March 21, 2017

Naloxegol Oral tablet

What is this medicine?

NALOXEGOL (nal OX e GAHL) is used to treat constipation caused by opioids (pain medicine). Tell your health care professional if you stop taking your opioid pain medicine.

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

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

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

  • cancer or tumor in abdomen, intestine, or stomach

  • diverticulitis

  • history of bowel blockage

  • history of stomach ulcer

  • inflammatory bowel disease

  • kidney disease

  • liver disease

  • Ogilvie's syndrome

  • stomach or intestine problems

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

  • pregnant or trying to get pregnant

  • breast-feeding

How should I use this medicine?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. Do not cut, crush or chew this medicine. Take your medicine one time each day, on an empty stomach, at least 1 hour before your first meal of the day or 2 hours after the meal. If you are unable to tolerate your dose, inform your healthcare provider so that your dose can be adjusted. Do not take additional laxatives except on your healthcare provider's advice. Your healthcare provider may prescribe other laxatives if your medicine does not work well enough after 3 days of treatment. Tell your healthcare provider if you stop taking your pain medicine. If you stop taking your pain medicine, you should also stop taking this medicine. Do not take your medicine more often than directed. Do not stop taking except on your doctor's advice.

A special MedGuide will be given to you before each treatment. 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.

Overdosage: If you think you've 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, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medicine?

  • carbamazepine

  • certain medicines for fungal infections like ketoconazole and itraconazole

  • clarithromycin

  • diltiazem

  • erythromycin

  • grapefruit juice

  • methylnaltrexone

  • naloxone

  • naltrexone

  • rifampin

  • St. John’s Wort

  • verapamil

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 medicine?

Visit your doctor for regular check ups. Tell your doctor if your symptoms do not get better or if they get worse. If you develop unusually persistent or worsening abdominal pain, stop taking your medicine and seek medical attention.

You may have symptoms of opioid withdrawal during treatment with this medicine. Symptoms include sweating, chills, diarrhea, stomach pain, anxiety, irritability, and yawning. Tell your health care provider if you have any of these symptoms. Also, if you take methadone to treat your pain, you may be more likely to have stomach pain and diarrhea compared to people who do not take methadone.If you take too much of this medicine, call your healthcare provider or go to the nearest emergency room right away.

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

  • new or worsening stomach pain

  • severe or prolonged diarrhea

  • signs and symptoms of opioid withdrawal such as sweating, chills, diarrhea, stomach pain, anxiety, irritability, and yawning

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

  • diarrhea

  • headache

  • nausea

  • stomach gas

  • 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 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. Follow the directions in the MedGuide.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Throw away any unused medicine 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.


March 21, 2017


U.S. FDA-approved Package Insert