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.

You should not use naldemedine 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.

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.

Usual Adult Dose for Constipation - Drug Induced:

0.2 mg orally once a day

Comments:
-Opioid analgesic doses do not require adjustments when starting this drug.
-Treatment should be discontinued if opioid pain medication is discontinued.

Use: Treatment of opioid-induced constipation (OIC) in patients with chronic, non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation

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.

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.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from light, excess heat and moisture (not in the bathroom).

Store naldemedine in a safe place so that no one else can take it accidentally or on purpose. Keep track of how many tablets are left so you will know if any are missing.

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unless your doctor tells you otherwise, continue your normal diet.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

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.

Naldemedine may cause serious side effects. 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 of naldemedine 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.

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.

Keep all appointments with your doctor.

This prescription is not refillable. Be sure to schedule appointments with your doctor on a regular basis so that you do not run out of medication.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.