Eluxadoline oral tablets

What is this medicine?

ELUXADOLINE (ee LUX ah dol ine) is an intestinal disorder drug. It is used to treat irritable bowel syndrome with diarrhea.

How should I use this medicine?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. Take this medicine with food. Take your medicine at regular intervals. Do not take it more often than directed. Do not stop taking except on your doctor'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 pediatrician regarding the use of this medicine in children. Special care may be needed.

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

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• breathing problems

• constipation

• sudden or severe upper belly pain

• vomiting

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

• dizziness

• nausea

• tiredness

What may interact with this medicine?

This medicine may interact with the following medications:

• alosetron

• antihistamines for allergy, cough and cold

• atropine

• certain medicines for bladder problems like oxybutynin, tolterodine

• certain medicines for HIV or hepatitis

• certain medicines for stomach problems like dicyclomine, hyoscyamine

• certain medicines for travel sickness like scopolamine

• certain medicines for Parkinson's disease like benztropine, trihexyphenidyl

• cyclosporine

• eltrombopag

• gemfibrozil

• ipratropium

• loperamide

• narcotic medicines for pain

• rifampin

• rosuvastatin

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.

Where should I keep my medicine?

Keep out of the reach of children. This medicine can be abused. Keep your medicine in a safe place to protect it from theft. Do not share this medicine with anyone. Selling or giving away this medicine 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 medicine after the expiration date.

What should I tell my health care provider before I take this medicine?

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 drug abuse or alcohol abuse problem

• history of pancreatitis or pancreatic disease

• kidney disease

• liver disease

• stomach or intestine problems

• an unusual or allergic reaction to eluxadoline, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

What should I watch for while using this medicine?

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

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

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine 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 medicine. Avoid alcoholic drinks.

This medicine has a risk of abuse and dependence. Your health care provider will check you for this while you take this medicine.