naldemedine
What is the most important information I should know about naldemedine?
You should not use this medicine if you have a blockage in your stomach or intestines.
Stop using naldemedine and call your doctor at once if you have severe stomach pain that does not go away (this can lead to serious medical problems).
Tell your doctor if you have symptoms of opioid withdrawal, such as sweating, feeling hot or cold, tremors, fast heartbeats, agitation, runny nose, watery eyes, vomiting, and diarrhea.
What is naldemedine?
Naldemedine reduces constipation caused by opioid pain medicine used to treat severe chronic pain.
Naldemedine is for use in adults who use opioid pain medicine to treat chronic pain that is not caused by active cancer.
Naldemedine may also be used for purposes not listed in this medication guide.
What should I discuss with my healthcare provider before taking naldemedine?
You should not use naldemedine if you are allergic to it, or if you have:
- a blockage in your stomach or intestines.
Tell your doctor if you have ever had:
- a stomach or intestinal disorder (including Crohn's disease, diverticulitis, or Ogilvie's syndrome);
- a stomach ulcer; or
- liver disease.
If you use naldemedine while you are pregnant, your baby could have opioid withdrawal symptoms. Tell your doctor if you are pregnant or if you become pregnant.
This medicine may cause opioid withdrawal symptoms in a nursing baby. Do not breast-feed while taking naldemedine, and for at least 3 days after your last dose.
Naldemedine is not approved for use by anyone younger than 18 years old.
How should I take naldemedine?
Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.
You may take naldemedine with or without food.
Call your doctor if your symptoms do not improve, or if they get worse.
Naldemedine may not work as well in people who have been taking opioids for less than 4 weeks.
Store naldemedine in the original container at room temperature, away from moisture and heat.
After you stop using opioid pain medicine, you should also stop taking naldemedine.
What happens if I miss a dose?
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.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What should I avoid while taking naldemedine?
Follow your doctor's instructions about any restrictions on food, beverages, or activity.
What are the possible side effects of naldemedine?
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Tell your doctor if you have symptoms of opioid withdrawal: sweating, fever, chills, warmth or tingling in your face, tremors, fast heartbeats, feeling anxious or agitated, yawning, runny nose, sneezing, watery eyes, stomach pain, nausea, vomiting, and diarrhea.
Stop using naldemedine and call your doctor at once if you have:
- severe diarrhea; or
- severe stomach pain that will not go away (this can lead to serious medical problems).
Common side effects may include:
- nausea, vomiting, stomach pain; or
- diarrhea.
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.
What other drugs will affect naldemedine?
Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.
Other drugs may affect naldemedine, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
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