine:
Tablet

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• It is best to take this medicine with food or milk.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: Skip the missed dose and go back to your regular dosing schedule. Do not double doses.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some foods and medicines can affect how eluxadoline works. Tell your doctor if you are using any of the following:
  
  • Alfentanil, alosetron, bupropion, ciprofloxacin, clarithromycin, cyclosporine, dihydroergotamine, eltrombopag, ergotamine, fentanyl, fluconazole, gemfibrozil, loperamide, paroxetine, pimozide, quinidine, rifampin, rosuvastatin, sirolimus, tacrolimus
  • Medicine to treat HIV/AIDS (including atazanavir, lopinavir, ritonavir, saquinavir, tipranavir)
  • Narcotic pain medicines
• Tell your doctor if you drink alcohol. You should limit the amount of alcohol you drink while you are taking this medicine. You should not take this medicine if you have a history of alcohol addiction or if you drink more than 3 alcoholic drinks a day.

Warnings While Using This Medicine:

• Tell your doctor right away if you are pregnant or breastfeeding, or if you have liver disease or a history of chronic or severe constipation. Tell your doctor if you do not have a gallbladder.
• This medicine may cause the following problems:
  
  • Sphincter of Oddi spasm (increased risk if you do not have a gallbladder)
  • Pancreatitis
• This medicine may make you dizzy or drowsy. Do not drive or do anything that could be dangerous until you know how this medicine affects you.
• Call your doctor if your symptoms do not improve or if they get worse. Call your doctor if you have constipation for more than 4 days.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Sudden and severe stomach pain, nausea, vomiting, fever, lightheadedness

If you notice these less serious side effects, talk with your doctor:

• Constipation

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088