Eluxadoline Tablets

What is this medication?

ELUXADOLINE (ee LUX ah dol ine) treats irritable bowel syndrome (IBS) with diarrhea. It works by slowing down an overactive bowel, which decreases the number of bowel movements you have.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Viberzi

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Drink more than 3 alcohol-containing drinks per day
• Gallbladder disease
• Have no gallbladder
• History of constipation
• History of pancreatitis or pancreatic disease
• History of substance use disorder
• Kidney disease
• Liver disease
• Stomach or intestine problems
• An unusual or allergic reaction to eluxadoline, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

Take this medication by mouth with a glass of water. Follow the directions on the prescription label. Take this medication with food. Take your medication at regular intervals. Do not take it more often than directed. Do not stop taking except on your care team's advice.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your care team about the use of this medication in children. Special care may be needed.

Patients over 65 years of age may have a stronger reaction to this medication.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, skip it. Take your next dose at the normal time. Do not take extra or 2 doses at the same time to make up for the missed dose.

What may interact with this medication?

This medication may interact with the following medications:

• Alosetron
• Antihistamines for allergy, cough and cold
• Atropine
• Certain medications for bladder problems, such as oxybutynin, tolterodine
• Certain medications for HIV or hepatitis
• Certain medications for Parkinson's disease, such as benztropine, trihexyphenidyl
• Certain medications for stomach problems, such as dicyclomine, hyoscyamine
• Certain medications for travel sickness, such as scopolamine
• Cyclosporine
• Eltrombopag
• Gemfibrozil
• Ipratropium
• Loperamide
• Opioid medications for pain
• Rifampin
• Rosuvastatin

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. Tell your care team if your symptoms do not start to get better or if they get worse.

This medication may cause constipation. If you do not have a bowel movement for 3 days, call your care team.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medication affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Alcohol may interfere with the effect of this medication. Avoid alcoholic drinks.

This medication has a risk of abuse and dependence. Your care team will check you for this while you take this medication.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Constipation
• Pancreatitis—severe stomach pain that spreads to your back or gets worse after eating or when touched, fever, nausea, vomiting
• Severe stomach pain

Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):

• Dizziness
• Gas
• Nausea
• Runny or stuffy nose
• Stomach pain
• Vomiting

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets. This medication can be abused. Keep your medication in a safe place to protect it from theft. Do not share this medication with anyone. Selling or giving away this medication is dangerous and against the law.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Throw away any unused medication after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.