Symproic blocks certain effects of opioid medication. An opioid is sometimes called a narcotic.

Symproic reduces constipation caused by opioid pain medicine used to treat severe chronic pain. Naldemedine works by treating constipation without reducing the pain-relieving effects of the narcotic.

Symproic as been shown to be effective in people who have taken opioid pain medicines (for at least 4 weeks) to treat chronic pain that is not caused by cancer.

You should not use Symproic if you have a blockage in your stomach or intestines.

Stop using Symproic 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.

Naldemedine may be habit-forming. Never share this medicine with another person. MISUSE OF HABIT-FORMING MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH.

Before taking this medicine

You should not use Symproic if you are allergic to naldemedine, or if you have:

• a blockage in your stomach or intestines.

To make sure Symproic is safe for you, 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 this medicine 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.

Symproic is not approved for use by anyone younger than 18 years old.

You may take this medicine with or without food.

Call your doctor if your symptoms do not improve, or if they get worse.

Symproic may not work as well in people who have been taking opioids for less than 4 weeks.

Store in the original container at room temperature, away from moisture and heat.

After you stop using opioid pain medicine, you should also stop taking Symproic.

Usual Adult Dose for Constipation - Drug Induced:

0.2 mg orally once a day

Comment:
-Discontinue therapy if treatment with the opioid pain medication is discontinued.

Use: For the treatment of opioid-induced constipation in adults 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 Symproic if you are allergic to naldemedine, or if you have:

• a blockage in your stomach or intestines.

To make sure Symproic is safe for you, 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 this medicine 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.

Symproic 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.

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 to Symproic: 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 this medicine 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 Symproic 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.

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 interact with 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.